padagis israel pharmaceuticals ltd - Medication Listings

Browse 151 medications manufactured by padagis israel pharmaceuticals ltd. Open a product record to review dosage forms, strengths, packaging, and related navigation.

omeprazole OMEPRAZOLE
#7 20 mg
PADAGIS ISRAEL PHARMACEUTICALS LTD FDA OTC

Use • treats frequent heartburn (occurs 2 or more days a week) • not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect

albuterol sulfate ALBUTEROL SULFATE
#9 8.5 g Inhaler
PADAGIS ISRAEL PHARMACEUTICALS LTD FDA Rx Only

The active ingredient of albuterol sulfate inhalation aerosol is albuterol sulfate, a racemic salt, of albuterol. Albuterol sulfate has the chemical name α 1 -[( tert -butylamino) methyl]-4-hydroxy- m -xylene-α,α'-diol sulfate (2:1) (salt), and has the following chemical structure: The molecular weight of albuterol sulfate is 576.7, and the empirical formula is (C 13 H 21 NO 3 ) 2 •H 2 SO 4 . Albuterol sulfate is a white to off-white crystalline powder. It is soluble in water and slightly soluble in ethanol. Albuterol sulfate is the official generic name in the United States, and salbutamol sulfate is the World Health Organization recommended generic name. Albuterol sulfate inhalation aerosol is a pressurized metered-dose aerosol unit with a dose counter. Albuterol sulfate inhalation aerosol is for oral inhalation only. It contains a microcrystalline suspension of albuterol sulfate in propellant HFA-134a (1, 1, 1, 2-tetrafluoroethane) and ethanol. Prime the inhaler before using for the first time and in cases where the inhaler has not been used for more than 2 weeks by releasing three sprays into the air, away from the face. After priming, each actuation delivers 108 mcg albuterol sulfate, from the actuator mouthpiece (equivalent to 90 mcg of albuterol base). Each canister provides 200 actuations (inhalations). This product does not contain chlorofluorocarbons (CFCs) as the propellant. chemical-structure

Childrens Ibuprofen IBUPROFEN
PADAGIS ISRAEL PHARMACEUTICALS LTD FDA OTC

Uses temporarily: • relieves minor aches and pains due to the common cold, flu, sore throat, headache and toothache • reduces fever

Childrens Ibuprofen IBUPROFEN
PADAGIS ISRAEL PHARMACEUTICALS LTD FDA OTC

Uses temporarily: • relieves minor aches and pains due to the common cold, flu, sore throat, headache and toothache • reduces fever

Ibuprofen IBUPROFEN
#25 100 mg/5 ml
PADAGIS ISRAEL PHARMACEUTICALS LTD FDA Rx Only

The active ingredient in Ibuprofen Oral Suspension USP, 100 mg/5 mL is ibuprofen, which is a member of the propionic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs). Ibuprofen is a racemic mixture of [+]S- and [-]R-enantiomers. It is a white to off-white crystalline powder, with a melting point of 74º to 77ºC. It is practically insoluble in water (<0.1 mg/mL), but readily soluble in organic solvents such as ethanol and acetone. Ibuprofen has a pKa of 4.43±0.03 and an n-octanol/water partition coefficient of 11.7 at pH 7.4. The chemical name for ibuprofen is (±)-2-(p-isobutylphenyl) propionic acid. The molecular weight of ibuprofen is 206.28. Its molecular formula is C 13 H 18 0 2 and it has the following structural formula: Ibuprofen Oral Suspension is a sweetened, orange colored, berry flavored suspension containing 100 mg of ibuprofen in 5 mL (20 mg/mL). Inactive ingredients include: anhydrous citric acid, artificial berry flavor, butylparaben, D&C red #33, FD&C yellow #6, glycerin, high fructose corn syrup, hypromellose, polysorbate 80, propylene glycol, purified water, sodium benzoate, sorbitol solution, xanthan gum. Structural Formula

ibuprofen IBUPROFEN
#25 5 ml
PADAGIS ISRAEL PHARMACEUTICALS LTD FDA OTC

Uses temporarily: • relieves minor aches and pains due to the common cold, flu, sore throat, headache and toothache • reduces fever

acetaminophen for children ACETAMINOPHEN
PADAGIS ISRAEL PHARMACEUTICALS LTD FDA OTC

Uses temporarily • reduces fever • relieves minor aches, pains, and headache

acetaminophen pain reliever fever reducer ACETAMINOPHEN
PADAGIS ISRAEL PHARMACEUTICALS LTD FDA OTC

Uses temporarily • reduces fever • relieves minor aches, pains, and headache

Childrens Acetaminophen ACETAMINOPHEN
PADAGIS ISRAEL PHARMACEUTICALS LTD FDA OTC

Uses temporarily: • reduces fever • relieves minor aches and pains due to: • the common cold • flu • headache • sore throat • toothache

Fexofenadine Hydrochloride FEXOFENADINE HYDROCHLORIDE
PADAGIS ISRAEL PHARMACEUTICALS LTD FDA OTC

Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: • runny nose • itchy, watery eyes • sneezing • itching of the nose or throat

Acyclovir ACYCLOVIR
50 mg Cream
PADAGIS ISRAEL PHARMACEUTICALS LTD FDA Rx Only

Acyclovir is a synthetic deoxynucleoside analogue active against herpes viruses. Acyclovir cream, 5% is a formulation for topical administration. The chemical name of acyclovir is 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-6 H -purin-6-one; it has the following structural formula: Acyclovir is a white, crystalline powder with the molecular formula C 8 H 11 N 5 O 3 and a molecular weight of 225. The maximum solubility in water at 37°C is 2.5 mg/mL. The pKa’s of acyclovir are 2.27 and 9.25. Each gram of acyclovir cream contains 50 mg (equivalent to 5% w/w) of acyclovir and the following inactive ingredients: cetostearyl alcohol, mineral oil, poloxamer 407, propylene glycol, sodium lauryl sulfate, water and white petrolatum. Chemical Structure

Adapalene ADAPALENE
PADAGIS ISRAEL PHARMACEUTICALS LTD FDA Rx Only

Adapalene Cream, 0.1%, contains adapalene 0.1% in an aqueous cream emulsion consisting of carbomer 934P, cyclomethicone, edetate disodium, glycerin, methyl glucose sesquistearate, methylparaben, PEG-20 methyl glucose sesquistearate, phenoxyethanol, propylparaben, purified water, squalane, and trolamine. The chemical name of adapalene is 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid. It is a white to off-white powder which is soluble in tetrahydrofuran, sparingly soluble in ethanol, and practically insoluble in water. The molecular formula is C 28 H 28 O 3 and molecular weight is 412.53. Adapalene is represented by the following structural formula. structural formula image

ADAPALENE AND BENZOYL PEROXIDE ADAPALENE AND BENZOYL PEROXIDE
PADAGIS ISRAEL PHARMACEUTICALS LTD FDA Rx Only

Adapalene and Benzoyl Peroxide Topical Gel, 0.3%/2.5% is a white to very pale yellow, opaque gel for topical use containing adapalene 0.3% and benzoyl peroxide 2.5%. Adapalene, a synthetic retinoid, is a naphthoic acid derivative with retinoid-like properties. The chemical name for adapalene is (6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid). It has the following structural formula: Adapalene: Molecular formula: C 28 H 28 O 3 Molecular weight: 412.5 Benzoyl Peroxide is a highly lipophilic oxidizing agent that localizes in both bacterial and keratinocyte cell membranes. The chemical name for benzoyl peroxide is dibenzoyl peroxide. It has the following structural formula: Benzoyl Peroxide: Molecular formula: C 14 H 10 O 4 Molecular weight: 242.23 Adapalene and Benzoyl Peroxide Topical Gel, 0.3%/2.5% contains the following inactive ingredients: acrylamide/sodium acryloyldimethyltaurate copolymer, docusate sodium, edetate disodium, glycerin, isohexadecane, poloxamer 124, polysorbate 80, propylene glycol, purified water, and sorbitan oleate. adapalene-chemical-structure.jpg benzoyl-peroxide-chemical-structure.jpg

adapalene and benzoyl peroxide ADAPALENE AND BENZOYL PEROXIDE
PADAGIS ISRAEL PHARMACEUTICALS LTD FDA Rx Only

Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% is a white to very pale yellow, opaque gel for topical use containing adapalene 0.1% and benzoyl peroxide 2.5%. Adapalene, a synthetic retinoid, is a naphthoic acid derivative with retinoid-like properties. The chemical name for adapalene is (6-[3-(1-adamantyl)-4-methoxyphenyl]-2- naphthoic acid). It has the following structural formula: Adapalene: Benzoyl Peroxide is a highly lipophilic oxidizing agent that localizes in both bacterial and keratinocyte cell membranes. The chemical name for benzoyl peroxide is dibenzoyl peroxide. It has the following structural formula: Benzoyl Peroxide: Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% contains the following inactive ingredients: acrylamide/sodium acryloyldimethyltaurate copolymer, docusate sodium, edetate disodium, glycerin, isohexadecane, poloxamer 124, polysorbate 80, propylene glycol, purified water, and sorbitan oleate. chemical structure adapalene.jpg chemical structure benzoyl peroxide.jpg

Alogliptin ALOGLIPTIN
25 mg Tablet
PADAGIS ISRAEL PHARMACEUTICALS LTD FDA Rx Only

Alogliptin tablets contain the active ingredient alogliptin, which is a selective, orally bioavailable inhibitor of the enzymatic activity of DPP-4. Chemically, alogliptin is prepared as a benzoate salt, which is identified as 2-({6-[(3 R )-3-aminopiperidin-1-yl]-3-methyl-2,4-dioxo-3,4-dihydropyrimidin-1(2 H )-yl}methyl)benzonitrile monobenzoate. It has a molecular formula of C 18 H 21 N 5 O 2 ∙C 7 H 6 O 2 and a molecular weight of 461.51 daltons. The structural formula is: Alogliptin benzoate is a white to off-white crystalline powder containing one asymmetric carbon in the aminopiperidine moiety. It is soluble in dimethylsulfoxide, sparingly soluble in water and methanol, slightly soluble in ethanol and very slightly soluble in octanol and isopropyl acetate. Each alogliptin tablet contains 34 mg, 17 mg or 8.5 mg alogliptin benzoate, which is equivalent to 25 mg, 12.5 mg or 6.25 mg, respectively, of alogliptin and the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, magnesium stearate, mannitol, and microcrystalline cellulose. In addition, the film coating contains the following inactive ingredients: ferric oxide (red or yellow), hypromellose, polyethylene glycol, and titanium dioxide and is marked with printing ink (Gray F1). Chemical Structure

alogliptin and metformin hydrochloride ALOGLIPTIN AND METFORMIN HYDROCHLORIDE
PADAGIS ISRAEL PHARMACEUTICALS LTD FDA Rx Only

Alogliptin and metformin HCl tablets contain two oral antihyperglycemic drugs used in the management of type 2 diabetes mellitus: alogliptin and metformin HCl. Alogliptin Alogliptin is a selective, orally bioavailable inhibitor of the enzymatic activity of DPP-4. Chemically, alogliptin is prepared as a benzoate salt, which is identified as 2-({6-[(3 R )-3-aminopiperidin-1-yl]-3-methyl-2,4-dioxo-3,4-dihydropyrimidin-1(2 H )-yl}methyl)benzonitrile monobenzoate. It has a molecular formula of C 18 H 21 N 5 O 2 ∙C 7 H 6 O 2 and a molecular weight of 461.51 daltons; the structural formula is: Alogliptin benzoate is a white to off-white crystalline powder containing one asymmetric carbon in the aminopiperidine moiety. It is soluble in dimethylsulfoxide, sparingly soluble in water and methanol, slightly soluble in ethanol and very slightly soluble in octanol and isopropyl acetate. Chemical Structure Metformin HCl Metformin HCl ( N,N -dimethylimidodicarbonimidic diamide hydrochloride) is not chemically or pharmacologically related to any other classes of oral antihyperglycemic agents. Metformin HCl is a white to off-white crystalline compound with a molecular formula of C 4 H 11 N 5 ∙HCl and a molecular weight of 165.63. Metformin HCl is freely soluble in water and is practically insoluble in acetone, ether and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin HCl is 6.68. The structural formula is as shown: Alogliptin and metformin HCl tablets are available as a tablet for oral administration containing 17 mg alogliptin benzoate equivalent to 12.5 mg alogliptin and: 500 mg metformin HCl which is equivalent to 389.93 mg metformin base (12.5 mg/500 mg) or 1000 mg metformin HCl which is equivalent to 779.86 mg metformin base (12.5 mg/1000 mg). Alogliptin and metformin HCl tablets contain the following inactive ingredients: crospovidone, magnesium stearate, mannitol, microcrystalline cellulose, and povidone; the tablets are film-coated with ferric oxide yellow, hypromellose 2910, talc, and titanium dioxide. Chemical Structure

Alogliptin and Pioglitazone ALOGLIPTIN BENZOATE AND PIOGLITAZONE HYDROCHLORIDE
PADAGIS ISRAEL PHARMACEUTICALS LTD FDA Rx Only

Alogliptin and pioglitazone tablets contain two oral antihyperglycemic drugs used in the management of type 2 diabetes mellitus: alogliptin and pioglitazone. Alogliptin Alogliptin is a selective, orally bioavailable inhibitor of the enzymatic activity of dipeptidyl peptidase-4 (DPP-4). Chemically, alogliptin is prepared as a benzoate salt, which is identified as 2-({6-[(3 R )-3-aminopiperidin-1-yl]-3-methyl-2,4-dioxo-3,4-dihydropyrimidin-1(2 H )-yl}methyl)benzonitrile monobenzoate. It has a molecular formula of C 18 H 21 N 5 O 2 ∙C 7 H 6 O 2 and a molecular weight of 461.51 daltons. The structural formula is: Alogliptin benzoate is a white to off-white crystalline powder containing one asymmetric carbon in the aminopiperidine moiety. It is soluble in dimethylsulfoxide, sparingly soluble in water and methanol, slightly soluble in ethanol and very slightly soluble in octanol and isopropyl acetate. Chemical Structure Pioglitazone Chemically, pioglitazone is prepared as hydrochloride (HCl) salt, which is identified as (±)-5-[[4-[2-(5-ethyl-2-pyridinyl)ethoxy]phenyl]methyl]-2,4-thiazolidinedione monohydrochloride. It has a molecular formula of C 19 H 20 N 2 O 3 S∙HCl and a molecular weight of 392.90 daltons. The structural formula is: Pioglitazone HCl is an odorless white crystalline powder that contains one asymmetric carbon in the thiazolidinedione moiety. The synthetic compound is a racemate and the two enantiomers of pioglitazone interconvert in vivo . It is soluble in N,N dimethylformamide, slightly soluble in anhydrous ethanol, very slightly soluble in acetone and acetonitrile, practically insoluble in water and insoluble in ether. Alogliptin and pioglitazone tablets are available as a fixed-dose combination tablet for oral administration containing 34 mg alogliptin benzoate equivalent to 25 mg alogliptin and any of the following strengths of pioglitazone HCl: 16.53 mg pioglitazone HCl equivalent to 15 mg pioglitazone (25 mg/15 mg) 33.06 mg pioglitazone HCl equivalent to 30 mg pioglitazone (25 mg/30 mg) 49.59 mg pioglitazone HCl equivalent to 45 mg pioglitazone (25 mg/45 mg) Alogliptin and pioglitazone tablets are also available as a fixed-dose combination tablet for oral administration containing 17 mg alogliptin benzoate equivalent to 12.5 mg alogliptin for the following strength of pioglitazone HCl: 33.06 mg pioglitazone HCl equivalent to 30 mg pioglitazone (12.5 mg/30 mg) Alogliptin and pioglitazone tablets contain the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, mannitol, and microcrystalline cellulose; the tablets are film-coated with ferric oxide (yellow and/or red), hypromellose, polyethylene glycol, talc, titanium dioxide, and are marked with printing ink (Red A1 or Gray F1). Chemical Structure

Ammonium Lactate AMMONIUM LACTATE
PADAGIS ISRAEL PHARMACEUTICALS LTD FDA Rx Only

*Ammonium Lactate Cream, 12% is a formulation of 12% lactic acid neutralized with ammonium hydroxide, as ammonium lactate with a pH of 4.4 - 5.4. Ammonium Lactate Cream, 12% also contains cetyl alcohol, glycerin, glyceryl stearate, laureth-4, light mineral oil, magnesium aluminum silicate, methylcellulose, methylparaben, PEG-100 stearate, polyoxyl 40 stearate, propylene glycol, propylparaben, and purified water. Lactic acid is a racemic mixture of 2-hydroxypropanoic acid and has the following structural formula: Ammonium Lactate Cream Structural Formula

Ammonium Lactate AMMONIUM LACTATE
PADAGIS ISRAEL PHARMACEUTICALS LTD FDA Rx Only

*Ammonium Lactate Lotion, 12% specially formulates 12% lactic acid neutralized with ammonium hydroxide, as ammonium lactate to provide a lotion pH of 4.5 - 5.5. It also contains cetyl alcohol, fragrance, glycerin, glyceryl stearate, laureth-4, light mineral oil, magnesium aluminum silicate, methylcellulose, methylparaben, PEG-100 stearate, polyoxyl 40 stearate, propylene glycol, propylparaben, and purified water. Lactic acid is a racemic mixture of 2-hydroxypropanoic acid and has the following structural formula: structural formula

AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE AZELASTINE HYDROCHLORIDE FLUTICASONE PROPIONATE
PADAGIS ISRAEL PHARMACEUTICALS LTD FDA Rx Only

Azelastine hydrochloride and fluticasone propionate nasal spray is formulated as a white, uniform metered-spray suspension for nasal administration. It is a fixed dose combination product containing an antihistamine (H 1 receptor antagonist) and a corticosteroid as active ingredients. Azelastine hydrochloride active ingredient occurs as a white, odorless, crystalline powder with a bitter taste. It has a molecular weight of 418.37. It is sparingly soluble in water, methanol, and propylene glycol and slightly soluble in ethanol, octanol, and glycerin. It has a melting point of 225°C and the pH of 5.2. Its chemical name is (±)-1-(2H)-phthalazinone,4-[(4-chlorophenyl) methyl]-2-(hexahydro-1-methyl-1H-azepin-4-yl)-, monohydrochloride. Its molecular formula is C 22 H 24 ClN 3 O•HCl with the following chemical structure: Fluticasone propionate active ingredient is a white powder with a melting point of 273°C, a molecular weight of 500.6, and the empirical formula is C 25 H 31 F 3 O 5 S. It is practically insoluble in water, freely soluble in dimethyl sulfoxide and dimethylformamide, and slightly soluble in methanol and 95% ethanol. Fluticasone propionate is a synthetic corticosteroid having the chemical name S-(fluoromethyl)-6α,9α-difluoro-11β-17-dihydroxy-16α-methyl-3-oxoandrosta-1,4-diene-17β-carbothioate, 17-propionate, and the following chemical structure: Azelastine hydrochloride and fluticasone propionate nasal spray, 137 mcg/50 mcg contains 0.1% solution of azelastine hydrochloride and 0.037% suspension of micronized fluticasone propionate in an isotonic aqueous suspension containing glycerin, microcrystalline cellulose and carboxymethylcellulose sodium, phenylethyl alcohol (2.5 mg/g), edetate disodium, benzalkonium chloride (0.1 mg/g), polysorbate 80, and purified water. It has a pH of approximately 6.0. After priming [see Dosage and Administration ( 2.2 )] , each metered spray delivers a 0.137 mL mean volume of suspension containing 137 mcg of azelastine hydrochloride (equivalent to 125 mcg of azelastine base) and 50 mcg of fluticasone propionate. The 23 g bottle provides 120 metered sprays, after priming. Chemical Structure Image 1 Chemical Structure Image 2

Bacitracin BACITRACIN
500 unit
PADAGIS ISRAEL PHARMACEUTICALS LTD FDA OTC

Uses first aid to help prevent infection in: • minor cuts • scrapes • burns

benzoyl peroxide BENZOYL PEROXIDE
PADAGIS ISRAEL PHARMACEUTICALS LTD FDA OTC

Use for the treatment of acne

benzoyl peroxide BENZOYL PEROXIDE
PADAGIS ISRAEL PHARMACEUTICALS LTD FDA OTC

Use for the treatment of acne

benzoyl peroxide BENZOYL PEROXIDE
PADAGIS ISRAEL PHARMACEUTICALS LTD FDA OTC

Use for the treatment of acne

benzoyl peroxide BENZOYL PEROXIDE
PADAGIS ISRAEL PHARMACEUTICALS LTD FDA OTC

Use for the treatment of acne

benzoyl peroxide BENZOYL PEROXIDE
PADAGIS ISRAEL PHARMACEUTICALS LTD FDA OTC

Use for the treatment of acne

BETAMETHASONE DIPROPIONATE BETAMETHASONE DIPROPIONATE
PADAGIS ISRAEL PHARMACEUTICALS LTD FDA Rx Only

Betamethasone dipropionate ointment contains betamethasone dipropionate USP, a synthetic adrenocorticosteroid, for dermatologic use. Betamethasone, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Betamethasone dipropionate is a white to cream white odorless crystalline powder insoluble in water. Chemically, it is 9-fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17,21- dipropionate. The structural formula is: Each gram of the 0.05% ointment contains 0.64 mg betamethasone dipropionate (equivalent to 0.5 mg betamethasone) in an ointment base of mineral oil and white petrolatum. structure

Betamethasone Dipropionate BETAMETHASONE DIPROPIONATE
PADAGIS ISRAEL PHARMACEUTICALS LTD FDA Rx Only

Betamethasone Dipropionate Lotion USP, 0.05% contains betamethasone dipropionate, USP, a synthetic adrenocorticosteroid, for dermatologic use. Betamethasone, an analog of prednisolone, has high corticosteroid activity and slight mineralocorticoid activity. Betamethasone dipropionate is the 17, 21-dipropionate ester of betamethasone. Chemically, betamethasone dipropionate is 9-fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate, with the empirical formula C 28 H 37 FO 7 , a molecular weight of 504.6, and the following structural formula: Betamethasone dipropionate is a white to creamy white, odorless crystalline powder, insoluble in water. Each gram of Betamethasone Dipropionate Lotion USP, 0.05% contains 0.64 mg betamethasone dipropionate (equivalent to 0.5 mg betamethasone) in a lotion base of carbomer homopolymer type B, isopropyl alcohol, and purified water. Sodium hydroxide is used to adjust pH. Image 1

Betamethasone Dipropionate BETAMETHASONE DIPROPIONATE
PADAGIS ISRAEL PHARMACEUTICALS LTD FDA Rx Only

Betamethasone dipropionate cream USP (augmented), 0.05% contains betamethasone dipropionate USP, a synthetic adrenocorticosteroid, for topical use in a cream base. Betamethasone, an analog of prednisolone, has a high degree of corticosteroid activity and a slight degree of mineralocorticoid activity. Betamethasone dipropionate is the 17,21-dipropionate ester of betamethasone. Chemically, betamethasone dipropionate is 9-fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate, with the empirical formula C 28 H 37 FO 7 , a molecular weight of 504.6, and the following structural formula: Betamethasone dipropionate is a white to creamy white, odorless crystalline powder, insoluble in water. Each gram of betamethasone dipropionate cream USP (augmented), 0.05% contains: 0.643 mg betamethasone dipropionate USP (equivalent to 0.5 mg betamethasone) in a white cream base of carbomer homopolymer type C; ceteareth-30; chlorocresol; cyclomethicone; glyceryl oleate/propylene glycol; propylene glycol; purified water; sodium hydroxide; sorbitol solution; white petrolatum; and white wax. chemical-structure

Betamethasone Valerate BETAMETHASONE VALERATE
PADAGIS ISRAEL PHARMACEUTICALS LTD FDA Rx Only

Betamethasone Valerate Foam, 0.12% contains betamethasone valerate, USP, a synthetic corticosteroid, for topical dermatologic use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory agents. Betamethasone valerate is 9-fluoro11ß,17, 21-trihydroxy-16ß-methylpregna-1, 4-diene-3, 20-dione 17-valerate, with the empirical formula C 27 H 37 FO 6 , a molecular weight of 476.58. The following is the chemical structure: Betamethasone valerate is a white to practically white, odorless crystalline powder, and is practically insoluble in water, freely soluble in acetone and in chloroform, soluble in alcohol, and slightly soluble in benzene and in ether. Betamethasone Valerate Foam, 0.12% contains 1.2 mg betamethasone valerate, USP, per gram in a thermolabile hydroethanolic foam vehicle consisting of cetyl alcohol, citric acid, ethanol (60%), polysorbate 60, potassium citrate, propylene glycol, purified water, and stearyl alcohol pressurized with a hydrocarbon (propane/butane) propellant. betamethasone valerate chemical structure

BRIMONIDINE BRIMONIDINE
0.33 % Gel
PADAGIS ISRAEL PHARMACEUTICALS LTD FDA Rx Only

Brimonidine Topical Gel, 0.33% contains brimonidine tartrate, an alpha adrenergic agonist. The molecular formula of brimonidine tartrate is C 11 H 10 BrN 5 • C 4 H 6 O 6 . It has the following structural formula: Chemically, brimonidine tartrate is 5-Bromo-6-(2-imidazolidinylideneamino) quinoxaline L-tartrate. Brimonidine tartrate has a molecular weight of 442.24 and appears as white to slightly yellowish powder. Each gram of Brimonidine Topical Gel, 0.33% contains 5 mg of the active ingredient brimonidine tartrate (equivalent to 3.3 mg of brimonidine free base), in a white to light yellow opaque gel composed of the inactive ingredients benzalkonium chloride, carbomer homopolymer type B, glycerin, propylene glycol, purified water, sodium hydroxide, and talc. Brimonidine Structure.jpg

BUDESONIDE BUDESONIDE
PADAGIS ISRAEL PHARMACEUTICALS LTD FDA Rx Only

Budesonide rectal foam contains budesonide, a non-halogenated synthetic glucocorticoid, as the active ingredient. It is a mixture of the 2 epimers (22R and 22S) differing in the position of an acetal chain. Both epimers are active glucocorticoids applied in a mixture of approximately 1:1. Budesonide is designated chemically as (RS)-11β, 16α, 17,21 tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with butyraldehyde. The empirical formula of budesonide is C 25 H 34 O 6 and its molecular weight is 430.5. Its structural formula is: Budesonide rectal foam contains 2 mg budesonide per metered dose. Inactive ingredients: cetyl alcohol, citric acid monohydrate, edetate disodium, emulsifying wax, polyoxyl (10) stearyl ether, propylene glycol, and purified water. Propellant: n-butane, isobutane, and propane. structure

Calcipotriene and Betamethasone Dipropionate CALCIPOTRIENE BETAMETHASONE DIPROPIONATE
PADAGIS ISRAEL PHARMACEUTICALS LTD FDA Rx Only

Calcipotriene and Betamethasone Dipropionate Ointment, 0.005%/0.064% contains calcipotriene and betamethasone dipropionate. It is intended for topical use only. Calcipotriene is a synthetic vitamin D 3 analogue. Chemically, calcipotriene is (5Z,7E,22E,24S)-24-cyclopropyl-9,10-secochola-5,7,10(19),22-tetraene-1 (alpha),3(beta),24-triol, with the empirical formula C 27 H 40 O 3 , a molecular weight of 412.3, and the following structural formula: Calcipotriene is a white to almost white crystalline compound. Betamethasone dipropionate is a synthetic corticosteroid. Betamethasone dipropionate has the chemical name 9-fluoro-11(beta),17,21-trihydroxy-16(beta)-methylpregna-1, 4-diene-3,20-dione17,21-dipropionate, with the empirical formula C 28 H 37 FO 7 , a molecular weight of 504.6, and the following structural formula: Betamethasone dipropionate is a white to almost white odorless powder. Each gram of Calcipotriene and Betamethasone Dipropionate Ointment contains 50.00 mcg of calcipotriene and 0.643 mg of betamethasone dipropionate (equivalent to 0.5 mg of betamethasone) in an off-white to yellow paraffin ointment base of mineral oil, PPG-15 stearyl ether, dl-alpha tocopherol and white petrolatum. calcipotriene chemical structure betamethasone dipropionate chemical structure

calcitriol CALCITRIOL
3 mcg/g Ointment
PADAGIS ISRAEL PHARMACEUTICALS LTD FDA Rx Only

Calcitriol Ointment, 3 mcg/g is a vitamin D analog intended for topical application to the skin. The chemical name of the active ingredient is (5Z,7E)-9, 10-secocholesta-5,7,10(19)-triene-1α, 3β,25-triol. The structural formula is: Calcitriol is a white or almost white crystalline solid. It is practically insoluble in water, soluble in alcohol and in fatty oils. The molecular formula is C 27 H 44 O 3 , and the molecular weight is 416.64. Calcitriol Ointment is a translucent ointment containing 3 mcg/g (0.0003% w/w) of calcitriol, packaged in aluminum tubes with screw caps. Other components of the ointment are mineral oil, dl-α-tocopherol, and white petrolatum. chem-stuct

cetirizine hydrochloride CETIRIZINE HYDROCHLORIDE
PADAGIS ISRAEL PHARMACEUTICALS LTD FDA OTC

Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: • runny nose • sneezing • itchy, watery eyes • itching of the nose or throat

Cetirizine Hydrochloride CETIRIZINE HYDROCHLORIDE
PADAGIS ISRAEL PHARMACEUTICALS LTD FDA Rx Only

Cetirizine hydrochloride is an orally active and selective H 1 -receptor antagonist. The chemical name is (±) - [2- [4- [ (4-chlorophenyl) phenylmethyl] -1- piperazinyl] ethoxy]acetic acid, dihydrochloride. Cetirizine hydrochloride is a racemic compound with an empirical formula of C 21 H 25 ClN 2 O 3 •2HCl. The molecular weight is 461.82 and the chemical structure is shown below: Cetirizine hydrochloride is a white, crystalline powder and is water soluble. Cetirizine hydrochloride oral solution, USP is a colorless to slightly yellow solution containing cetirizine hydrochloride at a concentration of 1 mg/mL (5 mg/5 mL) for oral administration. The pH is between 4 and 5. The inactive ingredients of the solution are: banana flavor, glacial acetic acid, glycerin, grape flavor, methylparaben, propylene glycol, propylparaben, sodium acetate anhydrous, sucrose, and water. Chemical Structure Image

cetirizine hydrochloride CETIRIZINE HYDROCHLORIDE
PADAGIS ISRAEL PHARMACEUTICALS LTD FDA OTC

Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: • runny nose • sneezing • itchy, watery eyes • itching of the nose or throat

Cetirizine hydrochloride and Pseudoephedrine hydrochloride CETIRIZINE HYDROCHLORIDE PSEUDOEPHEDRINE HYDROCHLORIDE

Uses • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: • runny nose • sneezing • itchy, watery eyes • itching of the nose or throat • nasal congestion • reduces swelling of nasal passages • temporarily relieves sinus congestion and pressure • temporarily restores freer breathing through the nose

Ciclopirox CICLOPIROX
PADAGIS ISRAEL PHARMACEUTICALS LTD FDA Rx Only

Ciclopirox Topical Solution, 8% contains a synthetic antifungal agent, ciclopirox. It is intended for topical use on fingernails and toenails and immediately adjacent skin. Each gram of Ciclopirox Topical Solution, 8% contains 80 mg ciclopirox in a solution base consisting of butyl ester of poly [vinylmethylether/maleic acid copolymer] in isopropyl alcohol, ethyl acetate, and isopropyl alcohol. Ethyl acetate and isopropyl alcohol are solvents that vaporize after application. Ciclopirox Topical Solution, 8% is a clear, colorless to slightly yellowish solution. The chemical name for ciclopirox is 6-cyclohexyl-1-hydroxy-4-methyl-2(1H)-pyridone, with the empirical formula C 12 H 17 NO 2 and a molecular weight of 207.27. The CAS Registry Number is [29342-05-0]. The chemical structure is: Chemical Structure

Ciclopirox CICLOPIROX
PADAGIS ISRAEL PHARMACEUTICALS LTD FDA Rx Only

Ciclopirox Shampoo, 1% contains the synthetic antifungal agent, ciclopirox for topical use. Each gram (equivalent to 0.96 mL) of Ciclopirox Shampoo, 1% contains 10 mg ciclopirox in a shampoo base consisting of disodium laureth sulfosuccinate, laureth-2, purified water, sodium chloride, and sodium laureth sulfate. Ciclopirox Shampoo, 1% is a colorless, translucent solution. The chemical name for ciclopirox is 6-cyclohexyl-1-hydroxy-4-methyl-2(1 H )-pyridone, with the empirical formula C 12 H 17 NO 2 and a molecular weight of 207.27. The CAS Registry Number is [29342-05-0]. The chemical structure is: chemical structure image

Ciclopirox olamine CICLOPIROX OLAMINE
PADAGIS ISRAEL PHARMACEUTICALS LTD FDA Rx Only

Ciclopirox Olamine Cream USP, 0.77% is for topical use. Each gram of ciclopirox olamine cream contains 7.70 mg of ciclopirox (as ciclopirox olamine) in a water miscible, vanishing cream base consisting of benzyl alcohol (1% as a preservative), cetyl alcohol, lactic acid, light mineral oil, myristyl alcohol, octyldodecanol, polysorbate 60, purified water, sorbitan monostearate, and stearyl alcohol. Ciclopirox olamine cream contains a synthetic, broad-spectrum, antifungal agent ciclopirox (as ciclopirox olamine). The chemical name is 6-cyclohexyl-1-hydroxy-4-methyl-2(1 H )-pyridone, 2-aminoethanol salt. The CAS Registry Number is 41621-49-2. The chemical structure is: Ciclopirox olamine cream has a pH of 7. Chemical Structure Image

Ciclopirox Olamine CICLOPIROX OLAMINE
PADAGIS ISRAEL PHARMACEUTICALS LTD FDA Rx Only

Ciclopirox Olamine Topical Suspension USP, 0.77% (w/w) is for topical use. Each gram of Ciclopirox Olamine Topical Suspension USP, 0.77% (w/w) contains 7.70 mg of ciclopirox (as ciclopirox olamine) in a water miscible suspension base consisting of benzyl alcohol (1% as a preservative), cetyl alcohol, lactic acid, light mineral oil, myristyl alcohol, octyldodecanol, polysorbate 60, purified water, sorbitan monostearate, and stearyl alcohol. Ciclopirox Olamine Topical Suspension USP, 0.77% (w/w) contains a synthetic, broad-spectrum, antifungal agent ciclopirox (as ciclopirox olamine). The chemical name is 6-cyclohexyl-1-hydroxy-4-methyl-2(1 H )-pyridone, 2-aminoethanol salt. The CAS Registry Number is 41621-49-2. Ciclopirox Olamine Topical Suspension USP, 0.77% (w/w) has a pH of 7. The chemical structure is: Structural Formula

clindamycin and benzoyl peroxide CLINDAMYCIN AND BENZOYL PEROXIDE
PADAGIS ISRAEL PHARMACEUTICALS LTD FDA Rx Only

Clindamycin and benzoyl peroxide topical gel, 1%/5% contains clindamycin phosphate, (7(S)-chloro-7-deoxylincomycin-2-phosphate). Clindamycin phosphate is a water soluble ester of the semi-synthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin. Chemically, clindamycin phosphate is (C 18 H 34 ClN 2 O 8 PS). The structural formula for clindamycin is represented below: Clindamycin phosphate has a molecular weight of 504.97 and its chemical name is Methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido) - 1-thio-L- threo-alpha-D-galacto-octopyranoside 2-(dihydrogen phosphate). Clindamycin and benzoyl peroxide topical gel, 1%/5% also contains benzoyl peroxide, for topical use. Chemically, benzoyl peroxide is (C 14 H 10 O 4 ). It has the following structural formula: Benzoyl peroxide has a molecular weight of 242.23. Each gram of clindamycin and benzoyl peroxide topical gel, 1%/5% contains, as dispensed, 10 mg (1%) clindamycin as phosphate and 50 mg (5%) benzoyl peroxide in a base of carbomer homopolymer type C, sodium hydroxide, dioctyl sodium sulfosuccinate, and purified water. Chemical Structure Chemical Structure

CLINDAMYCIN AND BENZOYL PEROXIDE CLINDAMYCIN AND BENZOYL PEROXIDE
PADAGIS ISRAEL PHARMACEUTICALS LTD FDA Rx Only

Clindamycin and benzoyl peroxide topical gel, 1%/5% contains clindamycin phosphate, (7(S)-chloro-7-deoxylincomycin-2-phosphate). Clindamycin phosphate is a water soluble ester of the semi-synthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin. Chemically, clindamycin phosphate is (C 18 H 34 ClN 2 O 8 PS). The structural formula for clindamycin is represented below: Clindamycin phosphate has a molecular weight of 504.97 and its chemical name is Methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido) - 1-thio-L- threo-alpha-D-galacto-octopyranoside 2-(dihydrogen phosphate). Clindamycin and benzoyl peroxide topical gel, 1%/5% also contains benzoyl peroxide, for topical use. Chemically, benzoyl peroxide is (C 14 H 10 O 4 ). It has the following structural formula: Benzoyl peroxide has a molecular weight of 242.23. Each gram of clindamycin and benzoyl peroxide topical gel, 1%/5% contains, as dispensed, 10 mg (1%) clindamycin as phosphate and 50 mg (5%) benzoyl peroxide in a base of carbomer homopolymer type C, sodium hydroxide, dioctyl sodium sulfosuccinate, and purified water. Chemical Structure Chemical Structure

clindamycin and benzoyl peroxide CLINDAMYCIN AND BENZOYL PEROXIDE
PADAGIS ISRAEL PHARMACEUTICALS LTD FDA Rx Only

Clindamycin and benzoyl peroxide topical gel, 1%/5% contains clindamycin phosphate, (7(S)-chloro-7-deoxylincomycin-2-phosphate). Clindamycin phosphate is a water soluble ester of the semi-synthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin. Chemically, clindamycin phosphate is (C 18 H 34 ClN 2 O 8 PS). The structural formula for clindamycin is represented below: Clindamycin phosphate has a molecular weight of 504.97 and its chemical name is Methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido) - 1-thio-L- threo-alpha-D-galacto-octopyranoside 2-(dihydrogen phosphate). Clindamycin and benzoyl peroxide topical gel, 1%/5% also contains benzoyl peroxide, for topical use. Chemically, benzoyl peroxide is (C 14 H 10 O 4 ). It has the following structural formula: Benzoyl peroxide has a molecular weight of 242.23. Each gram of clindamycin and benzoyl peroxide topical gel, 1%/5% contains, as dispensed, 10 mg (1%) clindamycin as phosphate and 50 mg (5%) benzoyl peroxide in a base of carbomer homopolymer type C, sodium hydroxide, dioctyl sodium sulfosuccinate, and purified water. Chemical Structure Chemical Structure

clindamycin and benzoyl peroxide CLINDAMYCIN AND BENZOYL PEROXIDE
PADAGIS ISRAEL PHARMACEUTICALS LTD FDA Rx Only

Clindamycin and benzoyl peroxide topical gel, 1%/5% contains clindamycin phosphate, (7(S)-chloro-7-deoxylincomycin-2-phosphate). Clindamycin phosphate is a water soluble ester of the semi-synthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin. Chemically, clindamycin phosphate is (C 18 H 34 ClN 2 O 8 PS). The structural formula for clindamycin is represented below: Clindamycin phosphate has a molecular weight of 504.97 and its chemical name is Methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido) - 1-thio-L- threo-alpha-D-galacto-octopyranoside 2-(dihydrogen phosphate). Clindamycin and benzoyl peroxide topical gel, 1%/5% also contains benzoyl peroxide, for topical use. Chemically, benzoyl peroxide is (C 14 H 10 O 4 ). It has the following structural formula: Benzoyl peroxide has a molecular weight of 242.23. Each gram of clindamycin and benzoyl peroxide topical gel, 1%/5% contains, as dispensed, 10 mg (1%) clindamycin as phosphate and 50 mg (5%) benzoyl peroxide in a base of carbomer homopolymer type C, sodium hydroxide, dioctyl sodium sulfosuccinate, and purified water. Chemical Structure Chemical Structure

Clindamycin Phosphate CLINDAMYCIN PHOSPHATE
PADAGIS ISRAEL PHARMACEUTICALS LTD FDA Rx Only

Clindamycin phosphate foam contains clindamycin (1%) as clindamycin phosphate. Clindamycin phosphate is a water-soluble ester of the semi-synthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic, lincomycin. The chemical name for clindamycin phosphate is methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl- trans -4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L- threo -α-D- galacto - octopyranoside 2-(dihydrogen phosphate). The structural formula for clindamycin phosphate is represented below: Molecular Formula: C 18 H 34 CIN 2 O 8 PS Molecular Weight: 504.97 g/mol Clindamycin phosphate foam contains clindamycin (1%) as clindamycin phosphate, USP at a concentration equivalent to 10 mg clindamycin per gram in a thermolabile hydroethanolic foam vehicle consisting of cetyl alcohol, ethanol (58%), polysorbate 60, propylene glycol, purified water, and stearyl alcohol pressurized with a hydrocarbon (propane/butane) propellant. clindamycin phosphate structural formula

Clindamycin Phosphate CLINDAMYCIN PHOSPHATE
PADAGIS ISRAEL PHARMACEUTICALS LTD FDA Rx Only

Clindamycin phosphate topical lotion, 1% contains clindamycin phosphate, USP, at a concentration equivalent to 10 mg clindamycin per milliliter. Clindamycin phosphate is a water soluble ester of the semi-synthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin. The lotion contains cetostearyl alcohol (2.5%); glycerin; glyceryl stearate SE (with potassium monostearate); isostearyl alcohol (2.5%); methylparaben (0.3%); sodium lauroyl sarcosinate; stearic acid; and purified water. The structural formula is represented below: The chemical name for clindamycin phosphate is Methyl 7-chloro-6,7,8-trideoxy-6-(1‑methyl- trans -4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L- threo -α-D- galacto ‑octopyranoside 2-(dihydrogen phosphate). clindamycin-structure

Clindamycin Phosphate CLINDAMYCIN PHOSPHATE
PADAGIS ISRAEL PHARMACEUTICALS LTD FDA Rx Only

Clindamycin Phosphate Topical Solution USP, 1% contains clindamycin phosphate USP at a concentration equivalent to 10 mg clindamycin per milliliter. Clindamycin phosphate is a water soluble ester of the semi-synthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin. The solution contains isopropyl alcohol 50% v/v, propylene glycol, purified water, and sodium hydroxide (to adjust the pH to between 4.0 - 7.0). The structural formula is represented below: The chemical name for clindamycin phosphate is Methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl- trans -4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L- threo - α-D- galacto -octopyranoside 2-(dihydrogen phosphate). Chemical Structure

CLINDAMYCIN PHOSPHATE CLINDAMYCIN PHOSPHATE
PADAGIS ISRAEL PHARMACEUTICALS LTD FDA Rx Only

Clindamycin Phosphate Gel USP, 1% contains clindamycin phosphate, USP, at a concentration equivalent to 10 mg clindamycin per gram. Clindamycin phosphate is a water soluble ester of the semi-synthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin. The gel contains allantoin, carbomer 974P, methylparaben, polyethylene glycol 400, propylene glycol, sodium hydroxide, and purified water. The structural formula is represented below: The chemical name for clindamycin phosphate is Methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl- trans -4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L- threo -α-D- galacto -octopyranoside 2-(dihydrogen phosphate). chemical-structure.jpg

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