hydrocortisone HYDROCORTISONE PADAGIS ISRAEL PHARMACEUTICALS LTD FDA Approved Each mL of Hydrocortisone Lotion USP, 2.5% contains 25 mg of hydrocortisone, USP in a vehicle consisting of carbomer homopolymer type C, ceteareth-20, cetyl alcohol, dehydroacetic acid, DMDM hydantoin, fragrance, glyceryl stearate, isopropyl palmitate, lactic acid, light mineral oil, myristyl alcohol, myristyl lactate, PEG-100 stearate, purified water, sodium hydroxide, sodium PCA, and stearyl alcohol. Chemically, hydrocortisone is [Pregn-4-ene-3, 20-dione, 11, 17, 21-trihydroxy-, (11ß)-] with the molecular formula C 21 H 30 O 5 and is represented by the following structural formula: Its molecular weight is 362.46 and its CAS Registry Number is 50-23-7. The topical corticosteroids, including hydrocortisone, constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. chemical structure.png
FunFoxMeds bottle
Substance Hydrocortisone
Route
TOPICAL
Applications
ANDA089074

Drug Facts

Composition & Profile

Strengths
2.5 % 59 ml 118 ml
Quantities
59 ml 118 ml
Treats Conditions
Indications And Usage Topical Corticosteroids Are Indicated For The Relief Of The Inflammatory And Pruritic Manifestations Of Corticosteroid Responsive Dermatoses

Identifiers & Packaging

Container Type BOTTLE
UNII
WI4X0X7BPJ
Packaging

HOW SUPPLIED Hydrocortisone Lotion USP, 2.5% is available as follows: 2 fl oz (59 mL) bottle (NDC 45802- 937 -16) 4 fl oz (118 mL) bottle (NDC 45802- 937 -26) Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]. Keep tightly closed. Keep out of the reach of children. Manufactured by Padagis Yeruham, Israel www.padagis.com Rev 12-23; Package/Label Display Panel NDC 45802-937-16 Rx Only Hydrocortisone Lotion USP, 2.5% For Topical Use Only 27C16 RC F3 2 FL OZ (59 mL) PEEL HERE label

Package Descriptions
  • HOW SUPPLIED Hydrocortisone Lotion USP, 2.5% is available as follows: 2 fl oz (59 mL) bottle (NDC 45802- 937 -16) 4 fl oz (118 mL) bottle (NDC 45802- 937 -26) Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]. Keep tightly closed. Keep out of the reach of children. Manufactured by Padagis Yeruham, Israel www.padagis.com Rev 12-23
  • Package/Label Display Panel NDC 45802-937-16 Rx Only Hydrocortisone Lotion USP, 2.5% For Topical Use Only 27C16 RC F3 2 FL OZ (59 mL) PEEL HERE label

Overview

Each mL of Hydrocortisone Lotion USP, 2.5% contains 25 mg of hydrocortisone, USP in a vehicle consisting of carbomer homopolymer type C, ceteareth-20, cetyl alcohol, dehydroacetic acid, DMDM hydantoin, fragrance, glyceryl stearate, isopropyl palmitate, lactic acid, light mineral oil, myristyl alcohol, myristyl lactate, PEG-100 stearate, purified water, sodium hydroxide, sodium PCA, and stearyl alcohol. Chemically, hydrocortisone is [Pregn-4-ene-3, 20-dione, 11, 17, 21-trihydroxy-, (11ß)-] with the molecular formula C 21 H 30 O 5 and is represented by the following structural formula: Its molecular weight is 362.46 and its CAS Registry Number is 50-23-7. The topical corticosteroids, including hydrocortisone, constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. chemical structure.png

Indications & Usage

Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

Dosage & Administration

Shake well before using. Topical corticosteroids are generally applied to the affected area as a thin film from two to four times daily depending on the severity of the condition. Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions. If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.

Warnings & Precautions
No warnings available yet.
Contraindications

Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

Adverse Reactions

The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, and miliaria.


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