Salicate SALICYLIC ACID 10% PURETEK COPRORATION FDA Approved Salicate™ is applied topically and used to remove excessive keratin in hyperkeratotic skin disorders. Each gram of Salicate™ contains salicylic acid 10% as the active ingredient and the following inactive ingredients: Aqua (Water Purified), Camellia Sinensis (Green Tea) Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract, Cucumis Sativus (Cucumber) Fruit Extract, Ethylhexylglycerin, Glycerin, Hydroxyethylcellulose, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Phenoxyethanol, Polysorbate 20, Propylene Glycol, Sodium Hydroxide, Symphytum Officinale (Comfrey) Leaf Extract.
FunFoxMeds bottle
Substance Salicylic Acid
Route
TOPICAL
Package NDC

Drug Facts

Composition & Profile

Treats Conditions
Indications Usage For Dermatologic Use Salicate Is A Topical Aid In The Removal Of Excessive Keratin In Hyperkeratotic Skin Disorders Including Verrucae And The Various Ichthyoses Keratosis Palmaris And Plantaris Keratosis Pilaris Pityriasis Rubra Pilaris And Psoriasis For Podiatric Use Salicate Is A Topical Aid In Removing Excessive Keratin On Dorsal And Plantar Hyperkeratotic Lesions

Identifiers & Packaging

Container Type BOTTLE
All Product Codes
UPC
0359088214039
UNII
O414PZ4LPZ
Packaging

How Supplied: Salicate™ is a serum supplied in a 1 fl oz Bottle. NDC 59088-214-03; Salicate™ Label

Package Descriptions
  • How Supplied: Salicate™ is a serum supplied in a 1 fl oz Bottle. NDC 59088-214-03
  • Salicate™ Label

Overview

Salicate™ is applied topically and used to remove excessive keratin in hyperkeratotic skin disorders. Each gram of Salicate™ contains salicylic acid 10% as the active ingredient and the following inactive ingredients: Aqua (Water Purified), Camellia Sinensis (Green Tea) Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract, Cucumis Sativus (Cucumber) Fruit Extract, Ethylhexylglycerin, Glycerin, Hydroxyethylcellulose, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Phenoxyethanol, Polysorbate 20, Propylene Glycol, Sodium Hydroxide, Symphytum Officinale (Comfrey) Leaf Extract.

Indications & Usage

Indications & Usage: For dermatologic Use Salicate™ is a topical aid in the removal of excessive keratin in hyperkeratotic skin disorders, including verrucae and the various ichthyoses, keratosis palmaris and plantaris, keratosis pilaris, pityriasis rubra pilaris, and psoriasis. For Podiatric Use Salicate™ is a topical aid in removing excessive keratin on dorsal and plantar hyperkeratotic lesions.

Dosage & Administration

Dosage & Administration: Clean and dry affected area of skin, then apply Salicate™ ™ serum over the affected skin once daily, or as directed by healthcare provider. Apply serum using a gauze or cotton pad evenly across treatment area using circular motions. Allow serum to work on the skin for 1 min or less. Use a sunscreen, wear protective clothing, and limit sun exposure while using this product and for a week afterwards. You will experience a stinging or tingling sensation. If excessive stinging or discomfort occurs, neutralize the serum by flushing the skin with cool water. Redness may occur for a short period of time, especially for those with sensitive skin types. If redness persists longer than 20-30 minutes, decrease the contact time of the serum or discontinue use. Stop Use and Ask a Doctor If • Excessive facial irritation or redness occurs 48-72 hours after application • Chest pain, faintness, or dizziness occurs • You experience pain, swelling, or severe burns • You experience an allergic reaction • Your skin becomes infected • If swallowed, seek medical help or contact a Poison Control Center Immediately *These statements have not been evaluated by the Food and Drug Administration. This product is not intended to treat, cure, prevent, mitigate or diagnose any disease or effect the structure or function of the human body.

Warnings & Precautions
Warnings: Salicate™ is for external use only. It is not for ophthalmic, oral, anal, or intravaginal use. Contact with eyes, lips, broken or inflamed skin, and mucous membranes should be avoided. Salicate™ should not be used by persons who have a known hypersensitivity to salicylic acid or other listed ingredients. Prolonged use over large areas, especially in children and those patients with significant renal or hepatic impairment, could result in salicylism. Concomitant use of other drugs which may contribute to elevated serum salicylate levels should be avoided where the potential for toxicity is present. In children under 12 years of age and those patients with renal or hepatic impairment, the area to be treated should be limited, and the patient should be monitored closely for signs of salicylate toxicity: nausea, vomiting, dizziness, loss of hearing, tinnitus, lethargy, hyperpnoea, diarrhea, psychic disturbances. In the event of salicylic acid toxicity, Salicate™ should be discontinued. Fluids should be administered to promote urinary excretion. Treatment with sodium bicarbonate (oral or intravenous) should be instituted as appropriate. Considering the potential risk of developing Reye's syndrome, salicylate products should not be administered to children or teenagers with varicella or influenza, unless directed by a physician. When using this product, skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time. Applying the serum more than once per week will increase the risk of skin sensitivity.
Contraindications

Section: Salicate™ should not be used in any patient known to be sensitive to salicylic acid or any other listed ingredients.

Adverse Reactions

Transient stinging, burning, itching or irritation is possible. Peeling of the skin may increase as the salicylic acid works to loosen excess keratin. If excessive burning, stinging or peeling occurs, discontinue use and consult your physician.

Drug Interactions

The following interactions are from a published review 5 and include reports concerning oral and topical salicylate administration. The relationship of these interactions to the use of SALICYLIC ACID is not known. A. Due to the competition of salicylate with other drugs for binding to serum albumin the following drug interactions may occur: Drug Description of Interaction Tolbutamide; Sulfonylureas Hypoglycemia potentiated Methotrexate Decreases tubular reabsorption; clinical toxicity from methotrexate can result Oral Anticoagulants Increased bleeding B. Drugs changing salicylate levels by altering renal tubular reabsorption: Drug Description of Interaction Corticosteroids Decreases plasma salicylate level; tapering doses of steroids may promote salicylism Ammonium Sulfate Increases plasma salicylate level C. Drugs with complicated interactions with salicylates: Drug Description of Interaction Heparin Salicylate decreases platelet adhesiveness and interferes with hemostasis in heparin-treated patients Pyrazinamide Inhibits pyrazinamide-induced hyperuricemia Uricosuric Agents Effect of probenecid, sulfinpyrazone, and phenylbutazone inhibited D. The following alterations of laboratory tests have been reported during salicylate therapy: 6 Laboratory Tests Effect of Salicylates Thyroid Function Decreased PBI; increased T uptake Urinary Sugar False negative with glucose oxidase; false positive with Clinitest with high-dose salicylate therapy (2-5g qd) 5 Hydroxyindole Acetic Acid False negative with fluorometric test Acetone, Ketone Bodies False positive FeCl in Gerhardt reaction; red color persists with boiling 17-OH corticosteroids False reduced values with >4.8 g qd salicylate Vanilmandelic Acid False reduced values Uric Acid May increase or decrease depending on the dose Prothrombin Decreased levels; slightly increased prothrombin time

Storage & Handling

Storage And Handling: KEEP THIS AND ALL MEDICATIONS OUT OF REACH OF CHILDREN. Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Protect from freezing. Manufactured in the USA by: PureTek Corporation Panorama City, CA 91402 For questions or information call toll-free: 877-921-787


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