salicylic acid

FDA Drug Profile — Salicylic Acid 2% Solution, Acne Moisturizer, Dr. Gross AB Acne Daily Breakout, Compound W One Step Plantar Foot Pads, Acne Cleanser

Drug Details

Generic Name
salicylic acid
Brand Names
Salicylic Acid 2% Solution, Acne Moisturizer, Dr. Gross AB Acne Daily Breakout, Compound W One Step Plantar Foot Pads, Acne Cleanser, Compound W One Step Pads, Compound W Liquid - First Aid, Hero Cosmetics Pimple Correct Salicylic Acid Acne Treatment, Salicylic Acid, Dermatouch Acnecare Pads, Dr Lift Blemish, Nutricentials Here You Glow Exfoliating Toner, SKIN MEDICA Purifying Foaming Wash, DHS SAL, natouch, Oxy Total Care Vitamin C Serum, Replenix Gly-Sal 2-2, Clear Smart Charcoal Blackhead Scrub, Oxy 3-IN-1 Acne Cleansing Pads, Oxy Total Care Creamy Facial Cleanser, Compound W Maximum Strength Fast Acting Liquid, Compound W Corn Remover, PanOxyl Clarifying Exfoliant, OXY ADVANCED CARE MAXIMUM STRENGTH 3-in-1 ACNE PADS, Dermatouch Acnecare Cleanser, ZRIZL wart Remover, Oxy Deep Pore Acne Cleansing Pads, Veraciti, PanOxyl Acne Banishing Body (Spray), Acnecare Dermacontrol Cream, SKIN PHARMACY ADVANCED ACNE THERAPY CLARIFYING DAILY CLEANSER, PanOxyl Acne Gel Wash, Dr.G A CLEAR ACNE FACIAL CLEANSER, Dr. Lift Acne Cleanser, SKINPHARMACY ADVANCED ACNE THERAPY OVERNIGHT SALICYLIC ACID, ZRIZ wart Remover, Acne Care Lotn, Acne Scrub, Satos Corn and Callus Remover, Compound W One Step Medicated Corn Remover, OXY Deep Pore Cleansing Pads, Compound W, Tula Skincare Keep It Clear Acne Foam Cleanser, MediPlast, Compound W for Kids One Step Strips, OXY ADVANCED CARE 3 in 1 RETEXTURIZING CLEANSING PADS, SKIN PHARMACY ADVANCED ACNE THERAPY OVERNIGHT SALICYLIC ACID, SKINPHARMACY ADVANCED ACNE THERAPY PORE REFINING FACIAL MASK
Application Number
M006
Sponsor
Deciem
NDC Codes
50
Dosage Forms
LOTION, CREAM, LIQUID, PLASTER, GEL, SOLUTION, SHAMPOO, SOAP, FOR SOLUTION, SWAB, AEROSOL, SPRAY
Routes
TOPICAL
Active Ingredients
SALICYLIC ACID, SULFUR, BENZOYL PEROXIDE

Indications and 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.

Warnings

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.