Active Ingredients
Salicylic Acid 1%
Salicylacne-1% Clearing Gel
FDA Label NDC 76523-107
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Valley Of The Sun Cosmetics for the product Salicylacne-1% Clearing Gel (NDC 76523-107). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warning, do not use, when using this product, keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Acne Treatment
Uses
Use for treatment of acne
Warning
For external use only
Do Not Use
Allergy alert: Do not use this product if you have a known allergy to salicylic acid
When Using This Product
Skin irritation and dryness is more likely occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time. Avoid contact with eyes. If contact occurs, flush thoroughly with water.
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
Apply with a cotton ball, sweeping gently over face and neck (Cover the entire affected area with a thin layer) one to two times daily. If dryness or peeling occurs, reduce usage to every other day. It is best for normal, dry, combination and oily skin.
Inactive Ingredients
Water(aqua), Propylene glycol, Glycerin, Acetyl glutathione (glutamine), Acrylates/C10-30 alkyl acrylates crosspolymer, Denatured alcohol (40-B), Benzoyl peroxide, Lactic acid, Polysorbate 20, Melaleuca alternifolia (*organic tea tree) leaf oil, Camelia sinesis (*organic green tea)leaf extract, Retinyl Palmitate (vitamin A), Carica (*organic papaya) fruit extract, Sodium ascorbyl phosphate (vitamin C), Bromelain (*organic pineapple steam leaf), Sodium PCA, Allium sativum (*organic garlic) oil, Citrus medica limonium (*organic lemon) fruit extract), Sodium hydroxide, Phenoxyethanol, Glycolic acid, Fragrance parfum
Package Label
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