Label: CLEARSKIN PROFESSIONAL ACNE MARK TREATMENT- salicylic acid cream
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Contains inactivated NDC Code(s)
NDC Code(s): 10096-0264-1, 10096-0264-2 - Packager: Avon Products, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated September 28, 2011
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- ACTIVE INGREDIENT
- INDICATIONS & USAGE
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WARNINGS
WARNINGS
For external use onlyWhen using this product:
- Avoid contact with eyes. If product contacts eyes, rinse thoroughly with water. Discontinue use if excessive skin irritation develops or increases. If irritation persists, seek medical attention.
- Using other topical acne medications at the same time or immediately after this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a health care practitioner.
- Sunburn Alert: Use only as directed. This product contains an alpha hydroxy acid that may increase your skin's sensitivity to the sun and particularly the possibility of sunburn. Please limit sun exposure and apply a sunburn protectant while using this product and for a week afterwards.
- Avoid contact with eyes. If product contacts eyes, rinse thoroughly with water. Discontinue use if excessive skin irritation develops or increases. If irritation persists, seek medical attention.
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DOSAGE & ADMINISTRATION
DIRECTIONS
- Clean the skin thoroughly before applying this product.
- Hold at an angle, gently rolling onto cleansed skin. Do not squeeze tube. Smooth product in with clean fingertips until fully absorbed.
- Cover the entire affected area with a thin layer one to three times daily.
- Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor.
- If bothersome dryness or peeling occurs, reduce application to once a day or every other day.
- Clean the skin thoroughly before applying this product.
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INACTIVE INGREDIENT
Inactive ingredients WATER/EAU, GLYCERIN, PPG-14 BUTYL ETHER, GLYCOLIC ACID, PROPANEDIOL, SODIUM HYDROXIDE, CETYL ALCOHOL, PEG-40 STEARATE, STEARETH-2, THIODIPROPIONIC ACID, SACCHAROMYCES/ZINC FERMENT, TRIOXAUNDECANEDIOIC ACID, POLYMETHYL METHACRYLATE, ORYZA SATIVA (RICE) STARCH, BIS-PEG-18 METHYL ETHER DIMETHYL SILANE, CHOLETH-24, CETETH-24, MAGNESIUM ALUMINUM SILICATE, XANTHAN GUM, DISODIUM EDTA, METHYLPARABEN, PARFUM/FRAGRANCE.
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INGREDIENTS AND APPEARANCE
CLEARSKIN PROFESSIONAL ACNE MARK TREATMENT
salicylic acid creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10096-0264 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 1 mL in 50 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10096-0264-2 1 in 1 CARTON 1 NDC:10096-0264-1 50 mL in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 09/28/2011 Labeler - Avon Products, Inc. (001468693) Establishment Name Address ID/FEI Business Operations Avon Products, Inc. 005149471 manufacture
