Label: ADVANCED 3 IN 1 EXFOLIATING CLEANSER- benzoyl peroxide 5.0% cream
- 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.
Updated December 8, 2017
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- ACTIVE INGREDIENT
- INDICATIONS & USAGE
WarningsFor external use only
Do not use if you have very sensitive skin or if you are sensitive to benzoyl peroxide.
When using this product • skin irritation and dryness are 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. • rinse right away with water if it gets in
eyes • avoid unnecessary sun exposure and use a sunscreen • avoid contact with the eyes, lips, and mouth • avoid contact with
hair and dyed fabrics, which may be bleached by this product • skin irritation may occur, characterized by redness, burning,
itching, peeling, or possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration.
Stop use and ask a doctor if irritation becomes severe.
- Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
ADVANCED 3 IN 1 EXFOLIATING CLEANSER
benzoyl peroxide 5.0% cream
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69842-839 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE 5 g in 100 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) C13-14 Isoparaffin (UNII: E4F12ROE70) Cocamidopropyl Betaine (UNII: 5OCF3O11KX) Laureth-7 (UNII: Z95S6G8201) Phenoxyethanol (UNII: HIE492ZZ3T) Ethylhexylglycerin (UNII: 147D247K3P) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69842-839-04 148 mL in 1 TUBE; Type 0: Not a Combination Product 06/15/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 06/15/2017 Labeler - CVS (062312574) Registrant - Product Quest Mfg. (927768135) Establishment Name Address ID/FEI Business Operations Product Quest Mfg. 927768135 manufacture(69842-839) , label(69842-839)