Label: VANISHING ACNE TREATMENT CREAM CVS HEALTH- benzoyl peroxide 10% cream
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Contains inactivated NDC Code(s)
NDC Code(s): 69842-671-01 - Packager: CVS
- 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 June 4, 2018
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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WARNINGS
Warnings
For external use only
Do not use • if you have very sensitive skin or 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 skin irritation becomes severe - Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away
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DOSAGE & ADMINISTRATION
Directions • cleanse the skin thoroughly before applying medication • cover the entire affected area
with a thin layer one to three times a day • 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. • if going
outside, use a sunscreen. Allow product to dry, then follow direction in the sunscreen labeling. If
sensitivity develops, discontinue use of both products and consult a doctor. - OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- Questions? 855-543-3784
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
VANISHING ACNE TREATMENT CREAM CVS HEALTH
benzoyl peroxide 10% creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69842-671 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Benzoyl Peroxide (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) Benzoyl Peroxide 10 g in 100 g Inactive Ingredients Ingredient Name Strength Aluminum Hydroxide (UNII: 5QB0T2IUN0) Bentonite (UNII: A3N5ZCN45C) CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) Isopropyl Myristate (UNII: 0RE8K4LNJS) POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9) Potassium Hydroxide (UNII: WZH3C48M4T) Potassium Sorbate (UNII: 1VPU26JZZ4) Propylene Glycol (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69842-671-01 28 g in 1 TUBE; Type 0: Not a Combination Product 08/15/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 08/15/2018 Labeler - CVS (062312574) Registrant - Product Quest Mfg (927768135) Establishment Name Address ID/FEI Business Operations Product Quest Mfg 927768135 manufacture(69842-671) , label(69842-671)