Label: ACNE SPOT TREATMENT- benzoyl peroxide 10% cream
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Contains inactivated NDC Code(s)
NDC Code(s): 59779-243-01 - 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 December 26, 2017
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- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Uses
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Warnings
For external use only.
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.
- rinse right away with water if it gets in eyes.
- avoid unnecessary sun exposure and use a sunscreen.
- avoid contact with 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, possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration.
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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 2 to 3 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 directions in the sunscreen labeling. if sensitivity develops, discontinue use of both products and cpnsult a doctor.
- Inactive ingredients
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ACNE SPOT TREATMENT
benzoyl peroxide 10% creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59779-243 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) GLYCERYL STEARATE SE (UNII: FCZ5MH785I) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) METHYLPARABEN (UNII: A2I8C7HI9T) POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59779-243-01 1 in 1 CARTON 10/31/2014 1 28 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 10/31/2014 Labeler - CVS (062312574) Registrant - Product Quest Mfg, LLC (927768135) Establishment Name Address ID/FEI Business Operations Product Quest Mfg, LLC 927768135 manufacture(59779-243) , label(59779-243)
