Label: GNP ACNE TREATMENT- benzoyl peroxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 46122-044-03 - Packager: Amerisource Bergen
- Category: HUMAN OTC DRUG LABEL
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 30, 2013
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- WARNINGS
- DO NOT USE
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WHEN USING
When using this product
- avoid contact with the eyes, lips and mouth
- avoid contact with hair or dyed fabrics, including carpet and clothing which may be bleached by this product
- with other topical acne medications, at the same time or immediately following use of this product, increased dryness or irritation of the skin may occur. If this occurs, only one medication should be used unless directed by a doctor
- skin irritation may occur, characterized by redness, burning, itching, peeling or possibly swelling. More frequent use or concentration may aggravate skin irritation. Mild irritation may be reduced by using the product less frequently or in a lower concentration.
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
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INDICATIONS & USAGE
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 to three times daily if needed or as direction by a doctor. If bothersome dryness or peeling occurs, reduce application to once a day or every other day.
- use to prevent new pimples from forming
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
GNP ACNE TREATMENT
benzoyl peroxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:46122-044 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 MINERAL OIL (UNII: T5L8T28FGP) PETROLATUM (UNII: 4T6H12BN9U) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) POLYSORBATE 60 (UNII: CAL22UVI4M) METHYLPARABEN (UNII: A2I8C7HI9T) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:46122-044-03 1 in 1 CARTON 1 28 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 06/30/2013 Labeler - Amerisource Bergen (007914906)
