Label: BENZOYL PEROXIDE gel
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Contains inactivated NDC Code(s)
NDC Code(s): 66078-033-02 - Packager: MD Formulation
- 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 May 18, 2011
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
Directions Cleanse skin thoroughly before applying medication. Cover the entire affected area with a thin layer 1 to 3 times dally. Because excessive drying of the skin may accur, start with 1 application daily, then gradually increase to 2 to 3 times daily If needed or as directed by a
physician. If bothersome dryness or peeling occurs, reduce application to once a day or every other other day.
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BENZOYL PEROXIDE
benzoyl peroxide gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66078-033 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 WATER (UNII: 059QF0KO0R) CARBOMER 934 (UNII: Z135WT9208) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) AMINOMETHYLPROPANOL (UNII: LU49E6626Q) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66078-033-02 54 in 1 CASE 1 1 in 1 CARTON 1 61.68 g in 1 CYLINDER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 09/23/2001 Labeler - MD Formulation (087008363) Registrant - Harmony Labs, inc. (105803274) Establishment Name Address ID/FEI Business Operations Harmony Labs, inc. 105803274 manufacture, label, pack, relabel, repack