Label: FAMILY CARE ACNE TREATMENT- benzoyl peroxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 65923-006-00 - Packager: UNITED EXCHANGE CORP.
- 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 September 23, 2015
If you are a consumer or patient please visit this version.
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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 eyes, lips and mouth
- avoid contact with hair or dyed fabrics including carpet and clothing which may be bleached by this product
- with other tropical 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 medications should be use 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 directed 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
- cleanse the skin thoroughly before applying medication
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
FAMILY CARE ACNE TREATMENT
benzoyl peroxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65923-006 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 PARAFFIN (UNII: I9O0E3H2ZE) PETROLATUM (UNII: 4T6H12BN9U) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X) POLYSORBATE 60 (UNII: CAL22UVI4M) METHYLPARABEN (UNII: A2I8C7HI9T) BUTYLPARABEN (UNII: 3QPI1U3FV8) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65923-006-00 1 in 1 CARTON 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 02/07/2012 Labeler - UNITED EXCHANGE CORP. (840130579)
