Label: ACNE CONTROL CLEANSER- benzoyl peroxide cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 October 25, 2011

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  • ACTIVE INGREDIENT

    BENZOYL PEROXIDE 10%

  • PURPOSE

    ACNE TREATMENT

  • USES

    FOR THE TREATMENT OF ACNE.

  • WARNINGS

    FOR EXTERNAL USE ONLY.

    WHEN USING THE PRODUCT

    • SKIN IRRITATION AND DRYNESS IS MORE LIKELY TO OCCUR IF YOU USE ANOTHER TOPICAL ACNE MEDICATION AT THE SAME TIME.
    • AVOID UNNECESSARY SUN EXPOSURE AND USE A SUNSCREEN
    • AVOID CONTACT WITH EYES, LIPS AND MOUTH.
    • AVOID CONTACT WITH HAIR OR 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 USING THIS PRODUCT AND ASK DOCTOR IF

    IRRITATION OR REDNESS BECOMES SEVERE.

    KEEP OUT OF REACH OF CHILDREN

    IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.  AVOID CONTACT WITH EYES.  IF CONTACT OCCURS FLUSH THOROUGHLY WITH WATER.

  • DIRECTIONS

    • WET FACE. GENTLY MASSAGE ALL OVER FACE FOR 20-30 SECONDS AVOIDING EYE AREA.  RINSE THOROUGHLY AND PAT DRY.
    • SINCE EXCESSIVE DRYNES OF SKIN MAY OCCUR, START WITH ONE APPLICATION DAILY AND INCREASE TO TWO TIMES A DAY IF NEEDED OR DIRECTED BY A DOCTOR. 
    • IF BOTHERSOME DRYNESS OR PEELING OCCURS, REDUCE APPLICATION TO ONCE A DAY OR EVERY OTHER DAY. 
    • IF GOING OUTSIDE, APPLY SUNSCREEN AFTER USING THIS PRODUCT.  IF IRRITATION OR SENSITIVITY DEVELOPS, STOP USING BOTH PRODUCTS AND ASK A DOCTOR.
  • OTHER INFORMATION

    KEEP TIGHTLY CLOSED.  AVOID STORING AT TEMPERATURES ABOVE 90 DEGREES FAHRENHEIT.

  • QUESTIONS OR COMMENTS

    1-888-309-9030

  • INACTIVE INGREDIENTS

    GLYCERIN, PETROLATUM, WATER, SODIUM C12-15 ALKYL BENZOATE, MINERAL OIL, SODIUM COCOYL ISETHIONATE, ZINC LACTATE, SODIUM C14-16 OLEFIN SULFONATE, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, POTASSIUM POLYPHOSPHATE, MENTHOL, FRAGRANCE, TITANIUM DIOXIDE, CARBOMER, TRIETHANOLAMINE.

  • Front and back labels

    image of the label

  • INGREDIENTS AND APPEARANCE
    ACNE CONTROL CLEANSER 
    benzoyl peroxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-825
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE10 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    WATER (UNII: 059QF0KO0R)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)  
    ZINC LACTATE (UNII: 2GXR25858Y)  
    SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
    POTASSIUM METAPHOSPHATE (UNII: 01DMT14Z63)  
    MENTHOL (UNII: L7T10EIP3A)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CARBOMER 934 (UNII: Z135WT9208)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    CARBOMER INTERPOLYMER TYPE A (55000 MPA.S) (UNII: 59TL3WG5CO)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55910-825-05141 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333D10/25/2011
    Labeler - DOLGENCORP INC (068331990)
    Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    APOLLO HEALTH AND BEAUTY CARE201901209manufacture
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