Label: BLEMISH CORRECTING SERUM- benzoyl peroxide gel

  • 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 February 26, 2013

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    ACTIVE INGREDIENT

    BENZOYL PEROXIDE 5%

  • PURPOSE

    PURPOSE

    ACNE TREATMENT

  • INDICATIONS & USAGE

    USES

    • TREATS ACNE
    • DRIES UP ACNE PIMPLES
    • HELPS PREVENT NEW ACNE PIMPLES
  • WARNINGS

    WARNINGS

    FOR EXTERNAL USE ONLY

  • DO NOT USE

    DO NOT USE

    • IF YOU HAVE VERY SENSITIVE SKIN
    • ARE SENSITIVE TO BENZOYL PEROXIDE
  • WHEN USING

    WHEN USING THIS PRODUCT

    • AVOID UNNECESSARY SUN EXPOSURE AND USE A SUNSCREEN
    • AVOID CONTACT WITH THE EYES, LIPS, AND MOUTH. AVOID CONTACT WITH HAIR AND DYED FABRICS, WHICH MAY BE BLEACHED BY THE 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.
    • 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.
  • STOP USE

    STOP USE AND ASK A DOCTOR IF TOO MUCH SKIN IRRITATION OR SENSITIVITY DEVELOPS OR INCREASES.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

  • DOSAGE & ADMINISTRATION

    DIRECTIONS

    • ON CLEAN AND DRY SKIN, APPLY A SMALL AMOUNT EVENLY OVER THE AFFECTED AREAS.
    • AVOID THE DELICATE EYE AREA.
    • START WITH ONE APPLICATION DAILY THEN GRADUALLY INCREASE TO TWO 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.
    • CONSULT A PHYSICIAN BEFORE USE.
  • OTHER SAFETY INFORMATION

    Other Information

    Store at 15-30°C (59-86°F)

  • INACTIVE INGREDIENT

    INGREDIENTS

    aqua (water), diglycerin, propanediol, butylene glycol, salicylic acid, allantoin, bisabolol, glycerin, angelica sinensis extract, avena sativa (oat) kernel extract, lecithin, ethylhexylglycerin, carbomer, acrylates/C10-30 alkyl acrylate , crosspolymer, aminomethyl propanol, phenoxyethanol, potassium sorbate

  • PRINCIPAL DISPLAY PANEL

    BB_Blemish Correcting Serum-BPO CX223

    BB_Blemish Correcting Serum-BPO_1oz_Tubes_ARTWORK_FR

  • INGREDIENTS AND APPEARANCE
    BLEMISH CORRECTING SERUM 
    benzoyl peroxide gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54272-102
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIGLYCERIN (UNII: 3YC120743U)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    SALICYLIC ACID (UNII: O414PZ4LPZ)  
    ALLANTOIN (UNII: 344S277G0Z)  
    .ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ANGELICA SINENSIS WHOLE (UNII: 697D19QDBN)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ANGELICA SINENSIS WHOLE (UNII: 697D19QDBN)  
    AVENA SATIVA TOP (UNII: 1ZX4OXU3N6)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    CARBOMER 934 (UNII: Z135WT9208)  
    CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54272-102-1130 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D02/21/2013
    Labeler - CEN BEAUTY LLC (078664118)
    Registrant - CEN BEAUTY LLC (078664118)