Label: BLEMISH CORRECTING SERUM- benzoyl peroxide gel 

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 02/13

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

  • ACTIVE INGREDIENT

    ACTIVE INGREDIENT

    BENZOYL PEROXIDE 5%

    Close
  • PURPOSE

    PURPOSE

    ACNE TREATMENT

    Close
  • INDICATIONS & USAGE

    USES

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

    WARNINGS

    FOR EXTERNAL USE ONLY

    Close
  • DO NOT USE

    DO NOT USE

    • IF YOU HAVE VERY SENSITIVE SKIN
    • ARE SENSITIVE TO BENZOYL PEROXIDE
    Close
  • 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.
    Close
  • STOP USE

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

    Close
  • 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.

    Close
  • 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.
    Close
  • OTHER SAFETY INFORMATION

    Other Information

    Store at 15-30°C (59-86°F)

    Close
  • 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

    Close
  • INGREDIENTS AND APPEARANCE
    BLEMISH CORRECTING SERUM 
    benzoyl peroxide gel
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:54272-102
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE 5 g  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    DIGLYCERIN  
    PROPANEDIOL  
    BUTYLENE GLYCOL  
    SALICYLIC ACID  
    ALLANTOIN  
    .ALPHA.-BISABOLOL, (+/-)-  
    GLYCERIN  
    ANGELICA SINENSIS WHOLE  
    GLYCERIN  
    ANGELICA SINENSIS WHOLE  
    AVENA SATIVA TOP  
    LECITHIN, SOYBEAN  
    ETHYLHEXYLGLYCERIN  
    CARBOMER 934  
    CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)  
    AMINOMETHYLPROPANOL  
    PHENOXYETHANOL  
    POTASSIUM SORBATE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:54272-102-11 30 mL in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333D 02/21/2013
    Labeler - CEN BEAUTY LLC (078664118)
    Registrant - CEN BEAUTY LLC (078664118)
    Close