Label: ACNE TREATMENT KIT PRESCRIPTION CARE- benzoyl peroxide   

  • Label RSS
  • NDC Code(s): 22431-112-01, 22431-113-01, 22431-114-01
  • Packager: Blue Cross Laboratories
  • 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 01/14

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  • ACTIVE INGREDIENT

    Active Ingredients Purpose

    Benzoyl Perioxide 2.5% Acne Treatment

    To prevent Acne

    Keep out of reach of children

    For external use only

    Warnings

    When using this product, avoid unnecessary sun exposure and use a sunscreen. Do not use this medication if you have very sensitive skin or if you are sensitive to benzoyl peroxide. This product may cause irritation, characterized by redness, burning, itching, peeling or possibly swelling. Mild irritation may be reduced by using the product less frequently or in a lower concentration. If irritation still continues, consult a doctor. Keep away from eyes, lips and mouth. This product may bleach hair or dyed fabrics. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

    Directions: Use Prescription Care 3-Step System everyday, twice a day for beautiful skin.

    Inactive Ingredient

    Inactive Ingredients: Water, Propylene Glycol, Ethoxydiglycol, Cetearyl Alcohol, Blyceryl Stearate, Ceteareth-20, Dimethicone, Panthenol, Fragrance, Cyclomethicone, Allantoin, Carbomer, Methylparaben, Propylparaben, Triethanol Amine, Diazolidinyl Urea, PEG-100, Stearate, Xanthan Gum

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  • PRINCIPAL DISPLAY PANEL




    image of back label

    image of front label

    Prescription Care

    Acne Treatment Kit

    Prescription Strength Acne Formula

    Acne Cleanser 4 fl.oz

    Renewing Toner 4 fl. oz.

    Acne Repair Lotion 4 fl. oz

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  • INGREDIENTS AND APPEARANCE
    ACNE TREATMENT KIT  PRESCRIPTION CARE
    benzoyl peroxide kit
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:22431-112
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:22431-112-01 1 in 1 KIT
    Quantity of Parts
    Part # Package Quantity Total Product Quantity
    Part 1 1 BOTTLE 118 mL
    Part 2 1 BOTTLE 118 mL
    Part 3 1 BOTTLE 118 mL
    Part 1 of 3
    ACNE CLEANSER 
    benzoyl peroxide liquid
    Product Information
    Item Code (Source) NDC:22431-113
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE 2.5 g  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    PROPYLENE GLYCOL  
    SORBITOL  
    DIMETHYL ISOSORBIDE  
    CETYL ESTERS WAX  
    TRIDECYL TRIMELLITATE  
    TRIDECYL STEARATE  
    GLYCERYL MONOSTEARATE  
    CHAMAEMELUM NOBILE  
    SODIUM PYRROLIDONE CARBOXYLATE  
    IMIDUREA  
    XANTHAN GUM  
    METHYLPARABEN  
    PROPYLPARABEN  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:22431-113-01 118 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333D 11/01/2008
    Part 2 of 3
    RENEWING TONER 
    face and neck (excluding shaving preparations)
    Product Information
    Other Ingredients
    Ingredient Kind Ingredient Name Quantity
    INGR WATER  
    INGR GLYCOLIC ACID  
    INGR ALOE VERA LEAF  
    INGR HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK  
    INGR CHAMAEMELUM NOBILE  
    INGR GLYCERIN  
    INGR PROPYLENE GLYCOL  
    INGR SODIUM PYRROLIDONE CARBOXYLATE  
    INGR POLYSORBATE 20  
    INGR PANTHENOL  
    INGR HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)  
    INGR ALLANTOIN  
    INGR IMIDUREA  
    INGR METHYLCHLOROISOTHIAZOLINONE  
    INGR METHYLISOTHIAZOLINONE  
    INGR SODIUM HYDROXIDE  
    INGR FD&C BLUE NO. 1  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 118 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    cosmetic 11/01/2009
    Part 3 of 3
    ACNE REPAIR 
    benzoyl peroxide lotion
    Product Information
    Item Code (Source) NDC:22431-114
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE 2.5 g  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    PROPYLENE GLYCOL  
    DIETHYLENE GLYCOL MONOETHYL ETHER  
    CETOSTEARYL ALCOHOL  
    GLYCERYL MONOSTEARATE  
    DIMETHICONE  
    PANTHENOL  
    CYCLOMETHICONE  
    ALLANTOIN  
    CARBOMER 934  
    METHYLPARABEN  
    PROPYLPARABEN  
    TROLAMINE  
    DIAZOLIDINYL UREA  
    POLYETHYLENE GLYCOL 4500  
    XANTHAN GUM  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:22431-114-01 118 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333D 11/01/2009
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333D 11/01/2009
    Labeler - Blue Cross Laboratories (008298879)
    Registrant - Blue Cross Laboratories (008298879)
    Establishment
    Name Address ID/FEI Business Operations
    Ningbo Liyuan Daily Chemical Products Co., Ltd. 530766098 manufacture(22431-112, 22431-113, 22431-114)
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