Label: PCA SKIN BPO CLEANSER- benzoyl peroxide gel

  • NDC Code(s): 68726-168-01, 68726-168-02, 68726-168-04
  • Packager: CP Skin Health Group, Inc.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated December 3, 2024

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • ACTIVE INGREDIENT

    Active Ingredient:       Benzoyl Peroxide (5.0%)   

    Purpose: Acne Cleanser

  • INDICATIONS & USAGE

    Uses: For the treatment of acne.  Helps keep skin clear of new acne pimples, blackheads and/or whiteheads.

  • WARNINGS

    Warnings: When using this product,avoid unnecessary sun exposure and use a sunscreen.

    ____________________________________________________________________________

    For external use only.

    ____________________________________________________________________________

    Using other topical acne drugs at the same time or immediately following the sue of this product may increase dryness or irritation of the skin.  If this occurs, only one drug should be sued unless directed by a physician.

    _________________________________________________________________________________________

    Do not use in or near the eyes.

    Keep out of reach of children.If swallowed, get medical help or contact Poison Control Center immediately.

  • DOSAGE & ADMINISTRATION

    Directions:

    • Apply a small amount of cleanser to damp skin with fingertips and massage into a light foaming lather.
    • Wash in a gentle circular motion.
    • Rinse with warm (not hot) water and pat dry.
    • Start with one treatment daily or as directed by a physician.
  • INACTIVE INGREDIENT

    Inactive Ingredients: Water/Aqua/Eau, Gluconolactone, Sodium C14-16 Olefin Sulfonate, Aminomethyl Propanol, Glycerin, Cocamidopropyl Betaine, Aloe Babadensis Leaf Juice, Sodium PCA, Tocopheryl Acetate,  Allantoin, Panthenol, Phytic Acid, Triticum Vulgare (Wheat) Germ Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Anthemis Nobilis Flower Extract, Vitis Vinifera (Grape) Seed Extract, Cucumis Sativus (Cucumber) Fruit Extract, Arnica Montana Flower Extract, Algae Extract, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Polyacrylate-13, Caprylyl Glycol, Polisobutene, Ehtylhexylglycerin, Hexylene Glycol, Polysorbate 20, Butylene Glycol, Phenoxyethanol, Citrus Grandis (Grapefruit) Peel Oil.

  • PRINCIPAL DISPLAY PANEL

    BPO Cleanser UC 7oz 2024

  • INGREDIENTS AND APPEARANCE
    PCA SKIN BPO CLEANSER 
    benzoyl peroxide gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68726-168
    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
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    GLUCONOLACTONE (UNII: WQ29KQ9POT)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    ARNICA MONTANA (UNII: O80TY208ZW)  
    CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)  
    CUCUMBER (UNII: YY7C30VXJT)  
    GRAPE (UNII: 6X543N684K)  
    CITRUS PARADISI SEED (UNII: 12F08874Y7)  
    WHEAT GERM (UNII: YR3G369F5A)  
    ALLANTOIN (UNII: 344S277G0Z)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    FYTIC ACID (UNII: 7IGF0S7R8I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68726-168-041 in 1 CARTON04/01/2010
    1NDC:68726-168-01206.5 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:68726-168-0230 mL in 1 BOTTLE; Type 0: Not a Combination Product04/01/201001/31/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00604/01/2010
    Labeler - CP Skin Health Group, Inc. (611921669)