Label: PCA SKIN BPO CLEANSER- benzoyl peroxide gel

  • NDC Code(s): 68726-168-01, 68726-168-02, 68726-168-04
  • Packager: Physicians Care Alliance DBA PCA SKIN
  • 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 June 28, 2021

If you are a consumer or patient 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

  • 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 Product04/01/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D04/01/2010
    Labeler - Physicians Care Alliance DBA PCA SKIN (969945133)