Label: PCA GEL- salicylic acid gel

  • NDC Code(s): 68726-445-01, 68726-445-02, 68726-445-03
  • Packager: CP Skin Health Group, Inc
  • 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 November 3, 2022

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  • Active Ingredients

    Salicylic Acid 2%

    Purpose

    Acne Treatment

  • Uses

    • For the treatment of acne
    • Helps keep skin clear of new acne pimples, blackheads or whiteheads
  • Warnings

      For external use only

    When using this product

    • 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 medication at a time.

    Keep out of reach of children.

    If product is swallowed, get medical help or contact a Poison Control Center right away

  • Directions

    • Clean the skin thoroughly before applying this product
    • Cover the entire affected area with a thin layer one to three times daily
    • because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three 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.
  • Inactive Ingredients

    Alcohol, Butylene Glycol, Cellulose, Denatonium Benzoate, Ethoxydiglycol, Ethyl Linoleate, Hexylresorcinol, Hydroxyethylcellulose, Isopentyldiol, Mandelic Acid, Pentylene Glycol, Polyacrylate Crosspolymer-6, Polyglyceryl-10 Dioleate, Polyglyceryl-10 Dipalmitate, Potassium Hydroxide, Sodium Acetate, t-Butyl Alcohol, Water

  • PRINCIPAL DISPLAY PANEL

    acnegel2020

  • INGREDIENTS AND APPEARANCE
    PCA GEL 
    salicylic acid gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68726-445
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
    DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)  
    DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
    ETHYL LINOLEATE (UNII: MJ2YTT4J8M)  
    HEXYLRESORCINOL (UNII: R9QTB5E82N)  
    ISOPENTYLDIOL (UNII: 19NOL5474Q)  
    MANDELIC ACID (UNII: NH496X0UJX)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)  
    POLYGLYCERYL-10 OLEATE (UNII: 55C81W76DH)  
    POLYGLYCERYL-10 DIPALMITATE (UNII: 84VD0IA2S6)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68726-445-021 in 1 CARTON08/01/2020
    1NDC:68726-445-0129.5 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:68726-445-037.3 mL in 1 TUBE; Type 0: Not a Combination Product08/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM00608/01/2020
    Labeler - CP Skin Health Group, Inc (611921669)
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