Label: CREAMY FOAM CLEANSER- salicylic acid cream

  • 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 July 27, 2022

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

  • ACTIVE INGREDIENT

    Active Ingredient: Purpose:

    Salicylic Acid 0.5% Acne Treatment

  • PURPOSE

    Uses:

    • treats acne
    • clears acne blemishes
    • helps prevent development of new acne
  • 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

  • INDICATIONS & USAGE

    When using this product

    • Skin Irritation and dryness is more likely to occur if you use another topical acne medication at the same time
  • WARNINGS

    Warning: For External Use only.

    avoid contact with eyes. If contact occurs, flush thoroughly eyes with water.

  • DOSAGE & ADMINISTRATION

    Directions:

    Cleanse Twice a day. Wet face. Apply to hands and lather to a foam while applying in a circular motion on the face. Massage face gently. RInse Thoroughly.

  • INACTIVE INGREDIENT

    Inactive Ingredients: Water, Butylene Glycol, Pentylene Glycol, Glycerin, Sodium Cocoyl Glutamate, Coco Betaine, Caprylyl Glycol, Cetyl Hydroxyethylcellulose, PCA Ethyl Cocoyl Arginate, Pyrus Malus (Apple) Fruit Extract, Beta Vulgaris (Beet) Root Extract, Fructooligosaccharides, Glycolic Acid, Caprylhydroxamic Acid, Piroctone Olamine, Tetrasodium Glutamate Diacetate, Bakuchiol, Sodium PCA, Aloe Barbadensis Leaf Juice, Artemisia Vulgaris Extract, Dipotassium Glycyrrhizate, Laminaria Digitata Extract, Zinc PCA, Cinnamomum Cassia Bark Extract, Sanguisorba Officinalis Root Extract, Zingiber Officinale (Ginger) Root Extract

  • PRINCIPAL DISPLAY PANEL

    DIME

    CREAMY FOAM CLEANSER

    GLYCOLIC + SALICYLIC ACID

    4 oz 120mL

    creamy Foam Cleanser box

    Foam Cleanser bottle

  • INGREDIENTS AND APPEARANCE
    CREAMY FOAM CLEANSER 
    salicylic acid cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82870-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID0.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETYL HYDROXYETHYLCELLULOSE (350000 MW) (UNII: T7SWE4S2TT)  
    GLYCOLIC ACID (UNII: 0WT12SX38S)  
    PIROCTONE OLAMINE (UNII: A4V5C6R9FB)  
    BEET (UNII: N487KM8COK)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG)  
    PYRROLIDONE CARBOXYLIC ACID ETHYL COCOYL ARGINATE (UNII: A53122S09O)  
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    COCO-BETAINE (UNII: 03DH2IZ3FY)  
    GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
    SANGUISORBA OFFICINALIS ROOT (UNII: 4NYV2HT01X)  
    APPLE (UNII: B423VGH5S9)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CHINESE CINNAMON (UNII: WS4CQ062KM)  
    BAKUCHIOL (UNII: OT12HJU3AR)  
    TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
    LAMINARIA DIGITATA (UNII: 15E7C67EE8)  
    ZINC PIDOLATE (UNII: C32PQ86DH4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82870-002-01120 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/11/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM00607/11/2022
    Labeler - Dime Beauty Co, LLC (058459261)