Label: ACNE SCRUB- salicylic acid liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 20, 2023

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  • ACTIVE INGREDIENT

    Active ingredient Purpose

    Salicylic Acid (1.0%)..........Acne Treatment

  • PURPOSE

    Purpose

    Acne Treatment

  • INDICATIONS & USAGE

    For treatment of acne

  • WARNINGS

    Warnings

    For external use only. Using other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor. Sensitivity Test for a New User. Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the steps stated in directions.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Center right away.

  • WHEN USING

    When using this product

    • Skin irritation and dryness is more likely to occur if you use another topical acne medication while using this product. If irritation occurs, use only one topical acne medication at a time.

  • DOSAGE & ADMINISTRATION

    Directions:

    Wet face. Apply to hands, add water and work into a lather. Massage face gently. Rinse thoroughly. 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 of peeling occurs, reduce application to once a day or every other day.

  • INACTIVE INGREDIENT

    Other Ingredients:

    Sucrose, Caprylic/Capric Triglyceride, Decyl Glucoside, Glycerin, Cocos Nucifera (Coconut) Oil, Cetearyl Alcohol, Cetearyl Glucoside, Olea Europaea (Olive) Fruit Oil, Citrus Limon (Lemon) Peel Oil, Tapioca Starch, Aqua, Tocopheryl Acetate (Vitamin E), Citric Acid, Lactic Acid, Malic Acid, Gluconic Acid, Ascorbic Acid (Vitamin C), Glycolic Acid, Tartaric Acid, Benzyl Alcohol, Fragrance.

  • PRINCIPAL DISPLAY PANEL

    PL ACNE SCRUB FDA

  • INGREDIENTS AND APPEARANCE
    ACNE SCRUB 
    salicylic acid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68062-2257
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID1.8 mg  in 180 mL
    Inactive Ingredients
    Ingredient NameStrength
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    SUCROSE (UNII: C151H8M554)  
    CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE (UNII: FJ1H6M2JG9)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    COCOS NUCIFERA WHOLE (UNII: 245J88W96L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68062-2257-1120 mL in 1 BOTTLE; Type 0: Not a Combination Product11/20/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00611/20/2023
    Labeler - Spa de Soleil (874682867)
    Registrant - Spa de Soleil (874682867)
    Establishment
    NameAddressID/FEIBusiness Operations
    Spa de Soleil874682867manufacture(68062-2257)