Label: ACNE CLEANSER- 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 (0.5%)..........Acne Treatment

  • PURPOSE

    Purpose

    Acne Treatment

  • INDICATIONS & USAGE

    For treatment of acne

  • WARNINGS

    Warnings

    For external use only

    Avoid contact with eyes. If contact occurs, rinse thoroughly with water.

    If swallowed, get medical help or contact a Poison Control Center right away. If excessive skin irritation develops or increases, discontinue use and consult a doctor. Keep out of reach of children.

  • 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:

    Wash affected area twice daily.

  • INACTIVE INGREDIENT

    Other Ingredients:

    Aqua, Sodium Methyl 2-Sulfolaurate, Disodium 2-Sulfolaurate, Glycerin, Ethoxydiglycol, Hydroxyethylcellulose, Guar Hydroxypropyltrimonium Chloride, Camellia Sinensis Leaf Extract, Aloe Barbadensis Leaf Extract, Sodium Hyaluronate (Hyaluronic Acid), Sodium Hydroxide, *CO Glycerin, *CO Calendula Officinalis Flower Extract, *CO Chamomilla Recutita (Matricaria) Flower Extract, *CO Citrus Limon (Lemon) Peel Extract, *CO Humulus Lupulus (Hops) Extract, *CO Lavandula Angustifolia (Lavender) Flower/Leaf/Stem Extract, *CO Pyrus Malus (Apple) Fruit Extract, *CO Spirulina Platensis Extract, *CO Cucumis Sativus (Cucumber) Seed Extract, *CO Camellia Sinensis Leaf Extract, Ascorbic Acid (Vitamin C), Tocopheryl Acetate (Vitamin E), Retinyl Palmitate (Vitamin A), Benzyl Alcohol, Dehydroacetic Acid, Fragrance. *CO Certified Organic

  • PRINCIPAL DISPLAY PANEL

    PL Acne Cleanser FDA

  • INGREDIENTS AND APPEARANCE
    ACNE CLEANSER 
    salicylic acid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68062-9905
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID1.15 mg  in 230 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM METHYL 2-SULFOLAURATE (UNII: I39GGJ23HV)  
    DISODIUM 2-SULFOLAURATE (UNII: 329M3829G2)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68062-9905-1240 mL in 1 BOTTLE; Type 0: Not a Combination Product11/19/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00611/19/2023
    Labeler - Spa de Soleil (874682867)
    Registrant - Spa de Soleil (874682867)
    Establishment
    NameAddressID/FEIBusiness Operations
    Spa de Soleil874682867manufacture(68062-9905)
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