Label: DERMATOUCH ACNECARE CLEANSER- salicylic acid liquid

  • 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 8, 2022

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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

    ACNECAREcleanser

  • INGREDIENTS AND APPEARANCE
    DERMATOUCH ACNECARE CLEANSER 
    salicylic acid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68062-9005
    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:68062-9005-1230 mL in 1 BOTTLE; Type 0: Not a Combination Product07/08/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D07/08/2022
    Labeler - Spa de Soleil (874682867)
    Registrant - Spa de Soleil (874682867)
    Establishment
    NameAddressID/FEIBusiness Operations
    Spa de Soleil874682867manufacture(68062-9005)
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