Label: CLEARSKIN BLACKHEAD ELIMINATING CLEANSER- salicylic acid gel

  • 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 January 1, 2019

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  • ACTIVE INGREDIENT

    Active ingredient                                          
    Salicylic Acid 2.0%..................................

    Purpose

    ..........Acne Treatment

  • INDICATIONS & USAGE

    Uses

    • for the treatment of acne
    • clears up blackheads
    • helps prevent new blackheads from forming
  • WARNINGS

    Warnings
    For external use only

    When using this product

    • avoid contact with eyes. If product contacts eyes, rinse thoroughly with water. If irritation persists, seek medical attention.
    • using other topical acne medications at the same time or immediately after 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.

    Keep out of reach of children. If swallowed, get medical help or
    contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions
    Moisten face and neck with warm water. Gently massage product onto
    skin using a light, circular motion. Avoid areas around the eyes. Rinse
    thoroughly and pat dry. May be used once daily.

  • INACTIVE INGREDIENT

    Inactive ingredients Water/Eau, Sodium C14-16 Olefin Sulfonate,
    Glycerin, Cocamidopropyl Betain, Polyethylene, Sodium Methyl Cocoyl
    Taurate, Acrylates Copolymer, Sodium Chloride, Aluminum Starch
    Octenylsuccinate, Sodium Lauroamphoacetate, Aloe Barbadensis Leaf
    Juice, Chamomilla Recutita (Matricaria) Flower Extract, Citric Acid, C20-40
    Alcohols, Parfum/Fragrance, Cocamidopropyl PG-Dimonium Chloride
    Phosphate, Disodium EDTA, Isododecane, Lysine Carboxymethyl Cysteinate,
    Polystyrene/Hydrogenated Polyisopentene Copolymer, Sodium C8-16
    Isoalkylsuccinyl Lactoglobulin Sulfonate, Sodium Hydroxide, Blue 1
    Lake/CI 42090, Violet 2/CI 60725.

  • QUESTIONS

    Questions? Call 1-800-FOR-AVON

  • PRINCIPAL DISPLAY PANEL

    image of PDPimage of label

  • INGREDIENTS AND APPEARANCE
    CLEARSKIN  BLACKHEAD ELIMINATING CLEANSER
    salicylic acid gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10096-0182
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID20 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10096-0182-1125 mL in 1 TUBE; Type 0: Not a Combination Product12/16/2009
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D12/16/2009
    Labeler - New Avon LLC (080143520)
    Establishment
    NameAddressID/FEIBusiness Operations
    Fareva Morton Grove, Inc.116752326manufacture(10096-0182)
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