Label: CLEARSKIN PORE PENETRATING COOLING TONER- salicylic acid liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 11/12

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  • ACTIVE INGREDIENT

    Active ingredient
    Salicylic Acid 0.5%.........................................

    Purpose
    ..................................................Acne Treatment

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  • INDICATIONS & USAGE

    Uses
    • for the treatment of acne
    • penetrates pores to help control acne blemishes

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  • WARNINGS

    Warnings
    For external use only.

    When using this product
    • avoid contact with eyes. If contact occurs, rinse thoroughly with water.
    • skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, use only one topical acne medication at a time unless directed by a health care practitioner.

    • Stop use and ask a doctor if rash or irritation develops or increases.

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

    Flammable. Keep away from heat or flame.

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  • DOSAGE & ADMINISTRATION

    Directions
    • Cleanse the skin thoroughly before applying the product.
    • Cover the entire affected area one to three times daily.
    • Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two to three times daily, if needed, or as directed by a health care practitioner.
    • If bothersome dryness or peeling occurs, reduce application to once a day or every other day.

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  • INACTIVE INGREDIENT

    Inactive ingredients
    water/eau, SD alcohol 40-B, hamamelis virginiana (witch hazel) extract, glycerin, polysorbate 20, eucalyptus globulus leaf extract, aloe barbadensis leaf extract, menthol, trideceth-9, sodium citrate, citric acid, quaternium-22, tetrasodium EDTA, parfum/fragrance, benzophenone-2, propylene glycol, disodium EDTA, yellow 6/CI 15985, blue 1/CI 42090, red 4/CI 14700.

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  • QUESTIONS

    Questions? Call 1-800-FOR-AVON or 1-800-265-AVON in Canada.

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  • INGREDIENTS AND APPEARANCE
    CLEARSKIN PORE PENETRATING  COOLING TONER
    salicylic acid liquid
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:10096-0289
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID 5 mg  in 1 mL
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:10096-0289-1 250 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333D 11/06/2012
    Labeler - Avon Products, Inc. (001468693)
    Establishment
    Name Address ID/FEI Business Operations
    Avon Products, Inc. 005149471 manufacture(10096-0289)
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