Label: CLEARSKIN PROFESSIONAL- 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 December 10, 2009

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active ingredient                              Purpose

    Salicylic Acid 2.00%....................................Acne Treatment

  • INDICATIONS & USAGE

    Uses

    • for the treatment of acne
    • reduces the number of acne blemishes
    • clears up most acne blemishes
  • WARNINGS

    Warnings
    For external use only

  • WHEN USING

    When using this product

    • avoid contact with eyes. If product contacts eyes, rinse thoroughly with water.
    • using other topical acne products at the same time or immediately after 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

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

  • Flammable

    Flammable. Keep away from heat or flame.

  • DOSAGE & ADMINISTRATION

    Directions

    • cleanse skin thoroughly before applying medication
    • cover the entire affected area with thin layer 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 doctor
    • if bothersome dryness or peeling occurs, reduce application to once aday or every other day
  • INACTIVE INGREDIENT

    Inactive ingredients Water/Eau, SD Alcohol 40-B, Propylene Glycol,
    Trideceth-9, Ethoxydiglycol, Hydroxyethylcellulose, Hamamelis Virginiana
    (Witch Hazel) Extract, Triticum Vulgare (Wheat) Germ Extract, Aloe Barbadensis
    Leaf Juice, Punica Granatum Fruit Juice, Silybum Marianum Extract,
    Chamomilla Recutita (Matricaria) Flower Extract, Thiodipropionic Acid,
    Saccharomyces/Zinc Ferment, Tocopherol, Styrene/VP Copolymer,
    Xanthan Gum, Parfum/Fragrance, Isododecane, Polystyrene/Hydrogenated
    Polyisopentene Copolymer, Sodium Laureth-40 Sulfate, Retinyl Palmitate,
    Glycolic Acid, Ammonium Hydroxide, Disodium EDTA.

  • QUESTIONS

    Questions? Call 1-800-FOR-AVON

  • PRINCIPAL DISPLAY PANEL

    image of PDPimage of cartonimage of carton

  • INGREDIENTS AND APPEARANCE
    CLEARSKIN PROFESSIONAL   INVISIBLE BLEMISH TREATMENT
    salicylic acid gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10096-0180
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Salicylic Acid (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) Salicylic Acid0.30 mL  in 15 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ISODODECANE (UNII: A8289P68Y2)  
    GLYCOLIC ACID (UNII: 0WT12SX38S)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10096-0180-21 in 1 CARTON
    1NDC:10096-0180-115 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33312/10/2009
    Labeler - Avon Products, Inc. (001468693)
    Establishment
    NameAddressID/FEIBusiness Operations
    Avon Products, Inc. 005149471manufacture