Label: CLEARSKIN CLEAR EMERGENCY INTENSIVE TREATMENT- 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 May 23, 2012

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  • ACTIVE INGREDIENT

    Active Ingredients
    Salicylic Acid 2.0%...................................................

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

  • INDICATIONS & USAGE

    Uses
    • for the treatment of acne

  • WARNINGS

    Warnings
    For external use only.

    FLAMMABLE
    Keep away from heat or flame.

    When using this product
    • avoid contact with eyes. If product contacts eyes, 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, only use one topical medication at a time.

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

    Sunburn Alert: Use only as directed. This product contains an alpha hydroxy acid that may increase your skin's sensitivity to the sun and possibility of sunburn. Use a sunscreen and limit sun exposure while using this product and for a week afterward.

  • DOSAGE & ADMINISTRATION

    DIRECTIONS
    • Clean the skin thoroughly before applying this product.
    • Cover the entire affected area with a 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 or three times daily if needed or as directed by a doctor.
    • If bothersome dryness or peeling occurs, reduce application to once a day or every other day.

  • INACTIVE INGREDIENT

    Inactive Ingredients: WATER/EAU, SD ALCOHOL 40-B, GLYCERIN, BUTYLENE GLYCOL, GLYCOLIC ACID, ETHOXYDIGLYCOL, THIODIPROPIONIC ACID, TRIOXAUNDECANEDIOIC ACID, TRITICUM VULGARE (WHEAT) GERM EXTRACT, PERILLA OCYMOIDES LEAF EXTRACT, SILYBUM MARIANUM EXTRACT, PENTYLENE GLYCOL, TRIS(TETRAMETHYLHYDROXYPIPERIDINOL) CITRATE, CARRAGEENAN, AMMONIUM HYDROXIDE, DISODIUM EDTA, PARFUM/FRAGRANCE.

  • QUESTIONS

    Questions? Call 1-800-FOR-AVON

  • PRINCIPAL DISPLAY PANEL

    image of PDPimage of DFB

  • INGREDIENTS AND APPEARANCE
    CLEARSKIN  CLEAR EMERGENCY INTENSIVE TREATMENT
    salicylic acid gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10096-0267
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 0.022 mL  in 1.1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10096-0267-210 in 1 CARTON
    1NDC:10096-0267-11.1 mL in 1 PACKET
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D12/20/2011
    Labeler - Avon Products, Inc. (001468693)
    Establishment
    NameAddressID/FEIBusiness Operations
    Avon Products, Inc.005149471manufacture
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