Label: MARK. BACK UP PLAN ANTI-ACNE BACK TREATMENT- salicylic acid spray

  • 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 29, 2009

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  • ACTIVE INGREDIENT

    Active/Medicinal ingredient                Purpose

    Salicylic Acid 2.0%..................Acne Treatment

  • INDICATIONS & USAGE

    Uses
    • helps in the treatment of acne
    • helps clear up acne blemishes
    • helps prevent new acne blemishes
    from forming
    • penetrates pores to eliminate most
    blackheads and acne pimples

  • WARNINGS

    Warnings
    For external use only

    When using this product
    • avoid contact with eyes. If product
    contacts eyes, rinse thoroughly with water.
    • if excessive skin irritation develops or
    increases, discontinue use. If irritation
    persists, consult a health care practitioner.
    • using other topical acne products at the
    same time or immediately following use of
    this product may increase dryness or
    irritation of the skin. If this occurs, only one
    product should be used unless directed by
    a health care practitioner

    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.

  • DOSAGE & ADMINISTRATION

    Directions
    • cleanse skin thoroughly with non-medicated
    cleanser before applying medication
    • apply to blemish-prone areas one to
    three times daily or as directed by a
    health care practitioner
    • 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

  • INACTIVE INGREDIENT

    Inactive/Non-medicinal ingredients:
    Water/Eau, SD Alcohol 40-B, Hamamelis
    Virginiana (Witch Hazel) Extract, Pyrus Malus
    (Apple) Fruit Extract, Cinnamomum Cassia
    Bark Extract, Trideceth-9, Potassium
    Hydroxide, Citric Acid, Disodium EDTA,
    Pyridoxine HCL.

  • QUESTIONS

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

  • PRINCIPAL DISPLAY PANEL

    image of carton

  • INGREDIENTS AND APPEARANCE
    MARK. BACK UP PLAN  ANTI-ACNE BACK TREATMENT
    salicylic acid spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10096-0192
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ) Salicylic Acid4.72 mL  in 118 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10096-0192-21 in 1 CARTON
    1NDC:10096-0192-1118 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33312/29/2009
    Labeler - Avon Products, Inc. (001468693)
    Establishment
    NameAddressID/FEIBusiness Operations
    Avon Products, Inc.001807106manufacture
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