Label: MARK.- 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 29, 2009

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  • ACTIVE INGREDIENT

    See attached 1092906 breakout plan FC.jpg

    Active ingredient                              Purpose
    Salicylic Acid 1.5%....................................Acne Treatment

  • INDICATIONS & USAGE

    Uses

    • helps in the treatment of acne
    • helps prevent new acne blemishes from forming
    • clears up acne blemishes
    • 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 irritation persists, seek medical attention
    • using other topical acne products at the same time or immediately after 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 doctor.

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

  • DOSAGE & ADMINISTRATION


    Directions

    • cleanse skin thoroughly before applying medication
    • 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 a day or every other day
  • INACTIVE INGREDIENT

    Inactive/Non-medicinal ingredients

    WATER/EAU
         SD ALCOHOL 40-B
         DIMETHICONE
         POLYSORBATE 20     
         GLYCERIN
         PYRUS MALUS (APPLE) FRUIT EXTRACT
         VANILLA PLANIFOLIA FRUIT EXTRACT
         ROSMARINUS OFFICINALIS (ROSEMARY) LEAF EXTRACT
         MENTHA PIPERITA (PEPPERMINT) LEAF EXTRACT
         SPIRAEA ULMARIA EXTRACT
         CINNAMOMUM CASSIA BARK EXTRACT
         CUCUMIS SATIVUS (CUCUMBER) FRUIT EXTRACT
         HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER
         ISOHEXADECANE
         XANTHAN GUM
         TRIMETHYLSILOXYSILICATE
         POLYMETHYL METHACRYLATE
         SILICA
         POLYSORBATE 60
         TALC
         SORBITAN ISOSTEARATE
         CAPRYLIC/CAPRIC TRIGLYCERIDE
         ISOPROPYL MYRISTATE
         DIPROPYLENE GLYCOL
         PYRIDOXINE HCL
         DISODIUM EDTA
         BENZYL ALCOHOL

  • QUESTIONS

    Questions? Call 1-800-meetmark

  • PRINCIPAL DISPLAY PANEL

    image of carton label
  • INGREDIENTS AND APPEARANCE
    MARK.   BREAK OUT PLAN
    salicylic acid gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10096-0195
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID.75 mL  in 50 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10096-0195-150 mL in 1 JAR
    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.005149471manufacture
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