Label: MARK. GET TREATMENT ANTI-ACNE OVERNIGHT 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 December 16, 2010

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

  • ACTIVE INGREDIENT

    Active Ingredient

    Salicylic Acid 1.7%

    Purpose

    Acne Treatment

  • INDICATIONS & USAGE

    Uses

    • for the treatment of acne
    • clears 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 irritation persists seek medical attention.
    • 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.

    Flammable.

    Keep away from heat or flame.

  • DOSAGE & ADMINISTRATION

    Directions

    • cleanse 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 to three times daily if needed of as directed by a doctor
    • if bothersome dryness, irritation of peeling occurs, reduce application to every other day
  • INACTIVE INGREDIENT

    Inactive Ingredients:

    WATER/EAU
         SD ALCOHOL 40-B
         SILICA
         KAOLIN
         MAGNESIUM ALUMINUM SILICATE
         SORBITAN LAURATE
         CITRIC ACID
         GLYCERIN
         POLYSORBATE 20
         ZINC OXIDE
         PYRUS MALUS (APPLE) JUICE
         VANILLA PLANIFOLIA FRUIT EXTRACT
         ROSMARINUS OFFICINALIS (ROSEMARY) LEAF EXTRACT
         MENTHA PIPERITA (PEPPERMINT) LEAF EXTRACT
         CINNAMOMUM CASSIA BARK EXTRACT
         TOCOPHERYL ACETATE
         CUCUMIS SATIVUS (CUCUMBER) FRUIT EXTRACT
         HYDROXYETHYLCELLULOSE
         TETRASODIUM EDTA
         FARNESYL ACETATE
         BUTYLENE GLYCOL
         CAPRYLIC/CAPRIC TRIGLYCERIDE
         PANTHENYL TRIACETATE
         ISOPROPYL MYRISTATE
         DIPROPYLENE GLYCOL  
         TITANIUM DIOXIDE/CI 77891
     
     

  • QUESTIONS

    Questions?

    Call 1-800-MEET-MARK

  • PRINCIPAL DISPLAY PANEL

    image of cartonimage of carton

  • INGREDIENTS AND APPEARANCE
    MARK.  GET TREATMENT ANTI-ACNE OVERNIGHT TREATMENT
    salicylic acid gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10096-0234
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 0.425 mL  in 25 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10096-0234-21 in 1 CARTON
    1NDC:10096-0234-125 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D12/16/2010
    Labeler - Avon Products, Inc. (001468693)
    Establishment
    NameAddressID/FEIBusiness Operations
    Avon Products, Inc.005149471manufacture