Label: MARK. HELP WANTED ANTI-ACNE EXFOLIATING CLEANSER- salicylic acid paste

  • 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 20, 2010

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  • ACTIVE INGREDIENT

    Active ingredient

    Salicylic Acid 0.5%.................

                        Purpose

    .....................Acne Treatment

  • INDICATIONS & USAGE

    Uses

    • for 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 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.

  • DOSAGE & ADMINISTRATION

    Directions

    • wet hands and face with warm water
    • pour into hands and work into a lather
    • gently massage into skin in a circular motion, avoiding the eye area
    • rinse and pat dry.
    • 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, irritation or peeling occurs, reduce application to every other day
  • INACTIVE INGREDIENT

    Inactive ingredients: WATER/EAU
         SODIUM LAURETH SULFATE
         KAOLIN
         COCAMIDE MEA
         GLYCOL STEARATE
         SODIUM COCO-SULFATE
         HYDROGENATED CASTOR OIL
         PYRUS MALUS (APPLE) JUICE
         VANILLA PLANIFOLIA FRUIT EXTRACT
         ROSMARINUS OFFICINALIS (ROSEMARY) LEAF EXTRACT
         MENTHA PIPERITA (PEPPERMINT) LEAF EXTRACT
         CINNAMOMUM CASSIA BARK EXTRACT
         CUCUMIS SATIVUS (CUCUMBER) FRUIT EXTRACT
         PEG-40 HYDROGENATED CASTOR OIL
         POLYETHYLENE
         BUTYLENE GLYCOL
         SHEA BUTTERAMIDOPROPYL BETAINE     
         SD ALCOHOL 40-B
         METHYLPARABEN
         DISODIUM EDTA
         GLYCINE SOJA (SOYBEAN) OIL
         HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL
         HYDRATED SILICA
         PHOSPHORIC ACID
         CAPRYLIC/CAPRIC TRIGLYCERIDE
         ISOPROPYL MYRISTATE
         DIPROPYLENE GLYCOL
         HEXYLENE GLYCOL
         METHYLCHLOROISOTHIAZOLINONE
         METHYLISOTHIAZOLINONE
           TITANIUM DIOXIDE/CI 77891

  • QUESTIONS

    Questions?

    Call 1-800-MEET-MARK

  • PRINCIPAL DISPLAY PANEL

    image of PDPimage of DFB

  • INGREDIENTS AND APPEARANCE
    MARK. HELP WANTED  ANTI-ACNE EXFOLIATING CLEANSER
    salicylic acid paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10096-0237
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 0.75 mL  in 150 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    KAOLIN (UNII: 24H4NWX5CO)  
    GLYCOL STEARATE (UNII: 0324G66D0E)  
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    PHOSPHORIC ACID (UNII: E4GA8884NN)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10096-0237-1150 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D12/20/2010
    Labeler - Avon Products, Inc. (001468693)
    Establishment
    NameAddressID/FEIBusiness Operations
    Avon Products, Inc.005149471manufacture