Label: ANTIBACTERIAL BODY WASH- triclosan liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 June 27, 2011

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  • Active Ingredient

    Triclosan 0.15%

  • Purpose

    Antibacterial

  • USES

    For washing to decrease bacteria on the skin.

  • WARNINGS

    FOR EXTERNAL USE ONLY.

    WHEN USING THIS PRODUCT

    AVOID CONTACT WITH EYES.  IF CONTACT OCCURS, RINSE THROUGHLY WITH WATER.

    STOP USING THIS PRODUCT AND ASK DOCTOR IF

    IRRITATION AND REDNESS DEVELOPS.

    KEEP OUT OF REACH OF CHILDREN

    IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

  • DIRECTIONS

    SQUEEZE A SMALL AMOUNT ONTO A WET WASHCLOTH, SPONGE, POUF OR HANDS AND APPLY TO BODY.  WORK INTO A RICH LATHER AND RINSE OFF.

  • QUESTIONS OR COMMENTS?

    1-800-842-7886

  • INACTIVE INGREDIENTS

    WATER, SODIUM LAURETH SULFATE, COCAMIDOPROPYL BETAINE, PEG-8, FRAGRANCE, GLYCERIN, ISOSTEARAMIDOPROPYL  MORPHOLINE LACTATE, POLYQUATERNIUM-10, COCAMIDOPROPYL PG-DIMONIUM CHLORIDE, DMDM HYDANTOIN, CITRIC ACID, TETRASODIUM EDTA, SODIUM CHLORIDE, BLUE 1 (CI42090), RED 33 (CI 17200).

  • PRINCIPAL DISPLAY PANEL

    IMAGE OF ANTIBACTERIAL BODY WASH

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL BODY WASH 
    triclosan liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49738-805
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN0.15 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    POLYETHYLENE GLYCOL 900 (UNII: UEP843BRCQ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    ISOSTEARAMIDOPROPYL MORPHOLINE LACTATE (UNII: 082Y3WQI5K)  
    POLYQUATERNIUM-10 (400 CPS AT 2%) (UNII: HB1401PQFS)  
    COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49738-805-18532 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E06/27/2011
    Labeler - Kmart Corporation (008965873)
    Registrant - Apollo Health and Beauty Care (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apollo Health and Beauty Care201901209manufacture
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