Label: ANTIBACTERIAL- 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 2, 2011

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  • ACTIVE INGREDIENT

    TRICLOSAN 0.15%

  • PURPOSE

    ANTIBACTERIAL

  • USES

    FOR HAND WASHING TO DECREASE BACTERIA ON THE SKIN.

  • WARNINGS

    FOR EXTERNAL USE ONLY.

    WHEN USING THIS PRODUCT

    AVOID CONTACT WITH EYES.  IF CONTACT OCCURS, RINSE THOROUGHLY 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

    USE TO REFILL A HAND SOAP PUMP BOTTLE. FROM THE PUMP BOTTLE APPLY A SMALL AMOUNT ONTO WET HANDS. LATHER AND RINSE CLEAN.

  • QUESTIONS OR COMMENTS

    1-866-842-7886

  • INACTIVE INGREDIENTS

    WATER, SODIUM C14-16 OLEFIN SULFONATE, LAURAMIDE DEA, SODIUM CHLORIDE, COCAMIDOPROPYL BETAINE, FRAGRANCE, CITRIC ACID, DMDM HYDANTOIN, GLYCERIN, TETRASODIUM EDTA, POLYQUATERNIUM-7, SILK PEPTIDE, HYDROLYZED SILK PROTEIN, ALOE BARBADENSIS LEAF JUICE, RED 40 (CI 16035), YELLOW 5 (19140), RED 33 (CI 17200)

  • PRINCIPAL DISPLAY PANEL

    IMAGE OF ANTIBACTERIAL

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL   REFILL
    triclosan liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49738-216
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN0.15 L  in 100 L
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM C14 OLEFIN SULFONATE (UNII: N816E2SOKI)  
    LAURIC DIETHANOLAMIDE (UNII: I29I2VHG38)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) (UNII: 0L414VCS5Y)  
    BOMBYX MORI FIBER (UNII: 6LK42KUV6W)  
    BOMBYX MORI FIBER (UNII: 6LK42KUV6W)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49738-216-641.89 L in 1 BOTTLE, PUMP
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E06/02/2011
    Labeler - KMART CORPORATION (008965873)
    Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    APOLLO HEALTH AND BEAUTY CARE201901209manufacture
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