Label: DG BODY 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 May 4, 2012

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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 USE AND ASK A DOCTOR IF

    IRRITATION OR REDNESS DEVELOPS AND LASTS MORE THAN 7 DAYS.

    KEEP OUT OF REACH OF CHILDREN

    IF ACCIDENTALLY INGESTED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

  • DIRECTIONS

    USE AS A REFILL FOR A PUMP DISPENSING BOTTLE. FROM PUMP BOTTLE, SQUEEZE A SMALL AMOUNT ONTO WET HANDS, LATHER INTO RICH FOAM AND RINSE WELL.

  • INACTIVE INGREDIENTS

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

  • LABEL COPY

    IMAGE OF THE LABEL

  • INGREDIENTS AND APPEARANCE
    DG BODY  ANTIBACTERIAL
    triclosan liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-296
    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 C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
    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)  
    SILK, ACID HYDROLYZED (1000 MW) (UNII: 8549W658QV)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55910-296-401180 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E05/02/2012
    Labeler - DOLGENCORP INC. (068331990)
    Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    APOLLO HEALTH AND BEAUTY CARE201901209manufacture
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