Label: DG BODY ANTIBACTERIAL HAND- triclosan soap

  • 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 17, 2015

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  • ACTIVE INGREDIENT

    TRICLOSAN 0.15%

    PURPOSE

    ANTIBACTERIAL

  • USES

    HELPS REDUCE BACTERIA ON THE SKIN

  • WARNINGS

    FOR EXTERNAL USE ONLY

    WHEN USING THIS PRODUCT

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

    STOP USING THIS PRODUCT AND ASK A DOCTOR IF

    IRRITATION OR REDNESS DEVELOPS AND LASTS

    KEEP OUT OF REACH OF CHILDREN

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

  • 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

  • OTHER INFORMATION

    STORE AT ROOM TEMPERATURE

  • INACTIVE INGREDIENTS

    WATER (AQUA), SODIUM LAURETH SULFATE, COCAMIDOPROPYL BETAINE, SODIUM CHLORIDE, COCOAMIDOPROPYL HYDROXYSULTAINE, GLYCERIN, FRAGRANCE (PARFUM), POLYQUATERNIUM-7, PPG-2 HYDROXYETHYL COCO/ISOSTEARAMIDE, DMDM HYDANTOIN, TETRASODIUM EDTA, CITRIC ACID, YELLOW 5 (CI 19140), RED 4 (CI 14700)

  • LABEL COPY

    IMAGE OF THE LABEL

  • INGREDIENTS AND APPEARANCE
    DG BODY  ANTIBACTERIAL HAND
    triclosan soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-294
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN1.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    COCAMIDOPROPYL HYDROXYSULTAINE (UNII: 62V75NI93W)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) (UNII: 0L414VCS5Y)  
    PPG-2 HYDROXYETHYL COCO/ISOSTEARAMIDE (UNII: EK4J71ZKEQ)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55910-294-411180 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E06/16/2015
    Labeler - DOLGENCORP INC (068331990)
    Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    APOLLO HEALTH AND BEAUTY CARE201901209manufacture(55910-294)
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