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 15, 2011

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  • ACTIVE INGREDIENT

    TRICLOSAN 0.115%

  • PURPOSE

    ANTIBACTERIAL

  • USES

    HELPS REDUCE GERMS ON HANDS.

  • 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 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

    APPLY ONTO WET HANDS, LATHER, WASH AND RINSE.

  • OTHER INFORMATION

    STORE AT ROOM TEMPERATURE.

  • INACTIVE INGREDIENTS

    WATER, SODIUM LAURETH SULFATE, COCAMIDOPROPYL BETAINE, DECYL GLUCOSIDE, POLYQUATERNIUM-7, PEG- 7 GLYCERYL COCOATE, PEG-120 METHYL GLUCOSE DIOLEATE, TETRASODIUM EDTA, SODIUM CHLORIDE, DMDM HYDANTOIN,CITRIC ACID, FRAGRANCE, BLUE 1 (CI 42090), RED 33 (CI 17200).

  • PRINCIPAL DISPLAY PANEL

    image of label

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL  
    triclosan liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47124-720
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN0.115 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) (UNII: 0L414VCS5Y)  
    PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)  
    PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:47124-720-641890 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E06/15/2011
    Labeler - WEGMANS FOOD MARKETS INC (059650069)
    Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    APOLLO HEALTH AND BEAUTY CARE201901209manufacture