FAMILY DOLLAR ANTIBACTERIAL HAND (TRICLOSAN) SOAP [FAMILY DOLLAR SERVICES INC.]

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FAMILY DOLLAR ANTIBACTERIAL HAND (TRICLOSAN) SOAP [FAMILY DOLLAR SERVICES INC.]
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NDC 55319-512-01, 55319-512-02
Set ID 58226b19-1e3f-4fdc-a14c-01cb8ac0ac16
Category HUMAN OTC DRUG LABEL
Packager Family Dollar Services Inc.
Generic Name
Product Class
Product Number
Application Number PART333A
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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

    • hands only
  • When using this product

     • avoid contact with the eyes, if contact occurs, rinse eyes with water.

  • Stop use and ask a doctor if

    irritation or redness develops.

  • Keep out of the reach of children

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    •wet hands • apply palmful to hands • scrub thoroughly • rinse thoroughly

  • Inactive ingredients

    water, sodium laureth sulfate, cocamidopropyl betaine, sodium chloride, cocamide DEA, glycerin, fragrance, Cocamidopropylamine Oxide, Decyl Glucoside, Po;yquatemium-7,  methylisothiazolinone, tetrasodium EDTA,  citric acid, benzophenone-4, FDC yellow no. 5, DC red no. 33

  • Package Label

    image of package label

  • INGREDIENTS AND APPEARANCE
    FAMILY DOLLAR ANTIBACTERIAL HAND 
    triclosan soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55319-512
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN0.15 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    COCAMIDOPROPYLAMINE OXIDE (UNII: M4SL82J7HK)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55319-512-01221 mL in 1 BOTTLE, PUMP
    2NDC:55319-512-021180 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/02/2014
    Labeler - Family Dollar Services Inc. (024472631)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ningbo Pulisi Daily Chemical Products Co.,Ltd.529047265manufacture(55319-512)
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