Label: FAMILY DOLLAR 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 January 2, 2014

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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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