Label: FAMILY DOLLAR ANTIBACTERIAL- 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 26, 2013

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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

     • do not get into 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

  • Inactive ingredients

    water, sodium laureth sulfate, cocamidopropyl betaine, sodium chloride, cocamide DEA, glycerin, fragrance, methylchloroisothiazolinone,  methylisothiazolinone,tetrasodium EDTA,  citric acid, benzophenone-4, FDC yellow no. 6, FDC yellow no. 5, DC red no. 33

  • Package Label

    image of package label

  • INGREDIENTS AND APPEARANCE
    FAMILY DOLLAR   ANTIBACTERIAL
    triclosan soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55319-156
    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)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    BENZOPHENONE (UNII: 701M4TTV9O)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55319-156-75221 mL in 1 BOTTLE, PUMP
    2NDC:55319-156-09266 mL in 1 BOTTLE, PUMP
    3NDC:55319-156-11333 mL in 1 BOTTLE, PUMP
    4NDC:55319-156-13400 mL in 1 BOTTLE, PUMP
    5NDC:55319-156-14414 mL in 1 BOTTLE, PUMP
    6NDC:55319-156-401180 mL in 1 BOTTLE, PLASTIC
    7NDC:55319-156-641890 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/21/2012
    Labeler - Family Dollar Services Inc. (024472631)
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