Label: FAMILY DOLLAR FOAMING ANTIBACTERIAL HAND WASH- 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 January 29, 2014

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  • Active Ingredient

    Triclosan 0.46%

  • Purpose

    Antibacterial

  • Use

     ■ For handwashing to decrease bacteria on the skin

  • Warnings

    For external use only.

    ■ Avoid eye contact. In case of eye contact flush with water. If irritation occurs discontinue use of product

  • When using this product

     

    ■ Avoid contact with eyes.  In case of eye contact, flush with water.

  • Stop use and ask a doctor if

    irritation or redness develops.

  • Keep out of reach of children

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

  • Directions

    ■ Pump into hands, wet as needed ■ Lather vigorously for at least 15 seconds ■ Wash skin, rinse thoroughly and dry.

  • Inactive ingredients

    water, sodium xylenesulfonate, ammonium lauryl sulfate, cocamidopropyl betaine, glycerin, propylene glycol, fragrance, polyquaternium-10, benzyl alcohol, methylchloroisothiazolinone,  methylisothiazolinone, citric acid, phenoxyethanol, methylparaben, ethylparaben, aloe barbadensis leaf juice, DC yellow no. 10, FDC blue no.1

  • Package Label

    image description

  • INGREDIENTS AND APPEARANCE
    FAMILY DOLLAR   FOAMING ANTIBACTERIAL HAND WASH
    triclosan liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55319-161
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN0.46 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM XYLENESULFONATE (UNII: G4LZF950UR)  
    AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POLYQUATERNIUM-10 (1000 MPA.S AT 2%) (UNII: GMR4PEN8PK)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55319-161-75221 mL in 1 BOTTLE, PUMP
    2NDC:55319-161-32947 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A12/30/2013
    Labeler - Family Dollar Services Inc. (024472631)
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