Label: 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 December 30, 2011

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  • ACTIVE INGREDIENT

    Drug Facts

    Active ingredient

    Triclosan 0.10% (or % in formula)

    Use helps fight germs on hands when used as a hand soap

    Warnings

    For external use only

    Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.  In case of eye contact, rinse thoroughly with water.

    Purpose

    Antibacterial hand soap

    Questions? (insert proper phone number)

    Directions wash hands and rinse

    Inactive ingredients water, .....

  • PRINCIPAL DISPLAY PANEL

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    Antibacterial Back LabelAntibac1

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    Antibacterial Front LabelAntibac2

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  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL 
    triclosan soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63691-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Triclosan (UNII: 4NM5039Y5X) (Triclosan - UNII:4NM5039Y5X) Triclosan.1 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63691-002-01304 mL in 1 BOTTLE
    2NDC:63691-002-02384 mL in 1 BOTTLE
    3NDC:63691-002-03414 mL in 1 BOTTLE
    4NDC:63691-002-04739 mL in 1 BOTTLE
    5NDC:63691-002-05828 mL in 1 BOTTLE
    6NDC:63691-002-061120 mL in 1 BOTTLE
    7NDC:63691-002-071770 mL in 1 BOTTLE
    8NDC:63691-002-083785 mL in 1 BOTTLE
    9NDC:63691-002-093990 mL in 1 BOTTLE
    10NDC:63691-002-10709 mL in 1 BOTTLE
    11NDC:63691-002-111005 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A02/13/1998
    Labeler - Sun Products Corporation (070931480)