Label: ANTIBACTERIAL- 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 October 26, 2016

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  • ACTIVE INGREDIENT

    Active Ingredient - Triclosan 0.115%

  • PURPOSE

    Purpose - Antibacterial

  • INDICATIONS & USAGE

    Uses for handwashing to decrease bacteria on the skin

  • WARNINGS

    Warning for external use only

  • STOP USE

    Stop us and ask a doctor if irritation or redness develops

  • WHEN USING

    When using this product do not get into eyes. If contact occurs, rinse eye thoroughly with water

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

  • DOSAGE & ADMINISTRATION

    Directions

    • Wet Hands
    • apply palmful to hands
    • scrub thoroughly
    • rinse
  • INACTIVE INGREDIENT

    Water, Sodium Laureth Sulfate, Sodium Chloride, DMDM Hydantoin, Citric Acid, Fragrance, EDTA, Yellow#5, Red# 33

  • PRINCIPAL DISPLAY PANEL

    Spa Soap Anitibacterial 1X

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL 
    triclosan liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71020-008
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN1.15 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    EDETIC ACID (UNII: 9G34HU7RV0)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C RED NO. 3 (UNII: PN2ZH5LOQY)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71020-008-641900 mL in 1 BOTTLE; Type 0: Not a Combination Product10/19/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A10/19/2016
    Labeler - Sante Manufacturing Inc (242048747)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sante Manufacturing Inc242048747manufacture(71020-008)
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