Label: TRICLOSAN- antibacterial liquid soap refill 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 May 30, 2016

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  • Drug Facts

    Active Ingredients

    Triclosan 0.115%

  • Purpose

    Antibacterial

  • Uses

    for handwashing or decrease bacteria to the skin

  • WARNINGS

    For external use only

  • Stop use and ask a doctor if

    irritation or redness develops

  • When using this product

    • do not get it into eyes, if contact occurs, rinse eye thoroughly with water
  • Keep out of reach of children

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

  • Directions

    • Wet hands
    • apply palmful to hands
    • scrub throughly
    • rinse
  • Inactive Ingredients

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

  • Package Label

    ​Spa Soap

    Antibacterial

    Liquid Soap

    Refill Antibacterial Liquid Soap

  • INGREDIENTS AND APPEARANCE
    TRICLOSAN 
    antibacterial liquid soap refill soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50157-119
    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)  
    EDETIC ACID (UNII: 9G34HU7RV0)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50157-119-32947 mL in 1 BOTTLE; Type 0: Not a Combination Product02/03/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A02/03/2016
    Labeler - Brands International (243748238)
    Registrant - Sante Manufacturing Inc (252365486)
    Establishment
    NameAddressID/FEIBusiness Operations
    Brands International243748238manufacture(50157-119)
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