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

If you are a consumer or patient please visit this version.

  • Drug Facts

    Active Ingredients

    Triclosan 0.115%

    Close
  • Purpose

    Antibacterial

    Close
  • Uses

    for handwashing or decrease bacteria to the skin

    Close
  • WARNINGS

    For external use only

    Close
  • Stop use and ask a doctor if

    irritation or redness develops

    Close
  • When using this product

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

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

    Close
  • Directions

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

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

    Close
  • Package Label

    ​Spa Soap

    Antibacterial

    Liquid Soap

    Refill Antibacterial Liquid Soap

    Close
  • INGREDIENTS AND APPEARANCE
    TRICLOSAN 
    antibacterial liquid soap refill soap
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:50157-119
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN 1.15 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    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 Code Package Description Marketing Start Date Marketing End Date
    1 NDC:50157-119-32 947 mL in 1 BOTTLE; Type 0: Not a Combination Product 02/03/2016
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333A 02/03/2016
    Labeler - Brands International (243748238)
    Registrant - Sante Manufacturing Inc (252365486)
    Establishment
    Name Address ID/FEI Business Operations
    Brands International 243748238 manufacture(50157-119)
    Close