Label: SPASOAP LIQUID ANTIBACTERIAL- triclosan solution

  • 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 November 22, 2019

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

View All Sections
  • Drug Facts

    Active Ingredients

    Triclosan 0.115%

  • Purpose

    Antibacterial

  • Uses

    for handwashing to decrease bacteria on the skin

  • Warnings

    For external use only.

  • STOP USE

    Stop use 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.

  • Directions

    • wet hands
    • apply palmful to hands
    • scrub thoroughly
    • rinse
  • Inactive ingredients

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

  • Package Label

    SpaSoap

    Liquid Soap
    Antibacterial
    Refill
    64 oz / 1.9L
    Hand Soap

    Label

  • INGREDIENTS AND APPEARANCE
    SPASOAP LIQUID ANTIBACTERIAL  
    triclosan solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50157-101
    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)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EDETIC ACID (UNII: 9G34HU7RV0)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50157-101-641900 mL in 1 BOTTLE; Type 0: Not a Combination Product01/24/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/24/2015
    Labeler - Brands International (243748238)
    Registrant - Sante Manufacturing Inc (252365486)
    Establishment
    NameAddressID/FEIBusiness Operations
    Brands International243748238manufacture(50157-101)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!