Label: SPA ORIGINALS ANTIBACTERIAL GOLD HAND- 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 September 27, 2011

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

View All Sections
  • Active Ingredient

    Triclosan 0.12%

    Purpose

    Antibacterial

  • Uses

    For hand washing, sanitizing and to decrease bacteria on the skin

  • Caution

    For external use only.

    When using this product


    avoid contact with the eyes

    Discontinue use and seek medical attention if

    skin irritant and redness develops

    Keep out of reach of children

    Children under six years should be supervised by an adult when using this product. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions for use

    Proper usage: Wet hands with water. Pump small amount into hands. Lather vigorously for 15 seconds. Rinse and dry thoroghly.


  • Inactive Ingredients

    Water, Sodium Alcohol Ether Sulphate, Coconut Diethanolamide, Sodium Dodecyl Sulfate, Dodecyl Dimethyl Betaine, Citric Acid, Sodium Cloride, Disodium EDTA, DMDM Hydantoin, Fragrance, Vitamin E, FDandC Yellow 5, Yellow 6

  • SPL UNCLASSIFIED SECTION

    MADE IN CHINA
    Distrubuted by Custom Solutions, Inc.
    Lee's Summit, MO 64064
    www.customsolutionsinc.com


  • PRINCIPAL DISPLAY PANEL

    Spa Originals

    Antibacterial Gold

    HAND SOAP

    enriched with vitamin e

    Kills Germs, Neutralizes Odors

    7.5 fl. oz. (221mL)

  • Package Labeling

    Spa Originals Antibacterial Gold Handsoap

  • INGREDIENTS AND APPEARANCE
    SPA ORIGINALS ANTIBACTERIAL GOLD HAND 
    triclosan soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76405-011
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN0.12 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    COCO DIETHANOLAMIDE (UNII: 92005F972D)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76405-011-02221 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E08/22/2011
    Labeler - Custom Solutions, Inc (966678240)
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!