Label: GERMASIDOL- 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 April 25, 2014

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  • INDICATIONS & USAGE SECTION

    Antiseptic handwash for handwashing to decrease baceria on the skin

  • OTC - PURPOSE SECTION

    Antiseptic handwash

  • OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

  • DOSAGE & ADMINISTRATION SECTION

    Moisten surface to be cleaned, apply soap, rub to create lather, and rinse. Repeat as needed.

  • WARNINGS SECTION

    1) For external use only.

    2) Do not use in the eyes.

    3) Discontinue use if irritation and redness develop. If condition persists for more than 72 hours consult a doctor

  • OTC - ACTIVE INGREDIENT SECTION

    Triclosan

  • INACTIVE INGREDIENT SECTION

    Carboxymethylcellulose Sodium

    Carboxymethylcellulose Sodium xxxxxxxxx

    Cocamidopropyl Betaine

    D&C Yellow #8

    Propylene Glycol

    Trisodium EDTA

    Water

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Dodge Germasidol 8.5oz.jpgimage description

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Dodge Germasidol 16oz.jpgimage description

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Dodge Germasidol 24oz.jpgimage description

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    odge Germasidol Gal.jpgimage description

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Dodge Germasidol 5 Gal.jpgimage description

  • INGREDIENTS AND APPEARANCE
    GERMASIDOL 
    triclosan soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:25113-333
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN0.0057 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    EDETATE TRISODIUM (UNII: 420IP921MB)  
    D&C YELLOW NO. 8 (UNII: 93X55PE38X)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:25113-333-85256 g in 1 BOTTLE
    2NDC:25113-333-16483 g in 1 BOTTLE
    3NDC:25113-333-24769 g in 1 BOTTLE
    4NDC:25113-333-013860 g in 1 JUG
    5NDC:25113-333-0519303 g in 1 JUG
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/29/2014
    Labeler - The Dodge Company Inc. (001045517)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bayscience Formulators LLC162930544manufacture(25113-333)
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