Label: GERMICIDA ANTIMICROBIAL- 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 June 12, 2012

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  • ACTIVE INGREDIENT

    Active Ingredient
    Triclosan 2%

  • PURPOSE

    Purpose
    Antiseptic

  • INDICATIONS & USAGE

    Use To decrease bacteria on the skin. Recommended for repeated use.
  • WARNINGS

    Warnings For external use only. Do not use • on broken skin • otherwise than as directed.
  • WHEN USING

    When using this product • avoid with eyes or on mucous membranes

  • STOP USE

    Stop use and ask a doctor if  • condition worsens • irritation or redness develops • if condition persists for more than 3 days

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of the reach of children. If swallowed contact a doctor or Poison Control Center immediately.

  • DOSAGE & ADMINISTRATION

    Directions Wet skin. Rub bar vigorously over the skin for approximately 2 minutes. Rinse and repeat.

  • INACTIVE INGREDIENT

    Inactive ingredients Coconut Oil, FDC Blue 1, Phenol, Tallow and titanium dioxide

  • PRINCIPAL DISPLAY PANEL

    Package Label
    image of package label


  • INGREDIENTS AND APPEARANCE
    GERMICIDA  ANTIMICROBIAL
    triclosan soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66449-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN2.0 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    COCONUT OIL (UNII: Q9L0O73W7L)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    PHENOL (UNII: 339NCG44TV)  
    BEEF TALLOW (UNII: 98HPY76U4W)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66449-004-0175 g in 1 BOX
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/30/2012
    Labeler - Laboratorios Roldan, S.A. (871410015)
    Establishment
    NameAddressID/FEIBusiness Operations
    Laboratorios Roldan, S.A.871410015manufacture
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