Label: SERVO-STAT T FOAM- triclosan liquid

  • 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 7, 2011

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  • ACTIVE INGREDIENT

    Active Ingredient

    Triclosan 0.3%

  • PURPOSE

    Purpose

    Antiseptic

  • INDICATIONS & USAGE

    Use

    for handwashing to decrease bacteria on the skin

  • WARNINGS

    Warnings

    For external use only

    When using this product

    do not get into eyes

    if contact occurs, rinse eyes thoroughly with water


    Stop use and ask a doctor if

    irritation and redness develop

    Keep out of reach of children.

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

  • DOSAGE & ADMINISTRATION

    Directions

    ready to use

    do not dilute

    wet hands and forearms

    apply 5 milliliters (teaspoonful) or palmful to hands and forearms

    scrub thoroughly for 1 minute and rinse


  • INACTIVE INGREDIENT

    Inactive Ingredients

    Water, Sodium Lauryl Sulfate, Sodium Laureth Sulfate, Cocamidopropylbetaine, Propylene Glycol, Tetrasodium EDTA, Isopropanol, Lauramine Oxide, Boric Acid, PEG-75 Lanolin, DMDM Hydantoin, and PCMX (Preservatives), Fragrance, Aloe Vera, FDC Red #40, FDC Yellow #6

  • PRINCIPAL DISPLAY PANEL

    Servo-Stat T Foam

    Antiseptic Hand Wash

    11105R-FM1000

    1000 ml (33.8 fl oz.)

    container label

  • INGREDIENTS AND APPEARANCE
    SERVO-STAT T FOAM 
    triclosan liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76378-014
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN0.3 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
    BORIC ACID (UNII: R57ZHV85D4)  
    PEG-75 LANOLIN (UNII: 09179OX7TB)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    CHLOROXYLENOL (UNII: 0F32U78V2Q)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76378-014-011000 mL in 1 BAG
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A02/01/2011
    Labeler - Enzyme Solutions, Inc. (004994559)
    Establishment
    NameAddressID/FEIBusiness Operations
    Enzyme Solutions, Inc.004994559manufacture
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