Label: SERVO STAT-FOAM- alcohol liquid

  • NDC Code(s): 76378-011-01, 76378-011-02, 76378-011-03, 76378-011-04, view more
    76378-011-05
  • Packager: Enzyme Solutions, Inc.
  • 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, 2020

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  • ACTIVE INGREDIENT

    Active Ingredient

    Ethyl Alcohol 62% v/v

  • PURPOSE

    Purpose

    Antiseptic

  • INDICATIONS & USAGE

    Use

    for hand-washing to decrease bacteria on the skin

    If hands are visibly soiled, use regular soap and water

    Recommended for repeated use

  • WARNINGS

    Warnings

    Flammable, keep away from fire and flames

    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

    apply to hands and rub lightly until dry without wiping or rinsing

  • INACTIVE INGREDIENT

    Inactive Ingredients

    water, DEA-C8-18 perfluoro-alkylethyl phosphate, propylene glycol

  • PRINCIPAL DISPLAY PANEL

    Servo

    Stat-Foam

    Waterless

    Antiseptic

    Item #: 11125R-FM4

    1000ML 33.8 FL. OZ.

    container label

  • INGREDIENTS AND APPEARANCE
    SERVO STAT-FOAM 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76378-011
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIETHANOLAMINE BIS(C8-C18 PERFLUOROALKYLETHYL)PHOSPHATE (UNII: 4J55VM509S)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76378-011-0159 mL in 1 BOTTLE; Type 0: Not a Combination Product12/07/2018
    2NDC:76378-011-02473 mL in 1 BOTTLE; Type 0: Not a Combination Product12/07/2018
    3NDC:76378-011-031000 mL in 1 BAG; Type 0: Not a Combination Product12/07/2018
    4NDC:76378-011-0450 mL in 1 BOTTLE; Type 0: Not a Combination Product12/07/2018
    5NDC:76378-011-053785 mL in 1 BOTTLE; Type 0: Not a Combination Product11/16/2020
    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(76378-011)
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