Label: SERVO STAT BAC- benzalkonium chloride liquid

  • Category: HUMAN OTC DRUG LABEL

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 14, 2013

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • ACTIVE INGREDIENT

    Active Ingredient

    Benzalkonium Chloride 0.1%

  • PURPOSE

    Purpose

    Antimicrobial

  • INDICATIONS & USAGE

    Uses

    For hand sanitizing to decrease bacteria on the skin.

    Recommended for repeated use.

  • WARNINGS

    Warnings

    For external use only.

    When using this product avoid contact with eyes.

    In case of eye contact, flush eyes with water.

    Stop use and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hours.

    Keep out of reach of children.

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

  • DOSAGE & ADMINISTRATION

    Directions

    Pump a small amount of foam into palm of hand.

    Rub thoroughly over all surfaces of both hands.

    Rub hands to gether briskly until dry.

  • INACTIVE INGREDIENT

    Inactive Ingredients

    Water, dihydroxypropyl PEG-5 linoleammonium chloride, glycereth-2 cocoate, behentrimonium chloride, dihydroxyethyl cocamine oxide, fragrance.

  • PRINCIPAL DISPLAY PANEL

    Servo Stat BAC

    Instant Foam Hand Sanitizer

    WARNING: EYE IRRITANT

    (SEE SIDE PANEL FOR DETAILS)

    KEEP OUT OF REACH OF CHILDREN

    ENZYME SOLUTIONS

    wwww.enzymesolutions.com

    1 Gallon  3.8 L

    Servo Stat BAC is a non-alcohol formula

    that is non-drying to the skin, which leaves

    hands smooth and soft.

    Foaming Formula

    Storage: Store at Room Temperature.

    Do NOT Mix with Other Chemicals.

    Batch

    Expiration Date

    container label

  • INGREDIENTS AND APPEARANCE
    SERVO STAT BAC  
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76378-020
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIHYDROXYPROPYL PEG-5 LINOLEAMMONIUM CHLORIDE (UNII: 0Y0NQR2GH1)  
    GLYCERETH-2 COCOATE (UNII: JWM00VS7HC)  
    BEHENTRIMONIUM CHLORIDE (UNII: X7GNG3S47T)  
    DIHYDROXYETHYL COCAMINE OXIDE (UNII: 8AR51R3BL5)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76378-020-011000 mL in 1 BAG
    2NDC:76378-020-023785 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A11/14/2013
    Labeler - Enzyme Solutions, Inc. (004994559)
    Establishment
    NameAddressID/FEIBusiness Operations
    Enzyme Solutions, Inc.004994559manufacture(76378-020)