Label: GBG- alcohol aerosol, foam

  • 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 February 7, 2018

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Ethyl Alcohol 62%

  • Purpose

    Antimicrobial

  • Use

    for hand-washing to decrease bacterial on the skin, only when water is not available

  • Warnings

    Flamable, 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

  • Directions

    • press valve once to deliver one squirt (about a quarter size) of foaming product onto the palm of your hand
    • rub hands together and allow to dry without wiping
  • Inactive Ingredients

    Water, Propane, Isobutane, n-Butane, Emulsifying wax, Fragrance

  • SPL UNCLASSIFIED SECTION

    Manufactured Exclusively For

    HealthLink®
    A Family of Medical Products

    Jacksonville, FL 32224 1-800-638-2625

  • PRINCIPAL DISPLAY PANEL - 199g Can Label HealthLink® A Family of Medical Products GBG FOAMING™ INSTANT HAND SANITIZER Mr. "G" The Transient Germ Net Wt.: 7 oz (199g)

    image description

  • INGREDIENTS AND APPEARANCE
    GBG 
    alcohol aerosol, foam
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63843-898
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.62 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    BUTANE (UNII: 6LV4FOR43R)  
    PROPANE (UNII: T75W9911L6)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63843-898-00199 g in 1 CAN; Type 0: Not a Combination Product09/01/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E09/01/2011
    Labeler - HealthLink (807714126)
    Registrant - Carroll Company (007372329)
    Establishment
    NameAddressID/FEIBusiness Operations
    Carroll Company007372329manufacture(63843-898)
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