Label: GERM FREE PLUS ANTIBACTERIAL HAND SANITIZER- alcohol gel

  • 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 July 15, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Ethyl Alcohol 70%

  • Purpose

    Antibacterial

  • Inactive ingredients

    Water, Carbomer, Triethanolamine, Glycerin

  • Uses

    For hand washing to reduce the bacteria on the skin, recommended for repeated use.

  • Directions

    Wet hands thoroughly with product and allow to dry without wiping.

  • Warnings

    For external use only: hands. Flammable, keep away from fire or flame. When using this product, keep out of eyes. In case of contact with eyes rinse with water. Stop use and ask a doctor if irritation and redness develop and persist.

    Keep out of reach of children.

    If swallowed, get medical help immediately.

  • STORAGE AND HANDLING

    Do not store above 105°F

  • PRINCIPAL DISPLAY PANEL - 1 Gallon Bottle Label

    Rompac

    Germ•Free +

    70% ALCOHOL
    Antibacterial Hand Sanitizer
    GEL

    1 Gallon (3.785 liters)

    PRINCIPAL DISPLAY PANEL - 1 Gallon Bottle Label
  • INGREDIENTS AND APPEARANCE
    GERM FREE PLUS ANTIBACTERIAL HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79357-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M) Alcohol70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    Triethanolamine Lactate (UNII: 064C51N81O)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79357-001-013785 mL in 1 BOTTLE; Type 0: Not a Combination Product07/08/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart333A07/08/2020
    Labeler - Rompac, Inc. (066717747)
    Establishment
    NameAddressID/FEIBusiness Operations
    Distribuidora Química Textil S.A. de C.V.811522390MANUFACTURE(79357-001)
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