Label: GERMIFREE ANTIMICROBIAL HAND GEL- ethyl 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 June 10, 2020

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  • Drug Facts

  • Active ingredient

    Ethyl alcohol 60% w/w

  • Purpose

    Antimicrobial

  • Use

    hand sanitizer to help reduce microbes on the skin

  • Warnings

    Flammable. Keep away from fire or flame

    For external use only

    When using this product, do not use in or near the eyes. If contact occurs, rinse thoroughly with water

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

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • put enough gel in your palm to cover hands and rub hands together rapidly until dry

    • children under 6 years of age should be supervised when using this product

  • Other information

    • store below 110°F (43°C)

    • may discolor certain fabrics or surfaces

  • Inactive ingredients

    carbomer, fragrance, glycerin, propylene glycol, silicone, triethanolamine, water (aqua)

  • SPL UNCLASSIFIED SECTION

    Kill Germs up to 99.99% of most common germs that may cause illness

    Distributed by:

    Acme United Corporation

    55 Walls Drive

    Fairfield, CT 06824

    1-800-835-2263

    Made in Egypt

  • Packaging

    Germfr60

  • INGREDIENTS AND APPEARANCE
    GERMIFREE ANTIMICROBIAL HAND GEL 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0924-0400(NDC:28691-6000)
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL67.7 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SILICON (UNII: Z4152N8IUI)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0924-0400-0160 mL in 1 BOTTLE; Type 0: Not a Combination Product06/11/2020
    2NDC:0924-0400-02100 mL in 1 BOTTLE; Type 0: Not a Combination Product06/11/2020
    3NDC:0924-0400-03200 mL in 1 BOTTLE; Type 0: Not a Combination Product06/11/2020
    4NDC:0924-0400-04500 mL in 1 BOTTLE; Type 0: Not a Combination Product06/11/2020
    5NDC:0924-0400-05750 mL in 1 BOTTLE; Type 0: Not a Combination Product06/11/2020
    6NDC:0924-0400-061000 mL in 1 BOTTLE; Type 0: Not a Combination Product06/11/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/11/2020
    Labeler - Acme United Corporation (001180207)
    Establishment
    NameAddressID/FEIBusiness Operations
    Acme United Corporation045924339relabel(0924-0400) , repack(0924-0400)
    Establishment
    NameAddressID/FEIBusiness Operations
    Acme United Corporation080119599relabel(0924-0400) , repack(0924-0400)
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