Label: GERM NIX ANTIBACTERIAL HAND SANITIZER- 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 March 28, 2020

If you are a consumer or patient please visit this version.

View All Sections
  • ACTIVE INGREDIENT

    Active ingredient

    Ethyl alcohol 60%

  • PURPOSE

    Purpose

    Antiseptic

  • INDICATIONS & USAGE

    Use • to decrease bacteria on the skin that could cause disease • recommended for repeated use.

  • WARNINGS

    Warning

    For external use only: Hands.

    Flammable: keep away from fire and flame.

    Use with caution for people with alcohol allergies.

    When using this product • keep out of eyes. In case of contact with eyes, flush thoroughly with water • Avoid contact with broken skin. Do not inhale or ingest.

    Stop use and ask a doctor if irritation and redness develop • and condition persists for more than 72 hours.

    Keep out of reach of children.

  • DOSAGE & ADMINISTRATION

    Directions Wet hands thoroughly with product and allow to dry without wiping. For children under 6, use only under adult supervision. Not recommended for infants.

  • STORAGE AND HANDLING

    Other information • Do not store above 105°F • May discolor some fabrics • Harmful to wood finish and plastics.

  • INACTIVE INGREDIENT

    Inactive ingredients: Pure water, carbomer, glycerin, triethanolamine, and organic plant extract

  • SPL UNCLASSIFIED SECTION

    Kills 99.99% of germs

    Effective at eliminating over 99.99% of common harmful germs and bacteria in less than 15 seconds.

    Distributed by • Perfect Hemp Organic Company S.EI Monte, CA 91733

    EXP: 18 months after production date

    Made in China

  • Packaging

    image description

  • INGREDIENTS AND APPEARANCE
    GERM NIX ANTIBACTERIAL HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74027-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL60 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74027-100-0160 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/28/2020
    2NDC:74027-100-02100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/28/2020
    3NDC:74027-100-03250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/28/2020
    4NDC:74027-100-04750 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/28/2020
    5NDC:74027-100-051000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/28/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/28/2020
    Labeler - Lee's Collection Inc. (022215540)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!