Label: GJ CHEMICAL ANTISEPTIC HAND SANITIZER- isopropyl alcohol spray

  • NDC Code(s): 75205-259-01, 75205-259-05, 75205-259-55
  • Packager: G. J. Chemical Co.
  • 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 November 22, 2021

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

View All Sections
  • Drug Facts

  • Active ingredient

    Isopropyl alcohol 75% v/v

  • Purpose

    Antiseptic

  • Uses

    • hand sanitizer to decrease bacteria on the skin
    • recommended for repeated use
    • for use when soap and water are not available

  • Warnings

    Flammable, keep away from fire/flame

    For external use only

    Do not use

    • in children less than 2 months of age
    • on open skin wounds

    When using this product • do not get into eyes. In case of contact, rinse eyes thoroughly with water

    Stop use and ask a doctor if
    • irritation and redness develop
    • 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.

  • Directions

    • wet hands thoroughly with product and allow to dry without wiping
    • supervise children under 6 years of age when using this product when using this product to avoid swallowing

  • Other information

    • store between 15-30°C (59-86°F).
    • avoid freezing and heat above 40°C (104°F)
  • Inactive ingredients

    glycerin, hydrogen peroxide, water

  • Questions? +1-973-589-1450

    You may also report serious side effects to this phone number.

    Mon-Fri 9:00 AM - 5:00 PM

  • SPL UNCLASSIFIED SECTION

    WOMEN OWNED

    CONTAINS: ISOPROPYL ALCOHOL

    ISOPROPYL ALCOHOL 75% ANTISEPTIC TOPICAL SOLUTION

    NON-STERILE SOLUTION

    Manufactured by: GJ Chemical Co.,
    128 Doremus Ave., Newark, NJ 07105

    www.GJChemical.com

  • Packaging

    GJIA1

    GJIA2

  • INGREDIENTS AND APPEARANCE
    GJ CHEMICAL ANTISEPTIC HAND SANITIZER 
    isopropyl alcohol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75205-259
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL75 L  in 100 L
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75205-259-013.78 L in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product06/30/202005/13/2024
    2NDC:75205-259-0518.9 L in 1 PAIL; Type 0: Not a Combination Product06/30/202005/13/2024
    3NDC:75205-259-55208 L in 1 DRUM; Type 0: Not a Combination Product06/30/202005/13/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/30/202005/13/2024
    Labeler - G. J. Chemical Co. (837920909)
    Establishment
    NameAddressID/FEIBusiness Operations
    G. J. Chemical Co.837920909manufacture(75205-259)
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!