Label: ZH ANTISEPTIC HAND SANITIZER- isopropyl 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 January 20, 2022

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

View All Sections
  • Drug Facts

  • Active ingredient

    Isopropyl alcohol 70% 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 to avoid swallowing

  • Other information

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

    carbomer, glycerin, hydroxypropyl cellulose, triethylamine, water (aqua)

  • Questions? +1-561-413-2135

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

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

  • SPL UNCLASSIFIED SECTION

    Isopropyl Alcohol 70% Antiseptic Topical,

    Non-sterile

    Manufactured by:
    ZH THERAPEUTICS
    Plot No. 51, Street S-10,
    RCCI Industrial Estate, Rawat,
    Islamabad, Pakistan 44000

    MADE IN PAKISTAN

  • Packaging

    ZHtherp

  • INGREDIENTS AND APPEARANCE
    ZH ANTISEPTIC HAND SANITIZER 
    isopropyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79393-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) (UNII: Z135WT9208)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
    TRIETHYLAMINE (UNII: VOU728O6AY)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79393-101-0160 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/22/2020
    2NDC:79393-101-02100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/22/2020
    3NDC:79393-101-03250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/22/2020
    4NDC:79393-101-04500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/22/2020
    5NDC:79393-101-051000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/22/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/22/2020
    Labeler - ZH THERAPEUTICS (645809570)
    Establishment
    NameAddressID/FEIBusiness Operations
    ZH THERAPEUTICS645809570manufacture(79393-101)
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!