Label: ALCOHOL HAND SANITIZER 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 December 15, 2020

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

View All Sections
  • Active Ingredient(s)

    Alcohol 75% v/v. Purpose: Antiseptic

  • Purpose

    Antiseptic, Hand Sanitizer

  • Use

    Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

  • Warnings

    Keep away from the source of fire and flame. For external use only.

  • Do not use

    in children less than 2 months of age
    on open skin wounds, damaged, inflamed or broken skin.

  • WHEN USING

    When using this product, keep out of eyes, ears, and mouth. Use only under adult supervision. In case of contact with eyes, rinse eyes thoroughly with water.
    Non staining, may discolor certain fabrics. People who are allergic to alchohol shuld use this product with caution.
    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • STOP USE

    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

  • KEEP OUT OF REACH OF CHILDREN

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

  • Directions

    • Place enough product on hands to cover all surfaces. Rub hands together until dry.
    • Supervise children under 6 years of age when using this product to avoid swallowing.
  • Other information

    • Store between 15-30C (59-86F)
    • Avoid freezing and excessive heat above 40C (104F)
  • Inactive ingredients

    acrylates/ C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, water

  • Package Label - Principal Display Panel

    78792-012-01 50ML

    78792-012-01 50ML

    78792-012-02 100ML

    78792-012-02 100ML

    78792-012-03 182ML

    78792-012-03 182ML

    78792-012-04 478ML

    78792-012-04 478ML

    78792-012-05 494ML

    78792-012-05 494ML

    78792-012-06 1000ML

    78792-012-06 1000ML

    78792-012-07 5000ML

    78792-012-07 5000ML

  • INGREDIENTS AND APPEARANCE
    ALCOHOL HAND SANITIZER 
    alcohol hand sanitizer gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78792-012
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78792-012-0150 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    2NDC:78792-012-05494 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    3NDC:78792-012-04478 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    4NDC:78792-012-03182 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    5NDC:78792-012-061000 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    6NDC:78792-012-02100 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    7NDC:78792-012-075000 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/30/2020
    Labeler - GUANGDONG THEAOSON TECHNOLOGY CO.,LTD (560428126)
    Registrant - GUANGDONG THEAOSON TECHNOLOGY CO.,LTD (560428126)
    Establishment
    NameAddressID/FEIBusiness Operations
    GUANGDONG THEAOSON TECHNOLOGY CO.,LTD560428126manufacture(78792-012)
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!