Label: CUIR HAND SANITIZER- 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 February 25, 2022

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

View All Sections
  • Drug Facts

  • Active ingredient

    Alcohol 80% v/v

    Purpose

    Antiseptic

  • Uses

    • Hand sanitizer to help reduce bacteria on the skin that potentially can cause disease.
    • For use when water soap & towel are not available.
  • Warnings

    Flammable, Keep away from heat or flame.

    For external use only.

    Do not use

    • In or near the eyes. In case of contact, rinse eyes thoroughly with water.
    • On children less than 2 months of age.
    • On open skin wounds.

    Stop use and ask a physician,

    if irritation or rash appears and lasts.

  • Directions

    • Place enough product on hands to cover all surfaces. Rub hands together until dry.

    Supervise children less than 6 years of age when using this product to avoid swallowing.
    If swallowed, get medical help or contact a Poison Control Center right away.

  • Other information

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

    Glycerin, hydrogen peroxide, purified water (USP)

  • Package Labeling:

    Bottle

  • Package Labeling:

    Bottle2

  • INGREDIENTS AND APPEARANCE
    CUIR HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78514-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.8 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78514-001-331000 mL in 1 BOTTLE; Type 0: Not a Combination Product08/18/2020
    2NDC:78514-001-16500 mL in 1 BOTTLE; Type 0: Not a Combination Product08/18/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E08/18/2020
    Labeler - Comercial Riley S.A. de C.V. (951578468)
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!