Label: 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 June 19, 2020

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

View All Sections
  • Active Ingredient(s)

    Ethyl Alcohol 70%

  • Purpose

    Antimicrobial

  • Use

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

  • Warnings

    For external use only. Flammable. Keep away from heat or flame

  • Do not use

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

    When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

  • 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.

    Keep the lid of this container tightly closed.

  • Inactive ingredients

    Carpobol 90, T.E.A Triethanolamine, Glycerin

  • 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)
  • Package Label - Principal Display Panel

    60 mL NDC:75778-005-60

    60mL

    118 mL NDC:75778-005-11

    118mL

    236 mL NDC:75778-005-23

    236 mL

    473 mL NDC:75778-005-47

    473mL

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75778-005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    POLYACRYLIC ACID (800000 MW) (UNII: D0I6NSZ87U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75778-005-6060 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product06/19/2020
    2NDC:75778-005-11118 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product06/19/2020
    3NDC:75778-005-23236 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product06/19/2020
    4NDC:75778-005-47473 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product06/19/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/19/2020
    Labeler - Audy Global Enterprises Inc. (079171473)
    Establishment
    NameAddressID/FEIBusiness Operations
    GRUPO DE ZAVALETA S.A. DE C.V.951577304manufacture(75778-005)
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!