Label: FIRST AID ONLY INSTANT 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 August 12, 2023

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

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Ethyl Alcohol 66.5%

  • Purpose

    Antiseptic

  • Uses

    For handwashing to decrease bacteria on skin without soap and water.

    .

  • Warnings

    For External use only.

    Flammable.keep away from fire or flame.

    Do not use in eyes. If this happens, rinse thoroughly with water.

    Stop use, ask a doctor if irritation develops and 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 & wrists thoroughly with product and allow to dry without wiping
  • Inactive ingredients

    aloe vera, carbomer, D&C green #5, D&C yellow #10, fragrance, purified water, triethanolamine

  • QUESTIONS

    Questions 1.800.835.2263

  • PRINCIPAL DISPLAY PANEL

    Box LabelBox Label

  • INGREDIENTS AND APPEARANCE
    FIRST AID ONLY INSTANT HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0924-0450(NDC:61010-1112)
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL665 mL  in 1 L
    Inactive Ingredients
    Ingredient NameStrength
    D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    ALOE (UNII: V5VD430YW9)  
    WATER (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    FRAGRANCE 13576 (UNII: 5EM498GW35)  
    CARBOMER 980 (UNII: 4Q93RCW27E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0924-0450-000.034 L in 1 POUCH; Type 0: Not a Combination Product08/11/2021
    2NDC:0924-0450-0110 in 1 BOX08/18/2023
    20.034 L in 1 POUCH; Type 0: Not a Combination Product
    3NDC:0924-0450-0220 in 1 BOX08/18/2023
    30.034 L in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E08/11/2021
    Labeler - Acme United Corporation (001180207)
    Establishment
    NameAddressID/FEIBusiness Operations
    Acme United Corporation045924339relabel(0924-0450) , repack(0924-0450)
    Establishment
    NameAddressID/FEIBusiness Operations
    Acme United Corporation080119599relabel(0924-0450) , repack(0924-0450)
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!