Label: 70% ALCOHOL HAND SANITIZER (NO WATER)- 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 13, 2023

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  • Active ingredient

    Alcohol 70% v/v. Purpose: Antiseptic

  • Purpose

    Antiseptic. Hand senitizer

  • INDICATIONS & USAGE

    Hand sanitizer gel, kills 99.99% BACTERIA

  • Inactive ingredients

    Acrylic polymer, triethanolamine, water

  • Directions

    Take an appropriate amount (2-3ml) of the product to moisten your hands and rub for 15 seconds until the liquid covers your hands, wait for drying, and do not need to wash with water

  • Warnings

    Flammable liquid, use it sawy from fire. This product is for external use.

  • Do not use

    Do not take it internally. Use with caution to people who are allergic to alcohol.

  • KEEP OUT OF REACH OF CHILDREN

    Please keep it out of reach of children

  • STOP USE

    Use with caution to people who are allergic to alcohol

  • WHEN USING

    Do not take it internally

  • Package Label - Principal Display Panel

    295 mL NDC: 76618-001-01

    PDP

  • INGREDIENTS AND APPEARANCE
    70% ALCOHOL HAND SANITIZER (NO WATER) 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76618-001(NDC:74621-005)
    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
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    WATER (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76618-001-01295 mL in 1 BOTTLE; Type 0: Not a Combination Product04/22/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/22/2020
    Labeler - Star USA Imports Inc (786189295)
    Registrant - Aogrand International Trade Corporation (421353092)
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