Label: 75% ALCOHOL 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 13, 2023

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  • Active ingredient

    Alcohol 75% v/v. Purpose: Antiseptic

  • Purpose

    Antiseptic. Hand senitizer

  • INDICATIONS & USAGE

  • Warnings

    For external use only.

    Flammable. Keep away from fire or flame.

    Do not apply around eyes. Do not use in ears & mouth.

  • DO NOT USE

    Do not apply around eyes. Do not use in ears & mouth.

  • WHEN USING

    When using this product, avoid contact with eyes. In case of contact flush eyes with water.

  • STOP USE

    Stop use and ask a doctor if redness or irritation develop and persist for more than 72 hours.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.

    Children must be supervised in use of this product.

  • Directions

    place enough product into your palms and thoroughly spread on both hands. rub into skin until dry.

  • OTHER SAFETY INFORMATION

    store below 110°F (43°C). may discolor certain fabrics or surfaces.

  • Inactive ingredients

    Carbomer, triethanolamine, glycerin, water

  • Package Label - Principal Display Panel

    500 mL NDC: 75617-001-01

    PDP

  • INGREDIENTS AND APPEARANCE
    75% ALCOHOL HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75617-001(NDC:74621-002)
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL7.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ACRYLIC ACID (UNII: J94PBK7X8S)  
    WATER (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75617-001-01500 mL in 1 BOTTLE; Type 0: Not a Combination Product04/20/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/20/2020
    Labeler - JASPERS GLOBAL MANUFACTURING INC (080766537)
    Registrant - Aogrand International Trade Corporation (421353092)
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