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

  • Uses

    • to decrease bacteria on the skin that could cause disease
    • recommended for repeated use
  • Warnings

    For external use only: hands

    Flammable. Keep away from fire or flame.

  • When using this product

    • Keep out of eyes. In case of contact with eyes, flush thoroughly with water.
    • Avoid contact with broken skin.
    • Do not inhale or ingest
  • Stop use and ask a doctor if

    • irritation or redness develops
    • condition persists for more than 72 hours
  • KEEP OUT OF REACH OF CHILDREN

    Keep it out of reach of children. If swallowed, get medical help or contact a poison control center right away.

  • Directions

    • wet hands thoroughly with product and allow to dry without wiping.
    • for children under 6, use only under adult supervision
    • not recommended for infants
  • Other information

    • do not store above 105F
    • may discolor some fabrics
    • harmful to wood finishes and plastics
  • Inactive ingredients

    Acrylic acid polymer, triethanolamine, water

  • Package Label - Principal Display Panel

    500mL NDC: 75617-002-01

    PDP

  • INGREDIENTS AND APPEARANCE
    75% ALCOHOL HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75617-002(NDC:74621-008)
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 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:75617-002-01500 mL in 1 BOTTLE; Type 0: Not a Combination Product05/23/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/23/2020
    Labeler - JASPERS GLOBAL MANUFACTURING INC (080766537)
    Registrant - Aogrand International Trade Corporation (421353092)
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