Label: ALCOHOL BASED HAND SANITIZER- hand sanitizer solution

  • NDC Code(s): 80334-0831-1, 80334-0831-2
  • Packager: Wuhan Snow Medical Disinfectant Co., Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 27, 2023

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  • Active Ingredient(s)

    Alcohol 75% v/v. Purpose: Antiseptic

  • Purpose

    Antiseptic, Hand Sanitizer

  • 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 and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • 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.

  • 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)
  • Inactive ingredients

    sterile distilled water

  • Package Label - Principal Display Panel

    100 mL NDC: 80334-0831-1 Package Label

  • Package Label - Principal Display Panel

    500 mL NDC: 80334-0831-2 Package Label

  • INGREDIENTS AND APPEARANCE
    ALCOHOL BASED HAND SANITIZER 
    hand sanitizer solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80334-0831
    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
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80334-0831-1100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/04/2020
    2NDC:80334-0831-2500 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product09/04/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)09/04/2020
    Labeler - Wuhan Snow Medical Disinfectant Co., Ltd (547743562)
    Registrant - Wuhan Snow Medical Disinfectant Co., Ltd (547743562)
    Establishment
    NameAddressID/FEIBusiness Operations
    Wuhan Snow Medical Disinfectant Co., Ltd547743562manufacture(80334-0831)
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