Label: SEPTIHOL HAND SANITIZER- alcohol aerosol, foam

  • NDC Code(s): 0519-6257-35, 0519-6257-36
  • Packager: STERIS Corporation
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 6, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Ethyl Alcohol 62% v/v

  • Purposes

    Antiseptic

  • Uses

    To help decrease bacteria/germs on the skin that could cause disease. For use when soap and water are not available. Recommended for repeated use.

  • Warnings

    For external use only. Flammable, keep away from fire or flame. Do not puncture or incinerate. Do not store above 120ºF (49ºC).

    When using this product

    Avoid contact with eyes. If splashed in eyes, rinse immediately and thoroughly with water. Do not use on open wounds, Discontinue use if irritation/redness occurs.

    Stop use and ask a physician if irritation occurs for more than 3 days, contact a physician.

    Keep out of reach of children. In case of ingestion, get medical help or contact a Poison Control Center immediately.

  • Directions

    Spray product on hands, enough to cover all surfaces. Rub hands together until all surfaces are wet and fully covered. Continue rubbing until hands feel dry. Do not rinse or wipe off sanitizer.

  • Other Information

    For best foam density store and use at a temperature of 55 - 85˚F (13 - 29˚C)

  • Inactive Ingredients

    Water, Hydrofluorocarbon 152a, Isobutane, Emulsifying Wax, Cetyl lactate, Steareth-2, Sodium Benzoate, Sodium Sesquicarbonate

  • PRINCIPAL DISPLAY PANEL - 255 g Bottle Label

    STERIS®

    SEPTIHOL™

    HAND SANITIZER

    Reorder Number:
    625736

    Contents:
    9 oz (255g)

    NDC# 0519-6257-36

    Antiseptic

    No-Rinse

    62% Ethyl Alcohol by Volume

    Manufactured for: STERIS Corporation
    7501 Page Avenue ■ St. Louis, MO 63133 ■ USA
    800-548-4873 ■ www.steris.com

    PRINCIPAL DISPLAY PANEL - 255 g Bottle Label
  • INGREDIENTS AND APPEARANCE
    SEPTIHOL HAND SANITIZER 
    alcohol aerosol, foam
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0519-6257
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M) Alcohol62 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    1,1-Difluoroethane (UNII: 0B1U8K2ME0)  
    Isobutane (UNII: BXR49TP611)  
    Cetyl lactate (UNII: A7EVH2RK4O)  
    Steareth-2 (UNII: V56DFE46J5)  
    Sodium Benzoate (UNII: OJ245FE5EU)  
    SODIUM SESQUICARBONATE (UNII: Y1X815621J)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0519-6257-3524 in 1 CASE05/01/2021
    1NDC:0519-6257-36255 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph drugM00305/01/2021
    Labeler - STERIS Corporation (139424188)
    Establishment
    NameAddressID/FEIBusiness Operations
    Accra Pac, Inc. (Voyant Beauty)024213616MANUFACTURE(0519-6257)
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