Label: HEXADERMAL ANTISEPTIC HAND SANITIZER- alcohol gel

  • NDC Code(s): 80256-000-00, 80256-000-01, 80256-000-02
  • Packager: KUZEY SAGLIK URUNLERI VE KIMYA SANAYI ANONIM SIRKETI KAZAN SUBESI
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 12, 2023

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  • Drug Facts

  • Active ingredient

    Ethyl alcohol 72%

    Purpose

    Antiseptic

  • Use

    for hand washing to decrease bacteria on the skin

  • Warnings

    For externale use only. Flammable. keep away from fire or flame.

    Do not use

    in the eyes.

    Stop use and ask a doctor if:

    • irritation and redness develop
    • condition persists for more than 72 hours.

    Keep 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

  • Other information

    Store below 110°F (43°C)

  • Inactive ingredients

    Aminomethylpropanol, Carbomer, Fragrance, Glycerin, Isopropyl Alcohol, Water.

  • Package Labeling:100ml

    Bottle

  • Package Labeling:250ml

    Bottle2

  • Package Labeling:500ml

    Bottle3

  • INGREDIENTS AND APPEARANCE
    HEXADERMAL ANTISEPTIC HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80256-000
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.72 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80256-000-00100 mL in 1 BOTTLE; Type 0: Not a Combination Product07/31/2020
    2NDC:80256-000-01250 mL in 1 BOTTLE; Type 0: Not a Combination Product07/31/2020
    3NDC:80256-000-02500 mL in 1 BOTTLE; Type 0: Not a Combination Product07/31/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)07/31/2020
    Labeler - KUZEY SAGLIK URUNLERI VE KIMYA SANAYI ANONIM SIRKETI KAZAN SUBESI (519910295)
    Establishment
    NameAddressID/FEIBusiness Operations
    KUZEY SAGLIK URUNLERI VE KIMYA SANAYI ANONIM SIRKETI KAZAN SUBESI519910295manufacture(80256-000)
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