Label: EXGERM ANTISEPTIC HAND SANITIZER- isopropyl alcohol liquid

  • NDC Code(s): 80284-000-01, 80284-000-02, 80284-000-03, 80284-000-04
  • Packager: International Biotech Factory, S.A. de C.V.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 21, 2023

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  • Drug Facts

  • Active ingredient

    Isopropyl alcohol 72%

    Purpose

    Antiseptic

  • Uses

    • for hand washing to decrease bacteria on the skin.
    • recommended for repeated use.
  • Warnings

    For external 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 right away.

  • Directions

    • wet hands thoroughly with product and allow to dry without wiping.
  • Other information

    • keep at room temperature.
    • avoid contact with skin accessories and wood.
  • Inactive ingredients

    distilled water, fragance, isopropyl myristate, lanolin, polyethylene glycol.

  • Package Labeling:1000ml

    Bottle

  • Package Labeling:500ml

    Bottle2

  • Package Labeling:250ml

    Bottle3

  • Package Labeling:60ml

    Bottle4

  • INGREDIENTS AND APPEARANCE
    EXGERM ANTISEPTIC HAND SANITIZER 
    isopropyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80284-000
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL0.72 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    LANOLIN (UNII: 7EV65EAW6H)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80284-000-041000 mL in 1 BOTTLE; Type 0: Not a Combination Product08/20/2020
    2NDC:80284-000-03500 mL in 1 BOTTLE; Type 0: Not a Combination Product08/20/2020
    3NDC:80284-000-02250 mL in 1 BOTTLE; Type 0: Not a Combination Product08/20/2020
    4NDC:80284-000-0160 mL in 1 BOTTLE; Type 0: Not a Combination Product08/20/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)08/20/2020
    Labeler - International Biotech Factory, S.A. de C.V. (814634911)
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