Label: INO MED 2 HAND SANITIZER- alcohol gel

  • NDC Code(s): 78306-501-11, 78306-501-12, 78306-501-14, 78306-501-15
  • Packager: GROUPE DISSAN, LE
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated June 13, 2020

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  • SPL UNCLASSIFIED SECTION

    This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

    The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

    1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
    2. Glycerol (1.45% v/v).
    3. Hydrogen peroxide (0.125% v/v).
    4. Sterile distilled water or boiled cold water.

    The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

  • Active Ingredient(s)

    Alcohol 80% 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 INGREDIENT

    SQUALANE GW89575KF9 IACT
    PANTHENOL WV9CM0O67Z IACT
    AMINOMETHYLPROPANOL LU49E6626Q IACT
    INULIN JOS53KRJ01 IACT
    CARBOMER INTERPOLYMER TYPE A (55000 CPS) 59TL3WG5CO IACT
    LIMONENE, (+)- GFD7C86Q1W IACT
    ALPHA-TOCOPHEROL ACETATE 9E8X80D2L0 IACT
    GLYCERIN PDC6A3C0OX IACT
    WATER 059QF0KO0R IACT
    HYALURONATE SODIUM YSE9PPT4TH IACT
    FRUCTOSE, DL- 02T79V874P IACT

  • PRINCIPAL DISPLAY PANEL

    3.78 label1 L label500 mL label100 mL label

  • INGREDIENTS AND APPEARANCE
    INO MED 2 HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78306-501
    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
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    SQUALANE (UNII: GW89575KF9)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    INULIN (UNII: JOS53KRJ01)  
    FRUCTOSE, DL- (UNII: 02T79V874P)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78306-501-12500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/13/2020
    2NDC:78306-501-141000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/13/2020
    3NDC:78306-501-11100 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/13/2020
    4NDC:78306-501-153800 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/13/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other06/13/2020
    Labeler - GROUPE DISSAN, LE (248967291)
    Registrant - Normand Robichaud Services conseils Inc. (242225051)
    Establishment
    NameAddressID/FEIBusiness Operations
    GROUPE DISSAN, LE248967291manufacture(78306-501)
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