INO MED 2 HAND SANITIZER- alcohol gel 
GROUPE DISSAN, LE

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.

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INO-MED2

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

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 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.

Directions

Other information

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

3.78 label1 L label500 mL label100 mL label

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)

Revised: 6/2020
Document Id: a7fdcad6-2fc7-2550-e053-2a95a90a1e70
Set id: a7fdcad6-2fd5-2550-e053-2a95a90a1e70
Version: 1
Effective Time: 20200613
 
GROUPE DISSAN, LE