HAND SANITIZER- alcohol liquid 
HAND SANITIZER- ethanol alcohol gel 
2ProtekU, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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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

Inactive ingredients

glycerin, hydrogen peroxide, purified water USP

Package Label

Label 1 Gal GELLabel 1 Gal

Label Gel 12oz12 oz. Label Gel

12 oz label12 oz label

8 oz GEL label

8 oz GEL

1 gal label 1 gal label

32 oz gel label 32 oz gel label

16 oz label 16 oz label

16 oz gel 16 oz gel

32 oz label 32 oz label

8 oz label 8 oz label

HAND SANITIZER 
alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77806-123
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL  in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.125 mL  in 100 mL
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77806-123-02236.58 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/2020
2NDC:77806-123-03354.88 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/2020
3NDC:77806-123-04473.17 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/2020
4NDC:77806-123-05946.35 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/2020
5NDC:77806-123-063785.41 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/2020
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/01/2020
HAND SANITIZER 
ethanol alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77806-234
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 70 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77806-234-08236.58 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/2020
2NDC:77806-234-09354.88 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/2020
3NDC:77806-234-10475.7 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/2020
4NDC:77806-234-11946.35 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/2020
5NDC:77806-234-123785.41 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/2020
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/01/2020
Labeler - 2ProtekU, LLC (131401095)
Establishment
NameAddressID/FEIBusiness Operations
2ProtekU, LLC131401095manufacture(77806-123, 77806-234)

Revised: 6/2020
Document Id: a7adc5b7-7a14-598c-e053-2995a90ab415
Set id: a578895b-56f8-76ab-e053-2a95a90a916d
Version: 2
Effective Time: 20200609
 
2ProtekU, LLC