HAND SANITIZER- sanitizer gel gel 
GDRG2, Inc.

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) (73%, 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 (1.00% v/v).
  3. Carbopol 940 (0.45% v/v).
  4. Triethanolamine (0.25% v/v).
  5. Sterile deionized 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)

Ethyl Alcohol 73% v/v. Purpose: Antiseptic

Purpose

Antimicrobial

Uses

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

Flammable. Keep away from heat or flame. For external use only.

Do not use

When using this product do not use it in or near the eyes. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash appears and lasts.

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 appears and lasts.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other information

Inactive ingredients

Deionized Water, Glycerol, Carbopol 940, Triethanolamine

Package Label - Principal Display Panel

29 mL NDC: 76999-7117-6
29 mL NDC: 76999-7117-6

60 mL NDC: 76999-7094-5
60 mL NDC: 76999-7094-5


250 mL NDC: 76999-7056-3
250 mL NDC: 76999-7056-3

HAND SANITIZER 
sanitizer gel gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76999-7131(NDC:56084-001)
Route of AdministrationEXTRACORPOREAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL40.8 mL  in 60 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX) 0.6 mL  in 60 mL
CARBOMER 940 (UNII: 4Q93RCW27E) 0.27 mL  in 60 mL
CUPRIC BIS(TRIETHANOLAMINE) (UNII: YBM44X0B6H) 0.15 mL  in 60 mL
WATER (UNII: 059QF0KO0R) 15.18 mL  in 60 mL
Product Characteristics
Colorwhite (Clear) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76999-7131-560 mL in 1 BOTTLE; Type 0: Not a Combination Product04/05/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E04/05/2020
HAND SANITIZER 
sanitizer gel gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76999-7056(NDC:56084-005)
Route of AdministrationEXTRACORPOREAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL170 mL  in 250 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX) 2.5 mL  in 250 mL
CARBOMER 940 (UNII: 4Q93RCW27E) 1.125 mL  in 250 mL
CUPRIC BIS(TRIETHANOLAMINE) (UNII: YBM44X0B6H) 0.625 mL  in 250 mL
WATER (UNII: 059QF0KO0R) 63.25 mL  in 250 mL
Product Characteristics
Colorwhite (Clear) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76999-7056-3250 mL in 1 BOTTLE; Type 0: Not a Combination Product04/05/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E04/05/2020
HAND SANITIZER 
sanitizer gel gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76999-7117(NDC:56084-003)
Route of AdministrationEXTRACORPOREAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL19.72 mL  in 29 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX) 0.29 mL  in 29 mL
CARBOMER 940 (UNII: 4Q93RCW27E) 0.1305 mL  in 29 mL
CUPRIC BIS(TRIETHANOLAMINE) (UNII: YBM44X0B6H) 0.0725 mL  in 29 mL
WATER (UNII: 059QF0KO0R) 7.337 mL  in 29 mL
Product Characteristics
Colorwhite (Clear) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76999-7117-629 mL in 1 BOTTLE; Type 0: Not a Combination Product04/05/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E04/05/2020
Labeler - GDRG2, Inc. (099224092)

Revised: 4/2020
Document Id: a4627d74-41c1-2be8-e053-2995a90ae101
Set id: a462eb01-54f6-1028-e053-2a95a90a6aac
Version: 1
Effective Time: 20200428
 
GDRG2, Inc.