E2 HAND WASH- e2 sanitizing hand soap soap 
HAND SANITIZER- alocohl liquid 
HAND SANITIZER- alcohol gel 
HAND SANITIZER WIPES- alcohol cloth 
Horizon Tool 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.

----------

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 - Principal Display Panel

3785.41 mL NDC: 74683-2001-2

3785.41 mL label

473 mL NDC: 74683-2001-1

473 mL front label

473 mL rear label

118 mL NDC: 74683-5001-4

118 mL label

250 mL NDC: 74683-5001-3

250 mL label

59 mL NDC: 74683-5001-2

59mL Label

473 mL NDC: 74683-5001-1

473 mL label

250 mL NDC: 74683-1002-1

250 mL label

3785.4 mL NDC: 74683-6200-3

3785.4 mL label

250 mL NDC: 7463-6200-2

250 mL label

3785.4 mL NDC: 74683-6200-1

3785.4 mL label

3785.4 mL NDC: 74683-6000-1 3785.4 mL label

59 mL NDC: 74683-2100-1 59ml label

946.35 mL NDC: 74683-3001-1 946.35 ml label

262 mL NDC: 74683-2500-1 262 mL wipe label

1892.71 mL NDC: 74683-5000-9 1892.71 mL label

208.2 L NDC: 74683-5000-8 208.2 L label

946.35 mL NDC: 74683-5000-7 946.35 mL rear label

946.35 mL NDC: 74683-5000-7 946.35 mL front label

473 mL NDC: 74683-5000-6 473 mL label

3785.41 mL NDC: 74683-5000-5 3785.41 mL 4cc label

3785.41 mL NDC: 74683-5000-4 3785.41 mL 10cc label

354.8 mL NDC: 74683-5000-3 354.8 mL label

236 mL NDC: 74683-5000-2 236 mL label

118 mL NDC: 74683-5000-1 118 mL label

118 mL NDC: 74683-4000-1

118 mL Tiger gel label

3 mL NDC 74683-3000-8

3mL gel rear

3 mL NDC 74683-3000-8

3mL gel front

3 mL NDC 74683-3000-9

3mL gel rear

3 mL NDC 74683-3000-9

3mL gel front

3785.41 mL NDC 74683-3000-7

3785.41mL gel

3785.41 mL NDC 74683-3000-6

3785.41mL gel

3785.41 mL NDC 74683-3000-5

3785.41mL gel

1892.71 mL NDC 74683-3000-4

1892.71mL gel

946.35 mL NDC 74683-3000-3

946.35mL gel rear

946.35 mL NDC 74683-3000-3

946.35mL gel front

118 mL NDC 74683-3000-2

118mL gel

59 mL NDC 74683-3000-1

59mL gel rear

59 mL NDC 74683-3000-1

59mL gel front

473 mL NDC 74683-1000-9

473mL gel TenSan

236 mL NDC 74683-1000-8 236mL gel TenSan

059 mL NDC: 74683-1000-6

59 mL gel front

059 mL NDC: 74683-1000-6

59 mL gel rear

74683-1000-7

118 mL gel

236 mL NDC: 74683-2000-1 236mL gel473 mL NDC: 74683-1000-2

473mL gel

946.35 mL NDC: 74683-1000-3 946.35 mL front label946.35 mL NDC: 74683-1000-3

946.35mL gel rear

1892.71 mL NDC: 74683-1000-4

1892.71mL gel3785.41 mL NDC: 74683-1000-5

3785.41mL gel473 mL NDC: 74683-2000-1

473mL liquid front473 mL NDC: 74683-2000-1

473mL liquid rear946.35 mL NDC: 74683-2000-2

946.35mL liquid front946.35 mL NDC: 74683-2000-2

946.35mL liquid rear1892.71 mL NDC: 74683-2000-3

1892.71mL liquid3785.41 mL NDC: 74683-2000-4

3785.41mL liquid

E2 HAND WASH 
e2 sanitizing hand soap soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74683-6200
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) 1.4 mL  in 100 mL
WATER (UNII: 059QF0KO0R) 87.6 mL  in 100 mL
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) 0.0004 mL  in 100 mL
METHYLCHLOROISOTHIAZOLINONE/METHYLISOTHIAZOLINONE MIXTURE (UNII: 15O9QS218W) 0.07 mL  in 100 mL
SODIUM LAURETH SULFATE (UNII: BPV390UAP0) 4.2 mL  in 100 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 1.4 mL  in 100 mL
SODIUM LAURYL SULFATE (UNII: 368GB5141J) 4 mL  in 100 mL
COCO DIETHANOLAMIDE (UNII: 92005F972D) 1.1 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74683-6200-13785.4 mL in 1 BOTTLE; Type 0: Not a Combination Product01/03/202309/22/2023
2NDC:74683-6200-2250 mL in 1 BOTTLE; Type 0: Not a Combination Product02/17/2023
3NDC:74683-6200-33785.4 mL in 1 BOTTLE; Type 0: Not a Combination Product02/17/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A01/03/2023
E2 HAND WASH 
e2 sanitizing hand soap soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74683-6000
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
COCO DIETHANOLAMIDE (UNII: 92005F972D) 1.5 mL  in 100 mL
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) 2 mL  in 100 mL
METHYLCHLOROISOTHIAZOLINONE/METHYLISOTHIAZOLINONE MIXTURE (UNII: 15O9QS218W) 0.1 mL  in 100 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 2 mL  in 100 mL
SODIUM LAURYL SULFATE (UNII: 368GB5141J) 5.6 mL  in 100 mL
WATER (UNII: 059QF0KO0R) 82.7 mL  in 100 mL
SODIUM LAURETH SULFATE (UNII: BPV390UAP0) 5.9 mL  in 100 mL
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) 0.0005 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74683-6000-13785.4 mL in 1 BOTTLE; Type 0: Not a Combination Product10/18/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A10/18/2022
HAND SANITIZER 
alocohl liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74683-2100
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
HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.125 mL  in 100 mL
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74683-2100-159 mL in 1 BOTTLE; Type 0: Not a Combination Product04/13/202108/01/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/13/202108/01/2023
HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74683-5000
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL715.4 mL  in 1021.95 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R) 282 mL  in 1021.95 mL
RAPIDGEL EZ1 (UNII: 33JH4A7R2K) 9.7 mL  in 1021.95 mL
FRAGRANCE CLEAN ORC0600327 (UNII: 329LCV5BTF) 0.044 mL  in 1021.95 mL
DENATONIUM BENZOATE ANHYDROUS (UNII: M5BA6GAF1O) 0.006 mL  in 1021.95 mL
GLYCERIN (UNII: PDC6A3C0OX) 14.8 mL  in 1021.95 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74683-5000-1118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/11/202006/30/2024
2NDC:74683-5000-2236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/11/202006/30/2024
3NDC:74683-5000-3354.8 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/11/202006/30/2024
4NDC:74683-5000-43785.41 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/11/202006/30/2024
5NDC:74683-5000-53785.41 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/11/202006/30/2024
6NDC:74683-5000-6473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/11/202006/30/2024
7NDC:74683-5000-7946.35 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/11/202006/30/2024
8NDC:74683-5000-8208200 mL in 1 DRUM; Type 0: Not a Combination Product11/11/202006/30/2024
9NDC:74683-5000-91892.71 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/11/202006/30/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A11/11/202006/30/2024
HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74683-3000
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL73 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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74683-3000-159 mL in 1 BOTTLE; Type 0: Not a Combination Product07/17/202006/30/2024
2NDC:74683-3000-2118 mL in 1 BLISTER PACK; Type 0: Not a Combination Product07/17/202006/30/2024
3NDC:74683-3000-3946.35 mL in 1 BOTTLE; Type 0: Not a Combination Product07/17/202006/30/2024
4NDC:74683-3000-41892.71 mL in 1 BOTTLE; Type 0: Not a Combination Product07/17/202006/30/2024
5NDC:74683-3000-53785.41 mL in 1 BOTTLE; Type 0: Not a Combination Product07/17/202006/30/2024
6NDC:74683-3000-63785.41 mL in 1 BOTTLE; Type 0: Not a Combination Product07/17/202006/30/2024
7NDC:74683-3000-73785.41 mL in 1 BOTTLE; Type 0: Not a Combination Product07/17/202006/30/2024
8NDC:74683-3000-93 mL in 1 POUCH; Type 0: Not a Combination Product07/17/202006/30/2024
9NDC:74683-3000-83 mL in 1 POUCH; Type 0: Not a Combination Product07/17/202006/30/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A07/17/202006/30/2024
HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74683-1000
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL73 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.125 mL  in 100 mL
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74683-1000-1236 mL in 1 BOTTLE; Type 0: Not a Combination Product04/24/202006/30/2024
2NDC:74683-1000-2473 mL in 1 BOTTLE; Type 0: Not a Combination Product04/24/202006/30/2024
3NDC:74683-1000-3946.35 mL in 1 BOTTLE; Type 0: Not a Combination Product04/24/202006/30/2024
4NDC:74683-1000-41892.71 mL in 1 BOTTLE; Type 0: Not a Combination Product04/24/202006/30/2024
5NDC:74683-1000-53785.41 mL in 1 BOTTLE; Type 0: Not a Combination Product04/24/202006/30/2024
6NDC:74683-1000-659 mL in 1 BOTTLE; Type 0: Not a Combination Product04/24/202006/30/2024
7NDC:74683-1000-7118 mL in 1 BOTTLE; Type 0: Not a Combination Product04/24/202006/30/2024
8NDC:74683-1000-8236 mL in 1 BOTTLE; Type 0: Not a Combination Product07/09/202006/30/2024
9NDC:74683-1000-9473 mL in 1 BOTTLE; Type 0: Not a Combination Product07/09/202006/30/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/24/202006/30/2024
HAND SANITIZER 
alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74683-2000
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
HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.125 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL  in 100 mL
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74683-2000-1473 mL in 1 BOTTLE; Type 0: Not a Combination Product04/24/202008/01/2023
2NDC:74683-2000-2946.35 mL in 1 BOTTLE; Type 0: Not a Combination Product04/24/202008/01/2023
3NDC:74683-2000-31892.71 mL in 1 BOTTLE; Type 0: Not a Combination Product04/24/202008/01/2023
4NDC:74683-2000-43785.41 mL in 1 BOTTLE; Type 0: Not a Combination Product04/24/202008/01/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/24/202008/01/2023
HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74683-4000
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL73 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL  in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.125 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74683-4000-1118 mL in 1 BOTTLE; Type 0: Not a Combination Product09/24/202008/01/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A09/24/202008/01/2023
HAND SANITIZER WIPES 
alcohol cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74683-2500
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX) 0.0145 mL  in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.00125 mL  in 100 mL
FRAGRANCE CLEAN ORC0600327 (UNII: 329LCV5BTF) 0.01 mL  in 100 mL
WATER (UNII: 059QF0KO0R) 0.27425 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74683-2500-1262 mL in 1 CANISTER; Type 0: Not a Combination Product11/13/202008/01/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A11/13/202008/01/2023
HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74683-3001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL73 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.125 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74683-3001-1946.35 mL in 1 BOTTLE; Type 0: Not a Combination Product04/08/202108/01/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/08/202108/01/2023
HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74683-1002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL715.4 mL  in 1021.95 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R) 282 mL  in 1021.95 mL
FRAGRANCE CLEAN ORC0600327 (UNII: 329LCV5BTF) 0.044 mL  in 1021.95 mL
RAPIDGEL EZ1 (UNII: 33JH4A7R2K) 9.7 mL  in 1021.95 mL
GLYCERIN (UNII: PDC6A3C0OX) 14.8 mL  in 1021.95 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74683-1002-1250 mL in 1 BOTTLE; Type 0: Not a Combination Product02/17/202308/01/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A02/17/202308/01/2023
HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74683-5001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL715.4 mL  in 1021.95 mL
Inactive Ingredients
Ingredient NameStrength
FRAGRANCE CLEAN ORC0600327 (UNII: 329LCV5BTF) 0.044 mL  in 1021.95 mL
RAPIDGEL EZ1 (UNII: 33JH4A7R2K) 9.7 mL  in 1021.95 mL
GLYCERIN (UNII: PDC6A3C0OX) 14.8 mL  in 1021.95 mL
DENATONIUM BENZOATE ANHYDROUS (UNII: M5BA6GAF1O) 0.006 mL  in 1021.95 mL
WATER (UNII: 059QF0KO0R) 282 mL  in 1021.95 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74683-5001-1473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/23/2023
2NDC:74683-5001-259 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/25/2023
3NDC:74683-5001-3250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/25/2023
4NDC:74683-5001-4118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/31/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/23/2023
HAND SANITIZER 
alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74683-2001
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
WATER (UNII: 059QF0KO0R)  
HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.125 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74683-2001-1473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/31/2023
2NDC:74683-2001-23785.41 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/31/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A07/31/2023
Labeler - Horizon Tool Inc. (602012460)
Establishment
NameAddressID/FEIBusiness Operations
Horizon Tool Inc.602012460manufacture(74683-5000, 74683-2500, 74683-3001, 74683-2100, 74683-6000, 74683-6200, 74683-1000, 74683-2000, 74683-3000, 74683-4000, 74683-1002, 74683-5001, 74683-2001)

Revised: 9/2023
Document Id: 05f48e44-e62d-3bd6-e063-6294a90a1376
Set id: a40afa46-a07d-f864-e053-2a95a90aef8a
Version: 24
Effective Time: 20230922
 
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