DailyMed - E2 HAND WASH- e2 sanitizing hand soap soap HAND SANITIZER- alocohl liquid HAND SANITIZER- alcohol gel HAND SANITIZER WIPES- alcohol cloth

NDC Code(s): 74683-1000-1, 74683-1000-2, 74683-1000-3, 74683-1000-4, view more
74683-1000-5, 74683-1000-6, 74683-1000-7, 74683-1000-8, 74683-1000-9, 74683-1002-1, 74683-2000-1, 74683-2000-2, 74683-2000-3, 74683-2000-4, 74683-2001-1, 74683-2001-2, 74683-2100-1, 74683-2500-1, 74683-3000-1, 74683-3000-2, 74683-3000-3, 74683-3000-4, 74683-3000-5, 74683-3000-6, 74683-3000-7, 74683-3000-8, 74683-3000-9, 74683-3001-1, 74683-4000-1, 74683-5000-1, 74683-5000-2, 74683-5000-3, 74683-5000-4, 74683-5000-5, 74683-5000-6, 74683-5000-7, 74683-5000-8, 74683-5000-9, 74683-5001-1, 74683-5001-2, 74683-5001-3, 74683-5001-4, 74683-6000-1, 74683-6200-1, 74683-6200-2, 74683-6200-3
Packager: Horizon Tool Inc.

Category: HUMAN OTC DRUG LABEL

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.

Drug Label Information

Updated September 22, 2023

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

Download DRUG LABEL INFO: PDF XML
Official Label (Printer Friendly)

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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 ingredients

glycerin, hydrogen peroxide, purified water USP
Package Label - Principal Display Panel

3785.41 mL NDC: 74683-2001-2

473 mL NDC: 74683-2001-1

118 mL NDC: 74683-5001-4

250 mL NDC: 74683-5001-3

59 mL NDC: 74683-5001-2

473 mL NDC: 74683-5001-1

250 mL NDC: 74683-1002-1

3785.4 mL NDC: 74683-6200-3

250 mL NDC: 7463-6200-2

3785.4 mL NDC: 74683-6200-1

3785.4 mL NDC: 74683-6000-1

59 mL NDC: 74683-2100-1

946.35 mL NDC: 74683-3001-1

262 mL NDC: 74683-2500-1

1892.71 mL NDC: 74683-5000-9

208.2 L NDC: 74683-5000-8

946.35 mL NDC: 74683-5000-7

946.35 mL NDC: 74683-5000-7

473 mL NDC: 74683-5000-6

3785.41 mL NDC: 74683-5000-5

3785.41 mL NDC: 74683-5000-4

354.8 mL NDC: 74683-5000-3

236 mL NDC: 74683-5000-2

118 mL NDC: 74683-5000-1

118 mL NDC: 74683-4000-1

3 mL NDC 74683-3000-8

3 mL NDC 74683-3000-8

3 mL NDC 74683-3000-9

3 mL NDC 74683-3000-9

3785.41 mL NDC 74683-3000-7

3785.41 mL NDC 74683-3000-6

3785.41 mL NDC 74683-3000-5

1892.71 mL NDC 74683-3000-4

946.35 mL NDC 74683-3000-3

946.35 mL NDC 74683-3000-3

118 mL NDC 74683-3000-2

59 mL NDC 74683-3000-1

59 mL NDC 74683-3000-1

473 mL NDC 74683-1000-9

236 mL NDC 74683-1000-8

059 mL NDC: 74683-1000-6

059 mL NDC: 74683-1000-6

74683-1000-7

236 mL NDC: 74683-2000-1 473 mL NDC: 74683-1000-2

946.35 mL NDC: 74683-1000-3 946.35 mL NDC: 74683-1000-3

1892.71 mL NDC: 74683-1000-4

3785.41 mL NDC: 74683-1000-5

473 mL NDC: 74683-2000-1

473 mL NDC: 74683-2000-1

946.35 mL NDC: 74683-2000-2

946.35 mL NDC: 74683-2000-2

1892.71 mL NDC: 74683-2000-3

3785.41 mL NDC: 74683-2000-4

INGREDIENTS AND APPEARANCE

E2 HAND WASH
e2 sanitizing hand soap soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:74683-6200
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 mg in 100 mL

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:74683-6200-1	3785.4 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/03/2023	09/22/2023
2	NDC:74683-6200-2	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/17/2023
3	NDC:74683-6200-3	3785.4 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/17/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	01/03/2023

E2 HAND WASH
e2 sanitizing hand soap soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:74683-6000
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 mg in 100 mL

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:74683-6000-1	3785.4 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/18/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	10/18/2022

HAND SANITIZER
alocohl liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:74683-2100
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	80 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
HYDROGEN PEROXIDE (UNII: BBX060AN9V)	0.125 mL in 100 mL
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)	1.45 mL in 100 mL

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:74683-2100-1	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/13/2021	08/01/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	04/13/2021	08/01/2023

HAND SANITIZER
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:74683-5000
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	715.4 mL in 1021.95 mL

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:74683-5000-1	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/11/2020	06/30/2024
2	NDC:74683-5000-2	236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/11/2020	06/30/2024
3	NDC:74683-5000-3	354.8 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/11/2020	06/30/2024
4	NDC:74683-5000-4	3785.41 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/11/2020	06/30/2024
5	NDC:74683-5000-5	3785.41 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/11/2020	06/30/2024
6	NDC:74683-5000-6	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/11/2020	06/30/2024
7	NDC:74683-5000-7	946.35 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/11/2020	06/30/2024
8	NDC:74683-5000-8	208200 mL in 1 DRUM; Type 0: Not a Combination Product	11/11/2020	06/30/2024
9	NDC:74683-5000-9	1892.71 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/11/2020	06/30/2024

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	11/11/2020	06/30/2024

HAND SANITIZER
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:74683-3000
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	73 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
GLYCERIN (UNII: PDC6A3C0OX)	1.45 mL in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V)	0.125 mL in 100 mL
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:74683-3000-1	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/17/2020	06/30/2024
2	NDC:74683-3000-2	118 mL in 1 BLISTER PACK; Type 0: Not a Combination Product	07/17/2020	06/30/2024
3	NDC:74683-3000-3	946.35 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/17/2020	06/30/2024
4	NDC:74683-3000-4	1892.71 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/17/2020	06/30/2024
5	NDC:74683-3000-5	3785.41 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/17/2020	06/30/2024
6	NDC:74683-3000-6	3785.41 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/17/2020	06/30/2024
7	NDC:74683-3000-7	3785.41 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/17/2020	06/30/2024
8	NDC:74683-3000-9	3 mL in 1 POUCH; Type 0: Not a Combination Product	07/17/2020	06/30/2024
9	NDC:74683-3000-8	3 mL in 1 POUCH; Type 0: Not a Combination Product	07/17/2020	06/30/2024

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	07/17/2020	06/30/2024

HAND SANITIZER
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:74683-1000
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	73 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
HYDROGEN PEROXIDE (UNII: BBX060AN9V)	0.125 mL in 100 mL
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)	1.45 mL in 100 mL

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:74683-1000-1	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/24/2020	06/30/2024
2	NDC:74683-1000-2	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/24/2020	06/30/2024
3	NDC:74683-1000-3	946.35 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/24/2020	06/30/2024
4	NDC:74683-1000-4	1892.71 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/24/2020	06/30/2024
5	NDC:74683-1000-5	3785.41 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/24/2020	06/30/2024
6	NDC:74683-1000-6	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/24/2020	06/30/2024
7	NDC:74683-1000-7	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/24/2020	06/30/2024
8	NDC:74683-1000-8	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/09/2020	06/30/2024
9	NDC:74683-1000-9	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/09/2020	06/30/2024

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	04/24/2020	06/30/2024

HAND SANITIZER
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:74683-2000
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	80 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
HYDROGEN PEROXIDE (UNII: BBX060AN9V)	0.125 mL in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	1.45 mL in 100 mL
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:74683-2000-1	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/24/2020	08/01/2023
2	NDC:74683-2000-2	946.35 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/24/2020	08/01/2023
3	NDC:74683-2000-3	1892.71 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/24/2020	08/01/2023
4	NDC:74683-2000-4	3785.41 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/24/2020	08/01/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	04/24/2020	08/01/2023

HAND SANITIZER
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:74683-4000
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	73 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)	1.45 mL in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V)	0.125 mL in 100 mL

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:74683-4000-1	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/24/2020	08/01/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	09/24/2020	08/01/2023

HAND SANITIZER WIPES
alcohol cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:74683-2500
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:74683-2500-1	262 mL in 1 CANISTER; Type 0: Not a Combination Product	11/13/2020	08/01/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	11/13/2020	08/01/2023

HAND SANITIZER
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:74683-3001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	73 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)	0.125 mL in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	1.45 mL in 100 mL

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:74683-3001-1	946.35 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/08/2021	08/01/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	04/08/2021	08/01/2023

HAND SANITIZER
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:74683-1002
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	715.4 mL in 1021.95 mL

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:74683-1002-1	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/17/2023	08/01/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	02/17/2023	08/01/2023

HAND SANITIZER
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:74683-5001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	715.4 mL in 1021.95 mL

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:74683-5001-1	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/23/2023
2	NDC:74683-5001-2	59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/25/2023
3	NDC:74683-5001-3	250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/25/2023
4	NDC:74683-5001-4	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/31/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	06/23/2023

HAND SANITIZER
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:74683-2001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	80 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)	0.125 mL in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	1.45 mL in 100 mL

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:74683-2001-1	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/31/2023
2	NDC:74683-2001-2	3785.41 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/31/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	07/31/2023

Labeler - Horizon Tool Inc. (602012460)

Name	Address	ID/FEI	Business Operations
Establishment
Horizon Tool Inc.		602012460	manufacture(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)

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Published Date (What is this?)	Version	Files
Sep 25, 2023	24 (current)	download
Aug 2, 2023	23	download
Jul 26, 2023	21	download
Jun 26, 2023	20	download
Jun 1, 2023	19	download
Feb 20, 2023	18	download
Jan 5, 2023	16	download
Oct 24, 2022	15	download
Oct 14, 2022	14	download
Apr 14, 2021	13	download
Apr 9, 2021	12	download
Nov 16, 2020	11	download
Nov 13, 2020	10	download
Sep 25, 2020	9	download
Jul 22, 2020	8	download
Jul 21, 2020	6	download
Jul 20, 2020	5	download
Jul 10, 2020	4	download
May 21, 2020	2	download
Apr 29, 2020	1	download

	RxCUI	RxNorm NAME	RxTTY
1	581662	ethanol 70 % Topical Gel	PSN
2	581662	ethanol 0.7 ML/ML Topical Gel	SCD
3	581662	ethanol 70 % Topical Gel	SY
4	581662	ethyl alcohol 70 % Topical Gel	SY
5	1241663	ethanol 80 % Topical Spray	PSN
6	1241663	ethanol 0.8 ML/ML Topical Spray	SCD
7	1241663	ethanol 80 % Topical Spray	SY
8	1489307	ethanol 70 % Medicated Pad	PSN
9	1489307	ethanol 0.7 ML/ML Medicated Pad	SCD
10	1489307	ethanol 70 % Medicated Pad	SY
11	1489307	ethanol 70 % Medicated Wipes	SY

Label: E2 HAND WASH- e2 sanitizing hand soap soap
HAND SANITIZER- alocohl liquid
HAND SANITIZER- alcohol gel
HAND SANITIZER WIPES- alcohol cloth

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	NDC
1	74683-1000-1
2	74683-1000-2
3	74683-1000-3
4	74683-1000-4
5	74683-1000-5
6	74683-1000-6
7	74683-1000-7
8	74683-1000-8
9	74683-1000-9
10	74683-1002-1
11	74683-2000-1
12	74683-2000-2
13	74683-2000-3
14	74683-2000-4
15	74683-2001-1
16	74683-2001-2
17	74683-2100-1
18	74683-2500-1
19	74683-3000-1
20	74683-3000-2
21	74683-3000-3
22	74683-3000-4
23	74683-3000-5
24	74683-3000-6
25	74683-3000-7
26	74683-3000-8
27	74683-3000-9
28	74683-3001-1
29	74683-4000-1
30	74683-5000-1
31	74683-5000-2
32	74683-5000-3
33	74683-5000-4
34	74683-5000-5
35	74683-5000-6
36	74683-5000-7
37	74683-5000-8
38	74683-5000-9
39	74683-5001-1
40	74683-5001-2
41	74683-5001-3
42	74683-5001-4
43	74683-6000-1
44	74683-6200-1
45	74683-6200-2
46	74683-6200-3

Label: E2 HAND WASH- e2 sanitizing hand soap soapHAND SANITIZER- alocohl liquidHAND SANITIZER- alcohol gelHAND SANITIZER WIPES- alcohol cloth

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E2 HAND WASH- e2 sanitizing hand soap soapHAND SANITIZER- alocohl liquidHAND SANITIZER- alcohol gelHAND SANITIZER WIPES- alcohol cloth

Number of versions: 20

E2 HAND WASH- e2 sanitizing hand soap soapHAND SANITIZER- alocohl liquidHAND SANITIZER- alcohol gelHAND SANITIZER WIPES- alcohol cloth

E2 HAND WASH- e2 sanitizing hand soap soapHAND SANITIZER- alocohl liquidHAND SANITIZER- alcohol gelHAND SANITIZER WIPES- alcohol cloth

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E2 HAND WASH- e2 sanitizing hand soap soapHAND SANITIZER- alocohl liquidHAND SANITIZER- alcohol gelHAND SANITIZER WIPES- alcohol cloth

If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.

Label: E2 HAND WASH- e2 sanitizing hand soap soap
HAND SANITIZER- alocohl liquid
HAND SANITIZER- alcohol gel
HAND SANITIZER WIPES- alcohol cloth

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

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

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

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