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 Code(s):
74683-1000-1,
74683-1000-2,
74683-1000-3,
74683-1000-4, view more74683-1000-5, 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, 74683-2100-1, 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, 74683-6000-1, 74683-6200-1, 74683-6200-2, 74683-6200-3
- Packager: Horizon Tool Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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 May 31, 2023
If you are a consumer or patient 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:
- 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.
- Glycerol (1.45% v/v).
- Hydrogen peroxide (0.125% v/v).
- 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)
- Purpose
- Use
- Warnings
- Do not use
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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
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other information
- Inactive ingredients
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Package Label - Principal Display Panel
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
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INGREDIENTS AND APPEARANCE
E2 HAND WASHÂ
e2 sanitizing hand soap soapProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:74683-6200 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.13 mg  in 100 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:74683-6200-1 3785.4 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/03/2023 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 Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 01/03/2023 E2 HAND WASHÂ
e2 sanitizing hand soap soapProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:74683-6000 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.13 mg  in 100 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:74683-6000-1 3785.4 mL in 1 BOTTLE; Type 0: Not a Combination Product 10/18/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 10/18/2022 HAND SANITIZERÂ
alocohl liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:74683-2100 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 80 mL  in 100 mL Inactive Ingredients Ingredient Name Strength HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.125 mL  in 100 mL WATER (UNII: 059QF0KO0R)  GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL  in 100 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:74683-2100-1 59 mL in 1 BOTTLE; Type 0: Not a Combination Product 04/13/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 04/13/2021 HAND SANITIZERÂ
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:74683-5000 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 715.4 mL  in 1021.95 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 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 Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 11/11/2020 06/30/2024 HAND SANITIZERÂ
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:74683-3000 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 73 mL  in 100 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL  in 100 mL HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.125 mL  in 100 mL WATER (UNII: 059QF0KO0R)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 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 Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 07/17/2020 06/30/2024 HAND SANITIZERÂ
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:74683-1000 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 73 mL  in 100 mL Inactive Ingredients Ingredient Name Strength HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.125 mL  in 100 mL WATER (UNII: 059QF0KO0R)  GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL  in 100 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 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 Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 04/24/2020 06/30/2024 HAND SANITIZERÂ
alcohol liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:74683-2000 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 80 mL  in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R)  HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.125 mL  in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL  in 100 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:74683-2000-1 473 mL in 1 BOTTLE; Type 0: Not a Combination Product 04/24/2020 2 NDC:74683-2000-2 946.35 mL in 1 BOTTLE; Type 0: Not a Combination Product 04/24/2020 3 NDC:74683-2000-3 1892.71 mL in 1 BOTTLE; Type 0: Not a Combination Product 04/24/2020 4 NDC:74683-2000-4 3785.41 mL in 1 BOTTLE; Type 0: Not a Combination Product 04/24/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 04/24/2020 HAND SANITIZERÂ
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:74683-4000 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 73 mL  in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R)  GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL  in 100 mL HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.125 mL  in 100 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:74683-4000-1 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 09/24/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 09/24/2020 HAND SANITIZER WIPESÂ
alcohol clothProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:74683-2500 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 70 mL  in 100 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:74683-2500-1 262 mL in 1 CANISTER; Type 0: Not a Combination Product 11/13/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 11/13/2020 HAND SANITIZERÂ
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:74683-3001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 73 mL  in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R)  HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.125 mL  in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL  in 100 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:74683-3001-1 946.35 mL in 1 BOTTLE; Type 0: Not a Combination Product 04/08/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 04/08/2021 HAND SANITIZERÂ
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:74683-1002 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 715.4 mL  in 1021.95 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:74683-1002-1 250 mL in 1 BOTTLE; Type 0: Not a Combination Product 02/17/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 02/17/2023 Labeler - Horizon Tool Inc. (602012460) Establishment Name Address ID/FEI Business Operations 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)