Workhorse E3 Gel Hand Sanitizer by Bunzl Processor Distribution LLC / ENVIRO TECH CHEMICAL SERVICES, INC.

Workhorse E3 Gel Hand Sanitizer by

Drug Labeling and Warnings

Workhorse E3 Gel Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Bunzl Processor Distribution LLC, ENVIRO TECH CHEMICAL SERVICES, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

WORKHORSE E3 GEL HAND SANITIZER- alcohol solution 
Bunzl Processor Distribution 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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Active Ingredient

Alcohol 70% v/v.

Purpose

Antiseptic

Use[s]

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 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.

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

carbomer, glycerin, hydrogen peroxide, purified water

Package Label - Principal Display Panel

WORKHORSE E3 GEL HAND SANITIZER 
alcohol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 21532-0004
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)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
WATER (UNII: 059QF0KO0R)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 21532-0004-7	3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/01/2020	12/31/2021
2	NDC: 21532-0004-8	208198 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/01/2020	12/31/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/01/2020	12/31/2021

Labeler - Bunzl Processor Distribution LLC (007169634)

Establishment
Name	Address	ID/FEI	Business Operations
ENVIRO TECH CHEMICAL SERVICES, INC.		805860483	manufacture(21532-0004)

Revised: 8/2021

Document Id: cadef490-5dd2-7230-e053-2a95a90a5551

34390-5

Set id: 4ce2f434-ab89-4ac2-b0b5-1a256a5940c3

Version: 3

Effective Time: 20210831