Alcohol-Free Foaming Hand Sanitizer by ENVIRO TECH CHEMICAL SERVICES, INC.

Alcohol-Free Foaming Hand Sanitizer by

Drug Labeling and Warnings

Alcohol-Free Foaming Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by ENVIRO TECH CHEMICAL SERVICES, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ALCOHOL-FREE FOAMING HAND SANITIZER- benzalkonium chloride liquid 
ENVIRO TECH CHEMICAL SERVICES, 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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Active Ingredient

Benzalkonium Chloride 0.14, % w/v

Purpose

Antiseptic

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.

Do not use
in children less than 2 months of age
on open skin wounds
in eyes

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

Purified water USP, glycerin, cocamidopropyl diemthylamine, and Cocamidopropyl betaine

Package Label - Principal Display Panel

ALCOHOL-FREE FOAMING HAND SANITIZER 
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66284-005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.4 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
COCAMIDOPROPYL DIMETHYLAMINE PROPIONATE (UNII: 83750MLC4A)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66284-005-01	59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/01/2020
2	NDC: 66284-005-02	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/01/2020
3	NDC: 66284-005-03	177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/01/2020
4	NDC: 66284-005-04	236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/01/2020
5	NDC: 66284-005-05	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/01/2020
6	NDC: 66284-005-06	946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/01/2020
7	NDC: 66284-005-07	4 in 1 CASE	08/01/2020
7		3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	08/01/2020	12/31/2021

Labeler - ENVIRO TECH CHEMICAL SERVICES, INC. (805860483)

Establishment
Name	Address	ID/FEI	Business Operations
ENVIRO TECH CHEMICAL SERVICES, INC.		805860483	manufacture(66284-005)

Revised: 7/2021

Document Id: c703f81b-aa85-0190-e053-2995a90abd87

34390-5

Set id: fad4397e-f1d5-485d-b39a-c92594376cf1

Version: 3

Effective Time: 20210713