11989693 Canada Inc. BAC Hand Sanitizer

Eco-Foam Hand Sanitizer by

Drug Labeling and Warnings

Eco-Foam Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by 11989693 Canada Inc., Armstrong Manufacturing Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ECO-FOAM HAND SANITIZER- benzalkonium chloride solution solution 
11989693 Canada 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.

----------

11989693 Canada Inc. BAC Hand Sanitizer

Active Ingredient

Benzalkonium Chloride 0.13% w/w

Purpose

Antiseptic Skin Cleanser

Uses

Antiseptic skin cleanser

Effective in destroying harmful bacteria to provide antiseptic cleansing

Warnings

For external use only

When using this product

avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Stop use and ask a doctor

if irritation develops.

Keep out of reach of children

If swallowed, call a Posion Control Center or get medical help right away.

Directions

Adults and children over 2 years. For occasional and personal domestic use. Supervise children when they use this product. Rub thoroughly into hands for at least 30 seconds.Allow to dry.

Other Information

Store at room temperature

Inactive Ingredients

Cocamidopropyl betaine, Glycerin, Lauramine oxide, Propylene glycol, Water

Questions?

Telephone (514) 548-2187

Bottle Labels

ECO-FOAM HAND SANITIZER 
benzalkonium chloride solution solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81281-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.3 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
GLYCERIN (UNII: PDC6A3C0OX)
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81281-001-01	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/16/2020	06/30/2022
2	NDC: 81281-001-02	3780 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/16/2020	06/30/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	12/16/2020	06/30/2022

Labeler - 11989693 Canada Inc. (204229343)

Establishment
Name	Address	ID/FEI	Business Operations
Armstrong Manufacturing Inc.		201874877	manufacture(81281-001)

Revised: 6/2022

Document Id: e1fbeaab-690c-4ef3-e053-2a95a90aa92b

34390-5

Set id: b696f9ea-ccf4-6e34-e053-2a95a90a57bc

Version: 3

Effective Time: 20220621