CHEMSTATION ALCOHOL FREE HAND SANITIZER- benzalkonium chloride liquid

Chemstation Alcohol free Hand Sanitizer by

Drug Labeling and Warnings

Chemstation Alcohol free Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by CHEMSTATION SOUTHERN CALIFORNIA, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Benzalkonium Chloride 0.14 v/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.

KEEP OUT OF REACH OF CHILDREN

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

Product label

INGREDIENTS AND APPEARANCE

CHEMSTATION ALCOHOL FREE HAND SANITIZER 
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80291-002
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 BETAINE (UNII: 5OCF3O11KX)
COCAMIDOPROPYL DIMETHYLAMINE PROPIONATE (UNII: 83750MLC4A)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80291-002-01	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/28/2020
2	NDC: 80291-002-02	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/28/2020
3	NDC: 80291-002-03	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/28/2020
4	NDC: 80291-002-04	3.785 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/28/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	08/28/2020

Labeler - CHEMSTATION SOUTHERN CALIFORNIA, INC. (825479186)

Establishment
Name	Address	ID/FEI	Business Operations
CHEMSTATION SOUTHERN CALIFORNIA, INC.		825479186	manufacture(80291-002)