CHEMSTATION ALCOHOL FREE HAND SANITIZER- benzalkonium chloride liquid 
CHEMSTATION SOUTHERN CALIFORNIA, 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 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


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

Other information

Inactive ingredients

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

Product label

image description

CHEMSTATION ALCOHOL FREE HAND SANITIZER 
benzalkonium chloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80291-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.4 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
COCAMIDOPROPYL DIMETHYLAMINE PROPIONATE (UNII: 83750MLC4A)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80291-002-0159 mL in 1 BOTTLE; Type 0: Not a Combination Product08/28/2020
2NDC:80291-002-02118 mL in 1 BOTTLE; Type 0: Not a Combination Product08/28/2020
3NDC:80291-002-03236 mL in 1 BOTTLE; Type 0: Not a Combination Product08/28/2020
4NDC:80291-002-043.785 mL in 1 BOTTLE; Type 0: Not a Combination Product08/28/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A08/28/2020
Labeler - CHEMSTATION SOUTHERN CALIFORNIA, INC. (825479186)
Establishment
NameAddressID/FEIBusiness Operations
CHEMSTATION SOUTHERN CALIFORNIA, INC.825479186manufacture(80291-002)

Revised: 8/2020
Document Id: ceac02fa-2915-4401-9ea6-a7103a1ca0d4
Set id: dd54b1ba-dbd6-412d-9b44-c5a9eef895fb
Version: 1
Effective Time: 20200827
 
CHEMSTATION SOUTHERN CALIFORNIA, INC.