NORTHMED HAND SANITIZER- benzalkonium chloride gel 
Northmed SIA

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 0.2%

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

Water, Glycerine, Panthenol, Aloe vera, Hydroxyethyl cellulose, Tetrasodium Glutamate Diacetate, Fragrance, Linalool, Citronellol

Package Label - Principal Display Panel

2 mL

Label

50 mL

Label

250 mL

Label

1000 mL

Label

4000 mL

Label

NORTHMED HAND SANITIZER 
benzalkonium chloride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78522-010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE2 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
PANTHENOL (UNII: WV9CM0O67Z)  
HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%) (UNII: 8136Y38GY5)  
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
.BETA.-CITRONELLOL, (+/-)- (UNII: 565OK72VNF)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78522-010-0124 in 1 PACKAGE07/22/2020
12 mL in 1 POUCH; Type 0: Not a Combination Product
2NDC:78522-010-0250 mL in 1 TUBE; Type 0: Not a Combination Product07/22/2020
3NDC:78522-010-03250 mL in 1 BOTTLE; Type 0: Not a Combination Product07/22/2020
4NDC:78522-010-041000 mL in 1 BAG; Type 0: Not a Combination Product07/22/2020
5NDC:78522-010-054000 mL in 1 BAG; Type 0: Not a Combination Product07/22/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A07/22/2020
Labeler - Northmed SIA (662588132)
Establishment
NameAddressID/FEIBusiness Operations
Northmed SIA662588132manufacture(78522-010)

Revised: 7/2020
Document Id: b3440acc-e0e8-47b3-a13e-475dd10dbaf8
Set id: 0b12811f-8101-4121-81ed-0d0c0ef12793
Version: 1
Effective Time: 20200722
 
Northmed SIA