BENZA CLEAN HAND SANITIZER- benzalkonium chloride liquid 
BIOSYN 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.

----------

Active Ingredient

Benzalkonium Chloride 0.13% 

Purpose

Antimicrobial and First Aid Antiseptic

Uses

For hand sanitizing to decrease bacteria on the skin. As a wound antiseptic to help prevent bacterial contamination in cuts, burns, scrapes, lacerations and skin infections.

Warnings

For external use only.

When using this product avoid contact with eyes. Incase of eye contact, flush eyes with water.
Discontinue useif irritation or redness develops. If condition persists for more than 72 hours, consult a doctor.

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, Sodium Bicarbonate, Colalipid C, Hydroxyethyl Cellulose, Green Tea Leaf Extract.

Package Label - Principal Display Panel

Label

BENZA CLEAN HAND SANITIZER 
benzalkonium chloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79832-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
COCAMIDOPROPYL PROPYLENE GLYCOL-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4)  
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79832-001-01473 mL in 1 BOTTLE; Type 0: Not a Combination Product09/18/2020
2NDC:79832-001-023785 mL in 1 BOTTLE; Type 0: Not a Combination Product09/18/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A09/18/2020
Labeler - BIOSYN INC (079797906)

Revised: 9/2020
Document Id: dbdb0bef-128a-45c2-a443-d64b62627d36
Set id: 1509ef50-c1d6-4161-8674-e644a8811684
Version: 1
Effective Time: 20200926
 
BIOSYN INC