KLEEN START 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.

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Kleen Start Liquid Hand Sanitizer

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. In case of eye contact, flush eyes with water.

Discontinue Use If

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

Inactive Ingredients

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

Principle Display Panel

Principle Display Panel

KLEEN START HAND SANITIZER 
benzalkonium chloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79832-401
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.0013 g  in 1 L
Inactive Ingredients
Ingredient NameStrength
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
WATER (UNII: 059QF0KO0R)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
COCAMIDOPROPYL PROPYLENE GLYCOL-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79832-401-803.78 L in 1 JUG; Type 0: Not a Combination Product02/01/202112/31/2024
2NDC:79832-401-140.405 L in 1 BOTTLE, PUMP; Type 0: Not a Combination Product02/01/202112/31/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A02/01/202112/31/2024
Labeler - BioSyn Inc (079797906)
Establishment
NameAddressID/FEIBusiness Operations
Toll Solutions004854914manufacture(79832-401)
Establishment
NameAddressID/FEIBusiness Operations
Higley Industries, Ins005467626manufacture(79832-401)

Revised: 1/2023
Document Id: f1fda07f-e1f7-2be6-e053-2995a90a4c05
Set id: ba4bea2e-aeea-084d-e053-2a95a90a04d4
Version: 3
Effective Time: 20230111
 
BioSyn Inc