KLEEN START HAND SANITIZER- benzalkonium chloride liquid

Kleen Start Hand Sanitizer by

Drug Labeling and Warnings

Kleen Start Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by BioSyn Inc, Toll Solutions, Higley Industries, Ins. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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. 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

• Pump onto hands as needed. Rub briskly until dry.
• Apply to wounds 3 times per day after cleaning. Allow to dry. May be bandaged once dry.

Inactive Ingredients

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

Principle Display Panel

INGREDIENTS AND APPEARANCE

KLEEN START HAND SANITIZER 
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79832-401
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.0013 g  in 1 L

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79832-401-80	3.78 L in 1 JUG; Type 0: Not a Combination Product	02/01/2021	12/31/2024
2	NDC: 79832-401-14	0.405 L in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	02/01/2021	12/31/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	02/01/2021	12/31/2024

Labeler - BioSyn Inc (079797906)

Establishment
Name	Address	ID/FEI	Business Operations
Toll Solutions		004854914	manufacture(79832-401)

Establishment
Name	Address	ID/FEI	Business Operations
Higley Industries, Ins		005467626	manufacture(79832-401)