DUROKLEEN SANITIZER- benzalkonium chloride liquid

DuroKleen Sanitizer by

Drug Labeling and Warnings

DuroKleen Sanitizer by is a Otc medication manufactured, distributed, or labeled by NuGenTec. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Benzalkonium Chloride 0.10%

Purpose

Antiseptic, Hand Sanitizer, Antibacterial

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. Flammable. Keep away from heat or flame

Do not use

• in children less than 2 months of age
• on open skin wounds

WHEN USING

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.

STOP USE

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Spray product on hands to cover and wet all surfaces. Rub thoroughly. Allow to dry without wiping
• Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

• Store between 15-30C (59-86F)
• Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

Ztrex 72 MUP, purified water USP

Package Label - Principal Display Panel

750mL is one bottle NDC: 77368-901-75

INGREDIENTS AND APPEARANCE

DUROKLEEN SANITIZER 
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77368-902
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.1 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
DIMETHYLTETRADECYL(3-(TRIMETHOXYSILYL)PROPYL)AMMONIUM CHLORIDE (UNII: N7BH1NTV97)	0.2 mL  in 100 mL
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77368-902-75	750 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	01/14/2021
2	NDC: 77368-902-02	60 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	01/14/2021
3	NDC: 77368-902-10	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/14/2021
4	NDC: 77368-902-05	18927 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/14/2021
5	NDC: 77368-902-01	3786 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/14/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/30/2020

Labeler - NuGenTec (090331927)

Registrant - NuGenTec (090331927)

Establishment
Name	Address	ID/FEI	Business Operations
NuGenTec		090331927	manufacture(77368-902)