Active Ingredient

Drug Facts

Active Ingredient

Benzalkonium Chloride ............0.12%

Purpose

Hand and Skin Sanitizer

Uses:

Hand sanitizer to help reduce germs that potentially cause disease.

Warning:

For external use only. Avoid contact with eyes. In case of eye contact, flush with water. Discontinue use if irritation or redness occurs.

Keep out of reach of children

Keep out of reach of children.

Directions:

Apply to dry hands, rub together, and let dry.

Inactive Ingredients:

3-Chloropropyltrimethoxysilane, Acetic Acid, Anhydrous Citric Acid, Cocomidoprophyl betaine, Octadecyldimethyl (3-trimethoxysilylpropyl)ammonium chloride, East Indian Lemongrass Oil, Isotonic Sodium Chloride Solution, Orange Oil, Water

Package Label - 1 Liter Pouch

pre•fense ™

Hand Sanitizer

Original lemongrass scent

protects

kills up to 99.99% of germs on contact

Moisturizes

silica based, alcohol-free

alcohol-free

won't dry out skin

www.prefense.com

Made in USA

DO NOT FREEZE

33.82 fl. oz./1 Liter

Label

PRE FENSE
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:48404-051
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	120 mg in 100 mL

Ingredient Name	Strength
Inactive Ingredients
ISOTONIC SODIUM CHLORIDE SOLUTION (UNII: VR5Y7PDT5W)
DIMETHYLOCTADECYL(3-(TRIMETHOXYSILYL)PROPYL)AMMONIUM CHLORIDE (UNII: IQ36O85WQ4)
METHYL ALCOHOL (UNII: Y4S76JWI15)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
WATER (UNII: 059QF0KO0R)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
EAST INDIAN LEMONGRASS OIL (UNII: UP0M8M3VZW)
ORANGE OIL (UNII: AKN3KSD11B)
(3-CHLOROPROPYL)TRIMETHOXYSILANE (UNII: T21BNL1S7F)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:48404-051-01	44.4 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/11/2020
2	NDC:48404-051-02	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/11/2020
3	NDC:48404-051-03	1000 mL in 1 POUCH; Type 0: Not a Combination Product	05/11/2020
4	NDC:48404-051-04	1893 mL in 1 JUG; Type 0: Not a Combination Product	05/11/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	505G(a)(3)	05/11/2020

Labeler - Prefense LLC (832498625)

Registrant - Prefense LLC (832498625)

Name	Address	ID/FEI	Business Operations
Establishment
Reynolds Engineering and Equipment, Inc.		807186333	manufacture(48404-051)

pre•fense Original Lemongrass Scent Hand Sanitizer

Active Ingredient

Purpose

Uses:

Warning:

Keep out of reach of children

Directions:

Inactive Ingredients:

Package Label - 1 Liter Pouch