PRE FENSE- benzalkonium chloride liquid

pre fense by

Drug Labeling and Warnings

pre fense by is a Otc medication manufactured, distributed, or labeled by Prefense LLC, Reynolds Engineering and Equipment, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Drug Facts

Active Ingredient

Amosilq (Benzalkonium Chloride/Silica Complex) ............0.12%

Purpose

Hand and Skin Sanitizer

Keep out of reach of children

Keep out of reach of children 2 years of age and younger.

Uses:

Convenient and effective skin sanitizer and protectant.

Warning:

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

Directions:

Apply to dry hands, rub together, and let dry. Hands will be protected for up to 24 hours or up to 10 hand washings with only one application.

Inactive Ingredients:

water, cocamidopropyl betaine, essential oil fragrance (orange peel, East Indian lemongrass oil) , citric acid

prefense Product Label

prefense

Lasts up to 24 hours

HAND SANITIZER

Lasts up to 24 hours
Alcohol free
Moisturizes skin
Safe for the whole family
Fresh citrus scent

Our patented formula containing silica complex will sooth and moisturize your skin throughout the day.

Move up to the new generation of hand sanitizers. Use moisturizing, alcohol free Prefense every day to keep germs away.

Made in USA

protects
kills germs up to 99.99% of germs on contact

moisturizes
silica based, alcohol free

Long lasting
through 10 washings

DO NOT FREEZE
US Patent # 6613755

www.prefense.com        640 pumps          8 fl.oz.

INGREDIENTS AND APPEARANCE

PRE FENSE 
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 48404-037
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	28.39 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EAST INDIAN LEMONGRASS OIL (UNII: UP0M8M3VZW)
ORANGE PEEL (UNII: TI9T76XD44)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 48404-037-01	44.4 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/15/2015
2	NDC: 48404-037-02	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/15/2015
3	NDC: 48404-037-03	1000 mL in 1 POUCH; Type 0: Not a Combination Product	06/15/2015
4	NDC: 48404-037-04	1893 mL in 1 JUG; Type 0: Not a Combination Product	06/15/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	06/15/2015

Labeler - Prefense LLC (832498625)

Registrant - Prefense LLC (832498625)

Establishment
Name	Address	ID/FEI	Business Operations
Reynolds Engineering and Equipment, Inc.		807186333	manufacture(48404-037)