PRE FENSE UNSCENTED- benzalkonium chloride liquid

pre fense unscented by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

Drug Facts

Active Ingredient

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

PURPOSE

Hand and Skin Sanitizer

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

INDICATIONS & USAGE

Hand sanitizer to help reduce germs that potentially cause disease.

WARNINGS

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

DOSAGE & ADMINISTRATION

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

INACTIVE INGREDIENT

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

PRINCIPAL DISPLAY PANEL

prefense

HAND SANITIZER

Alcohol free
Unscented

protects

kills up to 99.99% of germs on contact

Moisturizes

silica based, alcohol-free

won't dry out skin

Made in USA

DO NOT FREEZE

US Patent # 6613755

www.prefense.com

INGREDIENTS AND APPEARANCE

PRE FENSE UNSCENTED 
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 48404-050
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
ACETIC ACID (UNII: Q40Q9N063P)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
WATER (UNII: 059QF0KO0R)
(3-CHLOROPROPYL)TRIMETHOXYSILANE (UNII: T21BNL1S7F)
ISOTONIC SODIUM CHLORIDE SOLUTION (UNII: VR5Y7PDT5W)
METHYL ALCOHOL (UNII: Y4S76JWI15)
DIMETHYLOCTADECYL(3-(TRIMETHOXYSILYL)PROPYL)AMMONIUM CHLORIDE (UNII: IQ36O85WQ4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 48404-050-01	44.4 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/15/2020
2	NDC: 48404-050-02	236.6 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/15/2020
3	NDC: 48404-050-03	502.8 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/15/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	05/15/2020

Labeler - Prefense LLC (832498625)

Registrant - Prefense LLC (832498625)

Establishment
Name	Address	ID/FEI	Business Operations
Reynolds Engineering		807186333	manufacture(48404-050) , label(48404-050) , pack(48404-050)