PREFENZ SILICA BASED HAND SANITIZER - benzalkonium chloride liquid
Prefense LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Active Ingredient

Active Ingredient Purpose

Amosliq (Benzalkonium Chloride/Silica Complex) Antimicrobial

0.12%

Uses

Uses: Convenient and effective skin sanitizer and protectant.

Warnings

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

Directions: Apply to 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

Inactive Ingredients: Water, cocamidopropyl betaine, essential oil fragrance

Package Label

Alcohol Free PreFenz Botanicals Silica Based Hand Sanitizer Smooths, softens, protects 1 Application protects through 10 Hand Washings One spray for all day Prefenz Fresh Citrus.

Prefenz Botanicals patented formula provides safe, all-day antibacterial protection for all strains of staph, strep, E.coli, drug resistant MRSA strains, and more. Our Alcohol-Free formula contains moisturizing silica complex with soothing botanicals to fight drying, redness and chapping. For everyday protection, whether at work or play, Prefenz will safeguard you and your family against today's germs. Do Not Freeze. US Patent #6613755. Actual Test results indicate up to 60 hours of continuous protection. Individual results may vary.

PREFENZ SILICA BASED HAND SANITIZER
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:48404-106
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	12 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

#	Item Code	Package Description
Packaging
1	NDC:48404-106-01	44.36 mL in 1 BOTTLE
2	NDC:48404-106-02	236.588 mL in 1 BOTTLE
3	NDC:48404-106-03	1892.7 mL in 1 BOTTLE
4	NDC:48404-106-04	946.35 mL in 1 BOTTLE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333	01/01/2009

Labeler - Prefense LLC (832498625)

Registrant - Prefense LLC (832498625)

Name	Address	ID/FEI	Business Operations
Establishment
Prefense LLC		832498625	manufacture