Prefenz Silica Based Hand Sanitizer

Dosage form: liquid
Ingredients: BENZALKONIUM CHLORIDE 12mL in 100mL
Labeler: Prefense LLC
NDC Code: 48404-106

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 TypeHUMAN OTC DRUGItem Code (Source)NDC:48404-106
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE12 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
COCAMIDOPROPYL BETAINE 
CITRIC ACID MONOHYDRATE 
Packaging
#Item CodePackage Description
1NDC:48404-106-0144.36 mL in 1 BOTTLE
2NDC:48404-106-02236.588 mL in 1 BOTTLE
3NDC:48404-106-031892.7 mL in 1 BOTTLE
4NDC:48404-106-04946.35 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33301/01/2009
Labeler - Prefense LLC (832498625)
Registrant - Prefense LLC (832498625)
Establishment
NameAddressID/FEIOperations
Prefense LLC832498625manufacture

Revised: 06/2010
 
Prefense LLC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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