Label: PREFENZ SILICA BASED HAND SANITIZER - benzalkonium chloride liquid
- NDC Code(s): 48404-106-01, 48404-106-02, 48404-106-03, 48404-106-04
- Packager: Prefense LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Updated June 15, 2010
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- Active Ingredient
Active Ingredient Purpose
Amosliq (Benzalkonium Chloride/Silica Complex) Antimicrobial
Uses: Convenient and effective skin sanitizer and protectant.Close
Warning: For external use only. Avoid contact with eyes. In case of eye contact, flush with water. Discontinue use if irritation or redness occurs.Close
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.Close
- Inactive Ingredients
Inactive Ingredients: Water, cocamidopropyl betaine, essential oil fragranceClose
- 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.
- INGREDIENTS AND APPEARANCE
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 Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 12 mL in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 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 Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333 01/01/2009 Labeler - Prefense LLC (832498625) Registrant - Prefense LLC (832498625) Establishment Name Address ID/FEI Business Operations Prefense LLC 832498625 manufacture