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Name:Anti-bacterial Wipes
Manufacturer:Tongling Jieya Biological Technology Co., Ltd.
Category:Over-the-counter (OTC) Marketed Drugs


Drug Fact

ANTI-BACTERIAL WIPES  - benzalkonium chloride cloth 
Tongling Jieya Biological Technology Co., Ltd.

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.

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Drug Fact

Active Ingredient                                                 Purpose

Benzalkonium Chloride  0.155%                         Antiseptic 

Uses

Antiseptic that kills germs and helps prevent the spread of cold

Warnings:

For external use only

May irritate eys. Keep out of  reach of children.


            Directions

  • Lift label to open
  • Remove towel
  • Wipe hands thoroughly. Discard after use.
  • Reseal label to prevent drying

Inactive Ingredients

Water, Propylene Glycol, Aloe Vera, Polysorbate 20, Diazolideinyl Urea, Disodium Cocoamphodiacetate, Fragrance, Tetrasodium EDTA, Citric Acid, Iodopropynyl Buylcarbamate

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ANTI-BACTERIAL WIPES 
benzalkonium chloride cloth
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:50552-001
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE 0.155   in 100 
Inactive Ingredients
Ingredient Name Strength
Water 95.535 
PROPYLENE GLYCOL
POLYSORBATE 20 0.5 
DIAZOLIDINYLUREA 0.3 
ALOE VERA LEAF 0.2 
IODOPROPYNYL BUTYLCARBAMATE 0.1 
EDETATE DISODIUM 0.05 
ANHYDROUS CITRIC ACID 0.01 
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50552-001-01 80 CLOTH ( FILM) in 1 BOTTLE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333 02/03/2010

Labeler - Tongling Jieya Biological Technology Co., Ltd. (529736361)
Registrant - Tongling Jieya Biological Technology Co., Ltd. (529736361)
Establishment
Name Address ID/FEI Operations
Tongling Jieya Biological Technology Co., Ltd. 529736361 manufacture

Revised: 02/2010 Tongling Jieya Biological Technology Co., Ltd.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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