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Name:Antibacterial Wipes
Manufacturer:China Shaanxi Richbond Industrial Imp. & Exp. Ltd.
Category:Over-the-counter (OTC) Marketed Drugs


Antibacterial Wipes

ANTIBACTERIAL WIPES  - benzalkonium chloride swab 
China Shaanxi Richbond Industrial Imp. & Exp. 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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Antibacterial Wipes


Active Ingredient                                                Purpose
Benzalkonium chloride 0.1 percent                   Antibacterial 

Uses: for hand washing to decrease bacteria on the skin. May be used on face, arms and legs

Warnings:

For external use only

Keep out of reach of children, except with adult supervision.

Keep out of eyes. In case of contact, rinse with water.

If irritation or rash develops, discontinue use.

Consult doctor if irritation persists for more than 72 hours.

If swallowed, seek medical attention or contact a Poison Control Center.

Directions

Pull one sheet from pack.

Clean hands or affected area and discard

Re-seal label after each use to keep wipes fresh.


Inactive Ingredients: Water, Glycerin, Lauryl Glucoside, DMDM Hydantoin, Aloe Barbadensis Leaf Extract,

Disodium EDTA, PEG 12 Demethicone, Panthenol, Chamomila Recutita (Matricaria) Extract, Iodopropynyl Butlycarbamate, Tocopheryl Acetate, Allantoin

AntibacterialWipes

AntibacterialWipesCanister

AntibacterialWipesPolybag


ANTIBACTERIAL WIPES 
benzalkonium chloride swab
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:50014-100
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE 0.1 
Inactive Ingredients
Ingredient Name Strength
WATER  
GLYCERIN  
1,3-DIMETHYLOL-5,5-DIMETHYL-HYDANTOIN  
ALOE VERA LEAF  
EDETATE DISODIUM  
DIMETHICONE  
PANTHENOL  
MATRICARIA RECUTITA  
IODOPROPYNYL BUTYLCARBAMATE  
ALPHA-TOCOPHEROL ACETATE  
ALLANTOIN  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50014-100-16 16 SWAB ( SWAB) in 1 BAG None
2 NDC:50014-100-20 20 SWAB ( SWAB) in 1 CANISTER None
3 NDC:50014-100-10 10 SWAB ( SWAB) in 1 BAG None
4 NDC:50014-100-30 30 SWAB ( SWAB) in 1 CANISTER None
5 NDC:50014-100-40 40 SWAB ( SWAB) in 1 CANISTER None
6 NDC:50014-100-25 25 SWAB ( SWAB) in 1 CANISTER None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333 12/30/2009

Labeler - China Shaanxi Richbond Industrial Imp. & Exp. Ltd. (547705785)
Registrant - China Shaanxi Richbond Industrial Imp. & Exp. Ltd. (547705785)
Establishment
Name Address ID/FEI Operations
China Shaanxi Richbond Industrial Imp. & Exp. Ltd. 547705785 manufacture

Revised: 12/2009 China Shaanxi Richbond Industrial Imp. & Exp. Ltd.



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


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