OBSTETRICAL ANTISEPTIC - benzalkonium chloride swab 
Jiangsu Province JianErKang Medical Dressing 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 Facts

Cat. 40000-200A   NDC 34645-5002-3   Qty.1ea
Obstetrical Antiseptic Towelette
Antiseptic * For Single Use Only
Contains: Benzalkonium Chloride 0.13% w/w
For External Use Only * FOR PROFESSIONAL AND HOSPITAL USE
Caution: Keep out of reach of children
Distributed by:
Cardinal Health
Dublin OH, 43017 USA
Made in China


Active ingredient
Benzalkonium Chloride, 0.13% w/w

Purpose
First Aid Antiseptic

Use
First aid antiseptic to help prevent skin infection in minor cuts, scrapes, and burns

Warnings
For external use only.

Do not use
in the eyes or apply over large areas of the body
longer than 1 week unless directed by a doctor. In case of deep or puncture wounds, animal bites, or serious burns, consult a doctor.

Stop use and consult a doctor
if the condition persists or gets worse

Keep out of reach of children
If swallowed, get medical help or contact a Poison Control Center right away.

Directions
Clean the affected area
Apply a small amount of this product on the area 1 to 3 times daily
May be covered with a sterile bandage when dry

Inactive ingredients
purified water, sodium bicarbonate

Image of Pouch Label

Pouch Label

OBSTETRICAL ANTISEPTIC 
benzalkonium chloride swab
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:34645-5002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.0013 mL  in 1 mL
Product Characteristics
Color    Score    
ShapeSize
FlavorORANGE (Orange Fragrance) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:34645-5002-31.4 mL in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33301/01/2006
Labeler - Jiangsu Province JianErKang Medical Dressing Co.,Ltd (530968767)

Revised: 1/2010
Document Id: 60609692-3bf4-4c40-b5bd-00522b7ae659
Set id: e2133042-7387-4eec-863f-55e945e39482
Version: 3
Effective Time: 20100101
 
Jiangsu Province JianErKang Medical Dressing Co.,Ltd