OB CLEANSING TOWELETTE- 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.

----------

Drug Facts

Active Ingredient

Benzalkonium Chloride, 0.13%w/w

Purpose

First Aid Antiseptic

Use

First aid antiseptic to help reduce the risk of skin infection

Do Not

insert into the vagina

Do Not Use

In the eyes or apply over large areas of the body. In case of deep or puncture wounds, animal bites or serious burns, consult a doctor

Stop Use

and consult doctor; if the condition persists or gets worse. Do not use longer than 1 week unless directed by a doctor

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, if bandaged, let dry first

Inactive ingredients

O-Phenylphenol, Sodium bicarbonate, Purified water

Image of Pouch Label

Pouch Label

OB CLEANSING TOWELETTE 
benzalkonium chloride swab
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:34645-5038
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
2-PHENYLPHENOL (UNII: D343Z75HT8)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Color    Score    
ShapeSize
FlavorORANGE (ORANGE FLAVOR) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:34645-5038-31.4 mL in 1 POUCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)01/01/201008/21/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A01/01/201008/21/2018
Labeler - Jiangsu Province JianErKang Medical Dressing Co. ,Ltd. (530968767)

Revised: 8/2018
 
Jiangsu Province JianErKang Medical Dressing Co. ,Ltd.