BZK ANTIBACTERIAL BANDAGES- benzalkonium chloride swab
YIWU HAODING MEDICAL 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.

----------

Active Ingredients

Benzalkonium Chloride 0.10%

Purpose

Antiseptic

Use

First aid to help reduce the risk of infection in minor cuts ,scrapes,and burns.

Warnings

For external use only.

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

Do not use longer than 1 week unless directed by a physician. In case of deep or puncture wounds, animal bites, or serious burn, consult a physician.

Keep out of reach of children.if swallowed get medical help or contact Poison control Center right away.

Directions

Clean and dry the affected area. Apply a sterile bandage on the area 1 to 3 times daily.

Other information: not intended for use on delicate or sensitive skin.

Inactive Ingredient

None

BZK ANTIBACTERIAL BANDAGES
benzalkonium chloride swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69139-300
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.10 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69139-300-01	1 in 1 PACKAGE	08/03/2018	08/15/2018
1		0.5 g in 1 POUCH; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	08/03/2018	08/15/2018

Labeler - YIWU HAODING MEDICAL CO.,LTD (421362384)

Name	Address	ID/FEI	Business Operations
Establishment
YIWU HAODING MEDICAL CO.,LTD		421362384	manufacture(69139-300)

Revised: 8/2018

Document Id: 0b46a277-e3ab-427e-aa4c-518971fba040

Set id: 522e8a3d-3992-4cdd-bd27-83c2c1058a04

Version: 4

Effective Time: 20180815

YIWU HAODING MEDICAL CO.,LTD