ZONSEN BZK ANTISEPTIC- benzalkonium chloride swab
Wuhan Zonsen Medical Products 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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Zonsen BZK Antiseptic Towelette

Drug Facts

Active Ingredients

Benzalkonium Chloride 0.133%

Purpose

First Aid Antiseptic

Use

Antiseptic cleansing of face, hands and body to decrease bacteria on skin without soap and water.

Warnings

For external use only.

Do not use

in the eyes. If this happens, rinse thoroughly with water.

Stop use and ask a doctor

if irritation and redness develop and persists for more than 72 hours.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Tear open packet, unfold and use as a washcloth. Allow hands to dry without wiping.

Other information

Store at room temperature 15°C-30°C(59°F-86°F)

Inactive Ingredients:

purified water, sodium bicarbonate

Package Labeling:

Label2

ZONSEN BZK ANTISEPTIC
benzalkonium chloride swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:72932-002
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.33 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:72932-002-00	1 in 1 POUCH	04/01/2019
1		1.5 mL in 1 PACKET; 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	04/01/2019

Labeler - Wuhan Zonsen Medical Products Co., Ltd. (554474517)

Name	Address	ID/FEI	Business Operations
Establishment
Wuhan Zonsen Medical Products Co., Ltd.		554474517	manufacture(72932-002)