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NDC 72932-0002-00 Zonsen BZK Antiseptic 1.33 mg/mL Details

Zonsen BZK Antiseptic 1.33 mg/mL

Zonsen BZK Antiseptic is a TOPICAL SWAB in the HUMAN OTC DRUG category. It is labeled and distributed by Wuhan Zonsen Medical Products Co., Ltd.. The primary component is BENZALKONIUM CHLORIDE.

Product Information

NDC	72932-0002
Product ID	72932-002_8956add6-1d6f-37d3-e053-2a95a90a185c
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Zonsen BZK Antiseptic
Proprietary Name Suffix	n/a
Non-Proprietary Name	BENZALKONIUM CHLORIDE
Product Type	HUMAN OTC DRUG
Dosage Form	SWAB
Route	TOPICAL
Active Ingredient Strength	1.33
Active Ingredient Units	mg/mL
Substance Name	BENZALKONIUM CHLORIDE
Labeler Name	Wuhan Zonsen Medical Products Co., Ltd.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part333A
Listing Certified Through	2024-12-31

Package

Package Images

NDC 72932-0002-00 (72932000200)

Pricing Information	N/A
NDC Package Code	72932-002-00
Billing NDC	72932000200
Package	1 PACKET in 1 POUCH (72932-002-00) / 1.5 mL in 1 PACKET
Marketing Start Date	2019-04-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL b9bc85da-0774-429b-a8e4-d2024ed0b81f Details

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:

INGREDIENTS AND APPEARANCE

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)

Revised: 5/2019

Document Id: 8956add6-1d6f-37d3-e053-2a95a90a185c

Set id: b9bc85da-0774-429b-a8e4-d2024ed0b81f

Version: 4

Effective Time: 20190520