ZONSEN BZK ANTISEPTIC- benzalkonium chloride swab

United States - English - NLM (National Library of Medicine)

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Active ingredient:
Benzalkonium Chloride 0.133%, First Aid Antiseptic
Available from:
Wuhan Zonsen Medical Products Co., Ltd.
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Antiseptic cleansing of face, hands and body to decrease bacteria on skin without soap and water.
Authorization status:
OTC monograph not final
Authorization number:
72932-002-00

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:

ZONSEN BZK ANTISEPTIC

benzalkonium chloride swab

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:729 32-0 0 2

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

BENZALKO NIUM CHLO RIDE (UNII: F5UM2KM3W7) (BENZALKONIUM -

UNII:7N6 JUD5X6 Y)

BENZALKONIUM

CHLORIDE

1.33 mg

in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

SO DIUM BICARBO NATE (UNII: 8 MDF5V39 QO)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:729 32-0 0 2-0 0

1 in 1 POUCH

0 4/0 1/20 19

1

1.5 mL in 1 PACKET; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt333A

0 4/0 1/20 19

Wuhan Zonsen Medical Products Co., Ltd.

Labeler -

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

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Wuhan Zo nsen Medical Pro ducts Co ., Ltd.

554474517

ma nufa c ture (729 32-0 0 2)

Revised: 5/2019

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