BZK ANTISEPTIC TOWELETTE - benzalkonium chloride swab

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

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Active ingredient:
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)
Available from:
Yinjing Medical Technology (Shanghai) Co., Ltd.
INN (International Name):
BENZALKONIUM CHLORIDE
Composition:
BENZALKONIUM CHLORIDE 0.13 g in 100 g
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
First Aid Antiseptic First aid antiseptic to help prevent the risk of infection in minor cuts, scrapes and burns.
Authorization status:
OTC monograph not final
Authorization number:
44019-323-01

BZK ANTISEPTIC TOWELETTE - benzalkonium chloride swab

Yinjing Medical Technology (Shanghai) 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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BZK ANTISEPTIC TOWELETTE

Drug Facts

Active ingredient

Benzalkonium Chloride, 0.13% w/v

Purpos e

First Aid Antiseptic

Us e

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

Warnings

For external use only.

Do not use

in the eyes or apply over large areas of the body

longer than 1 week unless directed by a doctor.

Consult a doctor

in case of deep or puncture wounds, animal bites, or serious burns.

Stop use and consult a doctor

if the condition persists or gets worse.

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 when dry

Inactive ingredients

purified water, sodium bicarbonate

Shanghai Yinjing Medical Supplies Co., Ltd.

586 Yuanxi RD.Nanhui Industry Park,Shanghai 201300

Tel:+86-21-6801-6511 Http://www.yinjing.cn

E-mail: zhl@yinjing.cn

Made in China

NDC 44019-323-01

inin 1 pad/pouch

BZK ANTISEPTIC TOWELETTE

For External Use Only

Product Label

BZK ANTISEPTIC TOWELETTE

benzalkonium chloride swab

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:440 19 -323

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

0 .13 g

in 10 0 g

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:440 19 -

323-0 1

1 in 1 POUCH

0 8 /0 3/20 16

1

1.5 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System

(syringe, patch, etc.)

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

Yinjing Medical Technology (Shanghai) Co., Ltd.

OTC mo no graph no t final

pa rt333A

0 8 /0 3/20 16

Labeler -

Yinjing Medical T echnology (Shanghai) Co., Ltd. (530501535)

Registrant -

Yinjing Medical T echnology (Shanghai) Co., Ltd. (530501535)

Revised: 12/2017

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