BZK 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:
Dukal Corp
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
First Aid Antiseptic Antiseptic Cleansing of face, hands and body without soap and water. Air dries in seconds. In the eyes or apply over large areas of the body. If irritation, redness or other symptoms develop. Consult a doctor if the condition persists or gets worse.
Authorization status:
OTC monograph not final
Authorization number:
65517-0004-1, 65517-0004-2

BZK TOWELETTE - benzalkonium chloride swab

Dukal Corp

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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855 - BZK

Drug Facts

Active Ingredients

Benzalkonium Chloride, 0.133% w/v

Purpos e

First Aid Antiseptic

Us e

Antiseptic Cleansing of face, hands and body without soap and water. Air dries in seconds.

Do Not Use

In the eyes or apply over large areas of the body.

Stop Use

If irritation, redness or other symptoms develop. Consult a doctor if the condition persists or gets

worse.

Caution

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.

Inactive Ingredients

Sodium Bicarbonate, Water

Principal Display Panel - 1.4 mL Pouch Label

Dukal

CORPORATION

REF 855

NDC 65517-0004-1

BZK ANTISEPTIC

TOWELETTE

Contains Benzalkonium Chloride

1/Pouch LAte

Manufactured For: DUKAL CORPORATION

Ronkonkoma, NY 11779 www.dukal.com

Questions? 1-800-243-0741

Made in China D07110604 Rev7

Principal Display Panel - 2.1 mL Pouch Label

Dukal™

CORPORATION

REF 855C

NDC 65517-0004-2

NON-Sterile

BZK TOWELETTE

Contains Benzalkonium Chloride

For External Use Only

1/Pouch

DUKAL CORPORATION

(631) 656-3800

Ronkonkoma, NY 11779

www.dukal.com

Made in China

BZK TOWELETTE

benzalkonium chloride swab

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 5517-0 0 0 4

Route of Administration

TOPICAL

Dukal Corp

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)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 5517-0 0 0 4-1

1.4 mL in 1 POUCH; Type 0 : No t a Co mbinatio n Pro duct

0 1/0 1/20 0 6

2

NDC:6 5517-0 0 0 4-2

2.1 mL in 1 POUCH; Type 0 : No t a Co mbinatio n Pro duct

0 1/0 1/20 0 6

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 1/0 1/20 0 6

Labeler -

Dukal Corp (791014871)

Revised: 1/2020

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