BZK PADS- 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:
Dynarex Corporation
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Benzalkonium_OB First aid antiseptic to help prevent skin infection in minor cuts, scrapes and burns Antiseptic cleansing Perineal and maternity care Stop Use if: - irritation and redness develop - if condition persists for more than 72 hours, consult a physician. General antiseptic Ask a doctor before use if you have deep or puncture wounds animal bites serious burns Do not use - as a first aid antiseptic for more than 1 week - in the eyes - over large areas of the body
Authorization status:
OTC monograph not final
Authorization number:
67777-244-01

BZK PADS- benzalkonium chloride swab

Dynarex Corporation

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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1302 Cleansing Towelettes NDC 67777-244-01

Active Ingredient Purpose

Benzalkonium Chloride 0.13% v/v Antiseptic

Warnings

For external use only

Purpos e

Benzalkonium_OB

First aid antiseptic to help prevent skin infection in minor cuts, scrapes and burns

Antiseptic cleansing

Perineal and maternity care

Stop use if

Stop Use if:

irritation and redness develop

if condition persists for more than 72 hours, consult a physician.

Indications & Usage

General antiseptic

Ask a doctor before use if you have

deep or puncture wounds

animal bites

serious burns

Dosage & Administration

Dosage and Administration:

Tear at notch, remove towelette, use only once

As a first aid antiseptic

clean affeected area

apply 1 to 3 times daily

may be covered with a sterile bandage

if bandaged let dry first

Keep out of reach of children

Keep out of reach of children

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

Do not use

Do not use

as a first aid antiseptic for more than 1 week

in the eyes

over large areas of the body

Inactive ingredient section

Inactive ingredient(s): chlorothymal, ispropyl alcohol, water

Principal Display Panel

Benzalkonium_OB.jpg

BZK PADS

Dynarex Corporation

benzalkonium chloride swab

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 7777-244

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

1.3 mg

in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

CHLO RO THYMO L (UNII: LJ25TI0 CVT)

ISO PRO PYL ALCO HO L (UNII: ND2M416 30 2)

WATER (UNII: 0 59 QF0 KO0 R)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 7777-244-0 1 10 in 1 CASE

0 4/0 5/20 11

1

10 0 in 1 BOX

1

0 .55 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 5/20 11

Labeler -

Dynarex Corporation (008124539)

Registrant -

Dynarex Corporation (008124539)

Revised: 3/2019

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