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Name:Bzk Pads
Manufacturer:Dynarex Corporation
Category:Over-the-counter (OTC) Marketed Drugs


Benzalkonium Chloride Pads

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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Benzalkonium Chloride Pads

Active Ingredient                                     Purpose

Benzalkonium Chloride 0.5% v/v              Antiseptic

Use benzalkonium chloride cleansing pad

  • First aid antiseptic to help prevent skin infection in minor cuts, scrapes and burns
  • Antiseptic cleansing
  • Perineal and maternity care

Warnings

For external use only

Indications and Usage


General antiseptic

Ask a doctor before use if you have
  • deep or puncture wounds
  • animal bites
  • serious burns

Stop use if

Stop Use if:

  • irritation and redness develop
  • if condition persists for more than 72 hours, consult a physician.

Directions

Directions:

  • 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(s)

Benzalkonium Chloride Cleansing Pad

benzalkonium_chloride_cleansing_pad


BZK PADS 
benzalkonium chloride swab
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:67777-243
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE 1 g  in 750 g
Inactive Ingredients
Ingredient Name Strength
WATER  
ALCOHOL  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:67777-243-01 10 BOX ( BOX) in 1 CASE contains a BOX
1 100 PACKET ( PACKET) in 1 BOX This package is contained within the CASE (67777-243-01) and contains a PACKET
1 3 g in 1 PACKET This package is contained within a BOX and a CASE (67777-243-01)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 04/05/2011

Labeler - Dynarex Corporation (008124539)
Registrant - Dynarex Corporation (008124539)
Establishment
Name Address ID/FEI Operations
Taizhou Kanglin Health Protection Products Co Ltd 530576131 manufacture
Establishment
Name Address ID/FEI Operations
Sion Biotext Medical 532775194 manufacture

Revised: 04/2011 Dynarex Corporation



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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