BZK Antiseptic Towelette: Package Insert and Label Information

BZK ANTISEPTIC TOWELETTE- benzalkonium chloride swab
Davemed Healthcare 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.

Active Ingredients

Benzalkonium Chloride 0.13% v/v

Purpose

Antiseptic

Use

First aid antiseptic to help prevent skin infection in

  • minor cuts
  • scrapes, burns, anitiseptic cleansing
  • perineal and maternity care

Warnings

For external use only Do not use:

  • as an antiseptic for more than 1 week
  • in the eyes
  • over large areas of the body

Ask a doctor before use if you have

  • deep or puncture wounds
  • animal bites
  • serious burns

Stop use

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

Keep out of reach of children.if swallowed get medical help or contact Poison control Center right away.

Directions

  • Tear at notch
  • Remove towelette
  • Use only once

As a first aid antiseptic

  • clean affected area
  • apply 1 to 3 times daily
  • may be covered with a sterile bandage
  • if bandaged, let dry first

Inactive Ingredient

Water

  • Store at room temperature
  • Avoid excessive heat

label
(click image for full-size original)

BZK ANTISEPTIC TOWELETTE
benzalkonium chloride swab
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:70897-005
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE 0.0013 mg
Inactive Ingredients
Ingredient Name Strength
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70897-005-01 1 SWAB in 1 POUCH None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 01/24/2019
Labeler — Davemed Healthcare Co., Ltd (529128716)
Establishment
Name Address ID/FEI Operations
Davemed Healthcare Co., Ltd 529128716 manufacture (70897-005)

Revised: 01/2019 Davemed Healthcare Co., Ltd

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