BZK ANTISEPTIC TOWELETTE (BENZALKONIUM CHLORIDE) SWAB [DAVEMED HEALTHCARE CO., LTD]

BZK ANTISEPTIC TOWELETTE (BENZALKONIUM CHLORIDE) SWAB [DAVEMED HEALTHCARE CO., LTD]
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NDC 70897-005-01
Set ID 8039dbf4-4fdf-f5a6-e053-2991aa0ab210
Category HUMAN OTC DRUG LABEL
Packager Davemed Healthcare Co., Ltd
Generic Name
Product Class
Product Number
Application Number PART333A
  • 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

  • OTHER SAFETY INFORMATION

    • Store at room temperature
    • Avoid excessive heat
  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    BZK ANTISEPTIC TOWELETTE 
    benzalkonium chloride swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70897-005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.0013 mg
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70897-005-011 in 1 POUCH; Type 0: Not a Combination Product01/24/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/24/2019
    Labeler - Davemed Healthcare Co., Ltd (529128716)
    Establishment
    NameAddressID/FEIBusiness Operations
    Davemed Healthcare Co., Ltd529128716manufacture(70897-005)

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