Label: ANTISEPTIC WIPE- benzalkonium chloride cloth

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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.

Drug Label Information

Updated December 3, 2020

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  • ACTIVE INGREDIENT

    Benzalkonium Chloride 0.13% v/v

    Purpose

    Antiseptic

  • PURPOSE

    First aid antiseptic to help prevent skin infection in:

    • Minor Cuts
    • Scrapes
    • Burns
    • Antiseptic Cleasing
    • Perineal and maternity care
  • WARNINGS

    For External Use Only.

  • DO NOT USE

    Do not use

    • As an antiseptic for more than 1 week
    • In the eyes
    • Over large areas of the body
  • ASK DOCTOR

    Ask a doctor before use if you have

    • Deep or pucture wounds
    • Animal bites
    • Serious burns
  • STOP USE

    Stop use

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

  • INDICATIONS & USAGE

    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
  • OTHER SAFETY INFORMATION

    Other information

    • Store at room temperature
    • Avoid excessive heat
  • INACTIVE INGREDIENT

    Inactive ingredients

    • Water
  • DOSAGE & ADMINISTRATION

    ANTISEPTIC WIPE

    • 2in x 2.4in / 5cm x 6cm

  • PRINCIPAL DISPLAY PANEL

    BZK

  • INGREDIENTS AND APPEARANCE
    ANTISEPTIC WIPE 
    benzalkonium chloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70108-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.133 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70108-100-011.8 g in 1 POUCH; Type 0: Not a Combination Product08/03/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/03/2017
    Labeler - Ashtel Studios Inc. (148689180)
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