Label: MICROKLENZ ANTIMICROBIAL- benzethonium chloride liquid

  • NDC Code(s): 53329-073-08
  • Packager: Medline Industries, LP
  • 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 July 31, 2022

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  • Active ingredient

    Benzethonium Chloride 0.1%

  • Purpose

    First Aid Antiseptic

  • Uses

    For first aid to help prevent infection in:

    • minor cuts
    • scrapes
    • burns
  • Warnings

    For external use only. Avoid contact with eyes.

    Ask a doctor before use if you have

    • deep or puncture wounds
    • animal bites
    • serious burns

    When using this product

    • do not use in or near the eyes
    • do not apply over large areas of the body or in large quantities
    • do not use longer than 1 week unless directed by a doctor

    Stop use and ask a doctor if

    • condition worsen or if symptoms persist for more than 7 days or clear up and occur again within a few days.

    Keep out of reach of children.

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

  • Directions

    • Clean affected area
    • Adjust nozzle and spray a small amount of this product on the area 1 to 3 times daily
    • If used as a wet compress, keep bandage wet with solution
    • If covered with a sterile bandage, let dry first.
  • Inactive ingredients

    citric acid, cocamidopropyl betaine, disodium phosphate, phenoxyethanol, water

  • Manufacturing Information

    Manufactured for:

    Medline Industries, LP

    Three Lakes Drive, Northfield, IL 60093 USA

    Made in the USA with foreign and domestic materials

    www.medline.com

    1-800-MEDLINE (633-5463)

    REF: CRR108008

    V2 RG22SAP

  • Package Label

    Label V2 RG22SAP

  • INGREDIENTS AND APPEARANCE
    MICROKLENZ ANTIMICROBIAL 
    benzethonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-073
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE0.1 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53329-073-08236 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product01/01/2007
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/01/2007
    Labeler - Medline Industries, LP (025460908)
    Registrant - Medline Industries, LP (025460908)
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