Label: QUALITY CHOICE MERTHIOLATE- benzalkonium chloride liquid

  • NDC Code(s): 63868-493-02
  • Packager: Chain Drug Market Association
  • 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 March 17, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Benzalkonium chloride 0.13%

  • Purpose

    Antiseptic

  • Uses

    first aid to help prevent skin infection in minor cuts, scrapes, burns and insect bites.

  • Warnings

    For external use only

  • Ask a doctor before use if you have

    deep or puncture wounds, animal bites, serious burns.

  • When using this product

    do not get into eyes. If contact occurs, rinse eyes throughly with water. do not apply over large areas of the body. do not use over raw surfaces or blistered areas. do not use longer than 1 week unless directed by a doctor.

  • Stop use and ask a doctor if

    condition persists or gets worse. symptoms 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 immediately.

  • Directions

    adults and children 2 years and older. clean the affected area. apply a small amount on the area 1 to 3 times daily. may be covered with a sterile bandage. if bandaged, let it dry first. children under 2 years of age, do not use, consult a doctor.

  • Inactive ingredients

    Alcohol 10%, Acetone, FD&C Red No 4, purified water

  • Principal display panel

    Label

    image description

  • INGREDIENTS AND APPEARANCE
    QUALITY CHOICE MERTHIOLATE 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-493
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    ACETONE (UNII: 1364PS73AF)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63868-493-0259 mL in 1 BOTTLE; Type 0: Not a Combination Product12/12/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/25/1998
    Labeler - Chain Drug Market Association (011920774)
    Registrant - Pharma Nobis, LLC (118564114)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharma Nobis, LLC118564114analysis(63868-493) , manufacture(63868-493) , pack(63868-493) , label(63868-493)