Label: MERTHIOLATE- benzalkonium chloride cream

  • 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 May 5, 2015

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  • ACTIVE INGREDIENT

    Active Ingredients                                            Purpose

    Benzalkonium Chloride 0.13%          First Aid Antiseptic

  • PURPOSE

    Use first aid to help prevent skin infection in 

    • minor cuts
    • scrapes
    • burns
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • INDICATIONS & USAGE

    Merthiolate Tincture

    Mercury Free

    First Aid Antiseptic

    For External Use Only

  • DOSAGE & ADMINISTRATION

    Directions

    • clean the affected area
    • apply a small amount on the area 1 to 3 times daily
    • may be covered by a sterile bandage
    • if bandaged, let dry first

  • WARNINGS

    Warnings

    • For external use only
    • Ask a doctor before use if you have deep or puncture wounds, animal bites or serious burns.
    • When using this product
    • do not use in eyes or apply over large areas of the body
    • do not use longer than 1 week unless directed by a doctor
    • Stop use and ask a doctor if condition persists or gets worse
  • INACTIVE INGREDIENT

    Inactive Ingredients alcohol, acetone, purified water, FD&C red #22

  • PRINCIPAL DISPLAY PANEL

    label image

  • INGREDIENTS AND APPEARANCE
    MERTHIOLATE 
    benzalkonium chloride cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59561-709
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    ACETONE (UNII: 1364PS73AF)  
    WATER (UNII: 059QF0KO0R)  
    D&C RED NO. 22 (UNII: 1678RKX8RT)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59561-709-0130 g in 1 PACKAGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/05/2015
    Labeler - Caribe Natural, Inc (624210480)
    Establishment
    NameAddressID/FEIBusiness Operations
    World Perfumes, Inc101312044manufacture(59561-709)
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