Label: MERCUROCHROME- 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 8, 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 reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • INDICATIONS & USAGE

    Mercurochrome

    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 with 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 purified water, alcohol, FD&C red # 40.

  • PRINCIPAL DISPLAY PANEL

    label image

  • INGREDIENTS AND APPEARANCE
    MERCUROCHROME 
    benzalkonium chloride cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59561-708
    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
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59561-708-0130 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(59561-708)
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