Label: MONSELS SOLUTION- ferric subsulfate liquid

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated February 9, 2010

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  • DESCRIPTION

    Enter section text here

  • HOW SUPPLIED

    Light-resistant  8 ml  bottles.

  • INDICATIONS & USAGE

    Used as a styptic in its undiluted form.
  • WARNINGS AND PRECAUTIONS

    It should not be used in vesicular, bullous, or exudative (oozing) dermatoses because it may then cause permanent pigmentation on the skin. May be harmful if swallowed. For external use only. If swallowed, do not induce vomiting unless directed to do so by medical  personnel.  Never give anything by mouth to an unconscious person. Loosen tight clothing such as a collar, tie, belt or waistband. Get medical attention immediately. Keep out of reach of children. 

  • SPL UNCLASSIFIED SECTION

    Single use only. Do not reuse. Discard after one use. Do not use if seal is broken.

  • PRINCIPAL DISPLAY PANEL

    Image of MONSELS Label

  • INGREDIENTS AND APPEARANCE
    MONSELS SOLUTION 
    ferric subsulfate liquid
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:10481-0112
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FERRIC SUBSULFATE (UNII: 3QJ8WS6V8H) (FERRIC SUBSULFATE - UNII:3QJ8WS6V8H) FERRIC SUBSULFATE .21 g  in 1 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10481-0112-88 g in 1 BOTTLE, GLASS
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other02/09/2010
    Labeler - Gordon Laboratories (002333847)
    Registrant - Gordon Laboratories (002333847)
    Establishment
    NameAddressID/FEIBusiness Operations
    Gordon Laboratories002333847manufacture