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 December 7, 2011

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  • DESCRIPTION


  • HOW SUPPLIED

    Light-resistant 2 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

    Restricted to use by or on the order of a licensed Physician. Store at room temperature. Keep cap tightly sealed and protect from light.

  • PRINCIPAL DISPLAY PANEL

    Image of MONSELS Labels

  • 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:10481-0112-259 g in 1 BOTTLE, GLASS
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other12/07/2011
    Labeler - Gordon Laboratories (002333847)
    Registrant - Gordon Laboratories (002333847)
    Establishment
    NameAddressID/FEIBusiness Operations
    Gordon Laboratories002333847manufacture