Label: FERRIC SUBSULFATE solution

  • NDC Code(s): 59365-6065-0, 59365-6065-1
  • Packager: CooperSurgical, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated May 25, 2016

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  • SPL UNCLASSIFIED SECTION

    AstrinGyn®

    (Ferric Subsulfate, Aqueous)

    REF 6065

  • CONTENTS

    Ferric subsulfate 259mg/g [0.0638gm Fe 3+/ml]. Preserved with benzalkonium chloride 0.005%. Povidone USP 23.2%. Glycerin USP 13.3%. Purified Water USP.

  • DESCRIPTION

    AstrinGyn® (Ferric Subsulfate, Aqueous).

  • HOW SUPPLIED

    8 gm single-use glass bottles.

  • ACTIONS & USES

    AstrinGyn® is a styptic agent used for achieving local hemostasis. In punch biopsies of the full dermis, the time to achieve hemostasis is typically less than 20 seconds.1 One method for applying ferric subsulfate solution for dermal use consists of the physician placing fingers at the opposite edges of the wound and stretching the skin. The wound is then wiped with gauze, the ferric subsulfate solution applied, and the tension maintained for approximately 15 seconds.2 

  • WARNINGS

    For External Use Only. Should inadvertent ocular administration occur, the eye(s) should be washed immediately with large amounts of water or normal saline, occasionally lifting the upper and lower lids until no evidence of solution remains (approximately 15-20 minutes).

  • PRECAUTIONS

    As with all iron solutions applied to dermal surfaces denuded of epithelium or to mucous membranes, topical application of AstrinGyn® (ferric subsulfate) may result in hyperpigmentation (“tattooing”).3, 4

    Microscopically, this hyperpigmentation may be observed as ferrugination of collagen fibers and fibrin.5  In one study of uterine cervical tissue, ferric subsulfate solution penetrated denuded mucosa and produced coagulation necrosis to a maximum depth of 0.6 mm.6In an in vitro study, ferric subsulfate solution produced a radiopacity with a density intermediate between that of water/tissue and calcium.7Should a re-biopsy of the same lesion be required, pathologists and other physicians involved in the care of the patient should be aware of the previous use of ferric subsulfate solution. Previous use of ferric subsulfate solution may result in a histologic artifact upon re-biopsy of heavy pigmentation, similar to hemosiderin, together with shrinkage and discoloration of collagen bundles.8, 9 Similarly, previous use of ferric subsulfate solution may result in a radiographic artifact.

  • CAUTION

    Federal law (USA) prohibits dispensing without a prescription.

  • STORAGE

    Keep tightly closed and protect from light.  DO NOT use if seal is broken.  Store at room temperature 59°-86°F (15°-30° C).

  • DISPOSAL

    Opened containers with unused portions of product and applicator swabs containing residual product should be placed in a suitable, dry container for later disposal according to local hazardous waste practices. Waste containing AstrinGyn® should not be subjected to any thermal process whether intended for destruction or recycling purposes.

  • REFERENCES

    • Armstrong RB, Nichols J. Pachance J. Punch biopsy wounds treated with Monsel’s solution or a collagen matrix. A comparison of healing. Arch. Dermatol 1986;122:546-549.
    • Baden HP, Rapid hemostasis with Monsel’s solution (letter). Arch Dermatol 1984; 120:708.
    • Demis DJ, Clinical dermatology, Hagerstown MD: Harper & Row, 1986; pp. 11-4:1-11-4:5.
    • Camisa C, Roberts W. Monsel solution tattooing (letter). J Am Acad Dermatol 1983;8:753-754.
    • Amazon K, Robinson MJ, Rywlin AM. Ferrugination caused by Monsel’s solution. Clinical observations and experimentation. Am J Dermatopathol 1980;2:197-205.
    • Davis JR, Steinbronn KK, Graham AR, Dawson BV. Effects of Monsel’s solution in uterine cervix, AM J Clin Pathol 1984;82:332-335.
    • Horn MS, Circeo RB, Hassan C. Radiographic artifacts produced by silver nitrate and Monsel’s solution (letter). J Am Acad Dernatol 1983;8:560-562.
    • Olmstead PM, Lund HZ, Leonard DD. Monsel’s solution: a histologic nuisance. J Am Acad Dermatol 1980;3:492-498.
    • Wood C, Severin GL. Unusual histiocytic reaction to Monsel’s solution. Am J Dermatopathol 1980;2:261-264.
  • PRINCIPAL DISPLAY PANEL

    AstrinGyn ®
    Ferric
    Subsulfate, Aqueous
    Contents

    One Dozen (12)

    8 gm Vials

    NDC 59365-6065-1

    AstrinGyn ® Ferric Subsulfate, Aqueous Contents One Dozen (12) 8 gm Vials NDC 59365-6065-1

  • PRINCIPAL DISPLAY PANEL

    8gm       NDC 59365-6065-0
    AstrinGyn ®
    (Ferric
    Subsulfate)
    Aqueous

    PRINCIPAL DISPLAY PANEL
8gm       NDC 59365-6065-0
AstrinGyn ®
(Ferric Subsulfate)
Aqueous

  • INGREDIENTS AND APPEARANCE
    FERRIC SUBSULFATE 
    ferric subsulfate solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:59365-6065
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FERRIC SUBSULFATE (UNII: 3QJ8WS6V8H) (FERRIC CATION - UNII:91O4LML611) FERRIC CATION259 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    POVIDONE (UNII: FZ989GH94E)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59365-6065-112 in 1 CARTON10/01/1992
    1NDC:59365-6065-08 g in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED DRUG OTHER10/01/1992
    Labeler - CooperSurgical, Inc. (801895244)