FERRIC SUBSULFATE- ferric subsulfate solution 
CooperSurgical, Inc.

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Ferric Subsulfate Aqueous

DESCRIPTION

Ferric Subsulfate, Aqueous; 8gm single-use glass vials.

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.

INDICATIONS AND USAGE

Ferric Subsulfate, Aqueous, is a stypic 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 of applying ferric subsulfate solution for dermal use consists of the physician placing fingers at the opposite edge 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 eye contact 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 Ferric Subsulfate Aqueous (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 0.6mm.6 In an in vitro study, ferric subsulfate solution produced a radiopacity with a density intermediate between that of water/tissue and calcium.7

Should 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 Ferric Subsulfate Aqueous should not be subjected to any thermal process whether intended for destruction or recycling purposes.

REFERENCES

PRINCIPAL DISPLAY PANEL

Ferric Subsulfate 
Aqueous

Contents: 1 dozen (12) 8gm Vials

PRINCIPAL DISPLAY PANEL
Ferric Subsulfate 
Aqueous
Contents: 1 dozen (12) 8gm Vials

PRINCIPAL DISPLAY PANEL

8gm NDC 59365-5006-0
FERRIC SUBSULFATE

AQUEOUS

PRINCIPAL DISPLAY PANEL
8gm NDC 59365-5006-0
FERRIC SUBSULFATE
AQUEOUS

FERRIC SUBSULFATE 
ferric subsulfate solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:59365-5006
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:59365-5006-112 in 1 CARTON10/01/1992
1NDC:59365-5006-08 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)

Revised: 5/2016
Document Id: f50aaccf-8e41-4493-a6c1-a1f8f27d7ca2
Set id: 80541b3a-f10b-45d3-813e-ba7454d6155c
Version: 10
Effective Time: 20160525
 
CooperSurgical, Inc.