Monsels Solution

MONSELS SOLUTION- ferric subsulfate solution
MedGyn Products, Inc.

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.

Ferric Subsulfate 20%

Store at room temperature(15°-30°C). Keep away from heat and light.

Hemostasis of small cuts and biopsies

To be used by a licensed medical practitioner only. Unit dose. Discard after single use.

MANUFACTURED FOR:

MedGyn Products, Inc

100 W. Industrial Rd.

Addison,IL 60101 USA

Packaging

MONSELS SOLUTION ferric subsulfate solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70880-112 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FERRIC SUBSULFATE (FERRIC CATION) FERRIC CATION 20 g in 100 mL

Inactive Ingredients Ingredient Name Strength WATER

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:70880-112-08 12 BOTTLE in 1 BOX contains a BOTTLE 1 8 mL in 1 BOTTLE This package is contained within the BOX (70880-112-08)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 08/01/2016

Labeler — MedGyn Products, Inc. (103913430)

Revised: 07/2016 MedGyn Products, Inc.