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Fastract Topical Hemostat.

Generic name: ferric sulfate
Dosage form: gel

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.

FasTRACT™ topical hemostat is an increased activity coagulative hemostatic gel containing 10% ferric sulfate, built around a novel organic polymer. This unique formulation is easy to use and rinses clean. FasTRACT hemostatic gel provides superior hemostasis at a much lower concentration of ferric sulfate. Because it rinses cleanly, FasTRACT minimizes post-operative black discoloration under restorations.

  • Not for use in patients with known sensitivity or allergies to iron or iron salts.
  • Not for use in pulpectomy procedures.
  • Ensure the material has had time to react with the blood and exposed capillaries before proceeding with subsequent procedures.
  • Do not store above 100°F (38°C). Do not freeze. Do not use beyond indicated shelf life.
  • Do not use if the packaging has been damaged, or if the seals are found to be broken or open.
  • Shelf Life: 2 years

Twist on scrub tip brush for easy application. Deliver hemostatic gel directly to bleeding areas. Use the fiber-flocked ball to burnish/rub gel into bleeding capillaries. Continue to burnish until bleeding stops. When control of bleeding is achieved, use suction and heavy air/water spray to remove coagulum and residual gel from surface. If bleeding restarts, repeat application and burnishing.

Patents Pending. Caution: Federal law restricts this device to sale by or on the order of a licensed professional. Disclaimer: Benco Dental believes this information to be accurate and is offered only for the benefit of its customers for use of the product under proscribed conditions. This document is not to be considered a warranty or guarantee of product performance, and Benco Dental is not legally bound to such claims based on this document.

Rear Panel

Benco Dental. fasTRACT 10% Ferric Sulfate Kit / (3) 3cc Preloaded Tips / (50) Scrub Tips. Distributed by Benco Dental. 800-GO-BENCO. benco.com. 295 CenterPoint Blvd., Pittston, PA 18640. Store at room temperature. 65°F-85°F (18°C-30°C). Rx Only. NDC# 14060-01005. Barcode: [4953-419]. Made in China. Lot#. Expiration Date:

Side Panel

Coagulative Hemostatic Gel. 10% Ferric Sulfate Kit. (3) 3cc Preloaded Syringes / (50) Scrub Tips.

Front Panel

fasTRACT_Box_front.jpg

FASTRACT TOPICAL HEMOSTAT
ferric sulfate gel
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:14060-011
Route of Administration INTRAGINGIVAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Ferric Sulfate (Ferric Cation) Ferric Cation 142 mg
Inactive Ingredients
Ingredient Name Strength
Water
Packaging
# Item Code Package Description
1 NDC:14060-011-05 3 GEL in 1 PACKAGE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 02/08/2016
Labeler - CAO Group, Inc. (102422578)
Registrant - CAO Group, Inc. (102422578)
CAO Group, Inc.