FastStat Topical Hemostat: Package Insert / Prescribing Information - Drugs.com

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# FastStat Topical Hemostat

Package insert / prescribing information
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.

## Product Description

FastStat™ 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. FastStat hemostatic gel provides superior hemostasis at a much lower concentration of ferric sulfate. Because it rinses cleanly, FastStat 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 use beyuond expiration date.

- 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

1. Twist on FE ScrubTip™ brush for easy application.
2. 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.
3. When control of bleeding is achieved, use suction and heavy air/water spray to remove coagulum and residual gel from surface.
4. If bleeding restarts, repeat application and burnishing.

Caution: Federal law restricts this device to sale by or on the order of a licensed professional.

Disclaimer: CAO Group 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 CAO Group is not legally bound to such claims based on this document.

Manufactured by CAO (China) Medical Equipment Co,. Ltd. for CAO Group, Inc.

P 877.236.4408 F 801.256.9287
4628 West Skyhawk Drive, West Jordan, UT 84084-4501 U.S.A.
www.caogroup.com

SAL-CAI007C.1/23SEP2010

BACK PANEL INTRO KIT OUTER PACKAGING

PACKAGE CONTENTS: 3) 3cc preloaded syringes, 2) packs of 25 FEscrubTips™
See package insert for dosage information. Rx Only.
Dispose of properly after use. For complete safety information see product MSDS.
Do not use if the packaging has been damaged, or if the safety seals are found to be broken.

REORDER #
006-00075

Manufactured by CAO (China)
Medical Equipment Co., Ltd. for CAO Group, Inc.

4628 West Skyhawk Drive
West Jordan, UT 84084
U.S.A.
877-236-4408 (tel)
801-256-9287 (fax)
www.caogroup.com

STORAGE: [32°F/0°C to 100°F/38°C]

TO REORDER:
Contact your local distributor.

Expiration Date: [lot and date label]

[BARCODE #: 872320000486]

MADE IN CHINA

PAK-CT0013D.1/23SEP2010

BACK PANEL REFILL KIT OUTER PACKAGING

PACKAGE CONTENTS: 20) 3cc preloaded syringes, 1) packs of 100 FEscrubTips™
See package insert for dosage information. Rx Only.
Dispose of properly after use. For complete safety information see product MSDS.
Do not use if the packaging has been damaged, or if the safety seals are found to be broken.

REORDER #
006-00076

Manufactured by CAO (China)
Medical Equipment Co., Ltd. for CAO Group, Inc.

4628 West Skyhawk Drive
West Jordan, UT 84084
U.S.A.
877-236-4408 (tel)
801-256-9287 (fax)
www.caogroup.com

STORAGE: [32°F/0°C to 100°F/38°C]

TO REORDER:
Contact your local distributor.

Expiration Date: [lot and date label]

[BARCODE #: 872320000493]

MADE IN CHINA

PAK-CT0014D.1/23SEP2010

SIDE PANEL INTRO KIT OUTER PACKAGING

FastStat

Topical Hemostat

Ingredients: water/eau, ferric sulfate, proprietary polymer thickener

NDC# 1404001003

SIDE PANEL REFILL KIT OUTER PACKAGING

FastStat

Topical Hemostat

Ingredients: water/eau, ferric sulfate, proprietary polymer thickener

NDC# 1404001002

FastStat

Topical Hemostat

Stops Bleeding. Rinses Clean.

Introductory Kit

Net Qty, 3) 3cc preloaded syringes
Active ingredient: Ferric sulfate, 10%

FastStat

Topical Hemostat

Stops Bleeding. Rinses Clean.

Introductory Kit

Net Qty, 20) 3cc preloaded syringes
Active ingredient: Ferric sulfate, 10%

FASTSTAT TOPICAL HEMOSTAT ferric sulfate gel

Product Information
Product Type | HUMAN PRESCRIPTION DRUG LABEL | Item Code (Source) | NDC:14060-010
Route of Administration | INTRAGINGIVAL | DEA Schedule |

Active Ingredient/Active Moiety
Ingredient Name | Basis of Strength | Strength
Ferric Sulfate (Ferric Cation) | Ferric Cation | 142 mg in 1 g

Inactive Ingredients
Ingredient Name | Strength
Water |

Packaging
# | Item Code | Package Description
1 | NDC:14060-010-03 | 3 SYRINGE, PLASTIC in 1 KIT
1 |  | 3 g in 1 SYRINGE, PLASTIC

Marketing Information
Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date
unapproved drug other |  | 09/01/2010 |

Labeler - CAO Group, Inc. (102422578)

Registrant - CAO Group, Inc. (102422578)

CAO Group, Inc.

Medical Disclaimer