Hemox A

HEMOX A- aluminum chloride solution
Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak 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.

Hemox-A Solution is a topical astringent solution of Aluminum Chloride. Gingival retraction can be achieved using a plain gingival retraction cord moistened with Hemox-A Solution.

PRECAUTIONS:

Discontinue use if irritation appears. For topical application only. Avoid eye contact.

BENEFITS:

Hemox-A Solution stops gingival bleeding fast. If you should inadvertantly damage the gingival margin during tooth preparation or while placing a strip, band or a cerival matrix, moisten the area with Hemox-A Solution which will control and stop bleeding quickly. Hemox-A Solution contains no epinephrine. The use of vasoconstrictors for gingival retractions and bleeding is potentially dangerous and should be avoided. A plain gingival retraction cord can be dipped in Hemox-A Solution and then placed into the gingival sulcus for its hemostatic action.

DIRECTIONS:

Soak a cotton tipped applicator or a retraction cord with Hemox-A Solution. Apply to bleeding area with pressure until bleeding is stopped. Should a small dark coagulum appear, flush it away with water. This will have no effect on hemostatic action. Remove the impregnated cord from sulcus. Flush with water and dry with air. If hemostatis is not achieved, repeat application, rinse with water and air dry until bleeding is no longer present.

CONTRAINDICATIONS:

Do not use on patients with known history of hypersensitivity to aluminum chloride.

CAUTIONS:

Keep out of reach of children.

FOR PROFESSIONAL USE ONLY

HEMOX A aluminum chloride solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68400-203 Route of Administration DENTAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALUMINUM CHLORIDE (ALUMINUM CATION) ALUMINUM CHLORIDE 7500 mg in 30 mL

Inactive Ingredients Ingredient Name Strength WATER PROPYLENE GLYCOL POTASSIUM CHLORIDE DMDM HYDANTOIN

Product Characteristics Color white (colorless) Score Shape Size Flavor Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:68400-203-18 30 mL in 1 BOTTLE, GLASS None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 01/15/2013

Labeler — Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. (014769301)

Registrant — Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. (014769301)

Establishment
Name	Address	ID/FEI	Operations
Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.		014769301	manufacture (68400-203), label (68400-203)

Revised: 01/2022 Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.