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Hemox-A

Generic Name: aluminum chloride
Dosage Form: dental solution

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.

DESCRIPTION:

Hemox-A 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 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 which will control and stop bleeding quickly. Hemox-A 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 with Hemox-A. 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 in patients with a known history of hypersensitivity to aluminum chloride.

CAUTION:

Keep out of reach of children.

FOR PROFESSIONAL USE ONLY.

HEMOX A 
aluminum chloride solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL 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
1 NDC:68400-203-18 30 mL in 1 BOTTLE, GLASS
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. (078654194)
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. 078654194 manufacture(68400-203), label(68400-203)
Revised: 11/2013
 
Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.



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