HEMOX A- aluminum chloride solution

Hemox A by

Drug Labeling and Warnings

Hemox A by is a Prescription medication manufactured, distributed, or labeled by Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION:

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

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HEMOX A 
aluminum chloride solution

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Aluminum Chloride (UNII: 3CYT62D3GA) (ALUMINUM CATION - UNII:3XHB1D032B)	Aluminum Chloride	7500 mg  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Propylene Glycol (UNII: 6DC9Q167V3)
Potassium Chloride (UNII: 660YQ98I10)
DMDM HYDANTOIN (UNII: BYR0546TOW)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68400-203-18	30 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	10/01/2018

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	Business Operations
Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.		014769301	manufacture(68400-203) , label(68400-203)