FRENNA AC- aluminum chloride solution 
Dharma Research, 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.

----------

Benzyl Alcohol, Distilled Water, Potassium Chloride, Propylene Glycol.

Entire Label

Frenna AC is a topical astringent solution of Aluminum Chloride. Gingival retraction can be achieved using a plain gingival retraction cord moistened with Frenna AC. Stops gingival bleeding fast. If you should anadvertently damage the gingival margin during tooth preparation or while placing a strip, a band, or a cervical matrix, moisten the area with Frenna AC which will control and stop bleeding quickly. Frenna AC contains no epinephrine. The use of casoconstrictors for gingival retractions and bleeding is potentially dangerous and should be avoided.

A plain gingival retraction cord can be dipped in Frenna AC solution and then placed into the gingival sulcus for its hemostatic action.

Package Insert

FRENNA AC 
aluminum chloride solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53045-300
Route of Administration DENTAL, TOPICAL, ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALUMINUM CHLORIDE (UNII: 3CYT62D3GA) (ALUMINUM CATION - UNII:3XHB1D032B) ALUMINUM CHLORIDE 8.75 g  in 35 g
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)  
POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:53045-300-30 35 g in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 01/01/2013
Labeler - Dharma Research, inc. (078444642)
Registrant - Dharma Research, inc. (078444642)
Establishment
Name Address ID/FEI Business Operations
Dharma Research, inc. 078444642 manufacture(53045-300)

Revised: 4/2013
Document Id: ee0790f9-cba0-410b-ab2d-928f73577f21
Set id: d09ae142-6fd5-45e4-a9c4-44428885ccaf
Version: 1
Effective Time: 20130417
 
Dharma Research, inc.