Your browser does not support JavaScript! FRENNA AC (ALUMINUM CHLORIDE) SOLUTION [DHARMA RESEARCH, INC.]
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FRENNA AC (aluminum chloride) solution
[Dharma Research, inc.]


Category DEA Schedule Marketing Status
HUMAN PRESCRIPTION DRUG LABEL unapproved drug other
NOTE: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.
Drug Label Sections

  • Store at 59o - 86oF (15o - 30oC)
  • Protect from freezing

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

  • Discontinue use if irritation appears.
  • For topical application only.
  • Avoid eye contact.
  • Do not use in patients with a known history of hyper sensetivity to Aluminum Chloride.
  • For professional use only.
  • Federal law restricts this product to sale or use on the order of a dentist.

  • Soak a cotton tipped applicator with Frenna AC.
  • 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 hemostasis is not achieved, repeat application.
  • Rinse with water and air dry until bleeding is no longer present.

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 TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:53045-300
Route of AdministrationDENTAL, TOPICAL, ORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALUMINUM CHLORIDE (ALUMINUM CATION) ALUMINUM CHLORIDE8.75 g  in 35 g
Inactive Ingredients
Ingredient NameStrength
WATER 
POTASSIUM CHLORIDE 
PROPYLENE GLYCOL 
BENZYL ALCOHOL 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53045-300-3035 g in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other01/01/2013
Labeler - Dharma Research, inc. (078444642)
Registrant - Dharma Research, inc. (078444642)
Establishment
NameAddressID/FEIBusiness Operations
Dharma Research, inc.078444642manufacture(53045-300)

Revised: 4/2013
 
Dharma Research, inc.

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