Label: FRENNA AC- aluminum chloride solution 

  • Label RSS
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

Drug Label Information

Updated 04/13

If you are a consumer or patient please visit this version.

  • STORAGE AND HANDLING

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

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

    Close
  • WARNINGS AND PRECAUTIONS

    • 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.
    Close
  • INSTRUCTIONS FOR USE

    • 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.
    Close
  • INDICATIONS & USAGE

    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.

    Close
  • INGREDIENTS AND APPEARANCE
    FRENNA AC 
    aluminum chloride solution
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL 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 (ALUMINUM CATION) ALUMINUM CHLORIDE 8.75 g  in 35 g
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    POTASSIUM CHLORIDE  
    PROPYLENE GLYCOL  
    BENZYL ALCOHOL  
    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)
    Close