FRENNA AC (ALUMINUM CHLORIDE) SOLUTION [DHARMA RESEARCH, INC.]

FRENNA AC (ALUMINUM CHLORIDE) SOLUTION [DHARMA RESEARCH, INC.]
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NDC 53045-300-30
Set ID d09ae142-6fd5-45e4-a9c4-44428885ccaf
Category HUMAN PRESCRIPTION DRUG LABEL
Packager Dharma Research, inc.
Generic Name
Product Class
Product Number
Application Number
  • STORAGE AND HANDLING

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

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

  • 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.
  • 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.
  • 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.

  • PRINCIPAL DISPLAY PANEL

    IMG

    IMG2

  • INGREDIENTS AND APPEARANCE
    FRENNA AC 
    aluminum chloride solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:53045-300
    Route of AdministrationDENTAL, TOPICAL, ORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALUMINUM CHLORIDE (UNII: 3CYT62D3GA) (ALUMINUM CATION - UNII:3XHB1D032B) ALUMINUM CHLORIDE8.75 g  in 35 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53045-300-3035 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/2013
    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)

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