Label: FRENNA AC- aluminum chloride solution
- NDC Code(s): 53045-300-30
- Packager: Dharma Research, inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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.
Drug Label Information
Updated November 6, 2020
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- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- WARNINGS AND PRECAUTIONS
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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.
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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
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INGREDIENTS AND APPEARANCE
FRENNA AC
aluminum chloride solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53045-300 Route of Administration DENTAL, TOPICAL, ORAL 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; Type 0: Not a Combination Product 01/01/2013 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)
