FRENNA AC- aluminum chloride solution

Frenna AC by

Drug Labeling and Warnings

Frenna AC by is a Prescription medication manufactured, distributed, or labeled by Dharma Research, inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

PRINCIPAL DISPLAY PANEL

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.

PATIENT PACKAGE INSERT

INGREDIENTS AND APPEARANCE

FRENNA AC 
aluminum chloride solution

Product 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

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)