SPL v2
SPL
SPL Set ID d09ae142-6fd5-45e4-a9c4-44428885ccaf
Routes
DENTAL TOPICAL ORAL
Published
Effective Date 2020-11-06
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aluminum Cation (8.75 g)
Inactive Ingredients
Water Potassium Chloride Propylene Glycol Benzyl Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2013-01-01

Description

Store at 59 o - 86 o F (15 o - 30 o C) Protect from freezing


Medication Information

Indications and 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.

Description

Store at 59 o - 86 o F (15 o - 30 o C) Protect from freezing

Section 43685-7
  • 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.
Section 44425-7
  • Store at 59o - 86oF (15o - 30oC)
  • Protect from freezing
Section 51727-6

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

Section 51945-4

Section 59845-8
  • 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.

Structured Label Content

Indications and Usage (34067-9)

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.

Section 43685-7 (43685-7)
  • 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.
Section 44425-7 (44425-7)
  • Store at 59o - 86oF (15o - 30oC)
  • Protect from freezing
Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

Section 59845-8 (59845-8)
  • 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.

Advanced Ingredient Data


Raw Label Data

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