Pro-Den Rx

Zila Therapeutics, Inc.

Pro-Den Rx 1.1%

FULL PRESCRIBING INFORMATION

Neutral Sodium Fluoride Topical Gel – Dye Free Gel

A home care, self-applied topical fluoride treatment containing 1.1% Neutral Sodium Fluoride (5000 ppm F) for daily use in the protection against dental caries.

Active Ingredients: Neutral Sodium Fluoride 1.1% w/w (5000 ppm F).

Contains: 1.1% Sodium Fluoride (5000 ppm Fluoride Ion)

Inactive Ingredients: Flavor, hydroxyethyl cellulose, sucralose, purified water.

Clinical Pharmacology: Applying preparations containing high fluoride concentrations on a regular basis increases the fluoride ion levels in tooth enamel and improves tooth resistance to acid dissolution.

It is well recognized that regular use of 1.1% Neutral Sodium Fluoride (5000 ppm F) in mouthpiece applicators is safe and effective in preventing caries.^1-4 Pro-DenRx Brush-On Gel can be applied on a toothbrush as well as a mouthpiece tray. Plaque contributes to caries; therefore, reduction of plaque can help in preventing caries.

Contraindications: Do not use in children under 6 unless recommended by a dentist.

Warnings: KEEP OUT OF REACH OF CHILDREN. Children under 6 years old:  The potential for fluorosis from repeated swallowing is possible; therefore, children under 6 years old should use only if ordered by dentist and carefully supervised by parent.

Precautions: Limited to topical use in mouth only. DO NOT SWALLOW.

Overdosage: Swallowing a normal treatment dose (approximately 2 mg of fluoride) is not harmful.

Apply daily after usual brushing and flossing at bedtime or more often if your dentist recommends additional therapy based on your diagnosis. Cover brush head with Pro-DenRx 1.1% Neutral Sodium Fluoride Gel and brush around all tooth surfaces and gum line for at least one minute. Spit out gel. Adults: Wait 30 minutes before rinsing mouth; Children under 12: Immediately after use, rinse mouth thoroughly with water.

When using a mouthpiece or applicator, cover the inner surface with gel.  Place applicator in mouth and bite down lightly for at least 1 minute.  Remove applicator and rinse mouth.  Clean applicators with cold water.

Store at Room Temperature

How Supplied: Net Wt. 2 oz. (56 g) tube in a box.

Cool Mint: NDC 59883-824-02

References:

1. Accepted Dental Therapeutics Ed. 40 ADA Chicago, p. 405-407, 1984.

2. Englander HR, et al.: JADA 83:354-358 1971.

3. Englander HR, et al.: JADA 78:783-787 1969.

4. Englander HR, et al.: JADA 75:638-644 1967.

Rx only

1-800-228-5595

REORDER NUMBER: 2240MTM

442245                                  Rev. 1 1008

Made for and Distributed in US by:

Zila Therapeutics, Inc.
P.O. Box 3889, Batesville, AR 72503