Neutral Sodium Fluoride Topical Gel – Dye Free Gel

OTC - ACTIVE INGREDIENT

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

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

DESCRIPTION

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.

INACTIVE INGREDIENT

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

OTC - PURPOSE

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.

INDICATIONS AND USAGE

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.

OTC - KEEP OUT OF REACH OF CHILDREN

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.

WARNINGS

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.

DOSAGE AND ADMINISTRATION

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.

Berry Fresh: NDC 59883-826-02

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: 2240RBM

442247                                  Rev. 1 1008

Made for and Distributed in US by:

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL