Drug Facts

Description:

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

OTC - ACTIVE INGREDIENT

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

INACTIVE INGREDIENT

Diatomite, Flavor, Glycerin, Carboxymethyl Cellulose, Phosphoric Acid, Sodium Benzoate, Sodium Saccharin and 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 ProDenRx Brush-On Gel may be applied using a toothbrush. 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

PLEASE KEEP OUT OF REACH OF CHILDREN.

WARNINGS

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 (approx. 2 mg of fluoride) is not harmful.

DOSAGE AND ADMINISTRATION

Adults and Children over 6 years of age: Use in place of your regular toothpaste. Apply at bedtime or more often if your dentist recommends additional therapy based on the diagnosis. Cover brush head with ProDenRx 1.1% Neutral Sodium Fluoride Gel and brush around all tooth surfaces and gum line for at least 1 minute. Spit out gel.

Adults: Wait 30 minutes before rinsing mouth. For children under age 12: Rinse mouth thoroughly immediately after use.

Store at Room Temperature

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

Berry Fresh: NDC 59883-822-02

Cherry Limeade: NDC 59883-821-02

Cool Mint: NDC 59883-820-02

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: 2250RBM

Made for and Distributed in US by: Zila Therapeutics, Inc.
P.O. Box 3889, Batesville, AR 72503

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL