PRO-DEN RX- sodium fluoride gel

Pro-Den Rx by

Drug Labeling and Warnings

Pro-Den Rx by is a Otc medication manufactured, distributed, or labeled by DEN-MAT HOLDINGS, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT

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.

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

Inactive Ingredients:

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.

Warnings: PLEASE 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 (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.

Cherry Limeade: NDC: 59883-821-02

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: 2250CLM

Made for and Distributed in US by: Zila Therapeutics, Inc.

P.O. Box 3889, Batesville, AR 72503

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Warnings: PLEASE 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 SECTION

Warnings: PLEASE 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 (approx. 2 mg of fluoride) is not harmful.

INACTIVE INGREDIENT SECTION

Inactive Ingredients:

Diatomite, Flavor, Glycerin, Carboxymethyl Cellulose, Phosphoric Acid,

Sodium Benzoate, Sodium Saccharin and Purified Water.

INDICATIONS & USAGE SECTION

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.

DOSAGE & ADMINISTRATION SECTION

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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PRO-DEN RX 
sodium fluoride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59883-821
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	SODIUM FLUORIDE	4.3 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
DIATOMACEOUS EARTH (UNII: 2RF6EJ0M85)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)
PHOSPHORIC ACID (UNII: E4GA8884NN)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color		Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59883-821-02	1 in 1 CARTON	11/21/2008
1		56 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	11/21/2008

Labeler - DEN-MAT HOLDINGS, LLC (809857704)