PRO-DEN RX- sodium fluoride gel

Pro-Den Rx by

Drug Labeling and Warnings

Pro-Den Rx by is a Prescription medication manufactured, distributed, or labeled by Den-mat Holdings, Llc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Description:

A homecare, self-applied topical fluoride treatment containing 1.1% Neutral Sodium Fluoride (5000 ppm F). Daily use aids in the prevention of dental caries (decay).

Active Ingredients:

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

Inactive Ingredients:

Carboxymethyl cellulose sodium, flavor, phosphoric acid, purified water, sodium hydroxide and sucralose.

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:

A homecare, self-applied topical fluoride treatment. Aids in the prevention of dental caries (decay).

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.

Store at Room Temperature

Dosage and Administration:

Apply daily at bedtime, in place of your regular toothpaste 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 two minutes. Spit out gel. Adults: Wait 30 minutes before rinsing mouth. Children under 12: Rinse mouth thoroughly immediately after use.

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

How Supplied:

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

Cool Mint: NDC: 59883-824-02

Reorder 1-800-433-6628

Reorder Number: 2240MTM 965918

Manufactured for

Den-Mat Holdings, LLC

1017 W. Central Ave.,

Lompoc, CA 93436

©2014 Den-Mat Holdings, LLC.

All rights reserved.

Principal Display Panel - Carton Label

NDC: 59883-824-02

pro-denRx ®

aqueous gel

1.1% neutral sodium fluoride

cool mint
flavor

Contains: 1.1% sodium fluoride
(5000 ppm fluoride ion) in a
neutral topical aqueous gel

Net Wt. 2oz. (56 g)

DYE-FREE GEL

Principal Display Panel - Tube Label

NDC: 59883-824-02

1.1% neutral sodium fluoride

pro-denRx ® aqueous gel

cool mint
flavor

Contains: 1.1% sodium fluoride (5000 ppm fluoride ion) in a neutral topical aqueous gel

Net Wt. 2oz. (56 g) DYE-FREE GEL

INGREDIENTS AND APPEARANCE

PRO-DEN RX 
sodium fluoride gel

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 59883-824
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW)
PHOSPHORIC ACID (UNII: E4GA8884NN)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT (MINT)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59883-824-02	1 in 1 CARTON	01/20/2009
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
unapproved drug other		01/20/2009

Labeler - Den-mat Holdings, Llc (809857704)