Pro-Den Rx (Sodium Fluoride) gel
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.
Active Ingredients:
Neutral Sodium Fluoride 1.1% w/w (5000 ppm F).
Inactive Ingredients:
Carboxymethyl cellulose sodium, flavors, glycerin, mica, phosphoric acid, purified water, sodium benzoate, sodium hydroxide, sucralose, titanium dioxide and xylitol.
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 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:
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.
Store at Room Temperature
How Supplied:
Net Wt. 2 oz. (56 g) tube in a box.
Cool Mint: NDC 59883-820-02
Cherry Limeade: NDC 59883-821-02
Reorder 1-800-433-6628
Reorder Number: 2250CLM 965922
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 59883-821-02
pro-denRx®
dentifrice gel
1.1% PLUS
neutral sodium fluoride
cherry
limeade
flavor
Contains: 1.1% sodium fluoride
(5000 ppm fluoride ion) in a
neutral topical dentifrice gel
Net Wt. 2oz. (56 g)
DYE-FREE GEL
Principal Display Panel - Tube Label
NDC 59883-821-02
1.1% PLUS neutral sodium fluoride
pro-denRx® dentifrice gel
cherry
limeade
flavor
Contains: 1.1% sodium fluoride (5000 ppm fluoride ion) in a neutral topical dentifrice gel
Net Wt. 2oz. (56 g) DYE-FREE GEL
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