FDA Label for Pro-den Rx
View Indications, Usage & Precautions
Pro-den Rx Product Label
The following document was submitted to the FDA by the labeler of this product Den-mat Holdings, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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.
Otc - Keep Out Of Reach Of Children
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
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