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Pro-Den Rx by Zila Therapeutics, Inc.

Dosage form: gel
Ingredients: SODIUM FLUORIDE 4.3g in 1g
Labeler: Zila Therapeutics, Inc.
NDC Code: 59883-824

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Pro-Den Rx 1.1%

Neutral Sodium Fluoride Topical Gel – Dye Free 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.

OTC - ACTIVE INGREDIENT

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

Contains: 1.1% Sodium Fluoride (5000 ppm Fluoride Ion)

INACTIVE INGREDIENT

Inactive Ingredients: Flavor, hydroxyethyl cellulose, sucralose, 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 Pro-DenRx Brush-On Gel can be applied on a toothbrush as well as a mouthpiece tray. 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

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.

WARNINGS

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.

DOSAGE AND ADMINISTRATION

Apply daily after usual brushing and flossing at bedtime 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 one minute. Spit out gel. Adults: Wait 30 minutes before rinsing mouth; Children under 12: Immediately after use, rinse mouth thoroughly with water.

When using a mouthpiece or applicator, cover the inner surface with gel.  Place applicator in mouth and bite down lightly for at least 1 minute.  Remove applicator and rinse mouth.  Clean applicators with cold water.

Store at Room Temperature

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

Cool Mint: NDC 59883-824-02

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: 2240MTM

442245                                  Rev. 1 1008

Made for and Distributed in US by:

Zila Therapeutics, Inc.
P.O. Box 3889, Batesville, AR 72503

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRO-DEN RX 
sodium fluoride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59883-824
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) SODIUM FLUORIDE4.3 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
HYDROXYETHYL CELLULOSE (140 CPS AT 5%) 
SUCRALOSE 
WATER 
Product Characteristics
Color    Score    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:59883-824-021 TUBE (TUBE) in 1 CARTON
156 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35501/20/2009
Labeler - Zila Therapeutics, Inc. (883514127)
Establishment
NameAddressID/FEIOperations
Zila Therapeutics, Inc.883514127MANUFACTURE

Revised: 09/2010
 
Zila Therapeutics, Inc.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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