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Pro-Den Rx

Generic Name: sodium fluoride
Dosage Form: oral rinse

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Description:

Pro-DenRx® Neutral Sodium Fluoride Rinse is a neutral, aqueous solution.

Active Ingredient:

Sodium Fluoride 0.2% w/w (0.09% w/w fluoride ion).

Inactive Ingredients:

Purified water, Cetyl Pyridinium Chloride, citric acid, potassium sorbate, sucralose, flavor and Sodium Hydroxide.

Clinical Pharmacology:

Sodium fluoride when used topically promotes remineralization, increases resistance of teeth to acid dissolution, and impedes the cariogenic microbial process.

Indications and Usage:

Aids in the prevention of dental caries. May be used more than once a week if recommended by your dentist. Pro-DenRx® Rinse is ready to use, convenient and thus increases compliance.

Weekly rinsing with a neutral 0.2% sodium fluoride solution protects against dental cares in adults and children. May be used in areas where drinking water is fluoridated since topical fluoride cannot produce fluorosis.

Contraindications:

Do not use in children under age 6 years unless recommended by a dentist or physician.

Warnings:

PLEASE KEEP OUT OF REACH OF CHILDREN. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away. READ DIRECTIONS CAREFULLY BEFORE USING.

Precautions:

General: Not for systemic treatment. DO NOT SWALLOW.

Adverse Reactions:

NONE

Overdosage:

Swallowing a normal treatment dose (approximately 9 mg. of fluoride) is not harmful.

Dosage and Administration:

Adults and children over age 6 years: Rinse once a week, preferably at bedtime, after thoroughly brushing and flossing teeth. Rinse more often if your dentist recommends additional therapy based on your diagnosis. Pour 10 ml (2 teaspoons) of Pro-DenRx® 0.2% Sodium Fluoride Rinse into the graduated cup using the markings on its side. Swish vigorously around and between the teeth for one minute, then spit out. DO NOT SWALLOW. For maximum benefit, do not eat, drink, or rinse mouth for at least 30 minutes after use. Children 6 to 12 years old: Supervise while using this product. Children Under 6 years old: Consult your dentist or doctor before using.

How Supplied:

For home use: Plastic bottle containing 16 fl. oz. (473 ml) Cool Mint: NDC 59883-920-16.

RX only:

Storage: Store at Room Temperature

Reorder 1-800-433-6628
Manufactured for
Den-Mat Holdings, LLC 1017 W. Central Ave.
Lompoc, CA 93436

©2014 Den-Mat Holdings, LLC. All rights reserved.

Principal Display Panel - Bottle Label

NDC 59883-920-16

pro-denRx®

dye
free
rinse

0.2% sodium fluoride

mint
flavor

Contains: 0.2% Sodium Fluoride in a Neutral
Aqueous Solution (0.09% Fluoride Ion)

16 fl. oz.
(473 ml)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Pro-Den Rx 
sodium fluoride rinse
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:59883-920
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Sodium Fluoride (Fluoride Ion) Fluoride Ion 0.9 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
Water  
Cetylpyridinium Chloride  
Citric Acid Monohydrate  
Potassium Sorbate  
Sucralose  
Sodium Hydroxide  
Product Characteristics
Color      Score     
Shape Size
Flavor MINT (MINT) Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:59883-920-16 473 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 10/21/2008
Pro-Den Rx 
sodium fluoride rinse
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:59883-922
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Sodium Fluoride (Fluoride Ion) Fluoride Ion 0.9 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
Water  
Cetylpyridinium Chloride  
Citric Acid Monohydrate  
Potassium Sorbate  
Sucralose  
Sodium Hydroxide  
Product Characteristics
Color      Score     
Shape Size
Flavor BERRY (BERRY) Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:59883-922-16 473 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 10/21/2008 12/31/2014
Labeler - Den-mat Holdings, Llc (809857704)
Revised: 12/2015
 
Den-mat Holdings, Llc



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