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  5. Label Information: Pro-den Rx

FDA Label for Pro-den Rx

View Indications, Usage & Precautions

Table of Contents

    1. DESCRIPTION:
    2. ACTIVE INGREDIENT:
    3. INACTIVE INGREDIENTS:
    4. CLINICAL PHARMACOLOGY:
    5. INDICATIONS AND USAGE:
    6. CONTRAINDICATIONS:
    7. OTC - KEEP OUT OF REACH OF CHILDREN
    8. GENERAL PRECAUTIONS
    9. ADVERSE REACTIONS:
    10. OVERDOSAGE:
    11. DOSAGE AND ADMINISTRATION:
    12. HOW SUPPLIED:
    13. STORAGE AND HANDLING
    14. PRINCIPAL DISPLAY PANEL - BOTTLE LABEL

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:



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.


Otc - Keep Out Of Reach Of Children



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.


General 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 And Handling



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)

Principal Display Panel - Bottle Label - pro0x 0000 01

Principal Display Panel - Bottle Label - pro0x 0000 01


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