Pro-Den Rx: Package Insert / Prescribing Info
Package insert / product label
Generic name: sodium fluoride
Dosage form: oral rinse
Drug class: Mouth and throat products
Medically reviewed by Drugs.com. Last updated on Mar 4, 2024.
Pro-Den Rx 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.
Pro-Den Rx - 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 for Pro-Den Rx
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/Side Effects
NONE
Overdosage
Swallowing a normal treatment dose (approximately 9 mg. of fluoride) is not harmful.
Pro-Den Rx 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 is Pro-Den Rx 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 |
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PRO-DEN RX
sodium fluoride rinse |
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Medical Disclaimer
