Description:
Pro-DenRx® Neutral Sodium Fluoride Rinse is a neutral, aqueous solution.
Pro-den Rx Rinse
FDA Label NDC 59883-920
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Den-mat Holdings, Llc for the product Pro-den Rx (NDC 59883-920). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding description:, active ingredient:, inactive ingredients:, clinical pharmacology:, indications and usage:, contraindications:, otc - keep out of reach of children, general precautions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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)
* Please review the disclaimer below.
