PRO-DEN RX- sodium fluoride rinse

Pro-Den Rx by

Drug Labeling and Warnings

Pro-Den Rx by is a Prescription medication manufactured, distributed, or labeled by Den-mat Holdings, Llc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

PRO-DEN RX 
sodium fluoride rinse

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 59883-920
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.9 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT (MINT)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59883-920-16	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/21/2008

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	Item Code (Source)	NDC: 59883-922
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.9 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Product Characteristics
Color		Score
Shape		Size
Flavor	BERRY (BERRY)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59883-922-16	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/21/2008	12/31/2014

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)