SPL v7
SPL
SPL Set ID e39b19f7-2b3e-4c77-9544-623ebad84870
Route
ORAL
Published
Effective Date 2015-12-22
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.9 mg)
Inactive Ingredients
Water Cetylpyridinium Chloride Citric Acid Monohydrate Potassium Sorbate Sucralose Sodium Hydroxide

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2008-10-21 Until 2014-12-31
Description

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

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.

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.

Contraindications

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

Adverse Reactions

NONE

How Supplied

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

Medication Information

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.

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.

Contraindications

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

Adverse Reactions

NONE

How Supplied

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

Description

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

Section 34072-9

General: Not for systemic treatment. DO NOT SWALLOW.

Section 44425-7

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.

Section 50565-1

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.

Overdosage:

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

Description:

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

How Supplied:

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

RX only:

Active Ingredient:

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

Adverse Reactions:

NONE

Contraindications:

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

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.

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.

Package Label.principal Display Panel
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)

Structured Label Content

Section 34072-9 (34072-9)

General: Not for systemic treatment. DO NOT SWALLOW.

Section 44425-7 (44425-7)

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.

Section 50565-1 (50565-1)

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.

Overdosage:

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

Description:

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

How Supplied:

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

RX only:

Active Ingredient:

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

Adverse Reactions:

NONE

Contraindications:

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

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.

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.

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)
Principal Display Panel Bottle Label (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)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:34:34.084409 · Updated: 2026-03-14T21:40:57.506804