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NDC 59883-0920-16 Pro-Den Rx 0.9 mg/mL Details

Pro-Den Rx 0.9 mg/mL

Pro-Den Rx is a ORAL RINSE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Den-mat Holdings, Llc. The primary component is SODIUM FLUORIDE.

MedlinePlus Drug Summary

Fluoride is used to prevent tooth decay. It is taken up by teeth and helps to strengthen teeth, resist acid, and block the cavity-forming action of bacteria. Fluoride usually is prescribed for children and adults whose homes have water that is not fluoridated (already has fluoride added). This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

Related Packages: 59883-0920-16
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Fluoride

Product Information

NDC	59883-0920
Product ID	59883-920_82f8dd55-36df-0de0-e053-2991aa0a6bbf
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Pro-Den Rx
Proprietary Name Suffix	n/a
Non-Proprietary Name	Sodium Fluoride
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	RINSE
Route	ORAL
Active Ingredient Strength	0.9
Active Ingredient Units	mg/mL
Substance Name	SODIUM FLUORIDE
Labeler Name	Den-mat Holdings, Llc
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	UNAPPROVED DRUG OTHER
Application Number	n/a
Listing Certified Through	2024-12-31

Package

Package Images

NDC 59883-0920-16 (59883092016)

Pricing Information	N/A
NDC Package Code	59883-920-16
Billing NDC	59883092016
Package	473 mL in 1 BOTTLE, PLASTIC (59883-920-16)
Marketing Start Date	2008-10-21
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL e39b19f7-2b3e-4c77-9544-623ebad84870 Details

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

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

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

Ingredient Name	Strength
Inactive Ingredients
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

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

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		10/21/2008