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NDC 59883-0820-02 Pro-Den Rx 4.3 g/g Details

Pro-Den Rx 4.3 g/g

Pro-Den Rx is a ORAL GEL in the HUMAN OTC 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: 59883-0820-02
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Fluoride

Product Information

NDC	59883-0820
Product ID	59883-820_82f9290a-dfa2-1ba2-e053-2991aa0a41f4
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 OTC DRUG
Dosage Form	GEL
Route	ORAL
Active Ingredient Strength	4.3
Active Ingredient Units	g/g
Substance Name	SODIUM FLUORIDE
Labeler Name	DEN-MAT HOLDINGS, LLC
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part355
Listing Certified Through	2024-12-31

Package

Package Images

NDC 59883-0820-02 (59883082002)

Pricing Information	N/A
NDC Package Code	59883-820-02
Billing NDC	59883082002
Package	1 TUBE in 1 CARTON (59883-820-02) / 56 g in 1 TUBE
Marketing Start Date	2008-10-31
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 57080023-c62b-4bbe-a76c-ed7ae576640f Details

SPL UNCLASSIFIED SECTION

Drug Facts

Description:

A home care, self-applied topical fluoride treatment containing 1.1% Neutral Sodium Fluoride (5000 ppm F) for daily use to aid in the protection against dental caries in adults and pediatric patients.

OTC - ACTIVE INGREDIENT

Neutral Sodium Fluoride 1.1% w/w (5000 ppm F).

INACTIVE INGREDIENT

Diatomite, Flavor, Glycerin, Carboxymethyl Cellulose, Phosphoric Acid, Sodium Benzoate, Sodium Saccharin and Purified Water.

OTC - PURPOSE

Clinical Pharmacology: Applying preparations containing high fluoride concentrations on a regular basis increases the fluoride ion levels in tooth enamel and improves tooth resistance to acid dissolution.

INDICATIONS AND USAGE

It is well recognized that regular use of 1.1% Neutral Sodium Fluoride (5000 ppm F) in mouthpiece applicators is safe and effective in preventing caries. 1-4 ProDenRx Brush-On Gel may be applied using a toothbrush. Plaque contributes to caries; therefore, reduction of plaque can help in preventing caries.

Contraindications: Do not use in children under 6 unless recommended by a dentist.

OTC - KEEP OUT OF REACH OF CHILDREN

PLEASE KEEP OUT OF REACH OF CHILDREN.

WARNINGS

Children under 6 years old:

The potential for fluorosis from repeated swallowing is possible; therefore, children under 6 years old should use only if ordered by dentist and carefully supervised by parent.

Precautions:

Limited to topical use in mouth only. DO NOT SWALLOW.

Overdosage:

Swallowing a normal treatment dose (approx. 2 mg of fluoride) is not harmful.

DOSAGE AND ADMINISTRATION

Adults and Children over 6 years of age: Use in place of your regular toothpaste. Apply at bedtime or more often if your dentist recommends additional therapy based on the diagnosis. Cover brush head with ProDenRx 1.1% Neutral Sodium Fluoride Gel and brush around all tooth surfaces and gum line for at least 1 minute. Spit out gel.

Adults: Wait 30 minutes before rinsing mouth. For children under age 12: Rinse mouth thoroughly immediately after use.

Store at Room Temperature

How Supplied: Net Wt. 2 oz. (56 g) tube in a box.

Berry Fresh: NDC 59883-822-02

Cherry Limeade: NDC 59883-821-02

Cool Mint: NDC 59883-820-02

References:

1. Accepted Dental Therapeutics Ed. 40 ADA Chicago, p. 405-407, 1984.

2. Englander HR, et al.: JADA 83:354-358 1971.

3. Englander HR, et al.: JADA 78:783-787 1969.

4. Englander HR, et al.: JADA 75:638-644 1967.

Rx Only

1-800-228-5595

REORDER NUMBER: 2250RBM

Made for and Distributed in US by: Zila Therapeutics, Inc.

P.O. Box 3889, Batesville, AR 72503

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PRO-DEN RX

sodium fluoride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:59883-820
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	SODIUM FLUORIDE	4.3 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
DIATOMACEOUS EARTH (UNII: 2RF6EJ0M85)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)
PHOSPHORIC ACID (UNII: E4GA8884NN)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:59883-820-02	1 in 1 CARTON	10/31/2008
1		56 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355	10/31/2008

Labeler - DEN-MAT HOLDINGS, LLC (809857704)

Name	Address	ID/FEI	Business Operations
Establishment
Medical Products Laboratories, Inc.		002290302	manufacture(59883-820)

Revised: 2/2019

Document Id: 82f9290a-dfa2-1ba2-e053-2991aa0a41f4

Set id: 57080023-c62b-4bbe-a76c-ed7ae576640f

Version: 2

Effective Time: 20190228