Pro-Den Rx

Manufacturer
Den-mat Holdings, Llc
Effective date
2019-02-28
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 20:27:56

Label at a glance#

ProductPro-Den Rx
Active ingredientSODIUM FLUORIDE
Label structure11 sections

Dosage and administration

Dispense ½ oz. (approx. 1 pump) of Pro-DenRx 2.0% Neutral Sodium Fluoride Solution into the provided mixing cup. Instruct patient to rinse vigorously for 30 seconds with ½ oz. of the solution around and between teeth, then expectorate. For maximum benefit repeat the rinse procedure with an additional ½ oz. of solution. Pro-DenRx 2.0% Neutral Sodium Fluoride Solution may also be applied full strength, with cotton p...

Storage and handling

2.0% Neutral Sodium Fluoride (0.9% Fluoride Ion) oral solution supplied in a plastic bottle with child-resistant closure containing 64 fl. oz. (1.89 L). Store at room temperature. Protect from freezing. Do not store in direct sunlight. Rx Only Revised: 01/2015 1-800-433-6628 Reorder Number: 2037RBDT Manufactured for Den-Mat Holdings, LLC 1017 W. Central Ave. Lompoc, CA 93436 ©2015 Den-Mat Holdings, LLC. All rights...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

For topical application to aid in the protection against dental caries. Neutral pH is especially safe for crowns and restorations.

Dosage and Administration

DOSAGE & ADMINISTRATION SECTION

Dispense ½ oz. (approx. 1 pump) of Pro-DenRx 2.0% Neutral Sodium Fluoride Solution into the provided mixing cup. Instruct patient to rinse vigorously for 30 seconds with ½ oz. of the solution around and between teeth, then expectorate. For maximum benefit repeat the rinse procedure with an additional ½ oz. of solution. Pro-DenRx 2.0% Neutral Sodium Fluoride Solution may also be applied full strength, with cotton pledgets, to teeth isolated with cotton rolls.

Contraindications

CONTRAINDICATIONS SECTION

Hypersensitivity to fluoride.

Warnings and Precautions

WARNINGS AND PRECAUTIONS SECTION

For Professional Office Use Only. This product is not intended for home or unsupervised consumer use. Do not swallow. Keep out of reach of children. Not recommended for children under the age of 6. Limited to topical use in the mouth only.

Adverse Reactions

ADVERSE REACTIONS SECTION

The following adverse reactions are possible in individuals hypersensitive to fluoride: eczema, atopic dermatitis, urticaria, gastric distress, headache, and weakness.

Caution

SPL UNCLASSIFIED SECTION

Federal law prohibits dispensing without a prescription.

Overdosage

OVERDOSAGE SECTION

Accidental ingestion of large amounts of fluoride can cause: nausea, vomiting, abdominal pain, diarrhea, stupor and/or weakness (usually within 30 minutes). These symptoms may persist for 24 hours. If less than 5 mg fluoride/kg body weight (less than 23 mg fluoride/lb body weight) has been ingested, give calcium (milk) orally to relieve symptoms and observe for a few hours. If more than 5 mg fluoride/kg body weight (more than 23 mg fluoride/lb body weight) has been ingested, induce vomiting, give calcium (i.e., milk, 5% calcium gluconate or calcium lactate solution) and immediately seek medical assistance. For accidental ingestion of more than 15 mg fluoride/kg body weight (i.e., more than 6.9 mg fluoride/lb body weight) induce vomiting, transport and admit immediately to a hospital facility.

Ingredients

SPL UNCLASSIFIED SECTION

Water, Sodium Fluoride, PEG-40 Hydrogenated Castor Oil, Sodium Benzoate, Disodium Phosphate, Sodium Saccharin, Flavor, Methylparaben, Sodium Phosphate, Red #33.

How Supplied/Storage and Handling

HOW SUPPLIED SECTION

2.0% Neutral Sodium Fluoride (0.9% Fluoride Ion) oral solution supplied in a plastic bottle with child-resistant closure containing 64 fl. oz. (1.89 L). Store at room temperature. Protect from freezing. Do not store in direct sunlight.

Rx Only

Revised: 01/2015

1-800-433-6628

Reorder Number: 2037RBDT

Manufactured for

Den-Mat Holdings, LLC

1017 W. Central Ave.

Lompoc, CA 93436

©2015 Den-Mat Holdings, LLC. All rights reserved. 001394900 06/15SN

Principal Display Panel - 64 fl. oz. Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 59883-912-64

treatment rinse

2.0% neutral sodium fluoride

berry fresh flavor

IMPORTANT:
Read directions for proper use.

Net Wt. 64 fl. oz. (1.89 L)

Figure
Figure

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59883-912-642023-01-30C16284748780-1f386c64a-168f-0266-e053-dadaa90a7c1ad4235a56-a82b-48f0-b72f-5f0c58f54f26

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59883-912-64Pro-Den Rx1890 mL in 1 BOTTLE, PLASTICRINSE18902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59883-912PRO-DEN RX (SODIUM FLUORIDE) RINSE [DEN-MAT HOLDINGS, LLC]2Legacy NDC, 1 package rows20190301_d4235a56-a82b-48f0-b72f-5f0c58f54f26.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59883-91259883-912-64

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
82f91600-bbd0-30d0-e053-2991aa0adf68d4235a56-a82b-48f0-b72f-5f0c58f54f262019-02-28Warnings, Adverse reactionsExact identifier
spl id: 82f91600-bbd0-30d0-e053-2991aa0adf68
spl set id: d4235a56-a82b-48f0-b72f-5f0c58f54f26

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.