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Pro-Den Rx Package Insert

Updated:
Facts
Status:
Prescription (Rx)
Strength:
9 mg/mL
Active ingredient:

Source: FDA drug labeling via NLM DailyMed · About this document

Prescribing information (package insert) - Pro-Den Rx

Indications and Usage

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

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 pledgets, to teeth isolated with cotton rolls.

Recommended Frequency

Do not exceed four (4) treatments per year.

Contraindications

Hypersensitivity to fluoride.

Warnings and Precautions

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

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

Caution

Federal law prohibits dispensing without a prescription.

Overdosage

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

Water, Sodium Fluoride, Flavor, PEG-40 Hydrogenated Castor Oil, Sodium Benzoate, Disodium Phosphate, Sodium Saccharin, Methylparaben, Sodium Phosphate, Yellow #10, Blue #1.

How Supplied/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: 12/2017

1-800-433-6628

Reorder Number: 2037MTDT

Manufactured for

Den-Mat Holdings, LLC

1017 W. Central Ave.

Lompoc, CA 9343611

©2017 Den-Mat Holdings, LLC. All rights reserved. 001395000 12/17AS

About this document

Source: FDA drug labeling via NLM DailyMed · View the label on DailyMed

Revision date stated in the text: December 2017

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The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Pro-Den Rx

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Active ingredient Sodium fluoride 9 mg/mL
Dosage form Rinse
Route Oral
Marketing status listed in the FDA NDC Directory
Company (applicant) Den-Mat Holdings, Llc
FDA approval UNAPPROVED DRUG OTHERUnapproved drug
Manufacturers 2 labelers list this drug on DailyMed
Packages (NDC)
Package
9 mg/mL – 1890 ml in 1 bottle, plastic NDC 59883-911-64

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.