Other
For topical application to aid in the protection against dental caries. Neutral pH is especially safe for crowns and restorations.
Pro-den Rx
FDA Label NDC 59883-912
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Den-mat Holdings, Llc for the product Pro-den Rx (NDC 59883-912). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, dosage and administration, recommended frequency, contraindications, warnings and precautions, adverse reactions, caution, overdosage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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, PEG-40 Hydrogenated Castor Oil, Sodium Benzoate, Disodium Phosphate, Sodium Saccharin, Flavor, Methylparaben, Sodium Phosphate, Red #33.
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: 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
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 (Pro17 0000 01)
* Please review the disclaimer below.
