Pro-Den Rx SODIUM FLUORIDE DEN-MAT HOLDINGS, LLC FDA Approved Indications and Usage For topical application to aid in the protection against dental caries. Neutral pH is especially safe for crowns and restorations.
FunFoxMeds bottle
Substance Sodium Fluoride
Route
ORAL
Package NDC

Drug Facts

Composition & Profile

Strengths
2.0 % 0.9 % 1.89 l
Quantities
2017 count
Treats Conditions
Indications And Usage For Topical Application To Aid In The Protection Against Dental Caries Neutral Ph Is Especially Safe For Crowns And Restorations

Identifiers & Packaging

Container Type BOTTLE
All Product Codes
UNII
8ZYQ1474W7
Packaging

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; Principal Display Panel - 64 fl. oz. Bottle Label NDC 59883-911-64 treatment rinse 2.0% neutral sodium fluoride cool mint flavor IMPORTANT: Read directions for proper use. Net Wt. 64 fl. oz. (1.89 L) rinse_fluoride_image

Package Descriptions
  • 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
  • Principal Display Panel - 64 fl. oz. Bottle Label NDC 59883-911-64 treatment rinse 2.0% neutral sodium fluoride cool mint flavor IMPORTANT: Read directions for proper use. Net Wt. 64 fl. oz. (1.89 L) rinse_fluoride_image

Overview

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

Indications & Usage

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

Dosage & 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.

Warnings & 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.
Contraindications

Hypersensitivity to fluoride.

Adverse Reactions

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


Similar Drugs

Related medications based on brand, generic name, substance, active ingredients.

View all similar drugs →