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NDC 59883-0824-02 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 PRESCRIPTION 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: 59883-0824-02Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Fluoride
Product Information
NDC | 59883-0824 |
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Product ID | 59883-824_82f925fe-19ca-720a-e053-2a91aa0a9b27 |
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 PRESCRIPTION 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 | UNAPPROVED DRUG OTHER |
Application Number | n/a |
Listing Certified Through | 2024-12-31 |
Package
Package Images


NDC 59883-0824-02 (59883082402)
NDC Package Code | 59883-824-02 |
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Billing NDC | 59883082402 |
Package | 1 TUBE in 1 CARTON (59883-824-02) / 56 g in 1 TUBE |
Marketing Start Date | 2009-01-20 |
NDC Exclude Flag | N |
Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 7ac93812-7813-40a2-9f8f-9926a6e92cf9 Details
Description:
Inactive Ingredients:
Clinical Pharmacology:
Indications and Usage:
Warnings:
Overdosage:
Dosage and Administration:
Apply daily at bedtime, in place of your regular toothpaste or more often if your dentist recommends additional therapy based on your diagnosis. Cover brush head with Pro-DenRx 1.1% Neutral Sodium Fluoride Gel and brush around all tooth surfaces and gum line for at least two minutes. Spit out gel. Adults: Wait 30 minutes before rinsing mouth. Children under 12: Rinse mouth thoroughly immediately after use.
When using a mouthpiece or applicator, cover the inner surface with gel. Place applicator in mouth and bite down lightly for at least one minute. Remove applicator and rinse mouth. Clean applicator with cold water.
How Supplied:
Principal Display Panel - Carton Label
Principal Display Panel - Tube Label
INGREDIENTS AND APPEARANCE
PRO-DEN RX
sodium fluoride gel |
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Labeler - Den-mat Holdings, Llc (809857704) |