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NDC 59883-0920-16 Pro-Den Rx 0.9 mg/mL Details
Pro-Den Rx 0.9 mg/mL
Pro-Den Rx is a ORAL RINSE 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: 59883-0920-16Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Fluoride
Product Information
NDC | 59883-0920 |
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Product ID | 59883-920_82f8dd55-36df-0de0-e053-2991aa0a6bbf |
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 | RINSE |
Route | ORAL |
Active Ingredient Strength | 0.9 |
Active Ingredient Units | mg/mL |
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 59883-0920-16 (59883092016)
NDC Package Code | 59883-920-16 |
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Billing NDC | 59883092016 |
Package | 473 mL in 1 BOTTLE, PLASTIC (59883-920-16) |
Marketing Start Date | 2008-10-21 |
NDC Exclude Flag | N |
Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL e39b19f7-2b3e-4c77-9544-623ebad84870 Details
Inactive Ingredients:
Clinical Pharmacology:
Indications and Usage:
Aids in the prevention of dental caries. May be used more than once a week if recommended by your dentist. Pro-DenRx ® Rinse is ready to use, convenient and thus increases compliance.
Weekly rinsing with a neutral 0.2% sodium fluoride solution protects against dental cares in adults and children. May be used in areas where drinking water is fluoridated since topical fluoride cannot produce fluorosis.
Contraindications:
Warnings:
Dosage and Administration:
Adults and children over age 6 years: Rinse once a week, preferably at bedtime, after thoroughly brushing and flossing teeth. Rinse more often if your dentist recommends additional therapy based on your diagnosis. Pour 10 ml (2 teaspoons) of Pro-DenRx® 0.2% Sodium Fluoride Rinse into the graduated cup using the markings on its side. Swish vigorously around and between the teeth for one minute, then spit out. DO NOT SWALLOW. For maximum benefit, do not eat, drink, or rinse mouth for at least 30 minutes after use. Children 6 to 12 years old: Supervise while using this product. Children Under 6 years old: Consult your dentist or doctor before using.
How Supplied:
Principal Display Panel - Bottle Label
INGREDIENTS AND APPEARANCE
PRO-DEN RX
sodium fluoride rinse |
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PRO-DEN RX
sodium fluoride rinse |
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Labeler - Den-mat Holdings, Llc (809857704) |