Pro-Den Rx
Stannous Fluoride · Rinse · Oral
Uses
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.
Dosage and administration
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.
Contraindications
Contraindications: Do not use in children under age 6 years unless recommended by a dentist or physician.
Warnings
Warnings: PLEASE KEEP OUT OF REACH OF CHILDREN. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away. READ DIRECTIONS CAREFULLY BEFORE USING.
Precautions
Precautions: General: Not for systemic treatment. DO NOT SWALLOW.
Side effects
Adverse Reactions: NONE
Overdosage
Overdosage: Swallowing a normal treatment dose (approximately 9 mg. of fluoride) is not harmful.
Description
Description: Pro-DenRx ® Neutral Sodium Fluoride Rinse is a neutral, aqueous solution.
How supplied
How Supplied: For home use: Plastic bottle containing 16 fl. oz. (473 ml) Cool Mint: NDC 59883-920-16. RX only: Storage: Store at Room Temperature Reorder 1-800-433-6628 Manufactured for Den-Mat Holdings, LLC 1017 W. Central Ave. Lompoc, CA 93436 ©2014 Den-Mat Holdings, LLC. All rights reserved.
Storage
Storage: Store at Room Temperature Reorder 1-800-433-6628 Manufactured for Den-Mat Holdings, LLC 1017 W. Central Ave. Lompoc, CA 93436 ©2014 Den-Mat Holdings, LLC. All rights reserved.
Label text from the FDA structured product label by Den-mat Holdings, Llc (revised Feb 28, 2019). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Sodium Fluoride in 2 products
- Stannous Fluoride in 1 product
Pro-Den Rx NDC products (3)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 59883-720 | Stannous Fluoride 1.53 mg/g Rinse | Den-mat Holdings, Llc | OTC MONOGRAPH DRUG |
| 59883-911 | Sodium Fluoride 9 mg/mL Rinse | Den-Mat Holdings, Llc | UNAPPROVED DRUG OTHER |
| 59883-920 | Sodium Fluoride .9 mg/mL Rinse | Den-mat Holdings, Llc | UNAPPROVED DRUG OTHER |
Frequently asked questions
What is Pro-Den Rx used for?
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…
What are the side effects of Pro-Den Rx?
Adverse Reactions: NONE See the full label for the complete list.
Who makes Pro-Den Rx?
Pro-Den Rx is listed by 2 labelers in the FDA NDC directory, including Den-mat Holdings, Llc, Den-Mat Holdings, Llc.