PRO-DEN RX- sodium fluoride rinse

Pro-Den Rx by

Drug Labeling and Warnings

Pro-Den Rx by is a Prescription medication manufactured, distributed, or labeled by Den-mat Holdings, Llc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

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)

INGREDIENTS AND APPEARANCE

PRO-DEN RX 
sodium fluoride rinse

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 59883-912
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.9 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
METHYLPARABEN (UNII: A2I8C7HI9T)
SODIUM PHOSPHATE (UNII: SE337SVY37)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)

Product Characteristics
Color		Score
Shape		Size
Flavor	BERRY (BERRY)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59883-912-64	1890 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/21/2008

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		10/21/2008

Labeler - Den-mat Holdings, Llc (809857704)