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NDC 59883-0911-64 Pro-Den Rx 9 mg/mL Details

Pro-Den Rx 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.

Product Information

NDC	59883-0911
Product ID	59883-911_6a0ff4f9-a7f9-1e75-e053-2991aa0a2782
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	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 59883-0911-64 (59883091164)

Pricing Information	N/A
NDC Package Code	59883-911-64
Billing NDC	59883091164
Package	1890 mL in 1 BOTTLE, PLASTIC (59883-911-64)
Marketing Start Date	2008-10-21
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL ba020e07-ad41-4419-a503-f1245131b7d2 Details

Indications and Usage

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, Flavor, PEG-40 Hydrogenated Castor Oil, Sodium Benzoate, Disodium Phosphate, Sodium Saccharin, Methylparaben, Sodium Phosphate, Yellow #10, Blue #1.

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

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)

INGREDIENTS AND APPEARANCE

PRO-DEN RX

sodium fluoride rinse

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:59883-911
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	9 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
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 YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:59883-911-64	1890 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/21/2008

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

Labeler - Den-Mat Holdings, Llc (809857704)

Revised: 4/2018

Document Id: 6a0ff4f9-a7f9-1e75-e053-2991aa0a2782

Set id: ba020e07-ad41-4419-a503-f1245131b7d2

Version: 2

Effective Time: 20180417