2% Fluoride Rinse - Den-mat

2% Fluoride Rinse - Den-mat
SPL v2
SPL
SPL Set ID ba020e07-ad41-4419-a503-f1245131b7d2
Route
ORAL
Published
Effective Date 2017-12-18
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (9 mg)
Inactive Ingredients
Water Polyoxyl 40 Hydrogenated Castor Oil Sodium Benzoate Sodium Phosphate, Dibasic, Anhydrous Saccharin Sodium Methylparaben Sodium Phosphate D&c Yellow No. 10 Fd&c Blue No. 1

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2008-10-21

Description

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

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.

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.

Contraindications

Hypersensitivity to fluoride.

Adverse Reactions

The following adverse reactions are possible in individuals hypersensitive to fluoride: eczema, atopic dermatitis, urticaria, gastric distress, headache, and weakness.

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 ©2017 Den-Mat Holdings, LLC. All rights reserved. 001395000 12/17AS

How Supplied

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 ©2017 Den-Mat Holdings, LLC. All rights reserved. 001395000 12/17AS


Medication Information

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.

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.

Contraindications

Hypersensitivity to fluoride.

Adverse Reactions

The following adverse reactions are possible in individuals hypersensitive to fluoride: eczema, atopic dermatitis, urticaria, gastric distress, headache, and weakness.

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 ©2017 Den-Mat Holdings, LLC. All rights reserved. 001395000 12/17AS

How Supplied

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 ©2017 Den-Mat Holdings, LLC. All rights reserved. 001395000 12/17AS

Description

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

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.

Recommended Frequency

Do not exceed four (4) treatments per year.

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

©2017 Den-Mat Holdings, LLC. All rights reserved. 001395000 12/17AS

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)


Structured Label Content

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.

Adverse Reactions

The following adverse reactions are possible in individuals hypersensitive to fluoride: eczema, atopic dermatitis, urticaria, gastric distress, headache, and weakness.

Contraindications

Hypersensitivity to fluoride.

Indications and Usage

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

Recommended Frequency

Do not exceed four (4) treatments per year.

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.

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.

How Supplied/storage and Handling (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

©2017 Den-Mat Holdings, LLC. All rights reserved. 001395000 12/17AS

Principal Display Panel 64 Fl. Oz. Bottle Label (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)


Advanced Ingredient Data


Raw Label Data

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