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| Product NDC Code | 59883-920 | ||||
|---|---|---|---|---|---|
| Drug Name | Pro-den rx |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | RINSE | ||||
| RxCUI drug identifier | 562510, 1488074 |
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| Labeler Name | Den-mat Holdings, Llc | ||||
| Packages |
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Overdosage of Pro-Den Rx
Information about signs, symptoms, and laboratory findings of acute ovedosage and the general principles of overdose treatment.Overdosage: Swallowing a normal treatment dose (approximately 9 mg. of fluoride) is not harmful.
Adverse reactions
Information about undesirable effects, reasonably associated with use of the drug, that may occur as part of the pharmacological action of the drug or may be unpredictable in its occurrence. Adverse reactions include those that occur with the drug, and if applicable, with drugs in the same pharmacologically active and chemically related class. There is considerable variation in the listing of adverse reactions. They may be categorized by organ system, by severity of reaction, by frequency, by toxicological mechanism, or by a combination of these.Adverse Reactions: NONE
Clinical pharmacology
Information about the clinical pharmacology and actions of the drug in humans.Clinical Pharmacology: Sodium fluoride when used topically promotes remineralization, increases resistance of teeth to acid dissolution, and impedes the cariogenic microbial process.
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient: Sodium Fluoride 0.2% w/w (0.09% w/w fluoride ion).
Contraindications
Information about situations in which the drug product is contraindicated or should not be used because the risk of use clearly outweighs any possible benefit, including the type and nature of reactions that have been reported.Contraindications: Do not use in children under age 6 years unless recommended by a dentist or physician.
Description
General information about the drug product, including the proprietary and established name of the drug, the type of dosage form and route of administration to which the label applies, qualitative and quantitative ingredient information, the pharmacologic or therapeutic class of the drug, and the chemical name and structural formula of the drug.Description: Pro-DenRx ® Neutral Sodium Fluoride Rinse is a neutral, aqueous solution.
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients: Purified water, Cetyl Pyridinium Chloride, citric acid, potassium sorbate, sucralose, flavor and Sodium Hydroxide.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.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.
Spl product data elements
Usually a list of ingredients in a drug product.Pro-Den Rx Sodium Fluoride WATER CETYLPYRIDINIUM CHLORIDE CITRIC ACID MONOHYDRATE POTASSIUM SORBATE SUCRALOSE SODIUM HYDROXIDE SODIUM FLUORIDE FLUORIDE ION MINT Pro-Den Rx Sodium Fluoride WATER CETYLPYRIDINIUM CHLORIDE CITRIC ACID MONOHYDRATE POTASSIUM SORBATE SUCRALOSE SODIUM HYDROXIDE SODIUM FLUORIDE FLUORIDE ION BERRY
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Principal Display Panel - Bottle Label NDC 59883-920-16 pro-denRx ® dye free rinse 0.2% sodium fluoride mint flavor Contains: 0.2% Sodium Fluoride in a Neutral Aqueous Solution (0.09% Fluoride Ion) 16 fl. oz. (473 ml) Principal Display Panel - Bottle Label
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Image not available
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.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.
How supplied
Information about the available dosage forms to which the labeling applies, and for which the manufacturer or distributor is responsible. This field ordinarily includes the strength of the dosage form (in metric units), the units in which the dosage form is available for prescribing, appropriate information to facilitate identification of the dosage forms (such as shape, color, coating, scoring, and National Drug Code), and special handling and storage condition information.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 and handling
Information about safe storage and handling of the drug product.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.
General precautions
Information about any special care to be exercised for safe and effective use of the drug.General: Not for systemic treatment. DO NOT SWALLOW.
Precautions
Information about any special care to be exercised for safe and effective use of the drug.Precautions: General: Not for systemic treatment. DO NOT SWALLOW.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API