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| Product NDC Code | 59883-824 | ||||
|---|---|---|---|---|---|
| Drug Name | Pro-den rx |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | GEL | ||||
| RxCUI drug identifier | 392038, 1101883 |
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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 2 mg of fluoride) is not harmful. Store at Room Temperature
Clinical pharmacology
Information about the clinical pharmacology and actions of the drug in humans.Clinical Pharmacology: Applying preparations containing high fluoride concentrations on a regular basis increases the fluoride ion levels in tooth enamel and improves tooth resistance to acid dissolution.
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients: Neutral Sodium Fluoride 1.1% w/w (5000 ppm F).
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 6 unless recommended by a dentist.
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: A homecare, self-applied topical fluoride treatment containing 1.1% Neutral Sodium Fluoride (5000 ppm F). Daily use aids in the prevention of dental caries (decay).
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: Apply daily at bedtime, in place of your regular toothpaste or more often if your dentist recommends additional therapy based on your diagnosis. Cover brush head with Pro-DenRx 1.1% Neutral Sodium Fluoride Gel and brush around all tooth surfaces and gum line for at least two minutes. Spit out gel. Adults: Wait 30 minutes before rinsing mouth. Children under 12: Rinse mouth thoroughly immediately after use. When using a mouthpiece or applicator, cover the inner surface with gel. Place applicator in mouth and bite down lightly for at least one minute. Remove applicator and rinse mouth. Clean applicator with cold water.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients: Carboxymethyl cellulose sodium, flavor, phosphoric acid, purified water, sodium hydroxide and sucralose.
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: A homecare, self-applied topical fluoride treatment. Aids in the prevention of dental caries (decay).
Spl product data elements
Usually a list of ingredients in a drug product.Pro-Den Rx Sodium Fluoride SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM PHOSPHORIC ACID WATER SODIUM HYDROXIDE SUCRALOSE SODIUM FLUORIDE FLUORIDE ION MINT
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 - Carton Label NDC 59883-824-02 pro-denRx ® aqueous gel 1.1% neutral sodium fluoride cool mint flavor Contains: 1.1% sodium fluoride (5000 ppm fluoride ion) in a neutral topical aqueous gel Net Wt. 2oz. (56 g) DYE-FREE GEL Figure
Principal Display Panel - Tube Label NDC 59883-824-02 1.1% neutral sodium fluoride pro-denRx ® aqueous gel cool mint flavor Contains: 1.1% sodium fluoride (5000 ppm fluoride ion) in a neutral topical aqueous gel Net Wt. 2oz. (56 g) DYE-FREE GEL Figure
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.KEEP OUT OF REACH OF CHILDREN. Children under 6 years old: The potential for fluorosis from repeated swallowing is possible; therefore, children under 6 years old should use only if ordered by dentist and carefully supervised by parent.
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: Net Wt. 2 oz. (56 g) tube in a box. Cool Mint: NDC 59883-824-02 Reorder 1-800-433-6628 Reorder Number: 2240MTM 965918 Manufactured for Den-Mat Holdings, LLC 1017 W. Central Ave., Lompoc, CA 93436 ©2014 Den-Mat Holdings, LLC. All rights reserved.
Precautions
Information about any special care to be exercised for safe and effective use of the drug.Precautions: Limited to topical use in mouth only. 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: KEEP OUT OF REACH OF CHILDREN. Children under 6 years old: The potential for fluorosis from repeated swallowing is possible; therefore, children under 6 years old should use only if ordered by dentist and carefully supervised by parent.
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