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| Product NDC Code | 72247-108 | ||||
|---|---|---|---|---|---|
| Drug Name | Curodont repair fluoride plus |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | SPONGE | ||||
| Application Number | M021 | ||||
| Labeler Name | CREDENTIS AG | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.ACTIVE INGREDIENTS SODIUM FLUORIDE 0.05% (0.02% W/V FLUORIDE ION)
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.Anticavity dental treatment rinse. Contains 10 units A and 10 units B 10 x 0.0085 fl. oz. (10 x 0.25 ml)
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients anhydrous citric acid, chlorhexidine gluconate, hypromellose, oligopeptide-104, sodium hydroxide, trehalose dihydrate, tromethamine, water
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.USES AIDS IN THE PREVENTION OF DENTAL CAVITIES. ANTICAVITY DENTAL RINSE ENAMEL MINERALIZER REPAIRS WHITE SPOTS
Purpose
Information about the drug product’s indications for use.PURPOSE ANTICAVITY
Spl product data elements
Usually a list of ingredients in a drug product.CURODONT REPAIR FLUORIDE PLUS Sodium Fluoride OLIGOPEPTIDE-104 TROMETHAMINE HYPROMELLOSES SODIUM HYDROXIDE SODIUM FLUORIDE FLUORIDE ION CHLORHEXIDINE GLUCONATE WATER ANHYDROUS CITRIC ACID TREHALOSE DIHYDRATE
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.CRFP Box Gen 3
CRFP Pouch Gen 3
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.DO NOT USE AT HOME OR FOR UNSUPERVISED CONSUMER USE
Instructions for use
Information about safe handling and use of the drug product.DIRECTIONS See package insert for specific instructions for product activation From the Curodont Repair Fluoride Plus box, retrieve one UNIT A and peel off the color. From the pouch, retrieve one UNIT B. Keep the remaining unused UNIT B in the pouch for future use. Do not replace UNIT B with water, saline, or any other liquid. UNIT A and UNIT B are intended to always be used together. Pour the entire contents of UNIT B into the UNIT A receptacle containing the sponge, letting it absorb the liquid for at least 5 minutes to fully activate the proprietary formulation. Meanwhile, proceed with preparing the treatment site. Each set of UNIT A and UNIT B is intended to treat one initial lesion in a single patient. Perform oral prophylaxis on the teeth to be treated, including removal of the salivary pellicle using your preferred method (pumice/prophy paste/air polisher/2% sodium hypochlorite). Rinse and dry. Etch using 35% phosphoric acid for 20 seconds. For interproximal sites, use unwaxed dental floss to apply the etchant, if needed. Rinse. After ensuring that the sponge in UNIT A is fully soaked and soft, isolate the treatment site using basic aids such as cotton rolls, saliva ejector, dry aids, etc. Rubber dam is not necessary. Use cotton pliers to firmly grip the saturated sponge in UNIT A from one of its corners. Press the sponge on the lesion surface until the formula is deposited and hte sponge starts to appear dry. Use only saturated sponge per lesion. One 'lesion' is defined as one lesion on occlusal/buccal/lingual surfaces or one interproximal site with lesions on one or both adjacent surfaces. For interproximal sites, press the saturated sponge starting from lingual embrasure, moving to the buccal and, for any residual formula, the occlusal. Separators or wedges are not needed. Wait for 5 minutes before asking the patient to expectorate residues, if any. Dispose the used UNIT A and UNIT B. Instruct the patient not to rinse, eat or drink for 30 minutes.
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. IF MORE THAN USED FOR RINSING IS ACCIDENTALLY SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information Store at room temperature in a dry, cool place Single use only TAMPER EVIDENT: Do not use if safety packaging seal is broken or missing.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? Comments? Call 1-800-217-0064 or write vVardis Inc., at 651 N. Broad St., Middletown, DE 19709
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 FOR TOPICAL USE ONLY. FOR PROFESSION OFFICE USE ONLY DO NOT USE AT HOME OR FOR UNSUPERVISED CONSUMER USE 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.
FOR TOPICAL USE ONLY.
FOR PROFESSION OFFICE USE ONLY
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