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| Product NDC Code | 72247-106 | ||||
|---|---|---|---|---|---|
| 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 | part355 | ||||
| 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.DIRECTIONS Usual dosage is one treatment per tooth. After prophylaxis treatment, remove the pellicle of the concerned tooth by using 2% sodium hypochlorite for 10 seconds. Rinse the tooth surface with water. Remove inorganic deposits by pushing together the two cylinders and apply product with sponge on treatment area. After treatment time of five minutes have patient expectorate residues. For maximum benefits for the prevention of caries, instruct patient not to rinse, eat or drink for 30 minutes.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENTS WATER, CHLORHEXIDINE DIGLUCONATE, TROMETHAMINE, TREHALOSE DIHYDRATE, OLIGOPEPTIDE-104, HYDROXYPROPYL METHYLCELLULOSE, CITRIC ACID, 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.USES AIDS IN THE PREVENTION OF DENTAL CAVITIES ANTICAVITY DENTAL RINSE RESTORES ENAMEL FOR THE TREATMENT OF 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 ANHYDROUS CITRIC ACID SODIUM HYDROXIDE WATER CHLORHEXIDINE GLUCONATE TROMETHAMINE TREHALOSE DIHYDRATE OLIGOPEPTIDE 104 HYPROMELLOSE, UNSPECIFIED SODIUM MONOFLUOROPHOSPHATE FLUORIDE ION
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.UC
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 DO NOT USE IF SAFETY PACHAGING IS BROKEN OR MISSING. SINGLE USE ONLY. STORE IN A DRY AND COOL PLACE.
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 INTRAORAL USE ONLY. FOR PROFESSIONAL OFFICE USE ONLY. THIS PRODUCT IS NOT INTENDED FOR HOME OR UNSUPERVISED CONSUMER USE.
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