FDA Label for Curodont Repair Fluoride Plus
View Indications, Usage & Precautions
Curodont Repair Fluoride Plus Product Label
The following document was submitted to the FDA by the labeler of this product Credentis Ag. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredients
SODIUM FLUORIDE 0.05% (0.02% W/V FLUORIDE ION)
Purpose
ANTICAVITY
Uses
AIDS IN THE PREVENTION OF DENTAL CAVITIES.
- ANTICAVITY DENTAL RINSE
- ENAMEL MINERALIZER
- REPAIRS WHITE SPOTS
Warnings
FOR TOPICAL USE ONLY.
FOR PROFESSION OFFICE USE ONLY
Otc - Do Not Use
DO NOT USE
- AT HOME OR FOR UNSUPERVISED CONSUMER USE
Otc - Keep Out Of Reach Of Children
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.
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.
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.
Inactive Ingredients
anhydrous citric acid, chlorhexidine gluconate, hypromellose, oligopeptide-104, sodium hydroxide, trehalose dihydrate, tromethamine, water
Questions? Comments?
Call 1-800-217-0064 or write vVardis Inc., at 651 N. Broad St., Middletown, DE 19709
Dosage & Administration
Anticavity dental treatment rinse. Contains 10 units A and 10 units B
10 x 0.0085 fl. oz. (10 x 0.25 ml)
Package Label.Principal Display Panel
* Please review the disclaimer below.
