Active Ingredients
SODIUM FLUORIDE 0.05%
(0.02% W/V FLUORIDE ION)
Curodont Repair Fluoride Plus Sponge
FDA Label NDC 72247-109
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Credentis Ag for the product Curodont Repair Fluoride Plus (NDC 72247-109). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warnings, otc - keep out of reach of children, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
ANTICAVITY
Uses
AIDS IN THE PREVENTION OF DENTAL CAVITIES
- ANTICAVITY DENTAL RINSE
- RESTORES ENAMEL
- FOR THE TREATMENT OF WHITE SPOTS
Warnings
FOR TOPICAL INTRAORAL USE ONLY. FOR PROFESSIONAL OFFICE USE ONLY. THIS PRODUCT IS NOT INTENDED FOR HOME OR 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
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.
Other Information
DO NOT USE IF SAFETY PACHAGING IS BROKEN OR MISSING.
SINGLE USE ONLY.
STORE IN A DRY AND COOL PLACE.
Inactive Ingredients
WATER, CHLORHEXIDINE DIGLUCONATE, TROMETHAMINE, TREHALOSE DIHYDRATE, OLIGOPEPTIDE-104, HYDROXYPROPYL METHYLCELLULOSE, CITRIC ACID, SODIUM HYDROXIDE.
* Please review the disclaimer below.
