Curodont Repair Fluoride Plus
FDA Label NDC 72247-101

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 72247-101). 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, warning, 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

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
  • RESTORES ENAMEL
  • FOR THE TREATMENT OF WHITE SPOTS

Warning

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.

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. For patients with rampant or active caries, repeat treatment once or twice every six months.

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

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