FDA.reportPublic FDA data

CURODONT REPAIR FLUORIDE PLUS

Manufacturer
CREDENTIS AG | System Kosmetik Produktionsgesellschaft fur kosmetische Erzeugnisse mbH | VALIDA
Effective date
2020-01-06
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 23:46:46

Label at a glance#

ProductCURODONT REPAIR FLUORIDE PLUS
Active ingredientSODIUM MONOFLUOROPHOSPHATE
Label structure9 sections

Indications and uses

AIDS IN THE PREVENTION OF DENTAL CAVITIES ANTICAVITY DENTAL RINSE RESTORES ENAMEL FOR THE TREATMENT OF WHITE SPOTS

Dosage and administration

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 preve...

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

SODIUM FLUORIDE 0.05% (0.02% W/V FLUORIDE ION)

PURPOSE

OTC - PURPOSE SECTION

ANTICAVITY

USES

INDICATIONS & USAGE SECTION

AIDS IN THE PREVENTION OF DENTAL CAVITIES

  • ANTICAVITY DENTAL RINSE
  • RESTORES ENAMEL
  • FOR THE TREATMENT OF WHITE SPOTS

WARNING

WARNINGS SECTION

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 SECTION

KEEP OUT OF REACH OF CHILDREN.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

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

OTHER SAFETY INFORMATION

DO NOT USE IF SAFETY PACHAGING IS BROKEN OR MISSING.

SINGLE USE ONLY.

STORE IN A DRY AND COOL PLACE.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

WATER, CHLORHEXIDINE DIGLUCONATE, TROMETHAMINE, TREHALOSE DIHYDRATE, OLIGOPEPTIDE-104, HYDROXYPROPYL METHYLCELLULOSE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Curodont Repair Fluid_Outer_1Curodont Repair Fluid_Outer_1

Curodont Repair Fluid_Outer_2Curodont Repair Fluid_Outer_2

Curodont Repair Fluid_PrimaryCurodont Repair Fluid_Primary

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72247-10572247-105-11, 72247-105-12

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM MONOFLUOROPHOSPHATEC810JCZ56QACTIM
WATER059QF0KO0RIACT
CHLORHEXIDINE GLUCONATEMOR84MUD8EIACT
TROMETHAMINE023C2WHX2VIACT
TREHALOSE DIHYDRATE7YIN7J07X4IACT
OLIGOPEPTIDE-10Q46328TRNKIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT

Source Document#

Source XML · Source PDF

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
fecdecf4-0b25-e19c-e053-6394a90a9dce0dae079d-1f99-447b-8a02-2951985385002023-06-23WarningsExact identifier
spl set id: 0dae079d-1f99-447b-8a02-295198538500

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.