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

vVardis Professional Switzerland

Curodont (tm) Repair Fluoride Plus

vVardis technology

Anticavity dental treatment rinse

Contains 10 single packed single use applicator with 0.1ml rinse each

10 x 0.1 ml (10 x 0.033 FL OZ)

Important: read directions for proper use - see inside

curodont repair fluoride p1

curodont repair fluoride p2

curodont repair fluoride 1unit

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
77dc03a4-fbfc-e6a3-fe95-285bbae40d75	Product name	2	20250814
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829
bb6d6c68-649d-4e6d-a1f6-603d969c8f68	Product name	1	20160303

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
72247-101-12	2023-07-28	C162847	48780-1	0191ceaa-6455-198a-e063-dbdaa90aec3e	CREDENTIS - CURODONT REPAIR FLUORIDE PLUS - MAY CONSULTING

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
72247-101-11	CURODONT REPAIR FLUORIDE PLUS	0.1 mL in 1 CYLINDER	SPONGE	0.1		8
72247-101-12	CURODONT REPAIR FLUORIDE PLUS	10 in 1 BOX	SPONGE	10		8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72247-101	CURODONT REPAIR FLUORIDE PLUS (SODIUM FLUORIDE) SPONGE [CREDENTIS AG]	8	Legacy NDC, 2 package rows	20220115_76207c03-eb76-4c28-8645-ecc13f4aa852.zip

Products#

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

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

CURODONT REPAIR FLUORIDE PLUS
SODIUM FLUORIDE
WATER
CHLORHEXIDINE GLUCONATE
TROMETHAMINE
TREHALOSE DIHYDRATE
OLIGOPEPTIDE-10
HYPROMELLOSE, UNSPECIFIED
SODIUM MONOFLUOROPHOSPHATE
FLUORIDE ION

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
72247-101	72247-101-11, 72247-101-12

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
Name	UNII	Kind
WATER	059QF0KO0R	IACT
CHLORHEXIDINE GLUCONATE	MOR84MUD8E	IACT
TROMETHAMINE	023C2WHX2V	IACT
TREHALOSE DIHYDRATE	7YIN7J07X4	IACT
OLIGOPEPTIDE-10	Q46328TRNK	IACT
HYPROMELLOSE, UNSPECIFIED	3NXW29V3WO	IACT
SODIUM MONOFLUOROPHOSPHATE	C810JCZ56Q	ACTIM

Source Document#

Source XML

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
d55799dd-c6ad-1171-e053-2995a90a2d65			76207c03-eb76-4c28-8645-ecc13f4aa852	2022-01-11	Warnings	Exact identifier spl id: d55799dd-c6ad-1171-e053-2995a90a2d65 spl set id: 76207c03-eb76-4c28-8645-ecc13f4aa852

Reported adverse events (FAERS/openFDA)#

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