CURODONT REPAIR FLUORIDE PLUS

Manufacturer
CREDENTIS AG
Effective date
2025-06-23
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:03:47

Label at a glance#

ProductCURODONT REPAIR FLUORIDE PLUS
Active ingredientSODIUM FLUORIDE
Label structure12 sections

Indications and uses

AIDS IN THE PREVENTION OF DENTAL CAVITIES. ANTICAVITY DENTAL RINSE ENAMEL MINERALIZER REPAIRS WHITE SPOTS

Dosage and administration

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 ...

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
  • ENAMEL MINERALIZER
  • REPAIRS WHITE SPOTS

WARNINGS

WARNINGS SECTION

WARNINGS SECTION

FOR TOPICAL USE ONLY.

WARNINGS SECTION

FOR PROFESSION OFFICE USE ONLY

OTC - DO NOT USE SECTION

DO NOT USE

  • AT HOME OR FOR UNSUPERVISED CONSUMER USE

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

INSTRUCTIONS FOR USE SECTION

  • 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

OTHER SAFETY 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

INACTIVE INGREDIENT SECTION

anhydrous citric acid, chlorhexidine gluconate, hypromellose, oligopeptide-104, sodium hydroxide, trehalose dihydrate, tromethamine, water

Questions? Comments?

OTC - QUESTIONS SECTION

Call 1-800-217-0064 or write vVardis Inc., at 651 N. Broad St., Middletown, DE 19709

DOSAGE & ADMINISTRATION SECTION

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 - PDP - Box x10 - 72247-108-03

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

x10 boxx10 box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CRFP Pouch Gen 3CRFP Pouch Gen 3

Package Label - PDP - Box x20 - 72247-108-04

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

x20x20

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
77dc03a4-fbfc-e6a3-fe95-285bbae40d75Product name220250814
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
bb6d6c68-649d-4e6d-a1f6-603d969c8f68Product name120160303
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72247-108-01CURODONT REPAIR FLUORIDE PLUS0.25 mL in 1 DOSE PACKSPONGE0.252
72247-108-02CURODONT REPAIR FLUORIDE PLUS5 in 1 POUCHSPONGE52
72247-108-03CURODONT REPAIR FLUORIDE PLUS2 in 1 BOXSPONGE22
72247-108-04CURODONT REPAIR FLUORIDE PLUS4 in 1 BOXSPONGE42

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72247-10872247-108-01, 72247-108-02, 72247-108-03, 72247-108-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CURODONT REPAIR FLUORIDE PLUSSODIUM FLUORIDECREDENTIS AG290c57b0-a562-0a51-e063-6294a90a07202025-06-23WarningsExact identifier
ndc (package): 72247-108-01
ndc (package): 72247-108-03
ndc (package): 72247-108-02
ndc (package): 72247-108-04
ndc (product): 72247-108
ndc11 (package): 72247010803
ndc11 (package): 72247010802
ndc11 (package): 72247010804
ndc11 (package): 72247010801
spl id: 3840f669-e285-5f88-e063-6394a90af026
spl set id: 290c57b0-a562-0a51-e063-6294a90a0720

Reported adverse events (FAERS/openFDA)#

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