CURODONT REPAIR FLUORIDE PLUS- sodium fluoride sponge 
CREDENTIS AG

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

CREDENTIS - CURODONT REPAIR FLUORIDE PLUS - MAY CONSULTING

ACTIVE INGREDIENTS

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

PURPOSE

ANTICAVITY

USES

AIDS IN THE PREVENTION OF DENTAL CAVITIES

WARNING

FOR TOPICAL INTRAORAL USE ONLY. FOR PROFESSIONAL OFFICE USE ONLY. THIS PRODUCT IS NOT INTENDED FOR HOME OR UNSUPERVISED CONSUMER USE.

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

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

CURODONT REPAIR FLUORIDE PLUS 
sodium fluoride sponge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72247-101
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.02 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)  
TROMETHAMINE (UNII: 023C2WHX2V)  
TREHALOSE DIHYDRATE (UNII: 7YIN7J07X4)  
OLIGOPEPTIDE-10 (UNII: Q46328TRNK)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72247-101-1210 in 1 BOX01/11/2019
1NDC:72247-101-110.1 mL in 1 CYLINDER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35501/11/2019
Labeler - CREDENTIS AG (485450345)

Revised: 1/2022
Document Id: d55799dd-c6ad-1171-e053-2995a90a2d65
Set id: 76207c03-eb76-4c28-8645-ecc13f4aa852
Version: 8
Effective Time: 20220111
 
CREDENTIS AG