CURODONT REPAIR FLUORIDE PLUS- sodium fluoride sponge 
CREDENTIS AG

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CREDENTIS (Gen 2) - vVardis Professional - CURODONT REPAIR FLUORIDE PLUS (72247-109)

ACTIVE INGREDIENTS

SODIUM FLUORIDE 0.05%

(0.02% W/V FLUORIDE ION)

PURPOSE

ANTICAVITY

USES

AIDS IN THE PREVENTION OF DENTAL CAVITIES

WARNINGS

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. IF MORE THAN USED FOR RINSING IS ACCIDENTALLY SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

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.

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, CITRIC ACID, SODIUM HYDROXIDE.

UC

CURODONT REPAIR FLUORIDE PLUS 
sodium fluoride sponge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72247-109
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.02 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
WATER (UNII: 059QF0KO0R)  
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)  
TROMETHAMINE (UNII: 023C2WHX2V)  
TREHALOSE DIHYDRATE (UNII: 7YIN7J07X4)  
OLIGOPEPTIDE 104 (UNII: MUM5TLH7X6)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72247-109-1210 in 1 BOX08/27/2023
10.1 mL in 1 CYLINDER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02108/27/2023
Labeler - CREDENTIS AG (485450345)

Revised: 12/2024
Document Id: 28421f54-862e-60e1-e063-6294a90a4af4
Set id: 03ec09f9-4281-9ccb-e063-6294a90aadd8
Version: 3
Effective Time: 20241201
 
CREDENTIS AG