CURODONT REPAIR FLUORIDE PLUS- sodium fluoride sponge

CURODONT REPAIR FLUORIDE PLUS by

Drug Labeling and Warnings

CURODONT REPAIR FLUORIDE PLUS by is a Otc medication manufactured, distributed, or labeled by CREDENTIS AG. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

SODIUM FLUORIDE 0.05%

(0.02% W/V FLUORIDE ION)

PURPOSE

ANTICAVITY

USES

AIDS IN THE PREVENTION OF DENTAL CAVITIES

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

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

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CURODONT REPAIR FLUORIDE PLUS 
sodium fluoride sponge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72247-109
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.02 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72247-109-12	10 in 1 BOX	08/27/2023
1		0.1 mL in 1 CYLINDER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M021	08/27/2023

Labeler - CREDENTIS AG (485450345)