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, System Kosmetik Produktionsgesellschaft fur kosmetische Erzeugnisse mbH. 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

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

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CURODONT REPAIR FLUORIDE PLUS 
sodium fluoride sponge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72247-105
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.05 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)
TROMETHAMINE (UNII: 023C2WHX2V)
TREHALOSE DIHYDRATE (UNII: 7YIN7J07X4)
OLIGOPEPTIDE-10 (UNII: Q46328TRNK)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72247-105-12	10 in 1 BOX	01/11/2019
1	NDC: 72247-105-11	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 final	part355	01/11/2019

Labeler - CREDENTIS AG (485450345)

Registrant - CREDENTIS AG (485450345)

Establishment
Name	Address	ID/FEI	Business Operations
System Kosmetik Produktionsgesellschaft fur kosmetische Erzeugnisse mbH		328825757	manufacture(72247-105)

Establishment
Name	Address	ID/FEI	Business Operations
VALIDA		480120305	pack(72247-105)