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NDC 72247-0101-12 CURODONT REPAIR FLUORIDE PLUS 0.02 g/100mL Details

CURODONT REPAIR FLUORIDE PLUS 0.02 g/100mL

CURODONT REPAIR FLUORIDE PLUS is a ORAL SPONGE in the HUMAN OTC DRUG category. It is labeled and distributed by CREDENTIS AG. The primary component is SODIUM MONOFLUOROPHOSPHATE.

Product Information

NDC	72247-0101
Product ID	72247-101_d55799dd-c6ad-1171-e053-2995a90a2d65
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	CURODONT REPAIR FLUORIDE PLUS
Proprietary Name Suffix	n/a
Non-Proprietary Name	SODIUM FLUORIDE
Product Type	HUMAN OTC DRUG
Dosage Form	SPONGE
Route	ORAL
Active Ingredient Strength	0.02
Active Ingredient Units	g/100mL
Substance Name	SODIUM MONOFLUOROPHOSPHATE
Labeler Name	CREDENTIS AG
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part355
Listing Certified Through	2023-12-31

Package

Package Images

NDC 72247-0101-12 (72247010112)

Pricing Information	N/A
NDC Package Code	72247-101-12
Billing NDC	72247010112
Package	10 CYLINDER in 1 BOX (72247-101-12) / .1 mL in 1 CYLINDER (72247-101-11)
Marketing Start Date	2019-01-11
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 76207c03-eb76-4c28-8645-ecc13f4aa852 Details

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.

SPL UNCLASSIFIED SECTION

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

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

INGREDIENTS AND APPEARANCE

CURODONT REPAIR FLUORIDE PLUS

sodium fluoride sponge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:72247-101
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.02 g in 100 mL

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:72247-101-12	10 in 1 BOX	01/11/2019
1	NDC:72247-101-11	0.1 mL in 1 CYLINDER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355	01/11/2019

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