Credentis - Curodont Repair Fluoride Plus - May Consulting

Credentis - Curodont Repair Fluoride Plus - May Consulting
SPL v8
SPL
SPL Set ID 76207c03-eb76-4c28-8645-ecc13f4aa852
Route
ORAL
Published
Effective Date 2021-05-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.02 g)
Inactive Ingredients
Water Chlorhexidine Gluconate Tromethamine Trehalose Dihydrate Oligopeptide-10 Hypromellose, Unspecified

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2019-01-11

Description

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

Purpose

ANTICAVITY


Medication Information

Purpose

ANTICAVITY

Description

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

Uses

AIDS IN THE PREVENTION OF DENTAL CAVITIES

  • ANTICAVITY DENTAL RINSE
  • RESTORES ENAMEL
  • FOR THE TREATMENT OF WHITE SPOTS
Section 50565-1

KEEP OUT OF REACH OF CHILDREN.

Section 51945-4

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

Warning

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

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.

Active Ingredients

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

Inactive Ingredients

WATER, CHLORHEXIDINE DIGLUCONATE, TROMETHAMINE, TREHALOSE DIHYDRATE, OLIGOPEPTIDE-104, HYDROXYPROPYL METHYLCELLULOSE


Structured Label Content

Uses (USES)

AIDS IN THE PREVENTION OF DENTAL CAVITIES

  • ANTICAVITY DENTAL RINSE
  • RESTORES ENAMEL
  • FOR THE TREATMENT OF WHITE SPOTS
Section 50565-1 (50565-1)

KEEP OUT OF REACH OF CHILDREN.

Section 51945-4 (51945-4)

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

Purpose (PURPOSE)

ANTICAVITY

Warning (WARNING)

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

Directions (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 (OTHER INFORMATION)

DO NOT USE IF SAFETY PACHAGING IS BROKEN OR MISSING.

SINGLE USE ONLY.

STORE IN A DRY AND COOL PLACE.

Active Ingredients (ACTIVE INGREDIENTS)

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

Inactive Ingredients (INACTIVE INGREDIENTS)

WATER, CHLORHEXIDINE DIGLUCONATE, TROMETHAMINE, TREHALOSE DIHYDRATE, OLIGOPEPTIDE-104, HYDROXYPROPYL METHYLCELLULOSE


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)