Credentis (gen 2) - Vvardis Professional - Curodont Repair Fluoride Plus (72247-109)

Credentis (gen 2) - Vvardis Professional - Curodont Repair Fluoride Plus (72247-109)
SPL v3
SPL
SPL Set ID 03ec09f9-4281-9ccb-e063-6294a90aadd8
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
Anhydrous Citric Acid Sodium Hydroxide Water Chlorhexidine Gluconate Tromethamine Trehalose Dihydrate Oligopeptide 104 Hypromellose, Unspecified

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-08-27

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

Section 51945-4

Warnings

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.

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, CITRIC ACID, SODIUM HYDROXIDE.


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

Section 51945-4 (51945-4)

Purpose (PURPOSE)

ANTICAVITY

Warnings (WARNINGS)

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.

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, CITRIC ACID, SODIUM HYDROXIDE.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)