Credentis - Vvardis Professional - Curodont Protect (72247-107)

Credentis - Vvardis Professional - Curodont Protect (72247-107)
SPL v3
SPL
SPL Set ID 03ec591c-68c3-a380-e063-6394a90a131a
Route
ORAL
Published
Effective Date 2023-08-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.14 g)
Inactive Ingredients
Sorbitol Sodium Hydroxide Water Hydrated Silica Sodium Tripolyphosphate Sodium Gluconate Oligopeptide 104 Xylitol Carboxymethylcellulose Sodium, Unspecified Phosphoric Acid

Identifiers & Packaging

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

Description

STANNOUS FLUORIDE 0.454% (0.14% W/V FLUORIDE ION)

Purpose

ANTICAVITY AND ANTISENSITIVITY


Medication Information

Purpose

ANTICAVITY AND ANTISENSITIVITY

Description

STANNOUS FLUORIDE 0.454% (0.14% W/V FLUORIDE ION)

Use
  • AIDS IN THE PREVENTION OF DENTAL CAVITIES AND BUILDS INCREASING PROTECTION AGAINST PAINFUL SENSITIVITY OF THE TEETH.
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

Stop use and ask a doctor if

  • the problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.
  • pain/sensitivity still persists after 4 weeks of use.
Directions
  • Adults and children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision.
  • Children under 2 years of age: Consult a dentist or doctor.
Other Information

This product may produce surface staining of the teeth. Adequate toothbrushing may prevent these stains which are not harmful or permanent and may be removed by your dentist.

Active Ingredients

STANNOUS FLUORIDE 0.454%

(0.14% W/V FLUORIDE ION)

Inactive Ingredients

Sorbitol, Water, Hydrated Silica, Sodium Tripolyphosphate, Sodium Gluconate, Xylitol, Cellulose Gum, Oligopeptide-104, Sodium Hydroxide, Phosphoric Acid.


Structured Label Content

Use (USE)
  • AIDS IN THE PREVENTION OF DENTAL CAVITIES AND BUILDS INCREASING PROTECTION AGAINST PAINFUL SENSITIVITY OF THE TEETH.
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 AND ANTISENSITIVITY

Warnings (WARNINGS)

Stop use and ask a doctor if

  • the problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.
  • pain/sensitivity still persists after 4 weeks of use.
Directions (DIRECTIONS)
  • Adults and children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision.
  • Children under 2 years of age: Consult a dentist or doctor.
Other Information (OTHER INFORMATION)

This product may produce surface staining of the teeth. Adequate toothbrushing may prevent these stains which are not harmful or permanent and may be removed by your dentist.

Active Ingredients (ACTIVE INGREDIENTS)

STANNOUS FLUORIDE 0.454%

(0.14% W/V FLUORIDE ION)

Inactive Ingredients (INACTIVE INGREDIENTS)

Sorbitol, Water, Hydrated Silica, Sodium Tripolyphosphate, Sodium Gluconate, Xylitol, Cellulose Gum, Oligopeptide-104, Sodium Hydroxide, Phosphoric Acid.


Advanced Ingredient Data


Raw Label Data

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