SPL v1
SPL
SPL Set ID a8cedb67-afe9-4bc5-94fe-f1358281f4f7
Route
ORAL
Published
Effective Date 2022-05-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.22 g) Silicon Dioxide (5 g) Pyrophosphoric Acid (1 g) Pyridoxine (0.05 g)
Inactive Ingredients
Sorbitol Sodium Cocoyl Glutamate Sodium Cocoyl Isethionate Microcrystalline Cellulose Xylitol Magnesium Stearate Sodium Bicarbonate Xanthan Gum Hydroxypropyl Cellulose, Unspecified Levomenthol Sodium Chloride Malic Acid Coconut Oil Aloe Vera Leaf Carrot

Identifiers & Packaging

Pill Appearance
Shape: round Color: white Size: 10 mm Score: 1
Marketing Status
UNAPPROVED DRUG OTHER Active Since 2022-05-03

Description

Silicon Dioxide, Tetrasodium Pyrophosphate, Pyridoxine Hydrochloride, Sodium Fluoride

Purpose

Anti plaque Tartar Control Anti Cavity Against gum disease


Medication Information

Purpose

Anti plaque

Tartar Control

Anti Cavity

Against gum disease

Description

Silicon Dioxide, Tetrasodium Pyrophosphate, Pyridoxine Hydrochloride, Sodium Fluoride

Section 51945-4

Warning

Do not use for children under 6 years of age.

Directions

Adults and children 6 years of age and older; Gently chew 1 tablet until it crushed. Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor.

Active Ingredient

Silicon Dioxide, Tetrasodium Pyrophosphate, Pyridoxine Hydrochloride, Sodium Fluoride

Inactive Ingredient

D-Sorbitol, Sodium Cocoyl Glutamate, Sodium Cocoyl Isethionate, Microcrystalline Cellulose, Xylitol, Magnesium Stearate, Sodium Bicarbonate, Xanthan Gum, Hydroxypropylcellulose, Enzymatically Modified Stevia, L-Menthol, Bamboo Salt, Sodium Chloride, DL-Malic Acid, Combined Flavor(Coolmint Flavor Powder), Combined Flavor(Lemon Flavor Powder), Coconut Oil, Aloe Vera Gel, Carrot Extract, Calendula Extract

Indication & Usage Section

Prevention of cavities, plaque, gum disease, gingivitis and periodontal disease.

Keep Out of Reach of Children

Keep out of reach of children.


Structured Label Content

Section 51945-4 (51945-4)

Purpose (PURPOSE)

Anti plaque

Tartar Control

Anti Cavity

Against gum disease

Warning (WARNING)

Do not use for children under 6 years of age.

Directions

Adults and children 6 years of age and older; Gently chew 1 tablet until it crushed. Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor.

Active Ingredient (ACTIVE INGREDIENT)

Silicon Dioxide, Tetrasodium Pyrophosphate, Pyridoxine Hydrochloride, Sodium Fluoride

Inactive Ingredient (INACTIVE INGREDIENT)

D-Sorbitol, Sodium Cocoyl Glutamate, Sodium Cocoyl Isethionate, Microcrystalline Cellulose, Xylitol, Magnesium Stearate, Sodium Bicarbonate, Xanthan Gum, Hydroxypropylcellulose, Enzymatically Modified Stevia, L-Menthol, Bamboo Salt, Sodium Chloride, DL-Malic Acid, Combined Flavor(Coolmint Flavor Powder), Combined Flavor(Lemon Flavor Powder), Coconut Oil, Aloe Vera Gel, Carrot Extract, Calendula Extract

Indication & Usage Section (INDICATION & USAGE SECTION)

Prevention of cavities, plaque, gum disease, gingivitis and periodontal disease.

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

Keep out of reach of children.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)