SPL v1
SPL
SPL Set ID e6de7e8a-08c8-962f-e053-2995a90aee46
Route
ORAL
Published
Effective Date 2021-09-17
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
Xylitol Sorbitol

Identifiers & Packaging

Pill Appearance
Imprint: None Shape: round Color: white Size: 11 mm Score: 1
Marketing Status
UNAPPROVED DRUG OTHER Active Since 2022-08-01

Description

Silicon Dioxide, Tetrasodium Pyrophosphate, Pyridoxine Hydrochloride, Sodium Fluoride

Purpose

Helps protect against cavities and freshen breath.


Medication Information

Purpose

Helps protect against cavities and freshen breath.

Description

Silicon Dioxide, Tetrasodium Pyrophosphate, Pyridoxine Hydrochloride, Sodium Fluoride

Uses

for oral use only

Section 51945-4

Warning

Keep out of reach of children Under 6 years of age.

If more than used for brushing is accidentally swallowed, get

medical help or contact a Poison Control Center immediately.

This toothpaste contains 1000ppm of fluorine.

If children under 6 years of age swallowed an over dose, get

medical help or contact a Poison Control Center immediately.

Active Ingredient

Silicon Dioxide, Tetrasodium Pyrophosphate, Pyridoxine Hydrochloride, Sodium Fluoride

Inactive Ingredient

D-Sorbitol, Microcrystalline Cellulose, Sodium Chloride, Xylitol, Enzymatically Modified Stevia, Sodium Cocoyl Glutamate, GreenTea Flavor Powder, Combined Flavor(Coolmint Flavor Powder), Combined Flavor(Peppermint Flavor Powder), L-Menthol, Lemon Juice, Aloe Extract Powder, Tea Extract, Hydroxyapatite, Xanthan Gum, Hydroxypropylcellulose, Sodium Bicarbonate, Magnesium Stearate

Indication & Usage Section

Adults and children 6 years of age and older

Literally chew a tablet then brush teeeth thoroughly,

preferably after each meal or at least twice a day, every day,

or as directed by a dentist or physician.

DO NOT swallow a tablet.

Children under 6 years of age: Consult a dentist or doctor.

Keep Out of Reach of Children

Keep out of reach of children.


Structured Label Content

Uses (USES)

for oral use only

Section 51945-4 (51945-4)

Purpose (PURPOSE)

Helps protect against cavities and freshen breath.

Warning (WARNING)

Keep out of reach of children Under 6 years of age.

If more than used for brushing is accidentally swallowed, get

medical help or contact a Poison Control Center immediately.

This toothpaste contains 1000ppm of fluorine.

If children under 6 years of age swallowed an over dose, get

medical help or contact a Poison Control Center immediately.

Active Ingredient (ACTIVE INGREDIENT)

Silicon Dioxide, Tetrasodium Pyrophosphate, Pyridoxine Hydrochloride, Sodium Fluoride

Inactive Ingredient (INACTIVE INGREDIENT)

D-Sorbitol, Microcrystalline Cellulose, Sodium Chloride, Xylitol, Enzymatically Modified Stevia, Sodium Cocoyl Glutamate, GreenTea Flavor Powder, Combined Flavor(Coolmint Flavor Powder), Combined Flavor(Peppermint Flavor Powder), L-Menthol, Lemon Juice, Aloe Extract Powder, Tea Extract, Hydroxyapatite, Xanthan Gum, Hydroxypropylcellulose, Sodium Bicarbonate, Magnesium Stearate

Indication & Usage Section (INDICATION & USAGE SECTION)

Adults and children 6 years of age and older

Literally chew a tablet then brush teeeth thoroughly,

preferably after each meal or at least twice a day, every day,

or as directed by a dentist or physician.

DO NOT swallow a tablet.

Children under 6 years of age: Consult a dentist or doctor.

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)