SPL v1
SPL
SPL Set ID cf7c2791-c3b4-2163-e053-2995a90a4e8e
Route
ORAL
Published
Effective Date 2021-09-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.00154 g) Silicon Dioxide (0.035 g) Pyrophosphoric Acid (0.007 g) Pyridoxine (0.00035 g)
Inactive Ingredients
Sodium Bicarbonate Sorbitol

Identifiers & Packaging

Pill Appearance
Shape: round Color: white Size: 12 mm
Marketing Status
UNAPPROVED DRUG OTHER Active Since 2021-10-29
Description

Silicon Dioxide, Tetrasodium Pyrophosphate, Pyridoxine Hydrochloride, Sodium Fluoride

Purpose

■ Keeps teeth white and strong ■ Keep the oral cavity clean ■ Prevents tooth decay and bad breath caused by fluoride ■ Removing plaque, preventing gingivitis and periodontitis ■ Periodontal Disease Prevention ■ Gum Disease Prevention

Medication Information

Purpose

■ Keeps teeth white and strong

■ Keep the oral cavity clean

■ Prevents tooth decay and bad breath caused by fluoride

■ Removing plaque, preventing gingivitis and periodontitis

■ Periodontal Disease Prevention

■ Gum Disease Prevention

Description

Silicon Dioxide, Tetrasodium Pyrophosphate, Pyridoxine Hydrochloride, Sodium Fluoride

Uses

for oral use only

Section 51945-4

Warning

For oral use only

When using this product

■ Do not use other than brushing teeth and be careful not to swallow

Keep out of reach of children

■ if swallowed, seek medical help or contact the poison control center immediately

Active Ingredient

Silicon Dioxide, Tetrasodium Pyrophosphate, Pyridoxine Hydrochloride, Sodium Fluoride

Inactive Ingredient

D-Sorbitol,Microcrystalline Cellulose, Xylitol, Enzymatically Modified Stevia, Bamboo Salt, L-Menthol, CombinedFlavor(Coolmint Flavor Powder), Combined Flavor(Lemon Flavor Powder), Combined Flavor(SperamintFlavor Powder), Yuzu Extract, Chamomile Powder, Sodium Bicarbonate, Xanthan Gum,Hydroxypropylcellulose, Magnesium Stearate, Sodium Cocoyl Glutamate

Indication & Usage Section

adults and children above the age of 6: chew tablet briefly before brushing teeth thoroughly at least twice a day, after each meal or as recommended by your doctor or dentist

do not swallow the tablet

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)

■ Keeps teeth white and strong

■ Keep the oral cavity clean

■ Prevents tooth decay and bad breath caused by fluoride

■ Removing plaque, preventing gingivitis and periodontitis

■ Periodontal Disease Prevention

■ Gum Disease Prevention

Warning (WARNING)

For oral use only

When using this product

■ Do not use other than brushing teeth and be careful not to swallow

Keep out of reach of children

■ if swallowed, seek medical help or contact the poison control center immediately

Active Ingredient (ACTIVE INGREDIENT)

Silicon Dioxide, Tetrasodium Pyrophosphate, Pyridoxine Hydrochloride, Sodium Fluoride

Inactive Ingredient (INACTIVE INGREDIENT)

D-Sorbitol,Microcrystalline Cellulose, Xylitol, Enzymatically Modified Stevia, Bamboo Salt, L-Menthol, CombinedFlavor(Coolmint Flavor Powder), Combined Flavor(Lemon Flavor Powder), Combined Flavor(SperamintFlavor Powder), Yuzu Extract, Chamomile Powder, Sodium Bicarbonate, Xanthan Gum,Hydroxypropylcellulose, Magnesium Stearate, Sodium Cocoyl Glutamate

Indication & Usage Section (INDICATION & USAGE SECTION)

adults and children above the age of 6: chew tablet briefly before brushing teeth thoroughly at least twice a day, after each meal or as recommended by your doctor or dentist

do not swallow the tablet

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)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:59:49.411601 · Updated: 2026-03-14T22:59:56.071430