SPL v1
SPL
SPL Set ID cf7bbc45-282c-7b02-e053-2995a90a2376
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)
Inactive Ingredients
Sodium Chloride Sorbitol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2021-10-29
Description

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

Sodium Fluoride

Uses

for oral use only

Section 51945-4

Warning

For oral use only

When using this product

■ This toothpaste has a 1,000 ppm fluoride content

■ 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

Sodium Fluoride

Inactive Ingredient

Precipitated Calcium Carbonate

Xanthangum

Sodium Chloride

Steviol Glycoside

Xylitol

D-Sorbitol Solution

Concentrated Glycerin

Sodium Cocoyl Glutamate

Sodium Cocoyl Isethionate

Bioactive Herb Complex-C

L-Menthol

Menthol Pulegium Oil

Peppermint Oil

Spearmint Oil

Sage Extract

Aloe Extract

Green Tea Extract

Water

Indication & Usage Section

Brush thoroughly ofter each meal or at least twice a day, as directed by yourdoctorordendst

Do not swallow.

Do not use if seal is broken or missing.

store in a cool, dry place.

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

■ This toothpaste has a 1,000 ppm fluoride content

■ 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)

Sodium Fluoride

Inactive Ingredient (INACTIVE INGREDIENT)

Precipitated Calcium Carbonate

Xanthangum

Sodium Chloride

Steviol Glycoside

Xylitol

D-Sorbitol Solution

Concentrated Glycerin

Sodium Cocoyl Glutamate

Sodium Cocoyl Isethionate

Bioactive Herb Complex-C

L-Menthol

Menthol Pulegium Oil

Peppermint Oil

Spearmint Oil

Sage Extract

Aloe Extract

Green Tea Extract

Water

Indication & Usage Section (INDICATION & USAGE SECTION)

Brush thoroughly ofter each meal or at least twice a day, as directed by yourdoctorordendst

Do not swallow.

Do not use if seal is broken or missing.

store in a cool, dry place.

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: 2026-02-15T11:59:47.066564 · Updated: 2026-03-14T22:59:54.471917