SPL v1
SPL
SPL Set ID 953e23ce-1c2f-103c-e053-2995a90a3947
Route
ORAL
Published
Effective Date 2019-10-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.22 1)
Inactive Ingredients
Sodium Bicarbonate Sorbitol

Identifiers & Packaging

Pill Appearance
Shape: round Color: white Size: 12 mm
Marketing Status
OTC MONOGRAPH FINAL Active Since 2019-10-19
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 ■ Prevention of tartar deposition

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

■ Prevention of tartar deposition

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, get medical help or contact a person control center immediately

Active Ingredient

sodium fluoride

Inactive Ingredient

silica, sodium pyrophosphate, pyridoxine hydrochloride, D-sorbitol, microcrystalline cellulose, xylitol, sodium bicarbonate, tea extract, tocopherol acetate, etc

Indication & Usage Section

■ Within 3 times a day, chew 1 or 2 tablets sufficiently and then brush your teeth by brushing or brush your teeth by brushing them

■ scrub softly as like doing massage

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

■ Prevention of tartar deposition

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, get medical help or contact a person control center immediately

Active Ingredient (ACTIVE INGREDIENT)

sodium fluoride

Inactive Ingredient (INACTIVE INGREDIENT)

silica, sodium pyrophosphate, pyridoxine hydrochloride, D-sorbitol, microcrystalline cellulose, xylitol, sodium bicarbonate, tea extract, tocopherol acetate, etc

Indication & Usage Section (INDICATION & USAGE SECTION)

■ Within 3 times a day, chew 1 or 2 tablets sufficiently and then brush your teeth by brushing or brush your teeth by brushing them

■ scrub softly as like doing massage

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

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Source: dailymed · Ingested: 2026-02-15T11:56:53.974634 · Updated: 2026-03-14T22:55:41.063239