SPL v1
SPL
SPL Set ID 3fae966e-0246-b9f2-e063-6394a90a494c
Route
ORAL
Published
Effective Date 2025-09-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.74 g)
Inactive Ingredients
Sorbitol Silicon Dioxide Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-09-01

Description

Active ingredient(s) Sodium Monofluorophosphate 0.74%


Medication Information

Warnings and Precautions

Warnings

■ Contains 977ppm of fluoride.

■ Do not swallow and rinse mouth thoroughly after use

■ If you experience any problems with your gums or mouth during use, discontinue use and consult your doctor.

■ For children under 6 years of age, use small amounts of toothpaste. And use it under the supervision of a guardian to avoid sucking or swallowing.

■ Consult a physician or dentist immediately if a child under 6 years old has swallowed large quantities.

■ Keep out of the reach of children under 6 years of age.

Indications and Usage

Uses

■ Keep your teeth white and strong.

■ Keep your mouth clean.

■ Refresh the inside of the mouth.

■ Prevents tooth decay caused by fluoride and removes bad breath.

■ Increases aesthetic effect.

■ Prevention of plaque deposition, removal of plaque (anti-prag)

Dosage and Administration

Directions

■ Brushing the teeth with a suitable amount

Description

Active ingredient(s) Sodium Monofluorophosphate 0.74%

Section 50565-1

■ Keep out of the reach of children under 6 years of age.

Section 51727-6

Inactive ingredients

Sorbitol, Water, Silica, Glycerin, Sodium Cocoyl Glutamate, Cellulose Gum, Menthol, Mint Flavor, Carbon, Mentha Piperita (Peppermint) Oil, Xylitol, Mentha Viridis (Spearmint) Leaf Oil, Stevioside, Glycyrrhiza Glabra (Licorice) Root Extract, Taraxacum Officinale (Dandelion) Rhizome, Salvia Officinalis (Sage) Leaf Extract

Section 51945-4

Section 55105-1

Purpose

Caries prevention

Section 55106-9

Active ingredient(s)

Sodium Monofluorophosphate 0.74%

Section 60561-8

Other Information

■ Airtight container, Store in normal temperature (1~30℃)


Structured Label Content

Indications and Usage (34067-9)

Uses

■ Keep your teeth white and strong.

■ Keep your mouth clean.

■ Refresh the inside of the mouth.

■ Prevents tooth decay caused by fluoride and removes bad breath.

■ Increases aesthetic effect.

■ Prevention of plaque deposition, removal of plaque (anti-prag)

Dosage and Administration (34068-7)

Directions

■ Brushing the teeth with a suitable amount

Warnings and Precautions (34071-1)

Warnings

■ Contains 977ppm of fluoride.

■ Do not swallow and rinse mouth thoroughly after use

■ If you experience any problems with your gums or mouth during use, discontinue use and consult your doctor.

■ For children under 6 years of age, use small amounts of toothpaste. And use it under the supervision of a guardian to avoid sucking or swallowing.

■ Consult a physician or dentist immediately if a child under 6 years old has swallowed large quantities.

■ Keep out of the reach of children under 6 years of age.

Section 50565-1 (50565-1)

■ Keep out of the reach of children under 6 years of age.

Section 51727-6 (51727-6)

Inactive ingredients

Sorbitol, Water, Silica, Glycerin, Sodium Cocoyl Glutamate, Cellulose Gum, Menthol, Mint Flavor, Carbon, Mentha Piperita (Peppermint) Oil, Xylitol, Mentha Viridis (Spearmint) Leaf Oil, Stevioside, Glycyrrhiza Glabra (Licorice) Root Extract, Taraxacum Officinale (Dandelion) Rhizome, Salvia Officinalis (Sage) Leaf Extract

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose

Caries prevention

Section 55106-9 (55106-9)

Active ingredient(s)

Sodium Monofluorophosphate 0.74%

Section 60561-8 (60561-8)

Other Information

■ Airtight container, Store in normal temperature (1~30℃)


Advanced Ingredient Data


Raw Label Data

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