Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 5faf03ac-8052-423b-af5f-eb62e7f63561
Route
TOPICAL
Published
Effective Date 2022-05-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.74 g)
Inactive Ingredients
Sorbitol Glycerin Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2022-05-01

Description

Sodium Monofluorophosphate 0.74%

Purpose

Caries prevention


Medication Information

Purpose

Caries prevention

Description

Sodium Monofluorophosphate 0.74%

Uses

■ Keep your mouth clean.

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

■ Increases aesthetic effect.

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

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.

Directions

■ Brushing the teeth with a suitable amount

Active Ingredient

Sodium Monofluorophosphate 0.74%

Other Information

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

Inactive Ingredient

D-Sorbitol Solution, Concentrated Glycerin, Water, Silicon Dioxide, Sodium Lauryl Sulfate, Jasmine Flavor, Xylitol, Sodium Carboxymethylcellulose, Enzymatically Modified Stevia, Jasmine Mint Flavor, Titanium Oxide, Spearmint Oil, Aluminium Chlorohydroxy Allantoinate, Hydroxyapatite, L-Menthol, Propolis Extract10, Matricaria Extract, Green Tea Extract, Aloe Extract, Rosemary Extract, Grapefruit Extract, Taraxacum, officinale Extract, Clove extract, Moutan Root Extract

Keep Out of Reach of Children

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

Package Label.principal Display Panel


Structured Label Content

Uses

■ Keep your mouth clean.

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

■ Increases aesthetic effect.

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

Purpose (PURPOSE)

Caries prevention

Warnings (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.

Directions

■ Brushing the teeth with a suitable amount

Active Ingredient (ACTIVE INGREDIENT)

Sodium Monofluorophosphate 0.74%

Other Information (Other information)

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

Inactive Ingredient (INACTIVE INGREDIENT)

D-Sorbitol Solution, Concentrated Glycerin, Water, Silicon Dioxide, Sodium Lauryl Sulfate, Jasmine Flavor, Xylitol, Sodium Carboxymethylcellulose, Enzymatically Modified Stevia, Jasmine Mint Flavor, Titanium Oxide, Spearmint Oil, Aluminium Chlorohydroxy Allantoinate, Hydroxyapatite, L-Menthol, Propolis Extract10, Matricaria Extract, Green Tea Extract, Aloe Extract, Rosemary Extract, Grapefruit Extract, Taraxacum, officinale Extract, Clove extract, Moutan Root Extract

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

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

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)


Advanced Ingredient Data


Raw Label Data

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