SPL v1
SPL
SPL Set ID cb308074-fe4e-4b71-98e1-b4114e3434b5
Route
ORAL
Published
Effective Date 2021-05-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2021-05-01

Description

Sodium Monofluorophosphate 0.74%

Purpose

Gum Care


Medication Information

Purpose

Gum Care

Description

Sodium Monofluorophosphate 0.74%

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)

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.

Questions

■ unpaglobal.com

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 Ingredients

Silicon Dioxide, Allantoin Chlorohydroxy Aluminum, Sodium Carboxymethyl Cellulose, D-Sorbitol Liquid, Concentrated Glycerin, Licorice Extract, Mastic Oil, Sage Extract, Matricaria Extract, Aloe Extract (09), Enzymatically Modified Stevia, Xylitol, L-menthol, Activated Charcoal, Mint Scent, Spearmint Oil, Anethole, Sodium Bicarbonate, Hydroxyapatite, Titanium Dioxide, Sodium Cocoyl Glutamate, Purified Water

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 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)

Purpose (PURPOSE)

Gum Care

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.

Questions (QUESTIONS)

■ unpaglobal.com

Directions

Brushing the teeth with a suitable amount

Active Ingredient (ACTIVE INGREDIENT)

Sodium Monofluorophosphate 0.74%

Other Information

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

Inactive Ingredients (INACTIVE INGREDIENTS)

Silicon Dioxide, Allantoin Chlorohydroxy Aluminum, Sodium Carboxymethyl Cellulose, D-Sorbitol Liquid, Concentrated Glycerin, Licorice Extract, Mastic Oil, Sage Extract, Matricaria Extract, Aloe Extract (09), Enzymatically Modified Stevia, Xylitol, L-menthol, Activated Charcoal, Mint Scent, Spearmint Oil, Anethole, Sodium Bicarbonate, Hydroxyapatite, Titanium Dioxide, Sodium Cocoyl Glutamate, Purified Water

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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