SPL v1
SPL
SPL Set ID 3fb01bea-7205-49ba-e063-6294a90a3841
Route
ORAL
Published
Effective Date 2025-09-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.76 g)
Inactive Ingredients
Glycerin Sorbitol Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-07-01

Description

Active ingredient(s) Sodium Monofluorophosphate 0.76%


Medication Information

Warnings and Precautions

Warnings

■ Fluorine content of this toothpaste is 1000 ppm

■ 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

Use(s)

■ Keep your teeth white and strong

■ Keep your mouth clean

■ Refresh the inside of the mouth

■ Prevent cavities and remove bad breath caused by fluorine.

■ Increases aesthetic effect

■ Prevention of gingivitis and periodontal inflammation (alveolar abscess)

■ Prevention of periodontal disease

■ Prevention of gum disease

■ 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 0.76%

Section 50565-1

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

Section 51727-6

Inactive ingredients

Sorbitol, Hydrated Silica, Water, Glycerin, Xylitol, Cellulose Gum, Sodium Lauroyl Sarcosinate, Sodium Cocoyl Glutamate, Tetrasodium Pyrophosphate, Rubas Idaeus Fruit Extract, Menthol, Mentha Pulegium Oil, Stevioside, Tocopheryl Acetate, Mentha Piperita Oil, Citrus Limon (Lemon) Fruit Oil, Sodium Bicarbonate, Centella Asiatica Extract, Curcuma Longa Root Extract, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Eugenia Caryophyllus (Clove) Flower Oil, Clove Mint Flaovr, Cooling Flavor, Aloe Barbadensis Leaf Extract, Rosmarinus Officinalis Leaf Extract, Gardenia Yellow Color, Gardenia Blue Color

Section 51945-4

Section 55105-1

Purpose

Anti-cavity

Section 55106-9

Active ingredient(s)

Sodium Monofluorophosphate 0.76%

Section 60561-8

Other Information

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


Structured Label Content

Indications and Usage (34067-9)

Use(s)

■ Keep your teeth white and strong

■ Keep your mouth clean

■ Refresh the inside of the mouth

■ Prevent cavities and remove bad breath caused by fluorine.

■ Increases aesthetic effect

■ Prevention of gingivitis and periodontal inflammation (alveolar abscess)

■ Prevention of periodontal disease

■ Prevention of gum disease

■ 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

■ Fluorine content of this toothpaste is 1000 ppm

■ 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, Hydrated Silica, Water, Glycerin, Xylitol, Cellulose Gum, Sodium Lauroyl Sarcosinate, Sodium Cocoyl Glutamate, Tetrasodium Pyrophosphate, Rubas Idaeus Fruit Extract, Menthol, Mentha Pulegium Oil, Stevioside, Tocopheryl Acetate, Mentha Piperita Oil, Citrus Limon (Lemon) Fruit Oil, Sodium Bicarbonate, Centella Asiatica Extract, Curcuma Longa Root Extract, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Eugenia Caryophyllus (Clove) Flower Oil, Clove Mint Flaovr, Cooling Flavor, Aloe Barbadensis Leaf Extract, Rosmarinus Officinalis Leaf Extract, Gardenia Yellow Color, Gardenia Blue Color

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose

Anti-cavity

Section 55106-9 (55106-9)

Active ingredient(s)

Sodium Monofluorophosphate 0.76%

Section 60561-8 (60561-8)

Other Information

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


Advanced Ingredient Data


Raw Label Data

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