SPL v1
SPL
SPL Set ID 300370c4-8b86-42ed-9944-56bf2b0934fb
Route
ORAL
Published
Effective Date 2024-01-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.76 g)
Inactive Ingredients
Calcium Carbonate Anhydrous Dibasic Calcium Phosphate Alcloxa

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-12-01

Description

Sodium Monofluorophosphate 0.76%

Purpose

Antiplaque


Medication Information

Purpose

Antiplaque

Description

Sodium Monofluorophosphate 0.76%

Uses

■ Premium toothpaste for freshen bad breath and prevent dental plaque

■ It contains tartar-inhibiting ingredient "TSPP (Sodium Pyrophosphate)" to prevent tartar from accumulating (KFDA certified ingredient)

■ It contains natural surfactant derived from coconut, which makes your mouth less dry and keeps your mouth moist

■ 14 Hazardous Ingredients-Free (paraben, synthetic preservative, microbeads, synthetic surfactant, mineral oil, triclosan, human harmful scent, PEG/PG, saccharin, polypropylene, MIT/CMIT, polyethylene, artificial pigment)

■ Vegan toothpaste officially certified by the Korea Institute of Vegan Certification

■ Keep your teeth white and strong

■ Keep the mouth clean

■ Refresh the mouth

■ Fluorine prevents tooth decay and removes bad breath

■ increase the aesthetic effect

■ Prevention of gingivitis (diastolic fistula), prevention of periodontal disease, prevention of gum disease, prevention of tartar deposition, and removal of plaque (anti-plaque)

Warnings

■ The fluoride content of this toothpaste is 1000 PPM

■ Be careful not to swallow, and rinse the mouth thoroughly after use

■ If the use of this toothpaste causes abnormalities, such as damage to the gums or mouth, stop using it and consult with a doctor or dentist

■ When used by a child under the age of 6, a small amount of toothpaste the size of a pea at a time shall be used under the guidance of the guardian to prevent sucking or swallowing

■ If a child under the age of 6 swallows a large amount, consult a doctor or dentist immediately

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

Questions

■ www.toosty.kr

Directions

■ Use adequate amount of toothpaste on a toothbrush to brush your teeth and rinse off with water.

Other Information

■ Store in room temperature (1-30℃ or 33.8-86℉)

Active Ingredients

Sodium Monofluorophosphate 0.76%

Inactive Ingredients

Precipitated Calcium Carbonate, Dicalcium Phosphate Digydrated, Aluminium Chlorohydroxy Allantoinate, Sodium Pyrophosphate, Sodium Monofluorophosphate, D-Sorbitol Solution, Concentrated Glycerin, Sodium Carboxymethylcellulose, Silicon Dioxide, Xylitol, Stevioside, Lufa Extract, L-Menthol, Menthol Pulegium Oil, Peppermint Oil, Jasmine Mint Flavor, Sodium Cocoyl Glutamate, Sodium Lauroyl Sarcosinate, Water

Keep Out of Reach of Children

Keep out of reach of children under the age of 6

Package Label.principal Display Panel


Structured Label Content

Uses

■ Premium toothpaste for freshen bad breath and prevent dental plaque

■ It contains tartar-inhibiting ingredient "TSPP (Sodium Pyrophosphate)" to prevent tartar from accumulating (KFDA certified ingredient)

■ It contains natural surfactant derived from coconut, which makes your mouth less dry and keeps your mouth moist

■ 14 Hazardous Ingredients-Free (paraben, synthetic preservative, microbeads, synthetic surfactant, mineral oil, triclosan, human harmful scent, PEG/PG, saccharin, polypropylene, MIT/CMIT, polyethylene, artificial pigment)

■ Vegan toothpaste officially certified by the Korea Institute of Vegan Certification

■ Keep your teeth white and strong

■ Keep the mouth clean

■ Refresh the mouth

■ Fluorine prevents tooth decay and removes bad breath

■ increase the aesthetic effect

■ Prevention of gingivitis (diastolic fistula), prevention of periodontal disease, prevention of gum disease, prevention of tartar deposition, and removal of plaque (anti-plaque)

Purpose (PURPOSE)

Antiplaque

Warnings (WARNINGS)

■ The fluoride content of this toothpaste is 1000 PPM

■ Be careful not to swallow, and rinse the mouth thoroughly after use

■ If the use of this toothpaste causes abnormalities, such as damage to the gums or mouth, stop using it and consult with a doctor or dentist

■ When used by a child under the age of 6, a small amount of toothpaste the size of a pea at a time shall be used under the guidance of the guardian to prevent sucking or swallowing

■ If a child under the age of 6 swallows a large amount, consult a doctor or dentist immediately

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

Questions

■ www.toosty.kr

Directions

■ Use adequate amount of toothpaste on a toothbrush to brush your teeth and rinse off with water.

Other Information

■ Store in room temperature (1-30℃ or 33.8-86℉)

Active Ingredients (ACTIVE INGREDIENTS)

Sodium Monofluorophosphate 0.76%

Inactive Ingredients (INACTIVE INGREDIENTS)

Precipitated Calcium Carbonate, Dicalcium Phosphate Digydrated, Aluminium Chlorohydroxy Allantoinate, Sodium Pyrophosphate, Sodium Monofluorophosphate, D-Sorbitol Solution, Concentrated Glycerin, Sodium Carboxymethylcellulose, Silicon Dioxide, Xylitol, Stevioside, Lufa Extract, L-Menthol, Menthol Pulegium Oil, Peppermint Oil, Jasmine Mint Flavor, Sodium Cocoyl Glutamate, Sodium Lauroyl Sarcosinate, Water

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

Keep out of reach of children under the age of 6

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


Advanced Ingredient Data


Raw Label Data

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