300370c4-8b86-42ed-9944-56bf2b0934fb

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

Purpose

Antiplaque

Description

Sodium Monofluorophosphate 0.76%


Medication Information

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

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

Antiplaque

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℉)

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

Description

Sodium Monofluorophosphate 0.76%

Questions

■ www.toosty.kr

Active Ingredients

Sodium Monofluorophosphate 0.76%

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

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

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

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℉)

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

Questions

■ www.toosty.kr

Active Ingredients (ACTIVE INGREDIENTS)

Sodium Monofluorophosphate 0.76%

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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