SPL v1
SPL
SPL Set ID df32e6c1-7bb1-d058-e053-2995a90abf7b
Route
DENTAL
Published
Effective Date 2022-04-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.22 g) Silicon Dioxide (15 g) .alpha.-tocopherol (0.2 g)
Inactive Ingredients
Xylitol Water Levomenthol

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2022-04-06

Description

Silicon Dioxide, Sodium Fluoride, Tocopherol Acetate


Medication Information

Warnings and Precautions

(1) The fluoride content of this toothpaste is 1,000 ppm.(2) Do not swallow and rinse mouth thoroughly after use(3) If you experience any problems with your gums or mouth during use,discontinue use and consult your doctor(4) For children under 6 years of age, use small amounts of toothpaste. And use itunder the supervision of a guardian to avoid sucking or swallowing(5) Consult a physician or dentist immediately if a child under 6 years old hasswallowed large quantities(6) Keep out of the reach of children under 6 years of age

Indications and Usage

Brushing the teeth with a suitable amount

Dosage and Administration

For dental use only

Description

Silicon Dioxide, Sodium Fluoride, Tocopherol Acetate

Section 50565-1

Keep out of reach of children

Section 51727-6

Chitosan, Propolis Extract,Xylitol, L-Menthol, Glycyrrhiza Extract, Rosemary Extract, Green Tea Extract, AloeExtract, Sage Extract, Matricaria Extract, Sodium Bicarbonate, Peppermint Oil, SodiumCocoyl Glutamate, D-Sorbitol Solution, Concentrated Glycerin, SodiumCarboxymethylcellulose, Water

Section 51945-4

Section 55105-1

(1) Keep your teeth white and strong.(2) Keep your mouth clean.(3) Refresh the inside of the mouth.(4) Prevent tooth decay and remove bad breath due to fluorine.(5) Increase the esthetic effect.(6) Prevention of gingivitis and periodontitis(alveolar fistula)(7) Prevention of periodontal disease and gum disease(8) Plaque removal(anti-plaque)

Section 55106-9

Silicon Dioxide, Sodium Fluoride, Tocopherol Acetate


Structured Label Content

Indications and Usage (34067-9)

Brushing the teeth with a suitable amount

Dosage and Administration (34068-7)

For dental use only

Warnings and Precautions (34071-1)

(1) The fluoride content of this toothpaste is 1,000 ppm.(2) Do not swallow and rinse mouth thoroughly after use(3) If you experience any problems with your gums or mouth during use,discontinue use and consult your doctor(4) For children under 6 years of age, use small amounts of toothpaste. And use itunder the supervision of a guardian to avoid sucking or swallowing(5) Consult a physician or dentist immediately if a child under 6 years old hasswallowed large quantities(6) Keep out of the reach of children under 6 years of age

Section 50565-1 (50565-1)

Keep out of reach of children

Section 51727-6 (51727-6)

Chitosan, Propolis Extract,Xylitol, L-Menthol, Glycyrrhiza Extract, Rosemary Extract, Green Tea Extract, AloeExtract, Sage Extract, Matricaria Extract, Sodium Bicarbonate, Peppermint Oil, SodiumCocoyl Glutamate, D-Sorbitol Solution, Concentrated Glycerin, SodiumCarboxymethylcellulose, Water

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

(1) Keep your teeth white and strong.(2) Keep your mouth clean.(3) Refresh the inside of the mouth.(4) Prevent tooth decay and remove bad breath due to fluorine.(5) Increase the esthetic effect.(6) Prevention of gingivitis and periodontitis(alveolar fistula)(7) Prevention of periodontal disease and gum disease(8) Plaque removal(anti-plaque)

Section 55106-9 (55106-9)

Silicon Dioxide, Sodium Fluoride, Tocopherol Acetate


Advanced Ingredient Data


Raw Label Data

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