SPL v1
SPL
SPL Set ID bfaeca0e-0a11-4c4f-e053-2995a90af810
Route
DENTAL
Published
Effective Date 2021-04-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.22 g)
Inactive Ingredients
Xylitol Water

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2021-04-11

Description

Sodium fluoride


Medication Information

Warnings and Precautions

Storage method

1. Keep it at room temperature in a classified container.

2. Cover and store at room temperature.

3. Store in a not moisture and cool place.

4. Air may come out during use of this product, but there is no problem with its weight.

Usage Precautions

1. Be careful not to swallow. Rinse mouth thoroughly after use

2. If the use of toothpaste causes abnormalities such as gums or mouth injury, discontinue use and consult a doctor or dentist.

3. For children under 6 years of age, use a small amount of toothpaste as small as pea per use, and use under the guidance of a guardian to avoid sucking or swallowing.

4. If a child under 6 years old swallows large amount, consult with a doctor or dentist immediately.

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

Indications and Usage

apply appropriate amount of the tooth paste on the tooth brush and brush the teeth

Dosage and Administration

For dental use only

Description

Sodium fluoride

Section 50565-1

Keep out of reach of children

Section 51727-6

Dental type Silica

Ursodeoxycholic Acid

Potassium Phosphate, Dibasic

Potassium Phosphate, Monobasic

Tocopherol Acetate

Glycerine

Grapefruit Seed Extract

Xylitol

Carboxymethylcellulose Sodium

Xanthan gum

Stevioside

Peppermint oil

sodium chloride

Citric acid

Green tea Extract

D-Sorbitol

dl-menthol

Cocamidopropyl Betaine

Purified Water

Section 51945-4

Section 55105-1

Tooth whitening, tooth deay prevention, bod breath removal. Makes teeth strong. Keeps the mouth c;ean. Refreshes the Inside of the mouth. Increases the aesthetic effect. Prevention of gum disease, removal of plaque (ant-plaque)

Section 55106-9

Sodium fluoride


Structured Label Content

Indications and Usage (34067-9)

apply appropriate amount of the tooth paste on the tooth brush and brush the teeth

Dosage and Administration (34068-7)

For dental use only

Warnings and Precautions (34071-1)

Storage method

1. Keep it at room temperature in a classified container.

2. Cover and store at room temperature.

3. Store in a not moisture and cool place.

4. Air may come out during use of this product, but there is no problem with its weight.

Usage Precautions

1. Be careful not to swallow. Rinse mouth thoroughly after use

2. If the use of toothpaste causes abnormalities such as gums or mouth injury, discontinue use and consult a doctor or dentist.

3. For children under 6 years of age, use a small amount of toothpaste as small as pea per use, and use under the guidance of a guardian to avoid sucking or swallowing.

4. If a child under 6 years old swallows large amount, consult with a doctor or dentist immediately.

5. 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)

Dental type Silica

Ursodeoxycholic Acid

Potassium Phosphate, Dibasic

Potassium Phosphate, Monobasic

Tocopherol Acetate

Glycerine

Grapefruit Seed Extract

Xylitol

Carboxymethylcellulose Sodium

Xanthan gum

Stevioside

Peppermint oil

sodium chloride

Citric acid

Green tea Extract

D-Sorbitol

dl-menthol

Cocamidopropyl Betaine

Purified Water

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Tooth whitening, tooth deay prevention, bod breath removal. Makes teeth strong. Keeps the mouth c;ean. Refreshes the Inside of the mouth. Increases the aesthetic effect. Prevention of gum disease, removal of plaque (ant-plaque)

Section 55106-9 (55106-9)

Sodium fluoride


Advanced Ingredient Data


Raw Label Data

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