SPL v1
SPL
SPL Set ID a69aa6ef-be27-a4ad-e053-2a95a90aeefb
Route
DENTAL
Published
Effective Date 2013-04-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.76 g)
Inactive Ingredients
Water Silicon Dioxide Sorbitol Xylitol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2020-05-01

Description

SODIUM MONOFLUOROPHOSPHATE


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

Brush teeth thoroughly for at least one minute, preferably after each meal or at least twice a day (morning and evening) or as recommended by a dentist or physician

Dosage and Administration

For dental use only

Description

SODIUM MONOFLUOROPHOSPHATE

Section 50565-1

Keep out of reach of children

Section 51727-6

D-Sorbitol Solution, WATER, SILICON DIOXIDE, CONCENTRATED GLYCERIN, SODIUM COCOYL GLUTAMATE, POLYETHYLENE GLYCOL 1500, CARBOXYMETHYLCELLULOSE SODIUM, PEPPERMINT OIL, ACTIVE CARBON, L-MENTHOL, CITRUS PARADISI (GRAPEFRUIT) SEED EXTRACT, XYLITOL, SODIUM CHLORIDE, ENZYMATICALLY MODIFIED STEVIA, CHAMOMILLA RECUTITA (MATRICARIA) FLOWER EXTRACT, ALOE EXTRACT, SAGE EXTRACT

Section 51945-4

Section 55105-1

ANTI-CAVITY

Section 55106-9

SODIUM MONOFLUOROPHOSPHATE


Structured Label Content

Indications and Usage (34067-9)

Brush teeth thoroughly for at least one minute, preferably after each meal or at least twice a day (morning and evening) or as recommended by a dentist or physician

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)

D-Sorbitol Solution, WATER, SILICON DIOXIDE, CONCENTRATED GLYCERIN, SODIUM COCOYL GLUTAMATE, POLYETHYLENE GLYCOL 1500, CARBOXYMETHYLCELLULOSE SODIUM, PEPPERMINT OIL, ACTIVE CARBON, L-MENTHOL, CITRUS PARADISI (GRAPEFRUIT) SEED EXTRACT, XYLITOL, SODIUM CHLORIDE, ENZYMATICALLY MODIFIED STEVIA, CHAMOMILLA RECUTITA (MATRICARIA) FLOWER EXTRACT, ALOE EXTRACT, SAGE EXTRACT

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

ANTI-CAVITY

Section 55106-9 (55106-9)

SODIUM MONOFLUOROPHOSPHATE


Advanced Ingredient Data


Raw Label Data

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