SPL v1
SPL
SPL Set ID dbf9d3e4-ac12-424f-e053-2995a90a35e4
Route
DENTAL
Published
Effective Date 2022-04-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (1.10037 g)
Inactive Ingredients
Tartaric Acid Maltitol Sodium Bicarbonate

Identifiers & Packaging

Pill Appearance
Imprint: none Shape: round Color: white Size: 15 mm Score: 1
Marketing Status
UNAPPROVED DRUG OTHER Active Since 2022-04-06

Description

Sodium Fluoride


Medication Information

Warnings and Precautions

1) Observe the specified usage capacity.

2) Store in a cool place with no sunlight and less moisture.

3) Avoid swallowing.

4) This product contains 583 ppm of fluorine.

5) This product contains fluorine, so if you swallow a large amount, consult a doctor or dentist

immediately.

6) When used by children under the age of 6, use under the supervision of their guardians to

avoid swallowing.

7) Keep out of reach of children under the age of 6

Indications and Usage

USAGE : Put 1 tablet in the mouth and use the tongue and lips to rub the gums, teeth, and tongue, gargle it with water, and rinse it several times

Dosage and Administration

For dental use only

Description

Sodium Fluoride

Section 50565-1

Keep out of reach of children

Section 51727-6

Sodium Bicarbonate

Tartaric Acid

Hydroxypropylcellulose

Hydroxypropyl methylcellulose

Silica

Zea Mays (Corn) Starch

Sodium Cocoyl Glutamate

Maltitol

Mannitol

Erythritol

Potassium Acesulfame

Magnessium Stearate

Brilliant Blue

Menthol

Yucca Vera Leaf/Root Extract

fragrance

Section 51945-4

Section 55105-1

Tooth-decay prevention, Odor removal from the mouth and Oral Cleansing

Section 55106-9

Sodium Fluoride


Structured Label Content

Indications and Usage (34067-9)

USAGE : Put 1 tablet in the mouth and use the tongue and lips to rub the gums, teeth, and tongue, gargle it with water, and rinse it several times

Dosage and Administration (34068-7)

For dental use only

Warnings and Precautions (34071-1)

1) Observe the specified usage capacity.

2) Store in a cool place with no sunlight and less moisture.

3) Avoid swallowing.

4) This product contains 583 ppm of fluorine.

5) This product contains fluorine, so if you swallow a large amount, consult a doctor or dentist

immediately.

6) When used by children under the age of 6, use under the supervision of their guardians to

avoid swallowing.

7) Keep out of reach of children under the age of 6

Section 50565-1 (50565-1)

Keep out of reach of children

Section 51727-6 (51727-6)

Sodium Bicarbonate

Tartaric Acid

Hydroxypropylcellulose

Hydroxypropyl methylcellulose

Silica

Zea Mays (Corn) Starch

Sodium Cocoyl Glutamate

Maltitol

Mannitol

Erythritol

Potassium Acesulfame

Magnessium Stearate

Brilliant Blue

Menthol

Yucca Vera Leaf/Root Extract

fragrance

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Tooth-decay prevention, Odor removal from the mouth and Oral Cleansing

Section 55106-9 (55106-9)

Sodium Fluoride


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)