SPL v1
SPL
SPL Set ID df32cd2a-f78c-193c-e053-2995a90af100
Route
DENTAL
Published
Effective Date 2022-04-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.05 g)
Inactive Ingredients
Xylitol Water Sorbitol

Identifiers & Packaging

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

Description

Sodium Fluoride


Medication Information

Warnings and Precautions

1.General Attention

1) Please observe the prescribed usage and capacity.

2) Do not use it for children under the age of six.

3) Use it under the supervision of guardian when using it for children over the age of seven.

4) This product contains fluorine, so if you drink it incorrectly, consult your doctor or pharmacist.

2. Storage Precautions

1) Keep out of reach of children.

2) Avoid direct sunlight and store in a cool place as much as possible.

3) Do not replace it in other containers to prevent misuse and to preserve quality.

Indications and Usage

Put about 10 to 15ml in your mouth, gargle for about 30 seconds, and spit it out.

Dosage and Administration

For dental use only

Description

Sodium Fluoride

Section 50565-1

Keep out of reach of children

Section 51727-6

Sorbitol

Citric Acid

Sodium Citrate

Stevioside

Xylitol

Chitosan

Camellia Sinensis Leaf Extract

Citrus paradisi(Grapefruit) Fruit extract

Propolis Extract

Saponaria Officinalis Extract

Taraxacum Officinale (Dandelion) Extract

Mentol

Fragnance

water

Section 51945-4

Section 55105-1

Tooth-decay prevention, Odor removal from the mouth

Section 55106-9

Sodium Fluoride


Structured Label Content

Indications and Usage (34067-9)

Put about 10 to 15ml in your mouth, gargle for about 30 seconds, and spit it out.

Dosage and Administration (34068-7)

For dental use only

Warnings and Precautions (34071-1)

1.General Attention

1) Please observe the prescribed usage and capacity.

2) Do not use it for children under the age of six.

3) Use it under the supervision of guardian when using it for children over the age of seven.

4) This product contains fluorine, so if you drink it incorrectly, consult your doctor or pharmacist.

2. Storage Precautions

1) Keep out of reach of children.

2) Avoid direct sunlight and store in a cool place as much as possible.

3) Do not replace it in other containers to prevent misuse and to preserve quality.

Section 50565-1 (50565-1)

Keep out of reach of children

Section 51727-6 (51727-6)

Sorbitol

Citric Acid

Sodium Citrate

Stevioside

Xylitol

Chitosan

Camellia Sinensis Leaf Extract

Citrus paradisi(Grapefruit) Fruit extract

Propolis Extract

Saponaria Officinalis Extract

Taraxacum Officinale (Dandelion) Extract

Mentol

Fragnance

water

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Tooth-decay prevention, Odor removal from the mouth

Section 55106-9 (55106-9)

Sodium Fluoride


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)