SPL v1
SPL
SPL Set ID 3382776a-a10e-1823-e063-6394a90a6f91
Route
DENTAL
Published
Effective Date 2025-04-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.31 g) Silicon Dioxide (18.5 g) Nitrate Ion (5 g)
Inactive Ingredients
Carboxymethylcellulose Sodium, Unspecified Sorbitol

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2025-04-01

Description

Sodium fluoride 0.3152% (Total Fluoride Content 1,426 ppm Approx.) Dental type silica 18.50% Potassium nirate 5.00%

Purpose

Anti plaque, Anticaries, Anticavity, Antihypersensitivity


Medication Information

Purpose

Anti plaque, Anticaries, Anticavity, Antihypersensitivity

Description

Sodium fluoride 0.3152% (Total Fluoride Content 1,426 ppm Approx.) Dental type silica 18.50% Potassium nirate 5.00%

Uses

■ Builds increasing protection against painful sensitivity

■ Aids in the prevention of dental cavities.

Section 51945-4

Warnings

■ When using this product, if irritation occurs discontinue use, Stop use and ask a dentist if

■ For children under 6 years of age, use small amounts of toothpaste.

under the supervision of a guardian to avoid sucking or swallowing.

■ Consult a physician or dentist immediately if a child under 6 years old has swallowed large quantities.

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

Questions

https://docsmedi.kr

Tel: 82-031-922-2240, Fax: 82-43-883-2844

Directions

■ Adults and children 12 years of age and older:

• Apply at least 1-inch strip of the product onto a soft bristle toothbrush

• Brush teeth thoroughly for at least 1 minute twice a day (morning and evening), and not more than 3 times a day, or as recommended by a dentist or doctor. Make sure to brush all sensitive areas of the teeth. Minimize swallowing. Spit out after brushing.

■ Children under 12 years of age: Consult a dentist or doctor.

Active Ingredient

Sodium fluoride 0.3152%

(Total Fluoride Content 1,426 ppm Approx.)

Dental type silica 18.50%

Potassium nirate 5.00%

Other Information

■ Do not store this product in an inappropriate place such as high or low temperatures or under direct sun light

Inactive Ingredients

Sodium carboxymethyl cellulose, D-sorbitol solution, Concentrated glycerin, Xylitol, Enzymatically modified stevia, Hydroxyapatite, Taraxacum officinale extract, Turmeric root extract, Green tea extract, Calendula extract, Eucalyptus extract, Salvia officinalis (sage) extract, Aloe extract(09), L-menthol, Herb mint flavor, Cooling flavor, Menthol pulegium oil, Sodium lauroyl sarcosinate, Sodium cocoyl glutamate, Purified water

Keep Out of Reach of Children

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


Structured Label Content

Uses

■ Builds increasing protection against painful sensitivity

■ Aids in the prevention of dental cavities.

Section 51945-4 (51945-4)

Purpose (PURPOSE)

Anti plaque, Anticaries, Anticavity, Antihypersensitivity

Warnings (WARNINGS)

■ When using this product, if irritation occurs discontinue use, Stop use and ask a dentist if

■ For children under 6 years of age, use small amounts of toothpaste.

under the supervision of a guardian to avoid sucking or swallowing.

■ Consult a physician or dentist immediately if a child under 6 years old has swallowed large quantities.

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

Questions

https://docsmedi.kr

Tel: 82-031-922-2240, Fax: 82-43-883-2844

Directions

■ Adults and children 12 years of age and older:

• Apply at least 1-inch strip of the product onto a soft bristle toothbrush

• Brush teeth thoroughly for at least 1 minute twice a day (morning and evening), and not more than 3 times a day, or as recommended by a dentist or doctor. Make sure to brush all sensitive areas of the teeth. Minimize swallowing. Spit out after brushing.

■ Children under 12 years of age: Consult a dentist or doctor.

Active Ingredient (ACTIVE INGREDIENT)

Sodium fluoride 0.3152%

(Total Fluoride Content 1,426 ppm Approx.)

Dental type silica 18.50%

Potassium nirate 5.00%

Other Information

■ Do not store this product in an inappropriate place such as high or low temperatures or under direct sun light

Inactive Ingredients (INACTIVE INGREDIENTS)

Sodium carboxymethyl cellulose, D-sorbitol solution, Concentrated glycerin, Xylitol, Enzymatically modified stevia, Hydroxyapatite, Taraxacum officinale extract, Turmeric root extract, Green tea extract, Calendula extract, Eucalyptus extract, Salvia officinalis (sage) extract, Aloe extract(09), L-menthol, Herb mint flavor, Cooling flavor, Menthol pulegium oil, Sodium lauroyl sarcosinate, Sodium cocoyl glutamate, Purified water

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

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


Advanced Ingredient Data


Raw Label Data

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