SPL v3
SPL
SPL Set ID a02f8865-e7be-4ef4-b09c-dad846639764
Route
DENTAL
Published
Effective Date 2025-01-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Silicon Dioxide (16 g) Fluoride Ion (0.74 g)
Inactive Ingredients
Carboxymethylcellulose Sorbitol

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2022-12-01

Description

Silicon dioxide 16.0% Sodium monofluorophosphate 0.740% (Total Fluoride Content 977 ppm Approx.)

Purpose

Anticavity Toothpaste


Medication Information

Purpose

Anticavity Toothpaste

Description

Silicon dioxide 16.0% Sodium monofluorophosphate 0.740% (Total Fluoride Content 977 ppm Approx.)

Uses

■ Helps protect against cavities

Section 51945-4

Warnings

■ Do not swallow. Rinse mouth thoroughly after use.

■ For children under 6 years of age, use only a pea-sized amount of toothpaste under the supervision of a guardian to avoid sucking or swallowing.

■ If a child under 6 years of age swallows a large amount of toothpaste, consult a physician or dentist immediately.

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

Questions

■ https://docsmedi.kr

■ Tel: 82-031-922-2240, Fax: 82-031-365-4596

Directions

■ Adults and children 2 years of age and older: Brush teeth thoroughly preferably after each meal or at least twice a day or as directed by a dentist or doctor.

■ Children under 6 years: To minimize swallowing, use a pea-sized amount and supervise brushing until good habits are established.

■ Children under 2 years: Consult a dentist or doctor.

Active Ingredient

Silicon dioxide 16.0%

Sodium monofluorophosphate 0.740%

(Total Fluoride Content 977 ppm Approx.)

Other Information

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

Inactive Ingredients

Carboxymethyl cellulose, D-sorbitol solution, Sodium Hydrogencarbonate, Enzymatically modified stevia, Xylitol, Hydroxyapatite, Turmeric root extract, Centellaasiatica extract, HouttuyniacordataThunberg extract, Green tea extract, Salvia officinalis(sage) extract, Eucalyptus extract, naturalaromatics(Lime, Green grape) 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

■ Helps protect against cavities

Section 51945-4 (51945-4)

Purpose (PURPOSE)

Anticavity Toothpaste

Warnings (WARNINGS)

■ Do not swallow. Rinse mouth thoroughly after use.

■ For children under 6 years of age, use only a pea-sized amount of toothpaste under the supervision of a guardian to avoid sucking or swallowing.

■ If a child under 6 years of age swallows a large amount of toothpaste, consult a physician or dentist immediately.

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

Questions

■ https://docsmedi.kr

■ Tel: 82-031-922-2240, Fax: 82-031-365-4596

Directions

■ Adults and children 2 years of age and older: Brush teeth thoroughly preferably after each meal or at least twice a day or as directed by a dentist or doctor.

■ Children under 6 years: To minimize swallowing, use a pea-sized amount and supervise brushing until good habits are established.

■ Children under 2 years: Consult a dentist or doctor.

Active Ingredient (ACTIVE INGREDIENT)

Silicon dioxide 16.0%

Sodium monofluorophosphate 0.740%

(Total Fluoride Content 977 ppm Approx.)

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)

Carboxymethyl cellulose, D-sorbitol solution, Sodium Hydrogencarbonate, Enzymatically modified stevia, Xylitol, Hydroxyapatite, Turmeric root extract, Centellaasiatica extract, HouttuyniacordataThunberg extract, Green tea extract, Salvia officinalis(sage) extract, Eucalyptus extract, naturalaromatics(Lime, Green grape) 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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