SPL v5
SPL
SPL Set ID aaf08481-a2ff-48f6-8611-73a469efe1db
Route
DENTAL
Published
Effective Date 2025-01-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.22 g)
Inactive Ingredients
Silicon Dioxide Propolis Wax

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-10-01

Description

Sodium fluoride 0.22% (Total Fluoride Content 1,000 ppm Approx.)

Purpose

Anticavity Toothpaste


Medication Information

Purpose

Anticavity Toothpaste

Description

Sodium fluoride 0.22% (Total Fluoride Content 1,000 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

Sodium fluoride 0.22%

(Total Fluoride Content 1,000 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

Sodium Tocopheryl Acetate, Silicon Dioxide, Chitosan, Propolis Extract, D-sorbitol Solution, Sodium Carboxymethyl Cellulose, Licorice Extract, Ascorbic Acid, Camellia Sinensis Extract, Curcumin Extract, Xylitol, Enzymatically Modified Stevia, Sodium Cocoylglutamate, Sodium Bicarbonate, L-menthol, Peppermint Oil, 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)

Sodium fluoride 0.22%

(Total Fluoride Content 1,000 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)

Sodium Tocopheryl Acetate, Silicon Dioxide, Chitosan, Propolis Extract, D-sorbitol Solution, Sodium Carboxymethyl Cellulose, Licorice Extract, Ascorbic Acid, Camellia Sinensis Extract, Curcumin Extract, Xylitol, Enzymatically Modified Stevia, Sodium Cocoylglutamate, Sodium Bicarbonate, L-menthol, Peppermint Oil, 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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