SPL v1
SPL
SPL Set ID 229a9f92-7587-4912-87b7-a36266e9e78e
Route
ORAL
Published
Effective Date 2021-09-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.74 g)
Inactive Ingredients
Water Glycerin Sorbitol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2021-09-01

Description

Sodium Monofluorophosphate 0.74%

Purpose

Anti carries


Medication Information

Purpose

Anti carries

Description

Sodium Monofluorophosphate 0.74%

Uses

■ Keeps breath fresh with a light fragrance

■ Helps protect against cavities

■ Helps to strengthen the teeth

■ Removal of plaque

Warnings

■ Contains 977ppm of fluoride.

■ Do not swallow and rinse mouth thoroughly after use

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

■ unpaglobal.com

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 Monofluorophosphate 0.74%

Other Information

■ Do not store this product in an inappropriate place such as high or low temperatures or under direct sun light (1~30℃)

Inactive Ingredients

Glycerin, Sorbitol, Cellulose Gum, Glycyrrhiza Glabra (Licorice) Root Extract, Taraxacum Officinale (Dandelion) Rhizome, Salvia Officinalis (Sage) Leaf Extract, Stevioside, Xylitol, Carbon, Menthol, Mentha Piperita (Peppermint) Oil, Mentha Viridis (Spearmint) Leaf Oil, Mint Flavor, Grapefruitavor, Sodium Cocoyl Glutamate, Water

Keep Out of Reach of Children

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

Package Label.principal Display Panel


Structured Label Content

Uses

■ Keeps breath fresh with a light fragrance

■ Helps protect against cavities

■ Helps to strengthen the teeth

■ Removal of plaque

Purpose (PURPOSE)

Anti carries

Warnings (WARNINGS)

■ Contains 977ppm of fluoride.

■ Do not swallow and rinse mouth thoroughly after use

■ For children under 6 years of age, use small amounts of toothpaste. And use it 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 (QUESTIONS)

■ unpaglobal.com

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 Monofluorophosphate 0.74%

Other Information

■ Do not store this product in an inappropriate place such as high or low temperatures or under direct sun light (1~30℃)

Inactive Ingredients (INACTIVE INGREDIENTS)

Glycerin, Sorbitol, Cellulose Gum, Glycyrrhiza Glabra (Licorice) Root Extract, Taraxacum Officinale (Dandelion) Rhizome, Salvia Officinalis (Sage) Leaf Extract, Stevioside, Xylitol, Carbon, Menthol, Mentha Piperita (Peppermint) Oil, Mentha Viridis (Spearmint) Leaf Oil, Mint Flavor, Grapefruitavor, Sodium Cocoyl Glutamate, 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.

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)


Advanced Ingredient Data


Raw Label Data

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