82168-003

82168-003
SPL v2
SPL
SPL Set ID 28406739-6a8c-1ce8-e063-6394a90a08f8
Route
DENTAL
Published
Effective Date 2024-12-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.76 g)
Inactive Ingredients
Calcium Carbonate Aqua Glycerin Sorbitol Silica Sodium Lauryl Sulfate Sodium Saccharin Sodium Silicate Cellulose Gum Hydroxyethylcellulose

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-06-29

Description

Sodium monofluorophosphate 0.76%

Purpose

Anticavity toothpaste


Medication Information

Purpose

Anticavity toothpaste



Description

Sodium monofluorophosphate 0.76%

Use

Use helps protect against cavities



Section 50565-1

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



Section 50566-9

If in contact with the eyes, rinse thoroughly with water.

Section 50567-7

Please keep away from your eyes when using this product

Warnings

Keep out of reach of children under 6years of age. If more than used for brushing is

acidenaly sallowed, get medicalhelp or contact aPoisonControl Center right away.



Directions

Adults and children 2 years of age & 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 of age: Instruct in good brushing and rinsing habits (to minimize swallowing). Supervise children as

necessary until capable of using without supervision.

Children under 2 years of age: Consult a dentist or doctor.



Do Not Use

Do not use on open skin wounds

Other Information

●Store in a cool place, below 86°F, away from heat

●Do not use if quality seal is broken or missing



Active Ingredient(s)

Sodium monofluorophosphate 0.76%

Inactive Ingredients

Calcium carbonate, water, sorbitol, glycerin, hydrated silica, sodium lauryl sulfate, flavor, sodium saccharin, sodium silicate, trisodium

phosphate, cellulose gum, hydroxyethylcellulose, rosa canina (rose hip) fruit oil



Package Label Principal Display Panel


Structured Label Content

Use

Use helps protect against cavities



Section 50565-1 (50565-1)

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



Section 50566-9 (50566-9)

If in contact with the eyes, rinse thoroughly with water.

Section 50567-7 (50567-7)

Please keep away from your eyes when using this product

Purpose

Anticavity toothpaste



Warnings

Keep out of reach of children under 6years of age. If more than used for brushing is

acidenaly sallowed, get medicalhelp or contact aPoisonControl Center right away.



Directions

Adults and children 2 years of age & 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 of age: Instruct in good brushing and rinsing habits (to minimize swallowing). Supervise children as

necessary until capable of using without supervision.

Children under 2 years of age: Consult a dentist or doctor.



Do Not Use (Do not use)

Do not use on open skin wounds

Other Information (Other information)

●Store in a cool place, below 86°F, away from heat

●Do not use if quality seal is broken or missing



Active Ingredient(s)

Sodium monofluorophosphate 0.76%

Inactive Ingredients (Inactive ingredients)

Calcium carbonate, water, sorbitol, glycerin, hydrated silica, sodium lauryl sulfate, flavor, sodium saccharin, sodium silicate, trisodium

phosphate, cellulose gum, hydroxyethylcellulose, rosa canina (rose hip) fruit oil



Package Label Principal Display Panel (Package Label - Principal Display Panel)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)