82168-001

82168-001
SPL v2
SPL
SPL Set ID 2845d7af-7a0b-9bc8-e063-6294a90ac8b3
Route
DENTAL
Published
Effective Date 2024-11-29
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 Copernicia Cerifera (carnauba) Wax Carrageenan Sodium Saccharin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-11-29

Description

Sodium monofluorophosphate 0.76%

Purpose

Anticavity tothpaste


Medication Information

Purpose

Anticavity tothpaste



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 6 years of age. If more than used for brushing is

acidentally sallowed, get medical help or contact a Poison Control Center right away.



Directions

Adults and children 2 years of age & older: Brush teth 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, Aqua (Water), Glycerin, Sorbito, Slica, Aroma (Flavour), Sodium Lauryl Sulphate,

Copernicia Cerifera (Carnauba) Wax, Carboxymethyl Hyoroyetlhl-llulose, Chondrus Crispus (arrageenan),

Sodium Saccharin, Rosa Canina Fruit 0i, CI 77891



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 tothpaste



Warnings

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

acidentally sallowed, get medical help or contact a Poison Control Center right away.



Directions

Adults and children 2 years of age & older: Brush teth 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, Aqua (Water), Glycerin, Sorbito, Slica, Aroma (Flavour), Sodium Lauryl Sulphate,

Copernicia Cerifera (Carnauba) Wax, Carboxymethyl Hyoroyetlhl-llulose, Chondrus Crispus (arrageenan),

Sodium Saccharin, Rosa Canina Fruit 0i, CI 77891



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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)