82168-005

82168-005
SPL v2
SPL
SPL Set ID 291f0312-238c-71d5-e063-6294a90a39e1
Route
DENTAL
Published
Effective Date 2024-12-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.76 g)
Inactive Ingredients
Calcium Carbonate Water Glycerin Sorbitol Silica Sodium Lauryl Sulfate Cellulose Gum Sodium Silicate Benzyl Alcohol Tetrasodium Pyrophosphate Sodium Saccharin Menthol Hydroxyethylcellulose

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-12-13

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

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