82168-004

82168-004
SPL v2
SPL
SPL Set ID 291eba71-14da-fac3-e063-6294a90aa3cc
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
benzyl alcohol sodium saccharin hydroxyethylcellulose silica calcium carbonate water sorbitol sodium lauryl sulfate glycerin cellulose gum sodium silicate tetrasodium pyrophosphate

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2024-12-13

Purpose

Anticavity tothpaste

Description

Sodium monofluorophosphate 0.76%


Medication Information

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.

Purpose

Anticavity tothpaste

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.

Other Information

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

Do not use if quality seal is broken or missing

Inactive Ingredients

Calium Carbonate, Water, Sorbitol, Glycerin, Hydrated Silica, Sodium Lauryl

Sulfate, Aawour, Sodium Saccharin, Sodium Silicate, Trisodium Phosphate, Cellulose

Gum, Hydroyethylollulose, Benzyl Alcohol, Tetrasodium Pyrophosphate, Rosa

Canina (Rose hip) Fruit 0il.



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

Do Not Use

Do not use on open skin wounds

Active Ingredient(s)

Sodium monofluorophosphate 0.76%

Package Label Principal Display Panel


Structured Label Content

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.

Purpose

Anticavity tothpaste

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.

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

Inactive Ingredients (Inactive ingredients)

Calium Carbonate, Water, Sorbitol, Glycerin, Hydrated Silica, Sodium Lauryl

Sulfate, Aawour, Sodium Saccharin, Sodium Silicate, Trisodium Phosphate, Cellulose

Gum, Hydroyethylollulose, Benzyl Alcohol, Tetrasodium Pyrophosphate, Rosa

Canina (Rose hip) Fruit 0il.



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

Do Not Use (Do not use)

Do not use on open skin wounds

Active Ingredient(s)

Sodium monofluorophosphate 0.76%

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


Advanced Ingredient Data


Raw Label Data

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