82168-004

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

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

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.

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)

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.

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

Advanced Ingredient Data

[{"name": "BENZYL ALCOHOL", "unii": "LKG8494WBH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM SACCHARIN", "unii": "SB8ZUX40TY", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDROXYETHYLCELLULOSE", "unii": "T4V6TWG28D", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SILICA", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CALCIUM CARBONATE", "unii": "H0G9379FGK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM LAURYL SULFATE", "unii": "368GB5141J", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CELLULOSE GUM", "unii": "K679OBS311", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM SILICATE", "unii": "IJF18F77L3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FLUORIDE ION", "unii": "Q80VPU408O", "classCode": "ACTIM", "strengthNumerator": "0.76", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "TETRASODIUM PYROPHOSPHATE", "unii": "O352864B8Z", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Use": "Use helps protect against cavities", "50565-1": "Keep out of reach of children under 6 years of age.", "50566-9": "If in contact with the eyes, rinse thoroughly with water.", "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 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": "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."}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information