85346-001

Drug Facts

Composition & Product

Active Ingredients

fluoride ion (0.877 g)

Inactive Ingredients

stevia rebaudiana whole sorbitol citrus aurantium amara (bitter orange) flower oil camellia sinensis leaf xylitol magnesium stearate cocamidopropyl betaine mentha piperita (peppermint) oil mentha piperita (peppermint) leaf calcium carbonate

Identifiers & Packaging

Pill Appearance

Shape: round Color: white Size: 11 mm

Marketing Status

unapproved drug other active Since 2025-03-13

Medication Information

Warnings

Keep out of reach of children. Not to be used by children under 12 years of age.If more than used for brushing is accidentally swallowed get medical help or contact a Poison Control Center right away.

Active Ingredient

Sodium Monofluorophosphate 0.877% (1100ppm w/v fluoride ion)

Purpose

Anticavity Toothpaste

Directions

Adults: Wet your toothbrush and crush the tab between your teeth. Brush like normal. Rinse after using. Brush teeth thoroughly preferably after each meal or at least twice a day or as directed by a dentist or physician. Do not swallow

Directions: Bite 1 tablet and chew it into small pieces, wet your toothbrush, and brush gently. Do not swallow. Do not use if seal is broken or missing. Keep in a cool and dry place. Not suitable for children under 12.

Description

Sodium Monofluorophosphate 0.877% (1100ppm w/v fluoride ion)

Use

aids in the prevention of dental cavities

Section 44425-7

Store at room temperature and dry place.

Section 50565-1

Keep out of reach of children.

Section 50566-9

N/A

Section 50567-7

N/A

Section 50570-1

Do not swallow. Do not use if seal is broken or missing. Not suitable for children under 12.

Section 51727-6

Inactive ingredients: Sorbitol, Calcium Carbonate, Probiotics, Xylitol, Magnesium Stearate, Stevia Rebaudiana Extract,Tea (Camellia Sinensis) Polyphenols, Peppermint (Mentha Piperita) Oil, Bitter Orange (Citrus Aurantium) Flower Oil, Peppermint (Mentha Piperita) Leaf Oil, Cocamidopropyl Betaine.

Section 51945-4

Structured Label Content

Warnings

Keep out of reach of children. Not to be used by children under 12 years of age.If more than used for brushing is accidentally swallowed get medical help or contact a Poison Control Center right away.

Active Ingredient (55106-9)

Sodium Monofluorophosphate 0.877% (1100ppm w/v fluoride ion)

Purpose

Anticavity Toothpaste

Directions

Adults: Wet your toothbrush and crush the tab between your teeth. Brush like normal. Rinse after using. Brush teeth thoroughly preferably after each meal or at least twice a day or as directed by a dentist or physician. Do not swallow

Directions: Bite 1 tablet and chew it into small pieces, wet your toothbrush, and brush gently. Do not swallow. Do not use if seal is broken or missing. Keep in a cool and dry place. Not suitable for children under 12.

Use

aids in the prevention of dental cavities

Section 44425-7 (44425-7)

Store at room temperature and dry place.

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

N/A

Section 50567-7 (50567-7)

N/A

Section 50570-1 (50570-1)

Do not swallow. Do not use if seal is broken or missing. Not suitable for children under 12.

Section 51727-6 (51727-6)

Inactive ingredients: Sorbitol, Calcium Carbonate, Probiotics, Xylitol, Magnesium Stearate, Stevia Rebaudiana Extract,Tea (Camellia Sinensis) Polyphenols, Peppermint (Mentha Piperita) Oil, Bitter Orange (Citrus Aurantium) Flower Oil, Peppermint (Mentha Piperita) Leaf Oil, Cocamidopropyl Betaine.

Section 51945-4 (51945-4)

Advanced Ingredient Data

[{"name": "STEVIA REBAUDIANA WHOLE", "unii": "6U422Y08O2", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CITRUS AURANTIUM AMARA (BITTER ORANGE) FLOWER OIL", "unii": "D4BGE91OXH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CAMELLIA SINENSIS LEAF", "unii": "W2ZU1RY8B0", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "XYLITOL", "unii": "VCQ006KQ1E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "COCAMIDOPROPYL BETAINE", "unii": "5OCF3O11KX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MENTHA PIPERITA (PEPPERMINT) OIL", "unii": "AV092KU4JH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MENTHA PIPERITA (PEPPERMINT) LEAF", "unii": "A389O33LX6", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FLUORIDE ION", "unii": "Q80VPU408O", "classCode": "ACTIM", "strengthNumerator": "0.877", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "1"}, {"name": "CALCIUM CARBONATE", "unii": "H0G9379FGK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Use": "aids in the prevention of dental cavities", "44425-7": "Store at room temperature and dry place.", "50565-1": "Keep out of reach of children.", "50566-9": "N/A", "50567-7": "N/A", "50570-1": "Do not swallow. Do not use if seal is broken or missing. Not suitable for children under 12.", "51727-6": "Inactive ingredients: Sorbitol, Calcium Carbonate, Probiotics, Xylitol, Magnesium Stearate, Stevia Rebaudiana Extract,Tea (Camellia Sinensis) Polyphenols, Peppermint (Mentha Piperita) Oil, Bitter Orange (Citrus Aurantium) Flower Oil, Peppermint (Mentha Piperita) Leaf Oil, Cocamidopropyl Betaine.", "55106-9": "Sodium Monofluorophosphate 0.877% (1100ppm w/v fluoride ion)", "Purpose": "Anticavity Toothpaste", "Warnings": "Keep out of reach of children. Not to be used by children under 12 years of age.If more than used for brushing is accidentally swallowed get medical help or contact a Poison Control Center right away.", "Directions": "Adults: Wet your toothbrush and crush the tab between your teeth. Brush like normal. Rinse after using. Brush teeth thoroughly preferably after each meal or at least twice a day or as directed by a dentist or physician. Do not swallow Directions: Bite 1 tablet and chew it into small pieces, wet your toothbrush, and brush gently. Do not swallow. Do not use if seal is broken or missing. Keep in a cool and dry place. Not suitable for children under 12."}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information