bite toothpaste fluoride toothpaste bits

SPL v3

SPL

SPL Set ID fa433031-7376-0e5b-e053-6394a90a5f75

Route

dental

Published

Effective Date 2023-05-19

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

fluoride ion (0.76 g)

Inactive Ingredients

guar gum silicon dioxide sodium cocoyl glutamate sodium bicarbonate zinc citrate starch, corn magnesium stearate menthol peppermint xylitol calcium carbonate

Identifiers & Packaging

Pill Appearance

Imprint: z Shape: round Color: white Size: 6 mm

Marketing Status

otc monograph drug active Since 2023-05-19

Description

Sodium Monofluorophosphate 0.76 % (0.14 % w/w fluoride ion)

Medication Information

Warnings and Precautions

If more than used for brushing is accidentally swallowed, get medical help or contact Poison Control Center right away. Keep away from pets.

Active Ingredient

Sodium Monofluorophosphate 0.76 % (0.14 % w/w fluoride ion)

Indications and Usage

Helps protect against dental cavities

Dosage and Administration

Adult:

Wet your toothbrush and place one (1) toothpaste bit in your mouth and bite down. Brush teeth thoroughly preferably after each meal or at least twice daily or as directed by a dentist or physician.

Rinse after using.

Do not swallow.

Description

Sodium Monofluorophosphate 0.76 % (0.14 % w/w fluoride ion)

Section 50565-1

Keep out of reach of children under 6 years of age.

Section 51727-6

Calcium Carbonate, Colloidal Silicon Dioxide, Guar Gum, Magnesium Stearate, Menthol, Natural Flavor (Peppermint), Sodium Bicarbonate, Sodium Cocoyl Glutamate, Starch, Xylitol, Zinc Citrate.

Section 51945-4

Section 53413-1

BiteToothpaste.com

Section 55105-1

Anticavity

Section 60561-8

Store at room temperature and in a dry place

Structured Label Content

Warnings and Precautions (34071-1)

If more than used for brushing is accidentally swallowed, get medical help or contact Poison Control Center right away. Keep away from pets.

Active Ingredient (55106-9)

Sodium Monofluorophosphate 0.76 % (0.14 % w/w fluoride ion)

Indications and Usage (34067-9)

Helps protect against dental cavities

Dosage and Administration (34068-7)

Adult:

Wet your toothbrush and place one (1) toothpaste bit in your mouth and bite down. Brush teeth thoroughly preferably after each meal or at least twice daily or as directed by a dentist or physician.

Rinse after using.

Do not swallow.

Section 50565-1 (50565-1)

Keep out of reach of children under 6 years of age.

Section 51727-6 (51727-6)

Calcium Carbonate, Colloidal Silicon Dioxide, Guar Gum, Magnesium Stearate, Menthol, Natural Flavor (Peppermint), Sodium Bicarbonate, Sodium Cocoyl Glutamate, Starch, Xylitol, Zinc Citrate.

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

BiteToothpaste.com

Section 55105-1 (55105-1)

Anticavity

Section 60561-8 (60561-8)

Store at room temperature and in a dry place

Advanced Ingredient Data

[{"name": "GUAR GUM", "unii": "E89I1637KE", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FLUORIDE ION", "unii": "Q80VPU408O", "classCode": "ACTIM", "strengthNumerator": "0.76", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "1"}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM COCOYL GLUTAMATE", "unii": "BMT4RCZ3HG", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM BICARBONATE", "unii": "8MDF5V39QO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ZINC CITRATE", "unii": "K72I3DEX9B", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STARCH, CORN", "unii": "O8232NY3SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MENTHOL", "unii": "L7T10EIP3A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PEPPERMINT", "unii": "V95R5KMY2B", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "XYLITOL", "unii": "VCQ006KQ1E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CALCIUM CARBONATE", "unii": "H0G9379FGK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Helps protect against dental cavities", "34068-7": "Adult: Wet your toothbrush and place one (1) toothpaste bit in your mouth and bite down. Brush teeth thoroughly preferably after each meal or at least twice daily or as directed by a dentist or physician. Rinse after using. Do not swallow.", "34071-1": "If more than used for brushing is accidentally swallowed, get medical help or contact Poison Control Center right away. Keep away from pets.", "50565-1": "Keep out of reach of children under 6 years of age.", "51727-6": "Calcium Carbonate, Colloidal Silicon Dioxide, Guar Gum, Magnesium Stearate, Menthol, Natural Flavor (Peppermint), Sodium Bicarbonate, Sodium Cocoyl Glutamate, Starch, Xylitol, Zinc Citrate.", "53413-1": "BiteToothpaste.com", "55105-1": "Anticavity", "55106-9": "Sodium Monofluorophosphate 0.76 % (0.14 % w/w fluoride ion)", "60561-8": "Store at room temperature and in a dry place"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:45.932428 · Updated: 2026-03-14T23:05:42.419463