ice pop flavor sodium fluoride anticavity toothpaste

SPL v2

SPL

SPL Set ID 20e1603e-bcd1-6a5e-e063-6294a90ad1db

Route

dental

Published

Effective Date 2024-09-04

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

fluoride ion (0.243 g)

Inactive Ingredients

carboxymethylcellulose sodium, unspecified form sodium gluconate sodium phosphate fd&c blue no. 1 1,2-hexanediol sodium lauroyl sarcosinate glycerin sucralose xylitol hydrated silica potassium pyrophosphate xanthan gum lauryl glucoside water sorbitol zinc lactate methyl diisopropyl propionamide

Identifiers & Packaging

Marketing Status

otc monograph drug active Since 2024-08-30

Purpose

Anticavity

Description

Sodium Fluoride 0.24% (0.14%w/v fluoride ion)

Medication Information

Warnings

Warnings

Purpose

Anticavity

Directions

Adults and children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or use as directed by a dentist or doctor.
Instruct children under 6 years of age in good brushing and rinsing habits ( to minimize seallowing).
Supervise children as necessary until capable of using without supervision.
Children under 2 years of age: Consult a dentist or doctor.

Inactive Ingredients

Water

Sorbitol

Glycerin

Hydrated Silica

Xylitol

Flavor

Sodium Phosphate

Xanthan Gum

Sodium Lauroyl Sarcosinate

Sucralose

Tetrapotassium Pyrophosphate

1,2-Hexanediol

Cellulose Gum

Lauryl Glucoside

Methyl Diisopropyl Propionamide

Sodium Gluconate

Zinc Lactate

FD&C Blue No. 1

Description

Sodium Fluoride 0.24% (0.14%w/v fluoride ion)

Use

Aids in the prevention of dental cavities

Label

Do Not Use

Do not use in eye area

Active Ingredient

Sodium Fluoride 0.24%

(0.14%w/v fluoride ion)

When Using This Product

When using this product Do not swallow

Keep Out of Reach of Children

Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally seallowed, get medical help or contact a Poison Control Center right away.

Structured Label Content

Warnings

Warnings

Purpose

Anticavity

Directions

Adults and children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or use as directed by a dentist or doctor.
Instruct children under 6 years of age in good brushing and rinsing habits ( to minimize seallowing).
Supervise children as necessary until capable of using without supervision.
Children under 2 years of age: Consult a dentist or doctor.

Inactive Ingredients (Inactive ingredients)

Water

Sorbitol

Glycerin

Hydrated Silica

Xylitol

Flavor

Sodium Phosphate

Xanthan Gum

Sodium Lauroyl Sarcosinate

Sucralose

Tetrapotassium Pyrophosphate

1,2-Hexanediol

Cellulose Gum

Lauryl Glucoside

Methyl Diisopropyl Propionamide

Sodium Gluconate

Zinc Lactate

FD&C Blue No. 1

Use

Aids in the prevention of dental cavities

Label (label)

Do Not Use (Do not use)

Do not use in eye area

Active Ingredient (Active ingredient)

Sodium Fluoride 0.24%

(0.14%w/v fluoride ion)

When Using This Product (When using this product)

When using this product Do not swallow

Keep Out of Reach of Children (Keep out of reach of children)

Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally seallowed, get medical help or contact a Poison Control Center right away.

Advanced Ingredient Data

[{"name": "CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM", "unii": "K679OBS311", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FLUORIDE ION", "unii": "Q80VPU408O", "classCode": "ACTIB", "strengthNumerator": "0.243", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "SODIUM GLUCONATE", "unii": "R6Q3791S76", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM PHOSPHATE", "unii": "SE337SVY37", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C BLUE NO. 1", "unii": "H3R47K3TBD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "1,2-HEXANEDIOL", "unii": "TR046Y3K1G", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM LAUROYL SARCOSINATE", "unii": "632GS99618", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCRALOSE", "unii": "96K6UQ3ZD4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "XYLITOL", "unii": "VCQ006KQ1E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDRATED SILICA", "unii": "Y6O7T4G8P9", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POTASSIUM PYROPHOSPHATE", "unii": "B9W4019H5G", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "XANTHAN GUM", "unii": "TTV12P4NEE", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LAURYL GLUCOSIDE", "unii": "76LN7P7UCU", "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": "ZINC LACTATE", "unii": "2GXR25858Y", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "METHYL DIISOPROPYL PROPIONAMIDE", "unii": "6QOP5A9489", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Use": "Aids in the prevention of dental cavities", "Purpose": "Anticavity", "Warnings": "Warnings", "Directions": "Adults and children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or use as directed by a dentist or doctor. Instruct children under 6 years of age in good brushing and rinsing habits ( to minimize seallowing). 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 in eye area", "Active ingredient": "Sodium Fluoride 0.24% (0.14%w/v fluoride ion)", "Inactive ingredients": "Water Sorbitol Glycerin Hydrated Silica Xylitol Flavor Sodium Phosphate Xanthan Gum Sodium Lauroyl Sarcosinate Sucralose Tetrapotassium Pyrophosphate 1,2-Hexanediol Cellulose Gum Lauryl Glucoside Methyl Diisopropyl Propionamide Sodium Gluconate Zinc Lactate FD&C Blue No. 1", "When using this product": "When using this product Do not swallow", "Keep out of reach of children": "Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally seallowed, get medical help or contact a Poison Control Center right away."}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:08:15.702572 · Updated: 2026-03-14T23:12:26.991151