brush buddies crayola anticavity fluoride bubblegum

SPL v14

SPL

SPL Set ID 188d28f9-a814-0f98-e063-6294a90a106b

Route

oral

Published

Effective Date 2024-05-16

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

fluoride ion (0.03 g)

Inactive Ingredients

sorbitol sodium benzoate potassium sorbate citric acid monohydrate sucralose glycerin methyl diisopropyl propionamide polyoxyl 40 hydrogenated castor oil water d&c red no. 33 xylitol saccharin sodium cetylpyridinium chloride

Identifiers & Packaging

Marketing Status

otc monograph drug active Since 2024-05-16

Purpose

(0.02% w/v fluoride ino)-----Anticavity

Description

SODIUM FLUORIDE 0.03%

Medication Information

Warnings and Precautions

Keep out of reach of children under 6 years of age, lf youaccidentally swallow more than used for rinsing, seek professionalhelp or contact a Poison Control Center immediately.

Warnings

Keep out of reach of children under 6 years of age.lf you accidentally swallow more than used for rinsing, seek professional help or contact a Poison Control Center immediately.

Uses

helps protect teeth against cavities.

Purpose

(0.02% w/v fluoride ino)-----Anticavity

Directions

Adults and children 6 years and older:

Use daily after you brush your teeth with toothpaste
Rinse toothpaste from mouth prior to use.
Shake well before each use.Twist and remove cap.
Rinse or gargle for 30 seconds with 15 ml and spit out.
Do Notswallow the rinse.
Do Noteat or drink for 30 minutes after rinsing
Supervise children as necessary.
Children under 6 years of age, consult with a dentist or doctor.

Inactive Ingredients

Water

SORBITOL

GLYCERIN

XYLITOL

SODIUM BENZOATE

POTASSIUM SORBATE

PEG-40 HYDROGENATED CASTOR OIL

FLAVOR

SODIUM SACCHARIN

CETYLPYRIDINIUM CHLORIDE

METHYL DIISOPROPYL PROPIONAMIDE

SUCRALOSE

CITRIC ACID

D&C Red No.33（CI 17200）

Description

SODIUM FLUORIDE 0.03%

Section 51945-4

Active Ingredient

SODIUM FLUORIDE 0.03%

Structured Label Content

Warnings and Precautions (34071-1)

Keep out of reach of children under 6 years of age, lf youaccidentally swallow more than used for rinsing, seek professionalhelp or contact a Poison Control Center immediately.

Warnings

Keep out of reach of children under 6 years of age.lf you accidentally swallow more than used for rinsing, seek professional help or contact a Poison Control Center immediately.

Uses

helps protect teeth against cavities.

Purpose

(0.02% w/v fluoride ino)-----Anticavity

Directions

Adults and children 6 years and older:

Use daily after you brush your teeth with toothpaste
Rinse toothpaste from mouth prior to use.
Shake well before each use.Twist and remove cap.
Rinse or gargle for 30 seconds with 15 ml and spit out.
Do Notswallow the rinse.
Do Noteat or drink for 30 minutes after rinsing
Supervise children as necessary.
Children under 6 years of age, consult with a dentist or doctor.

Inactive Ingredients (Inactive ingredients)

Water

SORBITOL

GLYCERIN

XYLITOL

SODIUM BENZOATE

POTASSIUM SORBATE

PEG-40 HYDROGENATED CASTOR OIL

FLAVOR

SODIUM SACCHARIN

CETYLPYRIDINIUM CHLORIDE

METHYL DIISOPROPYL PROPIONAMIDE

SUCRALOSE

CITRIC ACID

D&C Red No.33（CI 17200）

Section 51945-4 (51945-4)

Active Ingredient (Active ingredient)

SODIUM FLUORIDE 0.03%

Advanced Ingredient Data

[{"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM BENZOATE", "unii": "OJ245FE5EU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POTASSIUM SORBATE", "unii": "1VPU26JZZ4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CITRIC ACID MONOHYDRATE", "unii": "2968PHW8QP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCRALOSE", "unii": "96K6UQ3ZD4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "METHYL DIISOPROPYL PROPIONAMIDE", "unii": "6QOP5A9489", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYOXYL 40 HYDROGENATED CASTOR OIL", "unii": "7YC686GQ8F", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "D&C RED NO. 33", "unii": "9DBA0SBB0L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "XYLITOL", "unii": "VCQ006KQ1E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SACCHARIN SODIUM", "unii": "SB8ZUX40TY", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CETYLPYRIDINIUM CHLORIDE", "unii": "D9OM4SK49P", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FLUORIDE ION", "unii": "Q80VPU408O", "classCode": "ACTIB", "strengthNumerator": "0.03", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"Uses": "helps protect teeth against cavities.", "34071-1": "Keep out of reach of children under 6 years of age, lf youaccidentally swallow more than used for rinsing, seek professionalhelp or contact a Poison Control Center immediately.", "Purpose": "(0.02% w/v fluoride ino)-----Anticavity", "Warnings": "Keep out of reach of children under 6 years of age. lf you accidentally swallow more than used for rinsing, seek professional help or contact a Poison Control Center immediately.", "Directions": "Adults and children 6 years and older: Use daily after you brush your teeth with toothpaste Rinse toothpaste from mouth prior to use. Shake well before each use.Twist and remove cap. Rinse or gargle for 30 seconds with 15 ml and spit out. Do Not swallow the rinse. Do Not eat or drink for 30 minutes after rinsing Supervise children as necessary. Children under 6 years of age, consult with a dentist or doctor.", "Active ingredient": "SODIUM FLUORIDE 0.03%", "Inactive ingredients": "Water SORBITOL GLYCERIN XYLITOL SODIUM BENZOATE POTASSIUM SORBATE PEG-40 HYDROGENATED CASTOR OIL FLAVOR SODIUM SACCHARIN CETYLPYRIDINIUM CHLORIDE METHYL DIISOPROPYL PROPIONAMIDE SUCRALOSE CITRIC ACID D&C Red No.33（CI 17200）"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:37.839833 · Updated: 2026-03-14T23:11:19.831195