3928-042-brush buddies crayola anticavity fluoride strawberry (0.02%)

SPL v3

SPL

SPL Set ID 1ba4a807-d6d5-04a0-e063-6294a90ae04d

Route

oral

Published

Effective Date 2024-05-01

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

fluoride ion (0.02 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 fd&c red no. 40

Identifiers & Packaging

Marketing Status

otc monograph drug active Since 2024-05-01

Purpose

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

Description

SODIUM FLUORIDE 0.02%

Medication Information

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 ion)---------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

FD&C Red No.40（CI 16035）

D&C Red No.33（CI 17200）

Description

SODIUM FLUORIDE 0.02%

Section 51945-4

Active Ingredient

SODIUM FLUORIDE 0.02%

Questions Or Comments?

Call toll free 1-877-274-8358

Structured Label Content

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 ion)---------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

FD&C Red No.40（CI 16035）

D&C Red No.33（CI 17200）

Section 51945-4 (51945-4)

Active Ingredient (Active ingredient)

SODIUM FLUORIDE 0.02%

Questions Or Comments? (Questions or comments?)

Call toll free 1-877-274-8358

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": "FD&C RED NO. 40", "unii": "WZB9127XOA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FLUORIDE ION", "unii": "Q80VPU408O", "classCode": "ACTIB", "strengthNumerator": "0.02", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"Uses": "helps protect teeth against cavities.", "Purpose": "(0.02% w/v fluoride ion)---------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 0.02%", "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 FD&C Red No.40（CI 16035） D&C Red No.33（CI 17200）", "Questions or comments?": "Call toll free 1-877-274-8358"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:37.853327 · Updated: 2026-03-14T23:11:19.831195