Brush Buddies Crayola Anticavity Fluoride Watermelon 73928-036 (0.05%)

SPL v3

SPL

SPL Set ID 1b4cf935-38a6-f4fb-e063-6394a90a4bc0

Route

ORAL

Published

Effective Date 2024-05-01

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Fluoride Ion (0.05 g)

Inactive Ingredients

Sorbitol Sodium Benzoate Polyoxyl 40 Hydrogenated Castor Oil Fd&c Yellow No. 5 Potassium Sorbate Cetylpyridinium Chloride Methyl Diisopropyl Propionamide Citric Acid Monohydrate Water Xylitol Fd&c Blue No. 1 Sucralose Glycerin

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2024-05-01

Description

SODIUM FLUORIDE 0.05%

Medication Information

Description

SODIUM FLUORIDE 0.05%

Uses

helps protect teeth against cavities.

Section 51945-4

Puropse

(0.05% w/v fluoride ion)---------Anticavity

Warnings

Keep out of reach of children under 6 years of age.If 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 0.05%

Inactive Ingredients

WATER

SORBITOL

GLYCERIN

XYLITOL

POTASSIUM SORBATE

SODIUM BENZOATE

PEG-40 HYDROGENATED CASTOR OIL

FLAVOR

SODIUM SACCHARIN

CETYLPYRIDINIUM CHLORIDE

METHYL DIISOPROPYL PROPIONAMIDE

SUCRALOSE

CITRIC ACID

FD&C Yellow No.5（CI 19140）

FD&C Blue No.1（CI 42090）

Questions Or Comments?

Call toll free 1-877-274-8358

Structured Label Content

Uses

helps protect teeth against cavities.

Section 51945-4 (51945-4)

Puropse

(0.05% w/v fluoride ion)---------Anticavity

Warnings

Keep out of reach of children under 6 years of age.If 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 (Active ingredient)

SODIUM FLUORIDE 0.05%

Inactive Ingredients (Inactive ingredients)

WATER

SORBITOL

GLYCERIN

XYLITOL

POTASSIUM SORBATE

SODIUM BENZOATE

PEG-40 HYDROGENATED CASTOR OIL

FLAVOR

SODIUM SACCHARIN

CETYLPYRIDINIUM CHLORIDE

METHYL DIISOPROPYL PROPIONAMIDE

SUCRALOSE

CITRIC ACID

FD&C Yellow No.5（CI 19140）

FD&C Blue No.1（CI 42090）

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": "POLYOXYL 40 HYDROGENATED CASTOR OIL", "unii": "7YC686GQ8F", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C YELLOW NO. 5", "unii": "I753WB2F1M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POTASSIUM SORBATE", "unii": "1VPU26JZZ4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CETYLPYRIDINIUM CHLORIDE", "unii": "D9OM4SK49P", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "METHYL DIISOPROPYL PROPIONAMIDE", "unii": "6QOP5A9489", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CITRIC ACID MONOHYDRATE", "unii": "2968PHW8QP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "XYLITOL", "unii": "VCQ006KQ1E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C BLUE NO. 1", "unii": "H3R47K3TBD", "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": "FLUORIDE ION", "unii": "Q80VPU408O", "classCode": "ACTIB", "strengthNumerator": "0.05", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"Uses": "helps protect teeth against cavities.", "Puropse": "(0.05% w/v fluoride ion)---------Anticavity", "Warnings": "Keep out of reach of children under 6 years of age. If 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 0.05%", "Inactive ingredients": "WATER SORBITOL GLYCERIN XYLITOL POTASSIUM SORBATE SODIUM BENZOATE PEG-40 HYDROGENATED CASTOR OIL FLAVOR SODIUM SACCHARIN CETYLPYRIDINIUM CHLORIDE METHYL DIISOPROPYL PROPIONAMIDE SUCRALOSE CITRIC ACID FD&C Yellow No.5（CI 19140） FD&C Blue No.1（CI 42090）", "Questions or comments?": "Call toll free 1-877-274-8358"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:37.843018 · Updated: 2026-03-14T23:11:19.831195