brush buddies crayola anticavity fluoride strawberry 0.03

brush buddies crayola anticavity fluoride strawberry 0.03
SPL v10
SPL
SPL Set ID 188ac743-3ba8-4da4-e063-6294a90a8f87
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
polyoxyl 40 hydrogenated castor oil cetylpyridinium chloride sucralose saccharin sodium citric acid monohydrate fd&c red no. 40 sorbitol methyl diisopropyl propionamide water potassium sorbate glycerin xylitol d&c red no. 33 sodium benzoate

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2024-05-01
Purpose

（0.02% w/v fluoride ion)----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 professionahelp 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 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 0.03%

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 professionahelp 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 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 0.03%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:37.837465 · Updated: 2026-03-14T23:11:19.831195