3928-042-brush Buddies Crayola Anticavity Fluoride Strawberry (0.02%)

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

Description

SODIUM FLUORIDE 0.02%

Purpose

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


Medication Information

Purpose

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

Description

SODIUM FLUORIDE 0.02%

Uses

helps protect teeth against cavities.

Section 51945-4

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 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.
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


Structured Label Content

Uses

helps protect teeth against cavities.

Section 51945-4 (51945-4)

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 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.
Active Ingredient (Active ingredient)

SODIUM FLUORIDE 0.02%

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)

Questions Or Comments? (Questions or comments?)

Call toll free 1-877-274-8358


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)