73928-048 Brush Buddies Brbie Anticavity Fluoride Bubblegum(0.05%)

73928-048 Brush Buddies Brbie Anticavity Fluoride Bubblegum(0.05%)
SPL v3
SPL
SPL Set ID 1b9ec370-eadf-92c4-e063-6294a90a9055
Route
ORAL
Published
Effective Date 2024-05-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.05 g)
Inactive Ingredients
Cetylpyridinium Chloride Polyoxyl 40 Hydrogenated Castor Oil Sucralose Saccharin Sodium Citric Acid Monohydrate 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

Description

SODIUM FLUORIDE 0.05%

Purpose

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


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.

Purpose

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

Description

SODIUM FLUORIDE 0.05%

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 0.05%

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)


Structured Label Content

Uses

helps protect teeth against cavities.

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.

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 0.05%

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)


Advanced Ingredient Data


Raw Label Data

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