BRUSH BUDDIES BARBIE ANTICAVITY FLUORIDE - BUBBLE GUM FLAVOR- sodium fluoride mouthwash

Brush Buddies Barbie ANTICAVITY FLUORIDE - Bubble Gum Flavor by

Drug Labeling and Warnings

Brush Buddies Barbie ANTICAVITY FLUORIDE - Bubble Gum Flavor by is a Otc medication manufactured, distributed, or labeled by Ashtel Studios Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Sodium fluoride 0.05%
(0.02% w/v fluoride ion)

Purpose

Anticavity

Uses

helps protect teeth against cavities.

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.

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)

Questions or comments?

Call toll free 1-877-274-8358

SPL UNCLASSIFIED SECTION

ALCOHOL & SUGAR FREE

PARABEN FREE

MATTEL

Helps Prevent Cavities
make brushing fun!®

BARBIE™ and associated trademarks and trade dress are owned by, and used under license from, Mattel. ©2024 Mattel.
barbie.com

DESIGNED IN U.S.A.
MADE IN CHINA

Brush Buddies®

BRUSHBUDDIES.COM

1-909-434-0911 INTERNATIONAL
COPYRIGHTS AND TRADEMARKS GRANTED OR PENDING WORLDWIDE
DISTRIBUTED BY: ASHTEL STUDIOS, INC. ONTARIO, CA 91761, USA

Packaging

INGREDIENTS AND APPEARANCE

BRUSH BUDDIES BARBIE ANTICAVITY FLUORIDE - BUBBLE GUM FLAVOR 
sodium fluoride mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70108-094
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	SODIUM FLUORIDE	0.05 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
GLYCERIN (UNII: PDC6A3C0OX)
XYLITOL (UNII: VCQ006KQ1E)
SODIUM BENZOATE (UNII: OJ245FE5EU)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)
METHYL DIISOPROPYL PROPIONAMIDE (UNII: 6QOP5A9489)
SUCRALOSE (UNII: 96K6UQ3ZD4)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)

Product Characteristics
Color		Score
Shape		Size
Flavor	BUBBLE GUM	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70108-094-01	355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/29/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M021	07/29/2024

Labeler - Ashtel Studios Inc. (148689180)