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Brush buddies hot wheels anticavity fluoride - strawberry flavor - Medication Information

Product NDC Code 70108-095
Drug Name

Brush buddies hot wheels anticavity fluoride - strawberry flavor

Type Brand
Active Ingredients
Sodium fluoride .05 g/100ml
Route ORAL
Dosage Form MOUTHWASH
Application Number M021
Labeler Name Ashtel Studios Inc.
Packages
Package NDC Code Description
70108-095-01 355 ml in 1 bottle, plastic (70108-095-01)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient Sodium fluoride 0.05% (0.02% w/v fluoride ion)

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
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 ingredient

A list of inactive, non-medicinal ingredients in a drug product.
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)

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
Uses helps protect teeth against cavities.

Purpose

Information about the drug product’s indications for use.
Purpose Anticavity

Spl product data elements

Usually a list of ingredients in a drug product.
Brush Buddies Hot Wheels ANTICAVITY FLUORIDE - STRAWBERRY FLAVOR Sodium Fluoride SODIUM FLUORIDE FLUORIDE ION WATER SORBITOL GLYCERIN XYLITOL SODIUM BENZOATE POTASSIUM SORBATE POLYOXYL 40 HYDROGENATED CASTOR OIL SACCHARIN SODIUM CETYLPYRIDINIUM CHLORIDE METHYL DIISOPROPYL PROPIONAMIDE SUCRALOSE CITRIC ACID MONOHYDRATE FD&C RED NO. 40 D&C RED NO. 33

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
Packaging Brush Buddies Hot Wheels Mouth Wash

Spl unclassified section

Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.
Drug Facts ALCOHOL & SUGAR FREE PARABEN FREE MATTEL HELPS PREVENT CAVITIES make brushing fun! ® HOT WHEELS™ and associated trademarks and trade dress are owned by, and used under license from, Mattel. ©2024 Mattel. HOTWHEELS.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

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
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.

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
Questions or comments? Call toll free 1-877-274-8358

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
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.

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API