Brush Buddies Crayola Anticavity Fluoride - Watermelon Flavor Mouthwash
FDA Label NDC 70108-090
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Ashtel Studios Inc. for the product Brush Buddies Crayola Anticavity Fluoride - Watermelon Flavor (NDC 70108-090). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drug facts, active ingredient, purpose, uses, warnings, otc - keep out of reach of children, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Sodium Fluoride 0.02%
(0.02% w/v fluoride ion)
Purpose
Anticavity
Uses
helps protect teeth against cavities.
Warnings
Otc - Keep Out Of Reach Of Children
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, FD&C Yellow No.5 (CI 19140), FD&C Blue No.1 (CI 42090)
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Packaging
Image Description (7010809001)
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