Evo Purple Whitening Anti-cavity Fluoride-cool Mint Mouthwash
FDA Label NDC 70108-247
11 label sections · Submitted to the FDA by Ashtel Studios, Inc. · 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 Evo Purple Whitening Anti-cavity Fluoride-cool Mint (NDC 70108-247). 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, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Sodium Fluoride 0.05%
Purpose
Anticavity
Uses
• Helps reduce Plaque-associated Gingivitis
• Helps control gum infections
Warnings
Stop use and ask dentist if
• Gingivitis, bleeding, or redness persists for more than 2 weeks.
• You have painful or swollen gums, pus, loose teeth, or increased spacing between teeth. These may be signs of periodontitis.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children under 6 years of age. If more than the rinsing amount is swallowed, seek medical help or contact a Poison Control Center right away.
Directions
• Adults and children 12 years and older:
Adults and children 12 years and older. Use 10 mL. (2 teaspoons) undiluted. Swish vigorously for 1 minute, then spit out. Use once a day.
• Children 6 years to under 12 years:
Should be supervised when using this product.
• Children under 6 years of age:
Not recommended for use.
• Do not swallow.
Other Information
• Do not exceed the recommended dosage.
• This rinse is not a substitute for brushing or flossing.
• Do not use if safety seal is broken or missing.
Inactive Ingredients
Water (Aqua), Sorbitol, Glycerin, Sodium Benzoate, PEG-40 Hydrogenated Castor Oil, PEG-400, Potassium Sorbate, Fragrance, Cetylpyridinium Chloride, Sodium Saccharin, Citric Acid, Sucralose, CI 16035, CI 42090
Questions Or Comments?
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Packaging
Anti-cavity Fluoride-cool Mint (70108247 2)
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