Active Ingredient
Sodium Fluoride 0.05%
Evo Sensitive Whitening Anti-cavity Fluoride Mouthwash
FDA Label NDC 70108-210
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 Evo Sensitive Whitening Anti-cavity Fluoride (NDC 70108-210). 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 active ingredient, purpose, uses, warnings, otc - keep out of reach of children, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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, Sorbitol, Glycerin, Xylitol, Sodium Benzoate, Potassium Sorbate, Peg-40 Hydrogenated Castor Oil, Mentha Haplocalyx Oil, Sodium Saccharin, Cetylpyridinium Chloride, Methyl Diisopropyl Propionamide, Sucralose, Citric Acid
Questions Or Comments?
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Packaging
Evo Anti-cavity (70108210 3)
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