Evo On-the-go Anti-cavity Fluoride-spearmint Mouthwash
FDA Label NDC 70108-246
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 On-the-go Anti-cavity Fluoride-spearmint (NDC 70108-246). 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 ingredients, 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 Ingredients
Sodium Fluoride 0.05% (0.02% w/v fluoride ion)
Purpose
Anticavity
Uses
Helps protect teeth against cavities.
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 used for brushing is accidentally swallowed, call Poison Help at 1-800-222-1222 or go to PoisonHelp.org.
Directions
• Adults and children 12 years and older:
Adults and children 12 years and older: Use 10 mL (one packet) undiluted. Swish vigorously for 1 minute, then spit out. Use twice daily.
• 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, Potassium Sorbate, PEG-400, Flavor, Cetylpyridinium Chloride, Sodium Saccharin, Citric Acid, Sucralose
Questions Or Comments?
Call toll free 1-877-274-8358
Packaging
Evoanticavitymouthwash (70108246 3)
* Please review the disclaimer below.
