FDA Label for 365 Whole Foods Market Anticavity/antigingivitis Mouthwash
View Indications, Usage & Precautions
365 Whole Foods Market Anticavity/antigingivitis Mouthwash Product Label
The following document was submitted to the FDA by the labeler of this product Whole Foods Market, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Eucalyptol 0.092%
Menthol 0.042%
Methyl Salicylate 0.060%
Thymol 0.064%
Sodium Fluoride 0.02% (0.01% w/v fluoride ion)
Dosage & Administration
Directions Adults and children 12 years of age and older: Use twice a day after brushing your teeth with a toothpaste • Vigorously swish 10mL of rinse between your teeth for 30 seconds and then spit out. Do not swallow the rinse • Do not eat or drink for 30 minutes after rinsing. • Children under 12 years of age: do not use/consult a doctor.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
Otc - Stop Use
• Stop use and ask a dentist if • Gingivitis, bleeding, or redness persists for more than 2 weeks. • You have painful of swollen gums, pus from the gum line, loose teeth, or increasing spacing between teeth. These may be signs or symptoms of periodontitis, a serious from of gum disease.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Inactive Ingredient
Inactive ingredients: water, ethyl alcohol (21.6% v/v), sorbitol, flavor, cocamidopropyl betaine, citric acid, stevia rebaudiana leaf extract, sodium citrate, sodium benzoate, mentha piperita (peppermint) oil, mentha spicata (spearmint) oil.
Recent Major Changes
Highlights:
• Dosage and Administration 24 Jan 2022
Indications & Usage
Uses • Aids in the prevention of dental cavities. • Helps remove plaque that leads to gingivitis, an early form of gum disease. • The combined daily use of a fluoride preventative treatment rinse and a fluoride toothpaste can help reduce the incidence of dental cavities.
Otc - Purpose
Uses • Aids in the prevention of dental cavities. • Helps remove plaque that leads to gingivitis, an early form of gum disease. • The combined daily use of a fluoride preventative treatment rinse and a fluoride toothpaste can help reduce the incidence of dental cavities.
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