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)
365 Whole Foods Market Anticavity/antigingivitis Mouthwash
FDA Label NDC 42681-0036
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Whole Foods Market, Inc. for the product 365 Whole Foods Market Anticavity/antigingivitis Mouthwash (NDC 42681-0036). 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 otc - active ingredient, dosage & administration, otc - keep out of reach of children, otc - stop use, otc - pregnancy or breast feeding, inactive ingredient, recent major changes, indications & usage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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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