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Distributed by: Whole Foods Market | Austin, TX 78703
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365 Whole Foods Market Spearmint Flavored Fluoride Mouthwash Anticavity Mouthwash
FDA Label NDC 42681-0048
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 for the product 365 Whole Foods Market Spearmint Flavored Fluoride Mouthwash Anticavity (NDC 42681-0048). 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 other, active ingredient, purpose, use, 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 0.02% (0.01% w/v fluoride Ion)
Purpose
Anticavity
Use
Aids in the prevention of dental cavities
Warnings
keep out of reach of children.
Otc - Keep Out Of Reach Of Children
If more than used for rinsing is accidentally swallowed, get medical help or contact a poison Control Center (1-800-22-1222) right away.
Directions
• Adults and children 6 years of age and older: Use twice a day after brushing your teeth with a toothpaste.
•Vigorously swish 10 milliliters (2 teaspoonfuls) of rinse between your teeth for 1 minute and then spit out.
•Do not swallow the rinse.
•Do not eat or drink for 30 minutes after rinsing.
•Instruct children under 12 years of age in good rinsing habits (to minimize swallowing). •Supervise children as necessary until capable of using without supervision.
• Children under 6 years of age: consult a dentist or doctor.
Other Information.
• This rinse is not intended to replace brushing or flossing
• Store at room temperature
•Cold weather may temporarily cloud this product
Inactive Ingredients
Water, Alcohol (12%), Sorbitol, Polysorbate 80, Stevia Rebaudiana Leaf Extract, Sodium Benzoate, Natural Flavor, Eucalyptol, Methyl Salicylate, Thymol, Menthol, Citric Acid, Sodium Hydroxide.
Questions, Comments?
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