Otc - Active Ingredient
Drug Facts
Active ingredient Purpose
Sodium fluoride 0.02% (0.01% w/v fluoride ion)............ Anticavity
Anticavity Mouth Rinse Low-foaming Spearmint Gel, Dentifrice
FDA Label NDC 87649-0718
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Dyson Technology Limited for the product Anticavity Mouth Rinse Low-foaming Spearmint (NDC 87649-0718). 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, otc - purpose, otc - keep out of reach of children, otc - when using, otc - do not use, other safety information, dosage & administration, warnings, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Use
Aids in the prevention of dental cavities.
Otc - Keep Out Of Reach Of Children
Warning
Keep out of the reach of children. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
Otc - When Using
Directions
Adults and children 6 years of age and older Use twice a day after brushing your teeth with a toothpaste. • vigorously swish 10 millilitres of rinse between your teeth for 1 minute and then spit out
Otc - Do Not Use
Other information
Do not use if seal inside screw cap is broken or missing.
Other Safety Information
Inactive ingredients
water, glycerin, xylitol, cetylpyridinium chloride, poloxamer 407, disodium phosphate, sodium phosphate, menthol, sodium saccharin, citric acid, flavor, carvone, mentha piperita(peppermint) oil, mentha viridis (spearmint) leaf oil, methyl salicylate, anethole, BHT.
Dosage & Administration
Use twice a day after brushing your teeth with a toothpaste. vigorously swish 10 millilitres 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.
Warnings
supervise children as necessary until capable of using without supervision. • children under 6 years of age: consult a dentist or doctor.
Inactive Ingredient
Inactive ingredients water, glycerin, xylitol, cetylpyridinium chloride, poloxamer 407, disodium phosphate, sodium phosphate, menthol, sodium saccharin, citric acid, flavor, carvone, mentha piperita(peppermint) oil, mentha viridis (spearmint) leaf oil, methyl salicylate, anethole, BHT.
Indications & Usage
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
Package Label.Principal Display Panel
Dyson
Anticavity mouth rinse
Low-foaming Spearmint
Alcohol free
Engineered for the Dyson Dental System’s camera, for gap detection and accurate flossing.
iMPORTANT: Read directions for proper use.
13.52 FL. OZ (400mL)
* Please review the disclaimer below.
