Otc - Active Ingredient
Active ingredient
Sodium fluoride 0.02% (0.01% w/v fluoride ion)............ Purpose Antiacvity
Anticavity Mouth Rinse Low-foaming Spearmint Mouthwash
FDA Label NDC 87649-7180
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 87649-7180). 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. • 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.
Otc - Do Not Use
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 Do not use if seal inside screw cap is broken or missing.
Other Safety Information
Other information Do not use if seal inside screw cap is broken or missing.
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. • 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.
Warnings
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.
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
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. • 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.
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. (400 mL)
* Please review the disclaimer below.
