Otc - Active Ingredient
Active ingredients: Purpose Sodium Fluoride 0.243% Anticavity (0.14% w/v fluoride ion). Potassium nitrate 5%. Antisensitivity
Active ingredient: Purpose Sodium fluoride 0.02% Anticavity (0.01% w/v fluoride ion).
The following Structured Product Label (SPL) was submitted to the FDA by Dyson Technology Limited for the product Dental System Starter Kit (NDC 87649-0001). 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 - do not use, dosage & administration, warnings, inactive ingredient, indications & usage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active ingredients: Purpose Sodium Fluoride 0.243% Anticavity (0.14% w/v fluoride ion). Potassium nitrate 5%. Antisensitivity
Active ingredient: Purpose Sodium fluoride 0.02% Anticavity (0.01% w/v fluoride ion).
Use: Aids in the prevention of dental cavities. Helps reduce painful sensitivity of the teeth to cold, heat, acids, sweets, or contact.
Use: Aids in the prevention of dental cavities.
Warning: Keep out of reach of children. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
Warning: 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.
Do not use this product longer than 4 weeks unless recommended by a dentist or doctor.
Do not use if seal inside screw cap is broken or missing.
Apply at least a 1-inch strip of the product onto a soft bristle toothbrush. Brush teeth thoroughly for at least 1 minute twice a day (morning and evening) or as recommended by a dentist or doctor.
Use twice a day after brushing your teeth with a toothpaste. • vigorously swish 10 milliliters of rinse between your teeth for 1 minute and then spit out
Warning: Keep out of reach of children. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. See your dentist if the problem persists or worsens. Do not use this product longer than 4 weeks unless recommended by a dentist or doctor.
Warning: 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.
Inactive ingredients: Glycerin, water, hydrated silica, xylitol, PVP, tetrasodium pyrophosphate, cellulose gum, flavor, PEG-40 hydrogenated castor oil, menthol, mentha piperita (peppermint) oil, sodium saccharin, anethole, mentha viridis (spearmint) leaf oil, carvone, limonene, beta-caryophyllene, blue 1.
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.
Directions: Adults and children 12 years of age and older: Apply at least a 1-inch strip of the product onto a soft bristle toothbrush. Brush teeth thoroughly for at least 1 minute twice a day (morning and evening) or as recommended by a dentist or doctor. Make sure to brush all sensitive areas of the teeth. Children under 12 years of age: Consult a dentist or doctor.
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 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.
Dyson
Dental system starter kit
Anticavity toothpaste and mouth rinse
IMPORTANT: Read directions for proper use
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