Inactive Ingredients
water, sorbitol, hydrated silica, glycerin, cocamidopropyl betaine, xanthan gum, flavor, titanium dioxide, sodium saccharin, sodium hydroxide, sucralose, yellow 10, blue 1
Topco Associates Llc Paste, Dentifrice
FDA Label NDC 36800-364
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Topco Associates Llc for the product Topco Associates Llc (NDC 36800-364). 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 inactive ingredients, directions, uses, warnings, otc - stop use, otc - keep out of reach of children, active ingredients / purpose, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Directions
Adults and children 12 years of age and older: apply at least a 1-inch strip of product onto a soft bristle toothbrush
- brush teeth thoroughly for at least one minute twice a day (morning and evening), and not more than 3 tims a day, or as recommended by a dentist or doctor. Make sure to brush all sensitive areas of the teeth. Minimiza swallowing. Spit out after brushing.
- children under 12 years of age: Consult a dentist or doctor.
Uses
- builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact
- aids in the prevention of dental cavities
Warnings
When using this product, if irritation occurs discontinue use.
Otc - Stop Use
Stop use and ask a dentist if
- the problem persists or worsen
- Sensitive teeth may indicate a resious problem that may need prompt care by a dentist.
- pain/sensitivity still persists after 4 weeks of use
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If more than used for burshing is accidentally swallowed, get medical help or contact a Poison Center right away.
Active Ingredients / Purpose
Potassium nitrate 5%....................................................Antihypersensitivity
Sodium fluoride 0.24% (0.15% w/v fluoride ion)............Anticavity
Dosage & Administration
adults and children 12 years of age and older: apply at least a 1-inch strip of the product onto a soft bristle toothbrush. Children under 12 years of age:consult a dentist or a doctor.
* Please review the disclaimer below.
