Otc - Active Ingredient
Active Ingredient Purpose
Stannous fluoride 0.454% (0.15% w/v fluoride ion) .......................... Anticavity/Antihypersensitivity
Sensitive Whitening Anticavity Paste, Dentifrice
FDA Label NDC 36800-201
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 for the product Sensitive Whitening Anticavity (NDC 36800-201). 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, uses, warnings, otc - keep out of reach of children, directions, other information, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Uses
- aids in the prevention of dental cavities
- builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact
Warnings
When using this product, if irritation occurs discontinue use
Stop use and ask a dentist if
- the problem persists or worsens. Sensitive teeth may indicate a serious 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 brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
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 one minute twise a day (morning and evening), and not more than 3 times a day, or as recommended by a dentist or doctor. Make sure to brush all sensitive areas of the teeth. Minimize swallowing. Spit out after brushing.
- children under 12 years of age: Consult a dentist or doctor.
Other Information
products containing stannous fluoride may produce surface staining of the teeth. Adequate toothbrushing may prevent these stains which are not harmful or permanent and may be removed by your dentist
this product is specifically formulated to prevent staining
store below 30°C (86°F)
Inactive Ingredient
glycerin, water, hydrated silica, pentasodium triphosphate, flavor, cocamidopropyl betaine, sodium lauryl sulfate, titanium dioxide, cellulose gum, sodium saccharin
Package Label.Principal Display Panel
Carton Artwork (Topco Restoredefend Ctn 2821001r1 001)
Sensitive
Anticavity Toothpaste for Sensitive Teeth
Net Wt 3.4 oz (96.3g)
Compare to Sensodyne
Repair & Protect Active Ingredient*
Restore
& Defend
Builds protective coating on
sensitive areas of teeth
* Please review the disclaimer below.
