Otc - Active Ingredient
Stannous fluoride 0.454% (0.15% w/v fluoride ion)
Restore And Defend Whitening Tp Paste, Dentifrice
FDA Label NDC 30142-256
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Kroger for the product Restore And Defend Whitening Tp (NDC 30142-256). 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, inactive ingredient, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, 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
Inactive Ingredient
glycerin, water, hydrated silica, pentasodium triphosphate, cellulose gum, cocamidopropyl betaine, flavor, sodium lauryl sulfate, titanium dioxide, sodium saccharin
Otc - Purpose
Anticavity, Antihypersensitivity
Indications & Usage
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 using 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/sensitivty still persists after 4 weeks of use
Keep out of reach of children.
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.
Dosage & Administration
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, preferably after each emal or at least twice a day (morning and evening) or as recommended by a dentist or physician.
Make sure to brush all sensitive areas of the teeth. Do not swallow. • children under 12 years of age: Consult a dentist or doctor.
* Please review the disclaimer below.
