Otc - Active Ingredient
Stannous fluoride 0.454% w/w (0.15% w/v fluoride ion) .... Anticavity/Antihypersensitivity
Walgreens Restore And Defend Paste, Dentifrice
FDA Label NDC 0363-1599
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Walgreens for the product Walgreens Restore And Defend (NDC 0363-1599). 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, indications & usage, dosage & administration, warnings, otc - keep out of reach of children, otc - purpose, 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, flavor, cocamidopropyl betaine, sodium lauryl sulfate, titanium dioxide, cellulose gum, sodium saccharin
Indications & Usage
Adults and children 12 years of age and older: apply at least a 1-inch strip of the produc tonto a soft bristle toothbrush. brush teeth thoroughly for at least one minute, preferably after each meal 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.
Dosage & Administration
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 pay 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 bushing is accidentally swallowed, get medical help or contact a poison control center right away.
Otc - Purpose
Products containing stannous fluoride may produce surface staining of the teeth. Adquate tooth brushing may prevent these stains which are not harmful or permanent and may be removed by your dentist. This product is specifically formulated to help prevent staining. Store below 30C (86F).
Package Label.Principal Display Panel
Pdp (5820059)
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