Otc - Active Ingredient
Potassium nitrate 5% .................................................. Antihypersensitivity
Sodium fluoride 0.25% (0.15% w/v fluoride ion).......... Anticavity
Pronamel Repair Whitening Paste, Dentifrice
FDA Label NDC 11822-6310
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Rite Aid for the product Pronamel Repair Whitening (NDC 11822-6310). 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, warnings, otc - purpose, indications & usage, otc - keep out of reach of children, dosage & administration, 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
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 stil persists after 4 weeks of use.
Otc - Purpose
Anthihypersensitivity
Anticavity
Indications & Usage
builds increasing protection against painful sensitivty of the teeth to cold, acids, sweets, or contact. Aids in the prevention of dental cavities.
Otc - Keep Out Of Reach Of Children
If more than used for brushing is accidentaly swallowed, get medical help or contact a Posion Control Center right away.
Dosage & Administration
adults and children 12 years of age and older: apply at least a 1-inch strip of the product ontp a soft bristle toothbrush. Brush teeth thoroughly for at least one minute twice 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.
Inactive Ingredient
water, hydrated silica, sorbitol, glycerin, PEG-8, flavor, cocamidopropyl betaine, titanium dioxide, xanthan gum, sodium saccharin, sodium hydroxide
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