FDA Label for Pronamel Repair Whitening
View Indications, Usage & Precautions
Pronamel Repair Whitening Product Label
The following document was submitted to the FDA by the labeler of this product Rite Aid. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Potassium nitrate 5% .................................................. Antihypersensitivity
Sodium fluoride 0.25% (0.15% w/v fluoride ion).......... Anticavity
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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