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 Publix Super Market Inc. 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%
Sodium fluoride 0.25% (0.15% w/v fluoride ion)
Otc - Purpose
Antihypersensitivity
Anticavity
Indications & Usage
builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact * aids in the prevention of dental cavities
Warnings
When using this product, of iffitation occurs discontine use.
Stop use and ask a dentist if the problem persists or worsen. Sensitive teeth may indicate a serious problem that many need prompt care by a dentist.* pain/sensitivty 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 accidently 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 onto 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
* Please review the disclaimer below.
