Otc - Active Ingredient
potassium nitrate 5%
Sodium fluoride 0.25% (0.15% w/v fluoride ion)
Pronamel Repair Whitening Paste, Dentifrice
FDA Label NDC 56062-514
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Publix Super Market Inc for the product Pronamel Repair Whitening (NDC 56062-514). 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, otc - purpose, indications & usage, warnings, 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
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.
