Otc - Active Ingredient
Potassium nitrate 5%
Sodium fluoride 0.25% (0.15% w/v fluoride ion)
Intensive Enamel Repair Whitening Tp Paste, Dentifrice
FDA Label NDC 36800-362
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Topco Associates Llc for the product Intensive Enamel Repair Whitening Tp (NDC 36800-362). 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, otc - when using, otc - stop use, otc - keep out of reach of children, dosage & administration, inactive ingredient, 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
Otc - When Using
When using this product, if irritation occurs discontinue use.
Otc - Stop 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 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 acidentally swallowed, get medical help or contact a Poison 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
Package Label.Principal Display Panel
Topco_enamelguard_intensive_ctn_2821090r1 (Topco Enamelguard Intensive Ctn 2821090r1)
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