Otc - Active Ingredient
Potassium nitrate 5%
Sodium fluoride 0.24% (0.15% w/v fluoride ion)
Natural White Sensitive Enamel Guard Alpine Mint Paste, Dentifrice
FDA Label NDC 62721-0002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Lornamead Products for the product Natural White Sensitive Enamel Guard Alpine Mint (NDC 62721-0002). 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, warnings, otc - stop use, indications & usage, otc - keep out of reach of children, inactive ingredient, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Antihypersensitivity
Anticavity
Warnings
Warnings
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.
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 - Keep Out Of Reach Of Children
Kep out of reach of children. if more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
Inactive Ingredient
water, hydrated silica, sorbitol, glycerin, PEG-8, cocamidopropyl betaine, flavor, titanium dioxide, xanthan gum, sodium saccharin, sodium hydroxide
Dosage & Administration
Directions
adults and children 12 years of age and older: appy at least a 1-inch strip of the product onto a soft bristle toothbrush
- brush teeth thoroughly for at least one minute wice 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.
Package Label.Principal Display Panel
Nw_enamelguard_ctn_2011571r1 (Nw Enamelguard Alpinemint Ctn 2011571r1)
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