Otc - Active Ingredient
Potassium nitrate 5%....................................................Antihypersensitivity
Sodium fluoride 0.24% (0.15% w/v fluoride ion)............Anticavity
Quality Choice Paste
FDA Label NDC 83324-291
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Chain Drug Marketing Association Inc for the product Quality Choice (NDC 83324-291). 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, inactive ingredient, otc - purpose, warnings, indications & usage, dosage & administration, otc - keep out of reach of children, 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
Inactive Ingredient
water, hydrated silica, sorbitol, glycerin, cocamidopropyl betaine, PEG-12, titanium dioxide, cellulose gum, flavor, sodium benzoate, sodium saccharin, red 40
Otc - Purpose
- 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, 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/esnsitivty still persists after 4 weeks of use.
Keep 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.
Indications & Usage
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 nore 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.
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 nore 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.
Otc - Keep 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.
Package Label.Principal Display Panel
Carton Artwork (Qc Sensitive Mint Carton 2821063r2 Ol Page 0001)
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