Active Ingredient(S)
Sodium Fluoride 0.62mg (28 mg flouride ion)
Unpaste Tablet, Chewable
FDA Label NDC 74355-666
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Avespan Llc for the product Unpaste (NDC 74355-666). 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 active ingredient(s), purpose, use, warnings, otc - when using, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Anti-cavity
Use
aids in the prevention of dental cavities
Warnings
- When using this product, if irritation or sensitivity occurs discontinue use.
- Keep out of the reach of children. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center immediately.
Otc - When Using
When using this product, if irritation or sensitivity occurs discontinue use.
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 immediately.
Directions
- Adults and children 6 years of age and older; chew one tablet briefly and brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor.
- Do not swallow the tablet.
- Supervise children under 6 years of age for brushing and rinsing.
Other Information
Store at 25-30°C (68-77°F). Protect from excessive moisture.
Inactive Ingredients
Sorbitol, Microcrystalline Cellulose, Sodium Bicarbonate, Mentha Piperita
(Peppermint) Oil, Sodium CocoylIsethionate, Tapioca Starch, Citric Acid,
Illite Clay, Organic Menthol, Stevia, Gum Arabic, Bentonite Clay, Vanilla
Bean, Sodium Alginate
Package Label - Principal Display Panel
Mint (Mint Muyme)
Mint 10 Tablets; NDC: 74355-666-11
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