Label: UP AND UP SENSITIVE MAXIMUM STRENGTH WHITENING- potassium nitrate, and sodium fluoride paste
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Contains inactivated NDC Code(s)
NDC Code(s): 11673-682-04 - Packager: Target Corporation
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated December 5, 2017
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- ACTIVE INGREDIENT
- PURPOSE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
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INDICATIONS & USAGE
Directions
- adults and children 12 years of age and older
- apply at least a 1-inch strip of product onto a soft bristle toothbrush
- brush teeth thoroughly for at least 1 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
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
UP AND UP SENSITIVE MAXIMUM STRENGTH WHITENING
potassium nitrate, and sodium fluoride pasteProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11673-682 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) POTASSIUM NITRATE 50 mg in 1 g SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 1.5 mg in 1 g Inactive Ingredients Ingredient Name Strength SORBITOL (UNII: 506T60A25R) WATER (UNII: 059QF0KO0R) HYDRATED SILICA (UNII: Y6O7T4G8P9) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) MENTHOL (UNII: L7T10EIP3A) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11673-682-04 1 in 1 CARTON 12/24/2015 1 113 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 12/24/2015 Labeler - Target Corporation (006961700)