Label: EXCEED TOTAL CARE SENSITIVE PEPPERMINT TOOTH POLISH- potassium nitrate and sodium fluoride paste, dentifrice
- NDC Code(s): 54473-340-01
- Packager: Melaleuca, Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated May 24, 2024
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- INDICATIONS & USAGE
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WARNINGS
Warnings
- Keep out of reach of children under 6 years of age. If more than used for brushing is accidently swallowed, get medical help or contact a Poison Control Center right away.
- Sensitivt teeth may indicate a serious problem that may need prompt care by a dentist. See your dentist if the problem persists or worsens. Do not use this product longer than 4 weeks unless recommended by a dentist or doctor.
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DOSAGE & ADMINISTRATION
Directions
- adults and children 12 years of age or older: apply at least a 1-inch strup of the tooth polish onto a soft bristle toothbrush. Brush teeth thoroughly for at least 1 minute twice a day (morning and evening) or as recommended by a dentist or doctor. Be sure to brush all sensitive areas of the teeth.
- children under 12 years of age: consult a dentist or doctor
- INACTIVE INGREDIENT
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- WHEN USING
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
EXCEED TOTAL CARE SENSITIVE PEPPERMINT TOOTH POLISH
potassium nitrate and sodium fluoride paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54473-340 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) POTASSIUM NITRATE 0.2272 g in 93.5 g SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE 4.675 g in 93.5 g Inactive Ingredients Ingredient Name Strength HYDRATED SILICA (UNII: Y6O7T4G8P9) POLOXAMER 407 (UNII: TUF2IVW3M2) PROPANEDIOL (UNII: 5965N8W85T) MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K) WATER (UNII: 059QF0KO0R) XANTHAN GUM (UNII: TTV12P4NEE) XYLITOL (UNII: VCQ006KQ1E) CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X) ZINC CITRATE (UNII: K72I3DEX9B) SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G) REBAUDIOSIDE A (UNII: B3FUD0528F) SORBITOL (UNII: 506T60A25R) BENZYL ALCOHOL (UNII: LKG8494WBH) SODIUM PYROPHOSPHATE (UNII: O352864B8Z) GLYCERIN (UNII: PDC6A3C0OX) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) LAURAMIDOPROPYL BETAINE (UNII: 23D6XVI233) SODIUM HYDROXIDE (UNII: 55X04QC32I) Product Characteristics Color Score Shape Size Flavor PEPPERMINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54473-340-01 93.5 g in 1 TUBE; Type 0: Not a Combination Product 11/10/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M022 01/08/2022 Labeler - Melaleuca, Inc (139760102) Establishment Name Address ID/FEI Business Operations Melaleuca, Inc 805617610 manufacture(54473-340)