Label: EXCEED TOTAL CARE SENSITIVE SPEARMINT TOOTH POLISH- potassium nitrate and sodium fluoride paste, dentifrice
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Contains inactivated NDC Code(s)
NDC Code(s): 54473-337-04 - Packager: Melaleuca, Inc
- 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 April 11, 2022
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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 SPEARMINT TOOTH POLISH
potassium nitrate and sodium fluoride paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54473-337 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 SPEARMINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54473-337-04 93.5 g in 1 TUBE; Type 0: Not a Combination Product 01/08/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 01/08/2022 Labeler - Melaleuca, Inc (139760102) Establishment Name Address ID/FEI Business Operations Melaleuca, Inc 805617610 manufacture(54473-337)
