Label: SENSITIVE TOOTH POLISH- potassium nitrate and sodium fluoride paste, dentifrice
- NDC Code(s): 54473-302-04
- 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 March 29, 2018
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
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, preferably after each meal or at least twice a day (morning and evening) or as recommended by a dentist or physician. Make sure to brush all sensitive areas of the teeth.
- children under 12 years of age: consult a dentist or physician
- PRECAUTIONS
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INACTIVE INGREDIENT
Inactive ingredients aloe barbadensis juice powder, ascorbyl palmitate, camellia sinensis leaf extract, chondurs crispus (carrageenan), commiphora myrrha oil, flavor, glycerin, hydrated sisica, melaleuca alternifolia (tea tree) leaf oil, papain, poloxamer 407, potassium acesulfame, sodium alkyl sulfate, sodium benzoate, sorbitol, tetrapotassium pyrophosphate, tetrasodium pyrphosphate, titanium dioxide, tocopheryl acetate, water, xanthan gum, xylitol, zinc citrate
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SENSITIVE TOOTH POLISH
potassium nitrate and sodium fluoride paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54473-302 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.26244 g in 108 g POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) POTASSIUM NITRATE 5.4 g in 108 g Inactive Ingredients Ingredient Name Strength ACESULFAME POTASSIUM (UNII: 23OV73Q5G9) ALOE VERA LEAF (UNII: ZY81Z83H0X) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) ASCORBYL PALMITATE (UNII: QN83US2B0N) CARRAGEENAN (UNII: 5C69YCD2YJ) GLYCERIN (UNII: PDC6A3C0OX) GREEN TEA LEAF (UNII: W2ZU1RY8B0) HYDRATED SILICA (UNII: Y6O7T4G8P9) MYRRH OIL (UNII: H74221J5J4) PAPAIN (UNII: A236A06Y32) POLOXAMER 407 (UNII: TUF2IVW3M2) POTASSIUM PYROPHOSPHATE (UNII: B9W4019H5G) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM LAURYL SULFATE (UNII: 368GB5141J) SODIUM PYROPHOSPHATE (UNII: O352864B8Z) SORBITOL (UNII: 506T60A25R) TEA TREE OIL (UNII: VIF565UC2G) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) WATER (UNII: 059QF0KO0R) XANTHAN GUM (UNII: TTV12P4NEE) XYLITOL (UNII: VCQ006KQ1E) ZINC CITRATE (UNII: K72I3DEX9B) Product Characteristics Color Score Shape Size Flavor MINT (Clean Mint) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54473-302-04 108 g in 1 TUBE; Type 0: Not a Combination Product 01/01/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 01/03/2012 Labeler - Melaleuca, Inc. (139760102) Establishment Name Address ID/FEI Business Operations Melaleuca, Inc. 805617610 manufacture(54473-302)
