Label: WHITENING TOOTH POLISH- sodium fluoride paste
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Contains inactivated NDC Code(s)
NDC Code(s): 54473-188-04 - Packager: Melaleuca, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 February 8, 2011
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
Directions
- adults and children 2 years of age and older: brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician
- instruct children under 6 years of age on good brushing and rinsing habits (to minimize swallowing)
- supervise children as necessary until capable of using without supervision
- children under 2 years of age: consult a dentist or physician
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INACTIVE INGREDIENT
Inactive ingredients: aloe barbadensis, ascorbyl palmitate, camellia sinensis leaf extract, commiphora myrrha oil, flavor, glycerin, hydrated silica, melaleuca alternifolia (tea tree) leaf oil, papain, poloxamer 407, potassium acesulfame, propolis extract, sodium alkyl sulfate, sodium benzoate, sorbitol, tetrapotassium pyrophosphate, tetrasodium pyrophosphate, titanium dioxide, tocopheryl acetate, water, xanthan gum, xylitol
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
WHITENING TOOTH POLISH
sodium fluoride pasteProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54473-188 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE 0.26244 g in 108 g Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) ASCORBYL PALMITATE (UNII: QN83US2B0N) GREEN TEA LEAF (UNII: W2ZU1RY8B0) MYRRH OIL (UNII: H74221J5J4) GLYCERIN (UNII: PDC6A3C0OX) HYDRATED SILICA (UNII: Y6O7T4G8P9) TEA TREE OIL (UNII: VIF565UC2G) PAPAIN (UNII: A236A06Y32) POLOXAMER 407 (UNII: TUF2IVW3M2) ACESULFAME POTASSIUM (UNII: 23OV73Q5G9) SODIUM LAURYL SULFATE (UNII: 368GB5141J) SODIUM BENZOATE (UNII: OJ245FE5EU) SORBITOL (UNII: 506T60A25R) POTASSIUM PYROPHOSPHATE (UNII: B9W4019H5G) SODIUM PYROPHOSPHATE (UNII: O352864B8Z) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) WATER (UNII: 059QF0KO0R) XANTHAN GUM (UNII: TTV12P4NEE) XYLITOL (UNII: VCQ006KQ1E) Product Characteristics Color Score Shape Size Flavor MINT (Cool Mint) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54473-188-04 108 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 04/01/2010 Labeler - Melaleuca, Inc. (139760102) Establishment Name Address ID/FEI Business Operations Melaleuca, Inc._Knoxville 805617610 manufacture
