Label: PCXX MINUTE FM LIME- sodium fluoride aerosol, foam
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Contains inactivated NDC Code(s)
NDC Code(s): 62007-270-07 - Packager: Ross Healthcare Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Drug Label Information
Updated February 3, 2015
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INGREDIENTS AND APPEARANCE
PCXX MINUTE FM LIME
sodium fluoride aerosol, foamProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62007-270 Route of Administration topical Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION .0272 mg in 1 g Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) .04 g in 1 g SODIUM LAURYL SULFATE (UNII: 368GB5141J) 1.2 mg in 1 g HYDROFLUORIC ACID (UNII: RGL5YE86CZ) 8.5 mg in 1 g SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW) .011 g in 1 g XANTHAN GUM (UNII: TTV12P4NEE) 4.2 mg in 1 g Product Characteristics Color Score Shape Size Flavor LIME Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62007-270-07 125 g in 1 BOTTLE, SPRAY Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 02/03/2015 Labeler - Ross Healthcare Inc. (244249012) Registrant - Ross Healthcare Inc. (244249012) Establishment Name Address ID/FEI Business Operations Ross Healthcare Inc. 244249012 manufacture(62007-270)