Label: PCXX ONE MINTE GEL VANILLA ORANGE- fluoride treatment gel
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Contains inactivated NDC Code(s)
NDC Code(s): 62007-011-16 - Packager: Ross Healthcare Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
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Drug Label Information
Updated May 21, 2014
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INGREDIENTS AND APPEARANCE
PCXX ONE MINTE GEL VANILLA ORANGE
fluoride treatment gelProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62007-011 Route of Administration topical Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 27.2 mg in 1 mg Inactive Ingredients Ingredient Name Strength FD&C RED NO. 40 (UNII: WZB9127XOA) .01 mg in 1 mg FD&C YELLOW NO. 5 (UNII: I753WB2F1M) .02 mg in 1 mg Product Characteristics Color orange Score Shape Size Flavor VANILLA, ORANGE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62007-011-16 1 mg in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 05/21/2014 Labeler - Ross Healthcare Inc. (244249012) Registrant - Ross Healthcare Inc. (244249012) Establishment Name Address ID/FEI Business Operations Ross Healthcare Inc. 244249012 manufacture(62007-011)
