Label: PCXX ONE MINUTE COOL PEPPERMINT- sodium fluoride gel
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Contains inactivated NDC Code(s)
NDC Code(s): 62007-054-16 - 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 ONE MINUTE COOL PEPPERMINT
sodium fluoride gelProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62007-054 Route of Administration topical Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION .02 mg in 1 mL Inactive Ingredients Ingredient Name Strength FD&C BLUE NO. 1 (UNII: H3R47K3TBD) .001 mg in 1 mL Product Characteristics Color blue Score Shape Size Flavor MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62007-054-16 473 mL in 1 BOTTLE, PLASTIC 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(62007-054)