PCXX ONE MINUTE COOL PEPPERMINT- sodium fluoride gel
Ross Healthcare Inc.
Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
| PCXX ONE MINUTE COOL PEPPERMINT |
sodium fluoride gel
|Product Information |
|Product Type ||HUMAN PRESCRIPTION DRUG ||Item Code (Source) ||NDC:62007-054 |
|Route of Administration ||topical ||DEA Schedule || |
|Active Ingredient/Active Moiety |
|Ingredient Name ||Basis of Strength ||Strength |
|SODIUM FLUORIDE (FLUORIDE ION) ||FLUORIDE ION ||.02 mg in 1 mL |
|Inactive Ingredients |
|Ingredient Name ||Strength |
| FD&C BLUE NO. 1 ||.001 mg in 1 mL |
|Product Characteristics |
|Color ||blue ||Score || |
|Shape || ||Size || |
|Flavor ||MINT ||Imprint Code || |
|Contains || |
|# ||Item Code ||Package Description ||Multilevel Packaging |
| 1 ||NDC:62007-054-16 ||473 mL in 1 BOTTLE, PLASTIC ||None |
| 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.
|Registrant — Ross Healthcare Inc. (244249012) |
| Establishment |
|Name ||Address ||ID/FEI ||Operations |
|Ross Healthcare Inc. || ||244249012 ||manufacture (62007-054) |
Revised: 02/2015 Ross Healthcare Inc.
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