Label: FLUORIDE DROPS- sodium fluoride liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 0288-5523-01 - Packager: Fluoritab Corporation
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Drug Label Information
Updated May 5, 2011
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- ACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
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- WARNINGS
- CONTRAINDICATIONS
- PURPOSE
- INDICATIONS & USAGE
- INACTIVE INGREDIENT
- WARNINGS AND PRECAUTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
FLUORIDE DROPS
sodium fluoride liquidProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0288-5523 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 2.5 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) METHYLPARABEN (UNII: A2I8C7HI9T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0288-5523-01 30 mL in 1 BOTTLE, DROPPER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 01/09/2011 Labeler - Fluoritab Corporation (005376702) Registrant - Fluoritab Corporation (005376702) Establishment Name Address ID/FEI Business Operations Medical Products Laboratories 002290302 manufacture, analysis Establishment Name Address ID/FEI Business Operations Fluoritab Corporation 005376702 label