Label: NEUTRAL RINSE- sodium fluoride liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 62007-210-64 - Packager: Ross Healthcare, Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated October 18, 2011
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- ACTIVE INGREDIENTS SECTION
- PURPOSE SECTION
- CHILDREN SECTION
- INDICATIONS AND USE SECTION
- WARNINGS SECTION
- DOSAGE AND ADMINISTRATION SECTION
- INACTIVE INGREDIENT SECTION
- PACKAGE LABEL
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INGREDIENTS AND APPEARANCE
NEUTRAL RINSE
sodium fluoride liquidProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62007-210 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE 2 mL in 100 mL Inactive Ingredients Ingredient Name Strength POTASSIUM SORBATE (UNII: 1VPU26JZZ4) WATER (UNII: 059QF0KO0R) SACCHARIN SODIUM DIHYDRATE (UNII: SB8ZUX40TY) XYLITOL (UNII: VCQ006KQ1E) Product Characteristics Color blue (BLUE 1) Score Shape Size Flavor MINT (COOL PEPERMINT) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62007-210-64 1893 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 09/01/2011 Labeler - Ross Healthcare, Inc. (244249012) Registrant - Ross Healthcare, Inc. (244249012) Establishment Name Address ID/FEI Business Operations Ross Healthcare, Inc. 244249012 manufacture