Label: IONITE R- sodium fluoride liquid
- NDC Code(s): 53045-265-64
- Packager: Dharma Research, Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Drug Label Information
Updated November 6, 2020
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- Official Label (Printer Friendly)
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INDICATIONS AND USAGE
This is a one-minute, ready-to-use fluoride treatment rinse for in-office patient use. Remove cap from bottle and insert enclosed pump into bottle and tighten. Pump ½ oz into a cup. Instruct patient to thoroughly rinse the entire amount around and between teeth for one minute, then spit-out rinse. Repeat the procedure to ensure maximum benefit. Instruct patient not to eat or drink for at least 30 minutes.
- DOSAGE FORM AND STRENGTH
- CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
Do not swallow. Keep out of reach of children. Read prescribing information fully before using this product. Use in children less than 6 years of age requires special supervision to prevent swallowing. If product is accidentally swallowed in quantities greater than would normally occur with a rinse, seek medical help right away.
- ADVERSE REACTIONS
- DESCRIPTION
- HOW SUPPLIED/STORAGE
- Ionite R Sodium Fluoride Rinse
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INGREDIENTS AND APPEARANCE
IONITE R
sodium fluoride liquidProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53045-265 Route of Administration DENTAL, ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 38 g in 1 L Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM CITRATE (UNII: 1Q73Q2JULR) SACCHARIN SODIUM (UNII: SB8ZUX40TY) XYLITOL (UNII: VCQ006KQ1E) Product Characteristics Color Score Shape Size Flavor SPEARMINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53045-265-64 1.9 L in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 11/03/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 11/03/2013 Labeler - Dharma Research, Inc. (078444642) Registrant - Dharma Research, Inc. (078444642) Establishment Name Address ID/FEI Business Operations Dharma Research, Inc. 078444642 manufacture(53045-265)
