Label: ORAL DEFENSE FLUORIDE RINSE- sodium fluoride mouthwash
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Contains inactivated NDC Code(s)
NDC Code(s): 52644-002-00, 52644-002-02 - Packager: Oral Defense, LLC
- Category: HUMAN OTC 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 April 18, 2013
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Purpose
- Uses
- Warnings
- Keep out of the reach of children.
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Directions
Adults and children 6 years of age and older
- Use once a day, preferably before bedtime, after brushing and flossing thoroughly.
- For mature adults with gum recession, it is beneficial to use an interdental proxy brush (toothpick type plastic brush) to remove all food debris between all teeth.
- Use 10ml (1/3oz) and vigorously swish between the teeth for 1 minute. Spit out. Do not swallow.
- Supervise children over 6 years of age until capable of suing without supervision.
- Consult with a dentist or doctor for use with children under 6 years of age.
- Do not take in food or drink for 30 minutes after application.
- Inactive Ingredients
- Labels
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INGREDIENTS AND APPEARANCE
ORAL DEFENSE FLUORIDE RINSE
sodium fluoride mouthwashProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52644-002 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION .2418 g in 474 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) EDETATE DISODIUM (UNII: 7FLD91C86K) POLOXAMER 407 (UNII: TUF2IVW3M2) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) SORBITOL (UNII: 506T60A25R) SACCHARIN SODIUM ANHYDROUS (UNII: I4807BK602) GLYCERIN (UNII: PDC6A3C0OX) POLYSORBATE 80 (UNII: 6OZP39ZG8H) NATAMYCIN (UNII: 8O0C852CPO) MINT (UNII: FV98Z8GITP) SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618) SODIUM HYDROXIDE (UNII: 55X04QC32I) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) Product Characteristics Color turquoise (Blue green) Score Shape Size Flavor VANILLA (Vanilla Mint) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52644-002-00 474 mL in 1 BOTTLE, PLASTIC 2 NDC:52644-002-02 60 mL in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 08/31/2010 Labeler - Oral Defense, LLC (962643164) Establishment Name Address ID/FEI Business Operations Coastal Products Company 782445688 manufacture(52644-002)
