Label: ORAL DEFENSE- cetylpyridinium chloride mouthwash
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Contains inactivated NDC Code(s)
NDC Code(s): 52644-001-00, 52644-001-02 - Packager: Oral Defense, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 May 18, 2012
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- Drug Facts
- Pupose
- Uses
- Warnings
- Keep out of the reach of children
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Directions
Healthy Mouth
Rinse with 1 capful after brushing your teeth with Oral Defense toothpaste when needed for breath refreshment and to maintain healthy mouth tissue.
Red, Bleeding gums and inflamed mouth
For best and speedy results use with Oral Defense toothpaste. Use 1 capful after brushing with Oral Defense Toothpaste for 1 minute. If the lesions or sores re in one area, hold the capful of rinse in your mouth over the lesion for 1 minute, or if not possible to hold for 1 minute then use twice, 1 capful for 30 seconds each before spitting out. The most critical time of application is at bedtime, when no food or water is to be consumed after use, as the rinse has ingredients that have a long effective residual throughout the night when healing is best to occur.
- Inactive Ingredients
- Questions or comments
- Labeling
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INGREDIENTS AND APPEARANCE
ORAL DEFENSE
cetylpyridinium chloride mouthwashProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52644-001 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE .47 mL in 474 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) EDETATE DISODIUM (UNII: 7FLD91C86K) POLOXAMER 407 (UNII: TUF2IVW3M2) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SORBITOL (UNII: 506T60A25R) SACCHARIN SODIUM (UNII: SB8ZUX40TY) GLYCERIN (UNII: PDC6A3C0OX) POLYSORBATE 80 (UNII: 6OZP39ZG8H) NATAMYCIN (UNII: 8O0C852CPO) SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618) PEPPERMINT OIL (UNII: AV092KU4JH) MENTHOL (UNII: L7T10EIP3A) SODIUM HYDROXIDE (UNII: 55X04QC32I) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) Product Characteristics Color turquoise (Blue/Green) Score Shape Size Flavor MINT (Cool mint) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52644-001-00 474 mL in 1 BOTTLE, PLASTIC 2 NDC:52644-001-02 60 mL in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 07/26/2010 Labeler - Oral Defense, LLC (962643164) Establishment Name Address ID/FEI Business Operations Coastal Products Company 782445688 manufacture(52644-001)
