Label: ANTISEPTIC- cetylpyridinium chloride rinse
- NDC Code(s): 46994-299-86
- Packager: Moran Foods, LLC
- Category: HUMAN OTC DRUG LABEL
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, 2022
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- Active ingredient
For this product
Stop use and ask a dentist if
- gingivitis, bleeding or redness persists for more than 2 weeks
- you have painful or swollen gums, pus from the gum line, loose teeth or increased spacing between the teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease.
- Other information
- Inactive ingredients
This rinse may cause temporary staining to the surface of teeth. This is not harmful, and adequate brushing may prevent its occurrence.
*This product is not manufactured or distributed by Procter & Gamble, distributor of Crest Pro-Health Multi-Protection Alcohol Free Rinse - Refreshing Clean Mint
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INGREDIENTS AND APPEARANCE
cetylpyridinium chloride rinse
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:46994-299 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE 0.7 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) POLOXAMER 188 (UNII: LQA7B6G8JG) SACCHARIN SODIUM (UNII: SB8ZUX40TY) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM BENZOATE (UNII: OJ245FE5EU) SUCRALOSE (UNII: 96K6UQ3ZD4) BENZOIC ACID (UNII: 8SKN0B0MIM) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:46994-299-86 1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/31/2007 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 07/31/2007 Labeler - Moran Foods, LLC (095484572) Registrant - Vi-Jon, LLC (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 790752542 manufacture(46994-299)