Label: ANTISEPTIC- cetylpyridinium chloride mouthwash
- NDC Code(s): 63940-299-86
- Packager: Liberty Procurement, Inc
- 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 June 22, 2022
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Use
- Warnings
- Stop use and ask a dentist if
- Keep out of reach of children under 6 years of age
- Directions
- Other information
- Inactive ingredients
- Safety Information
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SPL UNCLASSIFIED SECTION
*This product is not manufactured or distributed by Procter & Gamble, distributor of Crest Pro-Health Multi-Protection Alcohol Free Rinse - Refreshing Clean Mint.
COREVLAUES
Antiseptic
MOUTHWASH
ANTIGINGIVITIS/ANTIPLAQUE ORAL RINSE
MULTI-ACTION
Distributed by
Liberty Procurement, Inc.
650 Liberty Ave.
Union, NJ 07083 USA
Visit us at www.facevalues.com
299.005/299AK
- principal display panel
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INGREDIENTS AND APPEARANCE
ANTISEPTIC
cetylpyridinium chloride mouthwashProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63940-299 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:63940-299-86 1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/11/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 07/11/2016 Labeler - Liberty Procurement, Inc (804085293) Registrant - Vi-Jon, LLC (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 790752542 manufacture(63940-299) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 088520668 manufacture(63940-299)