Label: ANTISPETIC- cetylpyridinium chloride liquid
- NDC Code(s): 53942-299-86
- Packager: Demoulas Super Markets
- 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 29, 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
- SPL UNCLASSIFIED SECTION
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INGREDIENTS AND APPEARANCE
ANTISPETIC
cetylpyridinium chloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53942-299 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:53942-299-86 1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/21/2012 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 02/21/2012 Labeler - Demoulas Super Markets (007869647) Registrant - Vi-Jon, LLC (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 790752542 manufacture(53942-299) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 088520668 manufacture(53942-299)