Label: ANITSEPTIC MOUTH RINSE- eucalyptol, menthol, methyl salicylate, thymol mouthwash
- NDC Code(s): 68016-941-77
- Packager: Pharmacy Value Alliance 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 January 31, 2023
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients
- Purpose section
- Use
- Warnings
- Do not use
- Stop use and ask a dentist if
- Keep out of reach of children
- Directions
- Other information
- inactive ingredients
- Questions?
-
SPL UNCLASSIFIED SECTION
*This product is not manufactured or distributed by Johnson & Johnson Healthcare Products, distributor of Freshburst Listerine Antiseptic Mouthwash.
If for any reason you are not satisified with this product, please return it to the store where purchased for a full refund.
Distributed by:
Pharmacy Value Alliance LLC
407 East Lancaster Avenue,
Wayne, PA 19087
- principal display panel
-
INGREDIENTS AND APPEARANCE
ANITSEPTIC MOUTH RINSE
eucalyptol, menthol, methyl salicylate, thymol mouthwashProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68016-941 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength EUCALYPTOL (UNII: RV6J6604TK) (EUCALYPTOL - UNII:RV6J6604TK) EUCALYPTOL 0.92 mg in 1 mL MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 0.42 mg in 1 mL METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE 0.60 mg in 1 mL THYMOL (UNII: 3J50XA376E) (THYMOL - UNII:3J50XA376E) THYMOL 0.64 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) SORBITOL SOLUTION (UNII: 8KW3E207O2) POLOXAMER 407 (UNII: TUF2IVW3M2) BENZOIC ACID (UNII: 8SKN0B0MIM) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SODIUM CITRATE (UNII: 1Q73Q2JULR) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68016-941-77 1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/19/2003 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 08/19/2003 Labeler - Pharmacy Value Alliance LLC (101668460) Registrant - Vi Jon, LLC (790752542) Establishment Name Address ID/FEI Business Operations Vi Jon, LLC 790752542 manufacture(68016-941) Establishment Name Address ID/FEI Business Operations Vi Jon, LLC 088520668 manufacture(68016-941)