Label: ANTISEPTIC MOUTH RINSE- eucalyptol, menthol, methyol salicylate, thymol mouthwash
- NDC Code(s): 68998-072-12
- Packager: Marc Glassman, Inc
- Category: HUMAN OTC DRUG LABEL
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Drug Label Information
Updated April 10, 2023
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INGREDIENTS AND APPEARANCE
ANTISEPTIC MOUTH RINSE
eucalyptol, menthol, methyol salicylate, thymol mouthwashProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68998-072 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:68998-072-12 1500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/22/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 04/22/2019 Labeler - Marc Glassman, Inc (094487477) Registrant - Vi-Jon, LLC (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 790752542 manufacture(68998-072) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 088520668 manufacture(68998-072)