Label: MOUTH RINSE- eucalyptol, menthol, methyl salicylate, thymol mouthwash
- NDC Code(s): 55910-318-12, 55910-318-77, 55910-318-86
- Packager: Old East Main Co
- 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 6, 2023
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Since 1903 Rexall is a registered trademark of Rexall Sundown, Inc.
Distributed by Old East Main Co.
100 Mission Ridge
Goodlettsville, TN 37072
DSP-TN-21091
DSP-MO-20087
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INGREDIENTS AND APPEARANCE
MOUTH RINSE
eucalyptol, menthol, methyl salicylate, thymol mouthwashProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55910-318 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) BENZOIC ACID (UNII: 8SKN0B0MIM) POLOXAMER 407 (UNII: TUF2IVW3M2) SODIUM BENZOATE (UNII: OJ245FE5EU) CARAMEL (UNII: T9D99G2B1R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55910-318-12 1500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/11/2001 2 NDC:55910-318-77 500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/11/2001 3 NDC:55910-318-86 1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/11/2001 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 01/11/2001 Labeler - Old East Main Co (068331990) Registrant - Vi-Jon, LLC (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 790752542 manufacture(55910-318) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 088520668 manufacture(55910-318)