Label: EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL mouthwash
- NDC Code(s): 70677-1234-1
- Packager: Strategic Sourcing Services LLC
- 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 July 25, 2023
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- TEP
- Active ingredients
- Purpose
- Use
- Warnings
- Do not use if
- Stop use and ask a dentist if
- Keep out of reach of children
- Directions
- Other information
- Inactive ingredients
- Disclaimer
- Adverse Reaction
- Principal display panel
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INGREDIENTS AND APPEARANCE
EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL
eucalyptol, menthol, methyl salicylate, thymol mouthwashProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70677-1234 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:70677-1234-1 1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/09/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 02/09/2017 Labeler - Strategic Sourcing Services LLC (116956644) Registrant - Vi-Jon, LLC (088520668) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 790752542 manufacture(70677-1234) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 088520668 manufacture(70677-1234)