Label: ANTISPETIC- eucalyptol, menthol, methyl salicylate, thymol mouthwash
- NDC Code(s): 50594-664-12, 50594-664-77
- Packager: Big Lots
- 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 May 23, 2022
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- Active ingredients
- Purpose
- Use
- Warnings
- Do not use
- Stop use and ask a dentist if
- Keep out of reach of children.
- Directions
- Other information
- Inactive ingredients
- Questions or comments
- Disclaimer
- Adverse Reactions
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INGREDIENTS AND APPEARANCE
ANTISPETIC
eucalyptol, menthol, methyl salicylate, thymol mouthwashProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50594-664 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 (UNII: 506T60A25R) POLOXAMER 407 (UNII: TUF2IVW3M2) BENZOIC ACID (UNII: 8SKN0B0MIM) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SODIUM BENZOATE (UNII: OJ245FE5EU) FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50594-664-12 1500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/30/2015 2 NDC:50594-664-77 500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/30/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 04/30/2015 Labeler - Big Lots (017885351) Registrant - Vi-Jon, LLC (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 790752542 manufacture(50594-664) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 088520668 manufacture(50594-664)