Label: ANTISPETIC- eucalyptol, menthol, methyl salicylate, thymol mouthwash
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NDC Code(s):
0869-0664-12,
0869-0664-13,
0869-0664-19,
0869-0664-69, view more0869-0664-77, 0869-0664-86, 0869-0664-88
- Packager: Vi-Jon, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated April 25, 2024
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- 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
- ADA Council Statement
- Disclaimer
- ADVERSE REACTIONS
- principal display panel
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INGREDIENTS AND APPEARANCE
ANTISPETIC
eucalyptol, menthol, methyl salicylate, thymol mouthwashProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0869-0664 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 0.6 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:0869-0664-86 1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/15/1992 2 NDC:0869-0664-77 500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/15/1992 3 NDC:0869-0664-69 250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/15/1992 4 NDC:0869-0664-88 2000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/15/1992 04/25/2024 5 NDC:0869-0664-13 1250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/15/1992 09/27/2015 6 NDC:0869-0664-12 1500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/15/1992 7 NDC:0869-0664-19 94 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/15/1992 12/01/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug 505G(a)(3) 07/15/1992 Labeler - Vi-Jon, LLC (088520668) Registrant - Consumer Product Partners, LLC (119091520) Establishment Name Address ID/FEI Business Operations Consumer Product Partners, LLC 119091514 manufacture(0869-0664)