Label: LISTERINE ULTRACLEAN ANTISEPTIC COOL MINT- eucalyptol, menthol, methyl salicylate, thymol mouthwash
- NDC Code(s): 69968-0788-1, 69968-0788-2, 69968-0788-5, 69968-0788-9
- Packager: Johnson & Johnson Consumer Inc.
- 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 August 17, 2023
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- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 1.5 L Bottle Label
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INGREDIENTS AND APPEARANCE
LISTERINE ULTRACLEAN ANTISEPTIC COOL MINT
eucalyptol, menthol, methyl salicylate, thymol mouthwashProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69968-0788 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, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM 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) ZINC CHLORIDE (UNII: 86Q357L16B) SODIUM BENZOATE (UNII: OJ245FE5EU) SUCRALOSE (UNII: 96K6UQ3ZD4) SACCHARIN SODIUM (UNII: SB8ZUX40TY) FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69968-0788-5 500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/05/2023 2 NDC:69968-0788-1 1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/05/2023 3 NDC:69968-0788-2 1500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/05/2023 4 NDC:69968-0788-9 2 in 1 PACKAGE 02/05/2023 4 1500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 02/05/2023 Labeler - Johnson & Johnson Consumer Inc. (118772437)