Label: LISTERINE COOL MINT ANTISEPTIC- eucalyptol, menthol, unspecified form, methyl salicylate, and thymol liquid
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NDC Code(s):
69968-0550-1,
69968-0550-2,
69968-0550-3,
69968-0550-4, view more69968-0550-5, 69968-0550-8, 69968-0550-9
- Packager: Johnson & Johnson Consumer Inc.
- Category: HUMAN OTC DRUG LABEL
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 January 27, 2023
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- SPL UNCLASSIFIED SECTION
- Active ingredients
- Purposes
- Uses
- Warnings
- Directions
- Other information
- Inactive ingredients
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- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 1.5 L Bottle Label
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INGREDIENTS AND APPEARANCE
LISTERINE COOL MINT ANTISEPTIC
eucalyptol, menthol, unspecified form, methyl salicylate, and thymol liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69968-0550 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) 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:69968-0550-9 95 mL in 1 BOTTLE; Type 0: Not a Combination Product 12/03/2018 2 NDC:69968-0550-2 250 mL in 1 BOTTLE; Type 0: Not a Combination Product 12/03/2018 3 NDC:69968-0550-5 500 mL in 1 BOTTLE; Type 0: Not a Combination Product 12/03/2018 4 NDC:69968-0550-1 946.353 mL in 1 BOTTLE; Type 0: Not a Combination Product 12/03/2018 5 NDC:69968-0550-4 1419.529 mL in 1 BOTTLE; Type 0: Not a Combination Product 12/03/2018 6 NDC:69968-0550-3 3700 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/01/2019 7 NDC:69968-0550-8 2 in 1 PACKAGE 11/24/2020 7 NDC:69968-0550-4 1419.529 mL in 1 BOTTLE; 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 12/03/2018 Labeler - Johnson & Johnson Consumer Inc. (118772437)