Label: LISTERINE COOL MINT ANTISEPTIC- eucalyptol, menthol, methyl salicylate, thymol mouthwash
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NDC Code(s):
69968-0791-1,
69968-0791-2,
69968-0791-3,
69968-0791-4, view more69968-0791-5, 69968-0791-6, 69968-0791-9
- 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
- Active ingredient
- Purpose
- Uses
- Warnings
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- 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, methyl salicylate, thymol mouthwashProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69968-0791 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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 EUCALYPTOL (UNII: RV6J6604TK) (EUCALYPTOL - UNII:RV6J6604TK) EUCALYPTOL 0.92 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) POLOXAMER 407 (UNII: TUF2IVW3M2) BENZOIC ACID (UNII: 8SKN0B0MIM) SORBITOL (UNII: 506T60A25R) SODIUM BENZOATE (UNII: OJ245FE5EU) SACCHARIN SODIUM (UNII: SB8ZUX40TY) FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69968-0791-1 1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/21/2023 2 NDC:69968-0791-9 95 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/21/2023 3 NDC:69968-0791-3 250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/21/2023 4 NDC:69968-0791-2 1500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/21/2023 5 NDC:69968-0791-4 3700 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/21/2023 6 NDC:69968-0791-5 500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/21/2023 7 NDC:69968-0791-6 2 in 1 PACKAGE 03/21/2023 7 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 03/21/2023 Labeler - Johnson & Johnson Consumer Inc. (118772437)