Label: LISTERINE FRESHBURST ANTISEPTIC- eucalyptol, menthol, unspecified form, methyl salicylate, and thymol mouthwash
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NDC Code(s):
69968-0239-1,
69968-0239-2,
69968-0239-3,
69968-0239-5, view more69968-0239-8
- 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 January 9, 2023
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
- Warnings
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- Other information
- Inactive ingredients
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- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 1500 mL Bottle Label
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INGREDIENTS AND APPEARANCE
LISTERINE FRESHBURST ANTISEPTIC
eucalyptol, menthol, unspecified form, methyl salicylate, and thymol mouthwashProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69968-0239 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) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69968-0239-5 500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/17/2018 2 NDC:69968-0239-2 250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/03/2019 3 NDC:69968-0239-1 1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 09/18/2018 4 NDC:69968-0239-3 1500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/28/2018 5 NDC:69968-0239-8 2 in 1 PACKAGE 04/24/2020 10/11/2023 5 NDC:69968-0239-3 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 08/17/2018 Labeler - Johnson & Johnson Consumer Inc. (118772437)