Label: ANTISEPTIC- eucalyptol, menthol, methyl salicylate, thymol mouthwash
- NDC Code(s): 59779-072-12, 59779-072-69, 59779-072-77, 59779-072-86
- Packager: CVS Pharmacy, 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 27, 2023
If you are a consumer or patient please visit this version.
- 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
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SPL UNCLASSIFIED SECTION
*This product is not manufactured or distributed by Johnson & Johnson Healthcare Products, distributor of Listerine FreshBurst Antiseptic
Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
(c)2019 CVS/pharmacy
CVS.com 1-800-SHOP CVS
Made in the U.S.A. of U.S. and foreign components
V-16224
CVS Quality Money Back Guarantee
Please Recycle
DSP-TN-15000
DSP-MO-36
SDS-TN-15012
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Principal display panel
CVS Healh
Compare to the active ingredients in Listerine FreshBurst Antiseptic*
Antiseptic
Mouthwash
ANTIGINGIVITIS/ANTIPLAQUE
Kills germs that cause plaque, gingivitis & bad breath
Green Mint
ADA
Accepted
American
Dental
Association
- Helps reduce plaque
- Helps redice gingivitis
Sealed with printed neckband for your protection. Do not use if broken or missing.
1.5 L (50.7 FL OZ)
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INGREDIENTS AND APPEARANCE
ANTISEPTIC
eucalyptol, menthol, methyl salicylate, thymol mouthwashProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59779-072 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 0.60 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 CITRATE (UNII: 1Q73Q2JULR) 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:59779-072-77 500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/09/1995 2 NDC:59779-072-86 1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/09/1995 3 NDC:59779-072-12 1500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/09/1995 4 NDC:59779-072-69 250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/09/1995 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 08/09/1995 Labeler - CVS Pharmacy, Inc (062312574) Registrant - Vi-Jon, LLC (790752542)