Label: ANTISPETIC- eucalyptol, menthol, methyl salicylate, thymol mouthwash
- NDC Code(s): 56062-072-86
- Packager: Publix Super Markets
- 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 31, 2023
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- 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
-
SPL UNCLASSIFIED SECTION
SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION.
*This product is not manufactured or distributed by Johnson & Johnson Healthcare Products, distributor of FreshBurst Listerine
Distributed by: Publix Super Markets, Inc.,
3300 Publix Corporate Parkway
Lakeland, FL 33811 publix.com
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INGREDIENTS AND APPEARANCE
ANTISPETIC
eucalyptol, menthol, methyl salicylate, thymol mouthwashProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:56062-072 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 SOLUTION (UNII: 8KW3E207O2) 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:56062-072-86 1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/06/1998 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 01/06/1998 Labeler - Publix Super Markets (006922009) Registrant - Vi-Jon, LLC (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 790752542 manufacture(56062-072) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 088520668 manufacture(56062-072)