Label: ANITSEPTIC MOUTH RINSE- eucalyptol, menthol, methyl salicylate, thymol mouthwash
- NDC Code(s): 68016-941-77
- Packager: Pharmacy Value Alliance LLC
- 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 February 1, 2022
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- Official Label (Printer Friendly)
- Active ingredients
- Purpose section
- Use
- Warnings
- Do not use
- Stop use and ask a dentist if
- Keep out of reach of children
- Directions
- Other information
- inactive ingredients
- Questions?
- ADA Statement
- Disclaimer
- Adverse Reactions Section
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principal display panel
SEALED WITH PRINTED NECKBAND FOR Y0UR PROTECTION
COPARE TO FRESHBURST LISTERINE ANTISEPTIC MOUTHWASH
Premier
Value
Antiseptic
Mouthrinse
Antigingivitis/Antiplaque
spring mint
kills germs that cause bad breath, plaque & the gum disease gingivitis
ADA
Accepted
American
Dental
Association
1 L (33.8 FL OZ)
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INGREDIENTS AND APPEARANCE
ANITSEPTIC MOUTH RINSE
eucalyptol, menthol, methyl salicylate, thymol mouthwashProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68016-941 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:68016-941-77 1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/19/2003 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 08/19/2003 Labeler - Pharmacy Value Alliance LLC (101668460) Registrant - Vi Jon, LLC (790752542) Establishment Name Address ID/FEI Business Operations Vi Jon, LLC 790752542 manufacture(68016-941) Establishment Name Address ID/FEI Business Operations Vi Jon, LLC 088520668 manufacture(68016-941)