Label: ANTISEPTIC MOUTH RINSE- eucalyptol, menthol, methyl salicylate, thymol mouthwash
- NDC Code(s): 53942-318-12, 53942-318-13, 53942-318-86
- Packager: Demoulas 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 June 7, 2023
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- 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 chrildren
- Directions
- Other information
- Inactive ingredients
- Disclaimer
- Adverse reaction
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ANTISEPTIC
MOUTH RINSE
Original
Kills germs that
cause Bad Breath,
Plaque and the gum
disease Gingivitis
ADA Accepted
American Dental Association
- Helps reduce plaque
- Helps reduce gingivitis
Sealed With Printed Neckband For Your Protection
1 L (33.8 FL OZ)
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INGREDIENTS AND APPEARANCE
ANTISEPTIC MOUTH RINSE
eucalyptol, menthol, methyl salicylate, thymol mouthwashProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53942-318 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) BENZOIC ACID (UNII: 8SKN0B0MIM) POLOXAMER 407 (UNII: TUF2IVW3M2) SODIUM BENZOATE (UNII: OJ245FE5EU) CARAMEL (UNII: T9D99G2B1R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53942-318-86 1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/15/1990 2 NDC:53942-318-13 1250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/15/1990 3 NDC:53942-318-12 1500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/15/1990 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 07/15/1990 Labeler - Demoulas Super Markets (007869647) Registrant - Vi-Jon, LLC (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 790752542 manufacture(53942-318) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 088520668 manufacture(53942-318)