Label: ANTISPETIC- eucalyptol, menthol, methyl salicylate, thymol mouthwash
- NDC Code(s): 36800-664-12, 36800-664-69, 36800-664-77, 36800-664-86
- Packager: Topco Associates 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 May 24, 2022
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients
- Purpose
- Use
- Warnings
- Do not use
- Stop use
- Keep out of reach of children.
- Directions
- Inactive ingredients
- ADA Council Statement
- Disclaimer
- Adverse Reactions
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principal display panel
COMPARE TO LISTERINE
TopCare
everyday
Antiseptic
Mouthwash
ANTIGINVITIS/ANTIPLAQUE
BLUE MINT
- For better oral hygiene & fresher breath
- Kills germs that cause bad breath, plaque & the gum disease gingivitis
ADA
Accepted
American Dental Association
- Helps reduce plaque
- Helps reduce gingivitis
8.5 FL OZ (250 mL)
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INGREDIENTS AND APPEARANCE
ANTISPETIC
eucalyptol, menthol, methyl salicylate, thymol mouthwashProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-664 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 BENZOATE (UNII: OJ245FE5EU) FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:36800-664-69 250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/26/1992 2 NDC:36800-664-77 500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/26/1992 3 NDC:36800-664-86 1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/26/1992 4 NDC:36800-664-12 1500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/26/1992 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 10/26/1992 Labeler - Topco Associates LLC (006935977) Registrant - Vi-Jon, LLC (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 790752542 manufacture(36800-664) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 088520668 manufacture(36800-664)