Label: ANTISEPTIC MOUTH RINSE- eucalyptol, menthol, methyl salicylate, thymol mouthwash
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Contains inactivated NDC Code(s)
NDC Code(s): 36800-210-12, 36800-210-77, 36800-210-86 - 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 April 2, 2012
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- ACTIVE INGREDIENT
- INDICATIONS & USAGE
- WARNINGS
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- SPL UNCLASSIFIED SECTION
- ADVERSE REACTIONS
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PRINCIPAL DISPLAY PANEL
TopCare
CITRUS
Antiseptic
Mouth Rinse
Control Tartar
Kills Germs for Extended
Plaque Protection
Helps Fight Tartar Buildup
Fights Plaque and Gingivitis
Enhanced Breath Protection
COMPARE TO CITRUS ADVANCED
LISTERINE with tartar protection
Sealed With Printed Neckband For Your Protection
16.9 FL OZ (1.05 PT) 500 mL -
INGREDIENTS AND APPEARANCE
ANTISEPTIC MOUTH RINSE
eucalyptol, menthol, methyl salicylate, thymol mouthwashProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-210 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength EUCALYPTOL (UNII: RV6J6604TK) (EUCALYPTOL - UNII:RV6J6604TK) EUCALYPTOL 0.092 kg in 100 L MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 0.042 kg in 100 L METHYL SALICYLATE (UNII: LAV5U5022Y) (METHYL SALICYLATE - UNII:LAV5U5022Y) METHYL SALICYLATE 0.060 kg in 100 L THYMOL (UNII: 3J50XA376E) (THYMOL - UNII:3J50XA376E) THYMOL 0.064 kg in 100 L Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) SORBITOL (UNII: 506T60A25R) POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F) POLOXAMER 407 (UNII: TUF2IVW3M2) BENZOIC ACID (UNII: 8SKN0B0MIM) ZINC CHLORIDE (UNII: 86Q357L16B) SUCRALOSE (UNII: 96K6UQ3ZD4) SODIUM BENZOATE (UNII: OJ245FE5EU) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) FD&C RED NO. 40 (UNII: WZB9127XOA) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:36800-210-86 1.0 L in 1 BOTTLE, PLASTIC 2 NDC:36800-210-12 1.5 L in 1 BOTTLE, PLASTIC 3 NDC:36800-210-77 0.5 L in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 07/20/1992 Labeler - Topco Associates LLC (006935977) Registrant - Vi Jon (790752542) Establishment Name Address ID/FEI Business Operations Vi Jon 790752542 manufacture