Label: TARTAR CONTROL- eucalyptol mouthwash
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Contains inactivated NDC Code(s)
NDC Code(s): 55312-210-86 - Packager: Western Family
- 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 March 26, 2012
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- ACTIVE INGREDIENT
- INDICATIONS & USAGE
- WARNINGS
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
TARTAR CONTROL
eucalyptol mouthwashProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55312-210 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength EUCALYPTOL (UNII: RV6J6604TK) (EUCALYPTOL - UNII:RV6J6604TK) EUCALYPTOL .092 mL in 100 L MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL .042 mL in 100 L METHYL SALICYLATE (UNII: LAV5U5022Y) (METHYL SALICYLATE - UNII:LAV5U5022Y) METHYL SALICYLATE .060 mL in 100 L THYMOL (UNII: 3J50XA376E) (THYMOL - UNII:3J50XA376E) THYMOL .064 mL 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:55312-210-86 1 L in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 09/23/2010 Labeler - Western Family (192166072) Registrant - Vi Jon (790752542) Establishment Name Address ID/FEI Business Operations Vi Jon 790752542 manufacture