Label: TARTAR CONTROL PLUS- eucalyptol, menthol, methyl salicylate, thymol mouthwash
- NDC Code(s): 41163-855-12, 41163-855-86
- Packager: United Natural Foods, Inc. dba UNFI
- 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 10, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Use
- Warnings
- Do not use
- Stop use and ask a dentist if
- Keep out of reach of children.
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Directions
adults and children 12 years of age and older - vigorously swish 20 mL (2/3 FL OZ or 4 teaspoonfuls) between teeth for 30 seconds then spit out; do not swallow
children 6 years to under 12 years of age - supervise use
children under 6 years of age - do not use
- this rinse is not intended to replace brushing or flossing
- Other information
- Inactive ingredients
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SPL UNCLASSIFIED SECTION
This product is not manufactured or distributed by Johnson & Johnson Corporation, distributor of Listerine Ultraclean Cool Mint Antiseptic Mouthwash.
Sealed With Printed Neckband For Your Protection
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855-423-2630
DISTRIBUTED BY UNFI Providence, RI 02908 USA
DSP-TN-21091
DSP-MO-20087
- Principal display panel
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INGREDIENTS AND APPEARANCE
TARTAR CONTROL PLUS
eucalyptol, menthol, methyl salicylate, thymol mouthwashProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41163-855 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) ZINC CHLORIDE (UNII: 86Q357L16B) SODIUM BENZOATE (UNII: OJ245FE5EU) SUCRALOSE (UNII: 96K6UQ3ZD4) SACCHARIN SODIUM (UNII: SB8ZUX40TY) FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41163-855-86 1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/20/2017 2 NDC:41163-855-12 1500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/20/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 01/20/2017 Labeler - United Natural Foods, Inc. dba UNFI (943556183) Registrant - Vi-Jon, LLC (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 790752542 manufacture(41163-855) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 088520668 manufacture(41163-855)