Label: ANTISEPTIC MOUTH RINSE- eucalyptol. menthol, methyl salicylate, thymol mouthwash
- NDC Code(s): 41190-072-12, 41190-072-13, 41190-072-86
- Packager: Wakefern Food Corporation
- Category: HUMAN OTC DRUG LABEL
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 January 31, 2023
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients
- Use
- Warnings
- Directions
- Other information
- Inactive ingredients
- SPL UNCLASSIFIED SECTION
- principal display panel
- principal display panel
-
INGREDIENTS AND APPEARANCE
ANTISEPTIC MOUTH RINSE
eucalyptol. menthol, methyl salicylate, thymol mouthwashProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41190-072 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 SOLUTION (UNII: 8KW3E207O2) POLOXAMER 407 (UNII: TUF2IVW3M2) BENZOIC ACID (UNII: 8SKN0B0MIM) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SODIUM CITRATE (UNII: 1Q73Q2JULR) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41190-072-86 1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/28/1999 2 NDC:41190-072-13 1250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/28/1999 3 NDC:41190-072-12 1500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/28/1999 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 05/28/1999 Labeler - Wakefern Food Corporation (069722418) Registrant - Vi-Jon, LLC (790752542)