Label: ANTISEPTIC MOUTH RINSE- eucalyptol mouthwash
- NDC Code(s): 50804-072-69, 50804-072-86
- Packager: Perrigo Direct, INC.
- 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 October 3, 2022
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 Panel Display
Sealed With Printed Neckband For your Protection
GoodSense
NDC 50804-072-86
ANTISEPTIC MOUTH RINSESpring Mint
ADA Accepted
American Dental Association
- Helps prevent and reduce plaque
- Helps prevent and reduce gingivitis
Kills germs that cause bad breath, plaque & the gum disease gingivitis
Compare to the Active Ingredients in Listerine*
1 LITER (33.8 FLOZ)
-
INGREDIENTS AND APPEARANCE
ANTISEPTIC MOUTH RINSE
eucalyptol mouthwashProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50804-072 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 .42 mg in 1 mL METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE 0.6 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 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:50804-072-86 1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/15/2009 2 NDC:50804-072-69 250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/15/2009 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 08/15/2009 Labeler - Perrigo Direct, INC. (076059836) Registrant - Vi Jon (790752542) Establishment Name Address ID/FEI Business Operations Vi Jon 790752542 manufacture(50804-072) Establishment Name Address ID/FEI Business Operations Vi Jon 088520668 manufacture(50804-072)