Label: ANTISEPTIC- eucayptol, menthol, methyl salicylate, thymol mouthwash
- NDC Code(s): 50804-318-12, 50804-318-13, 50804-318-69, 50804-318-86
- 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 June 7, 2023
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- Official Label (Printer Friendly)
- Active ingredients
- Purpose
- Use
- Warnings
- Do not use
- Stop use and ask a dentist if
- keep out of reach of children
- Directions
- Other information
- Inactive ingredients
- SPL UNCLASSIFIED SECTION
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Principal display panel
Sealed With Printed Neckband For Your Protection
GoodSense
NDC 5084-318-12
Antiseptic Mouth Rinse
Original
Kills Germs That Cause
Bad Breath, Plaque & The Gum Disease Gingivitis
ADA Accepted American Dental Association
• Helps prevent and reduce plaque
• Helps prevent and reduce gingivitisCompare to active ingredients of Listerine
1.5 Liters (50.7 FLOZ)
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INGREDIENTS AND APPEARANCE
ANTISEPTIC
eucayptol, menthol, methyl salicylate, thymol mouthwashProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50804-318 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) BENZOIC ACID (UNII: 8SKN0B0MIM) POLOXAMER 407 (UNII: TUF2IVW3M2) SODIUM BENZOATE (UNII: OJ245FE5EU) CARAMEL (UNII: T9D99G2B1R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50804-318-69 250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 09/15/1990 2 NDC:50804-318-12 1500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 09/15/1990 3 NDC:50804-318-86 1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 09/15/1990 4 NDC:50804-318-13 1250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 09/15/1990 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 09/15/1990 Labeler - Perrigo Direct, Inc. (076059836) Registrant - Vi-Jon, LLC (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 790752542 manufacture(50804-318)