Label: ANTISEPTIC MOUTH RINSE- eucalyptol, menthol, methyol salicylate, thymol mouthwash
- NDC Code(s): 36800-072-12, 36800-072-77, 36800-072-86
- Packager: TOPCO ASSOCIATES, LLC
- 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 February 2, 2023
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Adverse reaction
*This product is not manufactured or distributed by Johnson & Johnson Healthcare Products, distributer of FreshBurst Listerine Antiseptic Mouthwash.
DISTRIBUTED BY TOPCO ASSOCIATES LLC
ELK GROVE VILLAGE, IL 60007
QUESTIONS? 1-888-423-0139
topcare@topco.com www.topcarebrand.com
The Top Care product is laboratory tested to guarantee its highest quality. Your total satisfaction is guaranteed.
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principal display panel
COMPARE TO LISTERINE*
TopCare
everyday
Antiseptic
Mouthwash
ANTIGINGIVITIS/ANTIPLAQUE
SPRING MINT
- For better oral hygiene & fresher breath
- Kills germs that cause bad breath, plaque & the gum disease gingivitis
ADA
Accepted
American Dental Association
- Helps reduce plaque
- Helps reduce gingivitis
33.8 FL OZ (1 QT 1.8 FL OZ) 1 L
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INGREDIENTS AND APPEARANCE
ANTISEPTIC MOUTH RINSE
eucalyptol, menthol, methyol salicylate, thymol mouthwashProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-072 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) 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:36800-072-86 1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/07/1995 2 NDC:36800-072-12 1500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/07/1995 3 NDC:36800-072-77 500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/07/1995 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 07/07/1995 Labeler - TOPCO ASSOCIATES, LLC (006935977) Registrant - Vi-Jon, LLC (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 790752542 manufacture(36800-072) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 088520668 manufacture(36800-072)