Label: ANTISPETIC- eucalyptol, menthol, methyl salicylate, thymol mouthwash
- NDC Code(s): 63981-664-12, 63981-664-86
- Packager: Costco Wholesale Corporation
- 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 January 12, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- 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
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claims
*This product is not manufactured or distributed by Johnson & Johnson Healthcare Products, distributor of Cool Mint Listerine Antiseptic Mouthwash.
"The ADA council on Scientific Affairs' Acceptance of Kirkland Signature Ice Mint Antiseptic Mouth Rinse is basaed on its finding that the product is effective in helping to prevent and reduce gingivitis and plaque above the gumline, when used as directed."
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Adverse Reactions
Distributed by:
Costco Wholesale Corporation
P.O. Box 34535
Seattle, WA 98124-1535, USA
1-800-774-2678, www.costco.com
Made in the USA with US and foreign components
664.002/664AS
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principal display panel
KIRKLAND
Signature
ANTISEPTIC
MOUTH RINSE
Antigingivitis/Antiplaque Mouthwsh
ice mint
KILLS GERMS THAT CAUSE
- BAD BREATH
- PLAQUE
- GINGIVITIS
ADA
Accepted
American
Dental
Association
Compare to the active ingredients of Cool Mint Listerine
SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION
1.5 L (50.7 FL OZ)
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INGREDIENTS AND APPEARANCE
ANTISPETIC
eucalyptol, menthol, methyl salicylate, thymol mouthwashProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63981-664 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) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SODIUM BENZOATE (UNII: OJ245FE5EU) FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63981-664-12 1500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/14/2011 2 NDC:63981-664-86 1000 mL in 1 PACKAGE; Type 0: Not a Combination Product 06/14/2011 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 06/14/2011 Labeler - Costco Wholesale Corporation (103391843) Registrant - Vi-Jon, LLC (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 790752542 manufacture(63981-664) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 088520668 manufacture(63981-664)