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Antispetic by Costco Wholesale Corporation

Medically reviewed on May 9, 2018

Dosage form: mouthwash
Ingredients: EUCALYPTOL 0.92mg in 1mL, MENTHOL 0.42mg in 1mL, METHYL SALICYLATE 0.60mg in 1mL, THYMOL 0.64mg in 1mL
Labeler: Costco Wholesale Corporation
NDC Code: 63981-664

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 Facts

Active ingredients

Active ingredients

Eucalyptol 0.092%

Menthol 0.042%

Methyl salicylate 0.060%

Thymol 0.064%

Purpose

Antigingivitis, antiplaque

use

helps control plaque that leads to gingivitis

Warnings

´╗┐For this product

Do not use

If you have painful or swollen gums, pus from the gum line, loose teeth or increased spacing between the teeth. See your dentist immediately. These may be signs of periodontitis, a serious form of gum disease.

Stop use and ask a dentist if

gingivitis, bleeding, or redness persists for more than 2 weeks.

Keep out of reach of children.

If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

adults and children 12 years of age and older - vigorously swish 20 mL (2/3 FL OZ or 4 teaspoonfuls) between teeth for 30 seconds then spit out; do not swallow

children under 12 years of age - consult a dentist or doctor

  • this rinse is not intended to replace brushing or flossing

Other information

cold weather may cloud this product. Its antiseptic properties are not affected. Store at room temperature (59°-77°F)

Inactive ingredients

water, alcohol 21.6%, sorbitol solution, flavor, poloxamer 407, benzoic acid, sodium saccharin, sodium benzoate, FD&C green no.3

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."

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

Principal Display Panel

KIRKLAND

Signature

ANTISEPTIC

MOUTH RINSE

Antigingivitis/Antiplaque Mouthrinse

ice mint

KILLS GERMS THAT CAUSE

  • BAD BEATH
  • 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)

ANTISPETIC 
eucalyptol, menthol, methyl salicylate, thymol mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63981-664
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
EUCALYPTOL (EUCALYPTOL) EUCALYPTOL0.92 mg  in 1 mL
MENTHOL (MENTHOL) MENTHOL0.42 mg  in 1 mL
METHYL SALICYLATE (SALICYLIC ACID) METHYL SALICYLATE0.60 mg  in 1 mL
THYMOL (THYMOL) THYMOL0.64 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
ALCOHOL 
SORBITOL 
POLOXAMER 407 
BENZOIC ACID 
SACCHARIN SODIUM 
SODIUM BENZOATE 
FD&C GREEN NO. 3 
Packaging
#Item CodePackage Description
1NDC:63981-664-121500 mL in 1 BOTTLE, PLASTIC
2NDC:63981-664-861000 mL in 1 PACKAGE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35606/14/2011
Labeler - Costco Wholesale Corporation (103391843)
Registrant - Vi-Jon (790752542)
Establishment
NameAddressID/FEIOperations
Vi-Jon790752542manufacture(63981-664)

 
Costco Wholesale Corporation

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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