ANTISEPTIC- eucalyptol, menthol, methyl salicylate, thymol mouthwash 
Cardinal Health, 110 dba Leader

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.

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Leader 664.003 664AU

Active ingredient

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.  Poison Control Center 1-800-222-1222 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

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, poloxamer 407, benzoic acid, sodium saccharin, sodium benzoate, Flavor, green 3

disclaimer

This product is not manufactured or distributed by Johnson & Johnson Healthcare Products, distributor of Listerine registered trademark of Listerine Cool Mint.

2019 Cardinal Health.  All Rights Reserved. CARDINAL HEALTH, the Cardinal Health LOGO, LEADER, and the Leader LOGO are trademarks or registered trademarks of Cardinal Health.  All other marks are the propertyh of their respective owners.

100% Money Back Guarantee

Return to place of purchase if not satisfied.

DISTRBUTED BY CARDINAL HEALTH

DUBLIN, OHIO, 43017

www.myleader.com

1-800-200-6313

principal display panel

LEADER

NDC 70000-0528-1

Antiseptic

Mothrinse

Antigingivitis/Antiplaque

Blue Mint

Kills Germs That Cause:

Bad Breath

Plaque

Gingivitis Gum Disease

COMPARE TO

LISTERINE

COOL MINT

active ingredients

100% Money

Back Guarantee

500 mL (16.9 FL OZ)

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

image description

ANTISEPTIC 
eucalyptol, menthol, methyl salicylate, thymol mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0528
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
EUCALYPTOL (UNII: RV6J6604TK) (EUCALYPTOL - UNII:RV6J6604TK) EUCALYPTOL0.92 mg  in 1 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.42 mg  in 1 mL
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE0.60 mg  in 1 mL
THYMOL (UNII: 3J50XA376E) (THYMOL - UNII:3J50XA376E) THYMOL0.64 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70000-0528-1500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/15/1997
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35606/15/1997
Labeler - Cardinal Health, 110 dba Leader (063997360)

Revised: 5/2022
Document Id: 18fd20ea-9e63-4930-949b-c5d334dd4b87
Set id: d176eebb-4870-4206-a52e-f581ecaff400
Version: 16
Effective Time: 20220513
 
Cardinal Health, 110 dba Leader