Leader 664.003/664au

Leader 664.003/664au
SPL v19
SPL
SPL Set ID d176eebb-4870-4206-a52e-f581ecaff400
Route
ORAL
Published
Effective Date 2025-05-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Eucalyptol (0.92 mg) Menthol (0.42 mg) Salicylic Acid (0.6 mg) Thymol (0.64 mg)
Inactive Ingredients
Water Alcohol Sorbitol Poloxamer 407 Benzoic Acid Saccharin Sodium Sodium Benzoate Fd&c Green No. 3

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 1997-06-15

Description

Eucalyptol 0.092% Menthol 0.042%  Methyl salicylate 0.060% Thymol 0.064%

Purpose

Antigingivitis, Antiplaque


Medication Information

Purpose

Antigingivitis, Antiplaque

Description

Eucalyptol 0.092% Menthol 0.042%  Methyl salicylate 0.060% Thymol 0.064%

Use

helps control plaque that leads to gingivitis

Warnings

for this product

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
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.

Disclaimer

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

Adverse Reaction

©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 property of their respective owners.

CIN 5566161 REV. 10/19

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

DSP-TN-15000

DSP-MO-34

SDS-TN-15012

Active Ingredient

Eucalyptol 0.092%

Menthol 0.042% 

Methyl salicylate 0.060%

Thymol 0.064%

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

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

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. 


Structured Label Content

Use

helps control plaque that leads to gingivitis

Purpose

Antigingivitis, Antiplaque

Warnings

for this product

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
Do Not Use (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.

Disclaimer (disclaimer)

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

Adverse Reaction (ADVERSE REACTION)

©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 property of their respective owners.

CIN 5566161 REV. 10/19

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

DSP-TN-15000

DSP-MO-34

SDS-TN-15012

Active Ingredient (Active ingredient)

Eucalyptol 0.092%

Menthol 0.042% 

Methyl salicylate 0.060%

Thymol 0.064%

Other Information (other information)

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

Inactive Ingredients (inactive ingredients)

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

Principal Display Panel (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

Stop Use and Ask A Dentist If (Stop use and ask a dentist if)

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

Keep Out of Reach of Children. (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. 


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Raw Label Data

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