Active Ingredient
Eucalyptol 0.092%, Menthol 0.042%
Methyl salicylate 0.060%, Thymol 0.064%
Antiseptic Mouthwash
FDA Label NDC 70000-0528
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cardinal Health, 110 Dba Leader for the product Antiseptic (NDC 70000-0528). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, use, warnings, do not use, stop use and ask a dentist if, keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
- 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
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.
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DISTRBUTED BY CARDINAL HEALTH
DUBLIN, OHIO, 43017
www.myleader.com
1-800-200-6313
Princpal 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 (Mm3)
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