Active Ingredients
Eucalyptol 0.092%
Menthol 0.042%
Methyl salicylate 0.060%
Thymol 0.064%
Antiseptic Mouthrinse Mouthwash
FDA Label NDC 83324-179
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Chain Drug Marketing Association for the product Antiseptic Mouthrinse (NDC 83324-179). 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 ingredients, purpose, use, warnings, do not use, stop use, 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
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
Disclaimer
This product is not manufactured or distribted by Johnson & Johnson Healthcare Products, distributor of Cool Mint Listerine
Adverse Reactions
Distributed by C.D.M.A., Inc
43157 W. Nine Mile
Novi, MI 48376-0995
www.qualitychoice.com
Questionw: 248-449-9300
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Sealed With Printed Neckband For Your Protection
QC
Quality
Choice
Compare to Cool Mint LITERINE*
Antiseptic
Mouth Rinse
Antigingvitis/Antiplaque
Kills Germs That Cause:
Bad Breath
Plaque
Gingiviis
Gum Disease
BLUE MINT
1 L (33.8 FL OZ)
Image Description (Mm01)
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