Active Ingredients
Eucalyptol 0.092%
Menthol 0.042%
Methyl salicylate 0.060%
Thymol 0.064%
Antispetic Mouthwash
FDA Label NDC 59779-664
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cvs Pharmacy, Inc. for the product Antispetic (NDC 59779-664). 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
help 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
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 unmder 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
Ada Council Statement
The ADA council on Scientific Affairs Acceptance of CVS Health Blue Mint Antiseptic Mouthwash is based on its finding that the product is effective in helping to prevent and reduce gingivitis and plaque above the gumline, when used as directed.
Disclaimer
This product is not manufactured or distributed by Johnson & Johnson Healthcare Products, distributor of Listerine Cool Mint Antiseptic
Adverse Reactions
Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsacket, RI 02895
2015 CVS/pharmacy
www.cvs.com 1-800-SHOP-CVS
Made in the U.S.A. of U.S. and foreign coponents
Principal Display Panel
CVS
Health
Compare to the active ingredients
in Listerine Cool Mint Antiseptic
Antiseptic
Mouthwash
ANTIGINGIVITIS/ANTIPLAQUE
Kills germs that cause plaque, gingivitis & bad breath
Blue Mint
ADA
Acepted
American
Dental
Association
Sealed with printed neckband
for your protection. Do not use
if broken or missing
1.5 L (50.7 FL OZ)
Image Description (Mm2)
* Please review the disclaimer below.
