Active Ingredients
Eucalyptol 0.092%
Menthol 0.042%
Methyl salicylate 0.030%
Thymol 0.064%
Antiseptic Mouthwash
FDA Label NDC 59779-072
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 Antiseptic (NDC 59779-072). 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 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
antigingivituis, 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.
Directions
- do not swallow
- not inteneded to replace brushing or flossing
adults and children 12 years of age and older - vigorously swish 20 ml between teeth for 30 seconds then spit out
children under 12 years of age - consult a dentist or doctor
Other Information
Store at room temperature (59° -77° F)
Inactive Ingredients
water, alcohol 21.6%, sorbitol solution, flavor, poloxamer 407, benzoic acid, sodium saccharin, sodium citrate, D&C yellow no. 10, FD&C green no.3
Disclaimer
This product is not manufactured or distributed by Johnson & Johnson Healthcare Products, distributor of Listerine FreshBurst Antiseptic
Adverse Reactions
Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
2016 CVS/pharmacy
CVS.com V-16224
072.002/072AL
Principal Display Panel
CVS
Healh
Compare to the active ingredients in Listerine FreshBurst Antiseptic
Antiseptic
Mouthwash
ANTIGINGIVITIS/ANTIPLAQUE
Kills germs that cause plaque, gingivitis & bad breath
Green Mint
ADA
Accepted
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.
