Active Ingredients
Active ingredients
Eucalyptol 0.0692%
Menthol 0.042%
Methyl salicylate 0.060%
Thymol 0.064%
Antispetic Mouthwash
FDA Label NDC 36800-664
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Topco Associates Llc for the product Antispetic (NDC 36800-664). 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
Purpose
Antigingivitis, antiplaque
Use
Use help control plaque that leads to gingivitis
Warnings
Warnings
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.
Stop Use
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.
Directions
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
Inactive Ingredients
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/pharmacy Blue Mint Antiseptic Mouthwash is based on its finding that the product is effectie 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
Adverse Reactions
DIST BY TOPCO ASSOCIATES LLC
7711 GROSS PROINT ROAD
SKOKIE, IL 60077
QUESTIONS? 1-888-423-0139
Principal Display Panel
TOPCARE
SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION
BLUE MINT
Antiseptic
Mouth
Rinse
ADA
Accepted
American
Dental
Associatin
Kills germs that cause bad breath, plaque, and the gum disease gingivitis
COMPARE TO LISTERINE
active ingredients
3.2 FL OZ (94 mL)
* Please review the disclaimer below.
