FDA Label for Antispetic

View Indications, Usage & Precautions

Antispetic Product Label

The following document was submitted to the FDA by the labeler of this product Topco Associates Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredients



Active ingredients

Eucalyptol 0.0692%

Menthol 0.042%

Methyl salicylate 0.060%

Thymol 0.064%


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

[email protected]


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.