FDA Label for Antiseptic

View Indications, Usage & Precautions

Antiseptic Product Label

The following document was submitted to the FDA by the labeler of this product Meijer Distribution, Inc. 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.

Tep



Sealed With Printed Neckband For Your Protection


Active Ingredent



Eucalyptol 0.092%

Menthol 0.042%

Methyl salicylate 0.060%

Thymol 0.064


Purpose



Antigingivitis/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 serios 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 Ingredient



water, alcohol 21.6%, sorbitol solution, flavor, poloxamer 407, benzoic acid, sodium saccharin, sodim citrate, D&C yellow no. 10, FD&C green no. 3


Questions



Call 1-888-593-0593


Ada Council Statement



The ADA Council on Scientific Affairs Acceptance of Meijer Fresh Mint Antiseptic Mouthwas is based on its finding tht 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 Listerne


Adverse Reactions



DISTRIBUTED BY

MEIJER DISTRIBUTION, INC.

GRAND RAPIDS, MI 49544

www.meijer.com

072.002/072AL


Principal Display Panel



NDC 41250-072-86

Compare to FreshBurst Listerine active ingredients

meijer

Fresh Mint

Mouthwash

Antigingivitis/Antiplaque

Antiseptic

Kills germs that cause bad breath, plaque and gingivitis

ADA

Accepted

American

Dental

Association

33.8 FL OZ (1L)


* Please review the disclaimer below.