FDA Label for Antiseptic Mouth Rinse

View Indications, Usage & Precautions

Antiseptic Mouth Rinse 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 Ingredients



Eucalyptol 0.092%

Menthol 0.042%

Methyl salicylate 0.060%

Thymol 0.064%


Use



Antigingivitis, Antiplaque

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



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 Ingredients



water, alcohol 26.9%, benzoic acid, poloxamer 407, sodium benzoate, caramel


Questions



Call 1-888-593-0593


Ada Council Statement



“The ADA Council on Scientific Affairs’ Acceptance of Meijers Original Antiseptic Mouth Rinse 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 Original Listerine


Adverse Reactions



DISTRIBUTED BY

MEIJER DISTRIBUTION, INC.

GRAND RAPIDS, MI 49544

www. meijer.com

318.003/318AH


Principal Display Panel



VALUE SIZE

1.5 LITER

NDC 41250-318-12

Compare to

Original

Listerine

Active ingredients

meijer

Original

Mouthwash

Antigngivitis/Antiplaque

Antiseptic

Kills germs that cause

bad breath, plaque

and gingivitis

ADA

Accepted

American

Dental

Association

50.7 FL OZ (1.5 L)


* Please review the disclaimer below.