FDA Label for Mouth Rinse

View Indications, Usage & Precautions

Mouth Rinse Product Label

The following document was submitted to the FDA by the labeler of this product Old East Main Co. 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 Ingredient



 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 is 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 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 (59⁰-77⁰F)


Inactive Ingredients



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


Tep



Sealed With Printed Neckband For Your Protection


Disclaimer



This product is not manufactured or distributed by Johnson & Johnson Healthcare Products, distributor of Original Listerine Antiseptic Mothwash


Adverse Reactions



DISTRIBUTED BY OLD EAST MAIN CO.

100 MISSION RIDGE

GOODLETTSVILLE, TN 37072

100% Quality Guaranteed

If you're not satisfied wit this product for any reason, please call us so we can make ou 100% satisfied.
(888)309-9030


Principal Display Panel



DG health

Compare to Original Listerine

Antiseptic Mouthwash

ANTISEPTIC

MOUTHWASH

Antigingivitis/Antiplaque

AMBER

Kills germs that cause bad breath, plaque, and the gum disease gingivitis

500 mL (16.9 FL OZ)

Since 1903

Rexall

Amber

Antiseptic

Mouthwash

Antigingivitis/Antiplaque

  • Kills 99.9% of germs commonly associated with gingivitis
  • Fights bad breath
  • Helps reduce plaque
  • 1.5 L (1 QT 1 PT 2.7 FL OZ) 50.7 FL OZ


* Please review the disclaimer below.