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 United Natural Foods, Inc. Dba Unfi. 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


Ada Council



The ADA Council on Scientific Affairs' Acceptance of Equaline Amber 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 Antiseptic Mothwash


Adverse Reactions



DISTRIBUTED BY SUPERVALU INC.

EDEN PRAIRIE, MN 55344 USA

Contact us at 1-877-932-7948,

or www.supervalu-ourownbrands.com

318.000/318AH


Principal Display Panel



NDC 41163-318-86

Compare to

Oringinal Listerine

Antiseptic Mouthwash

active ingredients

EQUALINE

antiseptic

mouthrinse

antigingivitis/antiplaque

ADA

Accepted

American 

Dental

Association

* Please review the disclaimer below.