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 Shopko. 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
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
Warnings
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. It antiseptic properties are not affected. Store at room temperature (59⁰ - 77⁰ F)
Inactive Ingredients
water, alcohol 21.6%, sorbitol solution, flavor, poloxamer 407, benzoic acid, sodium saccharin, sodium citrate, D+C yellow no. 10, FD+C green no.3
Disclaimer
This product is not manufactured or distributed by Johnson + Johnson Healthcare products, distributor of Fresh Burst Listerine
Adverse Reactions Section
Distributed by Shopko Stores Operating CO., LLC
Green Bay, WI, 54307
2012 ShopKo Stores Operating CO. LLC
www.shopko.com
Principal Display Panel
Shopko
COMPARE TO THE ACTIVE INGREDIENTS OF LISTERINE
Antiseptic
MOUTH
RINSE
Spring Mint
Kills Germs That Cause Bad Breath, Plaque + The Gum Disease Gingivitis
1.5 Liters (50.7 FL OZ)
* Please review the disclaimer below.