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 Winco Foods, Llc. 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 0.030%
Thymol 0.064%
Purpose
antigingivituis, 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 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 (59° -77° 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
Questions?
Or to report an adverse even call 800-824-1706
Monday - Friday 9am -4pm MST
Ada Council Statement
"The ADA Council on Scientific Affairs" Acceptance of WinCo Foods Spring Mint Antisetpic Mouth Rinse is based on its finding that the product is effective in helping to prevent and reduct 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 Freshburst LISTERINE Antiseptic Mouthwash.
Adverse Reactions
DISTRIBUTED BY:WINCO FOODS, LLC BOISE, ID 83704
Comments & Questions?
800-824-1706 www.wincofoods.com
Principal Display Panel
SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION
Compare to the active ingredients in
Freshburst LISTERINE Antiseptic Mouthwash
WinCo
FOODS
ANTISEPTIC
MOUTH RINSE
ANTIGINGIVITIS/ANTIPLAQUE
MOUTH RINSE
Kills Germs That Cause Bad Breath,
Plaque and Gingivitis Gum Disease
For Better Oral Hygiene and
Fresher Breath
ADA
Accepted
American
Dental
Association
Spring Mint
33.8 FL OZ (1 QT 1.8 FL OZ)
* Please review the disclaimer below.