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 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 0.060%
Thymol 0.064%
Purpose
Antigingivitis, 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
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
Or to report and adverse event call 800-824-1706
Monday - Friday 9am - 4 pm MST
Ada Council Statement
The ADA Council on Scientific Affairs Acceptance of WinCo Foods 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 manufactued or distributed by Johnson & Johnson Healthcare Products, distributor of Original LISTERINE Antiseptic Mouthwash
Adverse Reaction
DISTRIBUTED BY: WINCO FOODS, LLC, BOISE, ID 83704
318.003/318AH
Principal Display Panel
SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION
Compare to the active ingredients in
Original LISTERINE Antiseptic Mouthwash
WinCo
FOODS
ANTISEPTIC
Mouth Rinse
ANTIGINGIVITIS/ANTIPLAQUE
MOUTH RINSE
Kills Germs Tht Cause Bad Breath,
Plaque and Gingivitis Gum Disease
For Better Oral Hygiene and Fresher Breath
ADA
Accepted
American
Dental
Association
Original
33.8 FL OZ (1 QT 1.8 FL OZ) 1 L
* Please review the disclaimer below.