Active Ingredients
Eucalyptol 0.092%
Menthol 0.042%
Methyl salicylate 0.060%
Thymol 0.064%
Antiseptic Mouth Rinse Mouthwash
FDA Label NDC 11344-072
14 label sections · Submitted to the FDA by Nice-pak Products, Llc · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Nice-pak Products, Llc for the product Antiseptic Mouth Rinse (NDC 11344-072). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, purpose, use, warnings, do not use, stop use and ask a dentist if, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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 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 twice a day 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 - 77⁰F).
Inactive Ingredients
water, alcohol 21.6%, sorbitol, poloxamer 407, benzoic acid, sodium saccharin, flavor, sodium citrate, yellow 10, green 3
Questions?
Call 1-888-593-0593
Disclaimer
*This product is not manufactured or distributed by Kenvue, Inc., distributor of FreshBurst ® Listerine ® Antiseptic Mouthwash.
Adverse Reaction
DISTRIBUTED BY:
Nice-Pak Products, LLC
8800 Page Ave
St. Louis, MO 63114
DSP-TN-21091
DSP-MO-20087
Principal Panel Display
Sealed With Printed Neckband For Your Protection
swan ®
ANTISEPTIC
Mouth Rinse
ANTIGINGIVITIS/ANTIPLAQUE
spring mint ®
Kills Germs that Cause Bad Breath, Plaque & the Gum Disease Gingivitis.
Compare to Listerine ®Antiseptic Mouthwash*
ADA ACCEPTED
American Dental Association ®
- Helps prevent and reduce plaque
- Helps prevent and reduce gingivitis
500 mL (1.05 PT) 16.9 FL OZ
Image Description (Mm01)
Image Description (Mm02)
* Please review the disclaimer below.
