Claims
TARTAR CONTROL PLUS
ANTISEPTIC
Mouth Rinse
ANTIGINGIVITS/ANTIPLAQUE
Tartar Control Plus Antiseptic Mouthwash
FDA Label NDC 11344-855
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 Tartar Control Plus Antiseptic (NDC 11344-855). 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 claims, active ingredients, purpose, use, warnings, do not use, stop use and ask a dentist if, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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 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 6 years to under 12 years of age - supervise use
children under 6 years of age - do not use
- 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°to 86°F).
Inactive Ingredients
water, alcohol (21.6%), sorbitol, flavor, poloxamer 407, benzoic acid, zinc chloride, sodium benzoate, sucralose, sodium saccharin, green 3
Disclaimer
*This product is not manufactured or distributed by Kenvue, Inc., distributer of Listerine ® Ultraclean ® Cool Mint ® Antiseptic Mouthwash.
Adverse Reaction
Distributed by:
Nice-Pak Products, LLC
St. Louis, MO 63114
1-888-593-0593
DSP-TN-21091
DSP-MO-20087
Principal Panel Display
Sealed With Printed Neckband For Your Protection
swan ®
TARTAR CONTROL PLUS
ANTISEPTIC
Mouth Rinse
ANTIGINGIVITIS/ANTIPLAQUE
blue mint
Kills Germs that Cause Bad Breath, Plaque & the Gum Disease Gingivitis
Compare to Listerine ®Ultraclean ®Cool Mint ®Antiseptic Mouthwash*
1 L (33.8 FL OZ) 1.05 QT
Image Description (Mm01)
Image Description (Mm02)
* Please review the disclaimer below.
