Tep
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Eucalyptol, Menthol, Methyl Salicylate, Thymol Mouthwash
FDA Label NDC 70677-1234
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Strategic Sourcing Services Llc for the product Eucalyptol, Menthol, Methyl Salicylate, Thymol (NDC 70677-1234). 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 tep, active ingredients, purpose, use, warnings, do not use if, 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 sailcylate 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 incresed 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 rednss 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 under 12 years if 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 intened to replace brushng 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
Disclaimer
Our product is not manufactured or distributed by Johnson & Johnson Corporation, distributor of Original Listerine Antiseptic Mouthwash.
Adverse Reaction
©2023 McKesson Corporation
Distributed by: McKesson Corp.,
via Strategic Sourcing Services LLC
Memphis, TN 38141
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www.fosterandthrive.com
You may report serious side effects to 833-358-6431 Monday to Friday 9:00am to 7:00pm EST
REV07/23
DSP-TN-21091
DSP-MO-20087
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COMPARE TO ORIGINAL® LISTERINE® ANTISEPTIC MOUTHWASH*
Foster & Thrive
ANTISEPTIC Mouthwash
Eucalyptol 0.092%
Menthol 0.042%
Methyl sailcylate 0.060%
Thymol 0.064%
ORIGINAL FLAVOR
Kills germs that cause
- Plaque
- Gingivitis
- Bad Breath
1 L (1.05 QT) 33.8 FL OZ
Image Description (Mm01)
* Please review the disclaimer below.
