Eucalyptol, Menthol, Methyl Salicylate, Thymol Mouthwash
FDA Label NDC 70677-1233

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 70677-1233). 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, 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

Tep

Sealed With Printed Neckband For Your Protection

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 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 21.6%, sorbitol, poloxamer 407, benzoic acid, sodium saccharin, flavor, sodium citrate, yellow 10, green 3

Disclaimer

*This product is not manufactured or distributed by Johnson & Johnson Healthcare Products, distributor of FreshBurst Listerine Antiseptic Mouthwash.

Adverse Reactions

©2023 McKesson Corporation

Distributed by: McKesson Corp.

Via Strategic Sourcing Services LLC

Memphis, TN 38141

Mone Back Guarantee

www.fosterandthrive.com

You may report serious side effects to 833-358-6431 Monday to Friday 9:00am to 7:00pm EST

REV 07/23

DSP-TN-21091

DSP-MO-20087

Principal Display Panel

COMPARE TO FRESHBURST® LISTERINE® ANTISEPTIC MOUTHWASH*

Foster & Thrive

Antiseptic Mouthwash

Eucalyptol 0.092%

Menthol 0.042%

Methyl salicylate 0.060%

Thymol 0.064%

ANTIGINGIVITIS/ANTIPLAQUE

SPRING MINT® FLAVOR

Kills germs that cause

  • plaque
  • gingivitis
  • bad breath

    • 1l (1.05 QT) 33.8 FL OZ

    Image Description (Mm01)

    Image Description (Mm01)

* Please review the disclaimer below.