Eucalyptol, Menthol, Methyl Salicylate, Thymol Mouthwash
FDA Label NDC 46122-810

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Amerisource Bergen for the product Eucalyptol, Menthol, Methyl Salicylate, Thymol (NDC 46122-810). 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.

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

children under 12 years of age - consult a dentist or doctor

  • this rinse is not intended to replace brushing or flossing

Other Information

Store at room temperature (59°-77°F).

Inactive Ingredients

water, alcohol 21.6%, sorbitol, poloxamer 407, benzoic acid, sodium saccharin, sodium benzoate, flavor, green 3

Adverse Reaction

SATISFACTION GUARANTEED

Distributed By AmerisourceBergen

1 West First Avenue, Conshohocken, PA 19428

Questions or Concerns? 1-888-593-0593

www.mygnp.com DSP-TN-21091 DSP-MO-20087

Principal Display Panel

NDC 46122-810-29

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SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

Antiseptic

Mouthrinse

Antigingivitis/Antiplaque

Blue Mint

Kills germs that cause bad breath, plaque and gum disease gingivitis

250 mL (8.5 FL OZ)

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