Antiseptic Mouth Rinse Mouthwash
FDA Label NDC 83324-180

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Chain Drug Marketing Association for the product Antiseptic Mouth Rinse (NDC 83324-180). 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 for 30 seconds then spit out

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

  • do not swallow
  • 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 26.9%, benzoic acid, poloxamer 407, sodium benzoate, caramel

Disclaimer

*This product is not manufactured or distributd by Johnson & Johnson Healthcare Products, distributor of Original Listerine Antiseptic Mouthwash

Adverse Reaction

Distributed by C.DM.A., Inc

43157 W 9 Mile Rd

Novi, MI 48375

www.qualitychoice.com

Questions: 800-935-2362

100% QC SATISFACTION GUARANTEED

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QUALITY

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Compare to Original LISTERINE*

Antiseptic

Mouth Rinse

Antigingivitis/Antiplaque

Kills Germs That Cause:

Bad Breath

Plaque

Gingivitis

Gum Disease

Original

1 L (33.8 FL OZ)

Image Description (Mm3)

Image Description (Mm3)

* Please review the disclaimer below.