Antiseptic Mouth Rinse Mouthwash
FDA Label NDC 72036-318

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Harris Teeter for the product Antiseptic Mouth Rinse (NDC 72036-318). 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, keep out of reach of chrildren., directions, 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 Chrildren.

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 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 26.9%, benzoic acid, poloxamer 407, sodium benzoate, caramel

Disclaimer

*This product is not manufactued or distributed by Johnson & Johnson Healthcare Products, distributor of Original Listerine.

Claims

ADA Accepted

American Dental Association

  • Helps reduce plaque
  • Helps reduce gingivitis

Adverse Reaction

PROUDLY DISTRIBUTED BY:

HARRIS TEETER, LLC, MATTHEWS, NC 28105

1-800-432-6111 or harristeeter.com

Principal Display Panel

Sealed witth printed neeckband for your protection

Harris Teeter

Compare to Original Listerine ® Antiseptic

ORIGINAL

ANTISEPTIC

MOUTH RINSE

ANTIGINGIVITIS/ANTIPLAQUE

  • Kills Germs 
  • Fights Bad Breath

    • 1L (33.8 FL OZ)

    TOGTHER IN EDUCATION

    Image Description (Mm01)

    Image Description (Mm01)

* Please review the disclaimer below.