Listerine Mouthwash
FDA Label NDC 69968-0400

11 label sections · Submitted to the FDA by Kenvue Brands Llc · Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Kenvue Brands Llc for the product Listerine (NDC 69968-0400). 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 other, otc - purpose, use, otc - do not use, otc - ask doctor, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Other

→ Otc - Purpose

→ Use

→ Otc - Do Not Use

→ Otc - Ask Doctor

→ Otc - Keep Out Of Reach Of Children

→ Directions

→ Other Information

→ Inactive Ingredients

→ Questions?

→ Principal Display Panel - 1.0 L Bottle Label

Other

Drug Facts

Distributed by:
Kenvue Brands LLC
Summit, NJ 07901

Otc - Purpose

Active ingredient	Purpose
Eucalyptol (0.092%)	Antiplaque/antigingivitis
Menthol (0.042%)	Antiplaque/antigingivitis
Methyl Salicylate (0.060%)	Antiplaque/antigingivitis
Thymol (0.064%)	Antiplaque/antigingivitis

Use

helps prevent and reduce:

plaque
gingivitis

Otc - Do Not Use

Do not use in children under 12 years of age

Otc - Ask Doctor

Ask a dentist if symptoms persist, new symptoms appear, or conditions worsen after regular use

Otc - Keep Out Of Reach Of Children

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

rinse full strength for 30 seconds with 20mL (2/3 fluid ounce or 4 teaspoonfuls) morning and night
do not swallow

Other Information

this rinse is not intended to replace brushing or flossing
store at room temperature
cold weather may cloud this product. Its antiseptic properties are not affected.