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Distributed by:
Kenvue Brands LLC
Summit, NJ 07901
Listerine Original Intense Antiseptic Antigingivitis/ Antiplaque Mouthwash
FDA Label NDC 69968-0955
Full FDA labeling including 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 Original Intense Antiseptic Antigingivitis/ Antiplaque Mouthwash (NDC 69968-0955). 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, active ingredient, purpose, uses, warnings, otc - do not use, ask a dentist, otc - 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
Active Ingredient
Eucalyptol (0.092%)
Menthol (0.042%)
Methyl Salicylate (0.060%)
Thymol (0.064%)
Purpose
Antiplaque/antigingivitis
Uses
helps prevent and reduce: • plaque • gingivitis
Warnings
Warnings
Otc - Do Not Use
Do not use in children under 12 years of age
Ask A Dentist
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 20 mL (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.
Inactive Ingredients
Water, Alcohol (26.9% v/v), Benzoic Acid, Poloxamer 407, Sodium Benzoate, Caramel
Questions?
call toll-free 888-222-0182; or 215-273-8755 (collect)
Principal Display Panel - 1 L Bottle Label
ANTIGINGIVITIS / ANTIPLAQUE MOUTHWASH
LISTERINE®
ORIGINAL
ANTISEPTIC
POWERED BY ESSENTIAL OILS
FRESH &
CLEAN
KILLS 99.9% OF GERMS*
*THAT CAUSE BAD BREATH,
PLAQUE & GINGIVITIS
1.0 L (1 Qt 1.8FL Oz)
* Please review the disclaimer below.
