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Distributed by:
Kenvue Brands LLC
Summit, NJ 07901
Listerine Total Care Mild Alcohol Free Anticavity Fluoride Mouthwash
FDA Label NDC 69968-0951
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 Total Care Mild Alcohol Free Anticavity Fluoride Mouthwash (NDC 69968-0951). 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, use, warnings, 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
Active Ingredient
Sodium Fluoride 0.02% (0.01% w/v Fluoride ion)
Purpose
Anticavity
Use
aids in the prevention of dental cavities
Warnings
Warnings
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
• Adults and children 12 years of age and older:
• Use twice a day after brushing your teeth with a toothpaste
• vigorously swish 10 mL (2 teaspoonfuls) of rinse between your teeth for 1 minute and then spit out
• do not swallow the rinse
• do not eat or drink for 30 minutes after rinsing
• instruct children under 12 years of age in good rinsing habits (to minimize swallowing)
• supervise children as necessary until capable of using without supervision
• Children under 6 years of age: consult a dentist or a doctor
Other Information
• Store at room temperature.
Inactive Ingredients
Water, Sorbitol, Propylene Glycol, Sodium Lauryl Sulfate, Poloxamer 407, Flavor, Sodium Benzoate, Phosphoric Acid, Eucalyptol, Methyl Salicylate, Thymol, Sodium Saccharin, Menthol, Disodium Phosphate, Sucralose, Red 33, Blue 1
Questions?
call toll-free 888-222-0182; or 215-273-8755 (collect)
Principal Display Panel - 1 L Bottle Label
ANTICAVITY FLUORIDE MOUTHWASH
LISTERINE ®
TOTAL CARE
POWERED BY ESSENTIAL OILS + FLUORIDE
6
IN ONE
FOR A HEALTHIER MOUTH
360
CLEAN*
FRESHENS
BREATH
KILLS 99.9%
OF GERMS*
REPAIRS
ENAMEL
24 HR CAVITY
PROTECTION ⴕ
STRENGTHENS
TEETH
IMPORTANT: READ DIRECTIONS FOR PROPER USE
SODIUM FLUORIDE & ACIDULATED PHOSPHATE TOPICAL SOLUTION
1.0 L (1 Qt 1.8 FL Oz)
Listerine_1 (Listerine 1)
* Please review the disclaimer below.
