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Distributed by:
Kenvue Brands LLC
Summit, NJ 07901
Listerine Whitening Extra Mild Alcohol Free Anticavity Fluoride Mouthwash
FDA Label NDC 69968-1008
12 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 Whitening Extra Mild Alcohol Free Anticavity Fluoride Mouthwash (NDC 69968-1008). 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 ingredients, purpose, use, warnings, ask a dentist, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients
Sodium Fluoride 0.02% (0.01% w/v Fluoride ion)
Purpose
Anticavity
Use
aids in the prevention of dental cavities
Warnings
Warnings
Ask A Dentist
Stop use and ask a dentist if oral irritation or tooth sensitivity occurs
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 daily 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
• supervise children as necessary until capable of using without supervision
• Children under 12 years of age: consult a dentist or doctor
Other Information
- Store at room temperature
Inactive Ingredients
Water, Sorbitol, Propylene Glycol, Pentasodium Triphosphate, Tetrapotassium Pyrophosphate, Poloxamer 407, Flavor, Citric Acid, Sodium Methyl Cocoyl Taurate, Caprylyl Glycol, Eucalyptol, Thymol, Sodium Saccharin, Menthol, Sucralose
Questions?
call toll-free 888-222-0182; or 215-273-8755 (collect)
Principal Display Panel - 500 Ml Bottle Label
ANTICAVITY FLUORIDE MOUTHWASH
LISTERINE ®
WHITENING
ESSENITIAL OILS + FLUORIDE + WHITENING PHOSPHATES
3 SHADES WHITER TEETH IN 7 DAYS*†
FREE FROM
SENSITIVITY-
CAUSING
PEROXIDE
& DYES
STRENGTHENS
ENAMEL &
FRESHENS BREATH
500 mL (1.05 Pt)
Listerine_1 (Listerine 1)
* Please review the disclaimer below.
