Listerine Smart Rinse Anticavity Fluoride Rinse - Pink Lemonade Flavor Mouthwash
FDA Label NDC 69968-0691

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 Smart Rinse Anticavity Fluoride Rinse - Pink Lemonade Flavor (NDC 69968-0691). 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, otc - keep out of reach of children, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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Other

Drug Facts

Distributed by:
JOHNSON & JOHNSON
CONSUMER INC.
Skillman, NJ 08558

Active Ingredient

Sodium fluoride 0.02% (0.01% w/v fluoride ion)

Purpose

Anticavity

Use

Aids in the prevention of dental cavities

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 6 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 doctor

Other Information

  • Store at room temperature
  • Cold weather may temporarily cloud this product

Inactive Ingredients

Water, Sorbitol, Flavor, Phosphoric Acid, Cetylpyridinium Chloride, Sucralose, Sodium Saccharin, Disodium Phosphate, Red 40, Red 33

Questions?

call toll-free 888-222-0182 or 215-273-8755 (collect).

Principal Display Panel - 500 Ml Bottle Label

2X STRONGER TEETH FOR
BETTER CAVITY PROTECTION*
*with a brushing, in a lab study
ALCOHOL FREE

ANTICAVITY FLUORIDE RINSE
LISTERINE®

SMART RiNSE®
SODIUM FLUORIDE & ACIDULATED PHOSPAHTE TOPICAL SOLUTION

PINK
LEMONADE
FLAVOR

500 mL (16.9Fl Oz)

IMPORTANT: Read
directions for proper use.

Principal Display Panel (500 mL Bottle Label)

Principal Display Panel (500 mL Bottle Label)

* Please review the disclaimer below.