Listerine Smart Rinse Berry Splash Mouthwash
FDA Label NDC 69968-0606

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 Berry Splash (NDC 69968-0606). 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.

Label Section Quick Index

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 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
  • remove cap and hold bottle upright. Fill to 10 mL line by squeezing the front and back (not the sides) of the bottle. Stop squeezing. Excess liquid will drain back into the bottle. Pour in the cup.
  • 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

Inactive Ingredients

water, sorbitol, flavor, phosphoric acid, cetylpyridinium chloride, sucralose, sodium saccharin, disodium phosphate, red 33, green 3

Questions?

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

Principal Display Panel - 500 Ml Bottle Label

NEW!
2X STRONGER TEETH
FOR BETTER CAVITY PROTECTION*
ANTICAVITY FLUORIDE RINSE
LISTERINE®
SMART RiNSE®
SODIUM FLUORIDE & ACIDULATED PHOSPHATE TOPICAL SOLUTION
ALCOHOL FREE

*Versus brushing alone,
In a lab study.
IMPORTANT: Read
directions for proper use.

ADA
Accepted
American
Dental
Association®

BERRY
SLASH
500 mL (16.9 fl oz)

Principal Display Panel (500 mL Bottle Label)

Principal Display Panel (500 mL Bottle Label)

* Please review the disclaimer below.