Mouth Rinse Mouthwash
FDA Label NDC 0363-0163

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Walgreen Co. for the product Mouth Rinse (NDC 0363-0163). 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 active ingredients, purpose, use, warnings, 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

Active Ingredients

Sodium fluoride 0.0221% (0.01% fluoride ion)

Purpose

Anticavity

Use

aids in the prevention of dental cavities

Warnings

Warnings

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 under 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 anything 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 controlled room temperature 20⁰ - 25⁰C (68⁰ - 77⁰ F)

•cold weather may temporarily cloud this product

Inactive Ingredients

water, sorbitol, alcohol (21.6%), flavors, poloxamer 407 sodium lauryl sulfate, phosphoric acid, sucralose, dibasic sodium phosphate, FD+C yellow no.6, FD+C red no. 40, FC+C blue no.1

Questions

 Call 1-888-593-0593

Other

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION. DO NOT USE IF BAND AROUND CAP IS BROKEN OR MISSING.

This product is not manufactured or distributed by Johnson + Johnson Healthcare Products, distributed of Listerine Total Care Anticavity Mouthwash.*

DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD, DEERFIELD, IL 60015
100% SATISFACTION GUARANTEED
walgreens.com
MADE IN THE U.S.A. WITH U.S. AND FOREIGN COMPONENTS

Principal Display Panel

Well at Walgreens

ANTICAVITY Mouth Rinse

Sodiu Fluoride + Acidulated Phosphate Topical Solution

  • Helps prevent cavities + strengthen teeth
  • Help kill germs that cause bad breath
  • Restores enamel + freshen breath
  • IMPORTANT: Read directions for proper use

    • EUCALYPTUS MINT

    Compare to Listerie Total Care Anticavity Mouthwash Active Ingredient*

    33.8 FL OZ (1 L)

    163.004/163AE

* Please review the disclaimer below.