Health Mouthwash
FDA Label NDC 0363-0099

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 Health (NDC 0363-0099). 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 claims, disclaimer, active ingredients, purpose, use, warnings, stop use and ask a dentist if, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Claims

This rinse may cause temporary staining to the surface of teeth.  This is not harmful, and adequate brushing may prevent its occurence.

Disclaimer

This product is not manufactured or distributed b Procter + Gamble, distributor of Crest Pro-Health, Multi-Protection Rinse.

Active Ingredients

Cetylpyridinium chloride 0.07%

Purpose

Antigingivitis/Antiplaque

Use

helps control plaque that leads to gingivitis

Warnings

For this product

Stop Use And Ask A Dentist If

  • gingivitis, bleeding, or redness persists for more than 2 weeks
  • you have painful or swollen gums, pus from the gum line, loose teeth or increased spacing between the teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease.

Keep Out Of Reach Of Children

 under 6 years of age. 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 + older: rinse for 30 secnds with 20 mL (4 teaspoonfuls) twice a day
  • do not swallow
  • children 6 years to under 12 years of age: supervise use
  • when used after brushing, rinse mouth with water first
  • children under 6 years of age: do not use

Other Information

  • this rinse is not intended to replace brushing or flossing

Inactive Ingredients

water, glycerin, flavor, poloxamer 188, sodium saccharin, propylene glycol, sodium benzoate, sucralose, benzoic acid, blue 1

Questions

Call 1-888-593-0593

Adverse Reactions

DISTRIBUTED BY: WALGREEN CO.

200 WILMOT RD., DEERFIELD, IL 60015

100% SATISFACTION GUARANTEED

walgreens.com    2013 Walgreen Co.

MADE IN THE U.S.A. WITH U.S. AND FOREIGN COMPONENTS

Principal Display Panel

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

Well at

Walgreens

MULTI-ACTION

Mouth Rinse

Anti-Plaque

  • Kills germs
  • Helps prevent plaque & the gum disease gingivitis
  • Alcohol free
  • MINT

    Compare to Crest Pro-Health Multi-Protection Rinse active ingredient

    33.8 FL OZ

* Please review the disclaimer below.