Zestymint Antiseptic Mouthwash
FDA Label NDC 56062-299

13 label sections · Submitted to the FDA by Publix Super Markets, Inc. · Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Publix Super Markets, Inc. for the product Zestymint Antiseptic (NDC 56062-299). 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, active ingredient, purpose, use, warnings, stop use and ask a dentist if, keep out of reach of children under 6 years of age., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Claims

P

ALCOHOL FREE

Multi-Protection

ANTIGINGIVITIS/ANTIPLAQUE MOUTHRINSE

SCAN HERE FOR MORE INFORMATION

Publix

Active Ingredient

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 seconds 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

Disclaimers

This rinse may cause temporary staining to the surface of teeth.

This is not harmful, and adequate brushing may prevent its occurence.

*This product is not manufactured or distributed by Procter & Gamble, distributor of Crest ® Pro-Health ®Multi-Protection Alcohol Free Rinse Refreshing Clean Mint.

Adverse Reaction

DISTRIBUTED BY PUBLIX SUPER MARKETS, INC.

3300 PUBLIX CORPORATE PARKWAY, LAKELAND, FL 33811 publix.com

Publix Guarantee: Complete Satisfaction or your money back

Principal Display Panel

ALCOHOL-FREE

Mutli-Protection

ANTIGINGIVITIS/ANTISEPTIC MOUTHRINSE

Helps prevent plaque.

Helps prevent gingivitis.

Helps keep teeth feeling clean.

Freshens breath.

No burn of alcohol.

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COMPARE TO THE ACTIVE INGREDIENT OF CREST ® PRO-HEALTH ®MULTI-PROTECTION ALCOHOL-FREE RINSE*

Sealed With Printed Neckband For Your Protection

33.8 FL OZ (1.05 QT 1.8 FL OZ) 1 L

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