FDA.reportPublic FDA data

ANTISEPTIC

Manufacturer
Moran Foods, LLC | Vi-Jon, LLC
Effective date
2022-05-18
Label type
HUMAN OTC DRUG LABEL
Version
13
Source
legacy-cache
Hydrated at
2026-08-01 21:52:30

Label at a glance#

ProductANTISEPTIC
Active ingredientCETYLPYRIDINIUM CHLORIDE
Label structure11 sections

Dosage and administration

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

Label contents#

Full prescribing information#

Claims

SPL UNCLASSIFIED SECTION

Best Choice Zesty Mint Mouth Rinse

For better oral hygiene and fresher breath

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Cetylpyridinium chloride 0.07%

Purpose

OTC - PURPOSE SECTION

Antigingivitis, Antiplaque

Use

INDICATIONS & USAGE SECTION

helps control plaque that leads to gingivitis

Warnings

WARNINGS SECTION

For this product

Stop use and ask a dentist if

OTC - STOP USE SECTION

  • 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

if more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

OTHER SAFETY INFORMATION

  • this rinse is not intended to replace brushing or flossing

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions?

OTC - QUESTIONS SECTION

Call 1-800-593-0593

Adverse Reactions

SPL UNCLASSIFIED SECTION

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

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

Best Choice 100% Guaranteed

www.bestchoicebrand.com

PROUDLY DISTRIBUTED BY:
Moran Foods, LLC

Adverse reaction

ADVERSE REACTIONS SECTION

Best Choice 100% Guaranteed

www.bestchoicebrand.com

PROUDLY DISTRIBUTED BY:

Moran Foods, LLC

principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Best Choice

Sealed With Printed Neckband For Your Protection

COMPARE TO THE ACTIVE

INGREDIENT CREST PRO HEALTH

ZESTY MINT

Mouth Rinse

ANTISEPTIC

ANTIGINGIVITIS/ANTIPLAQUE

Kills Germs That Cause Bad Breath, Plaque

& Gingivitis Gum Disease

1 L (33.8 FL OZ)

image descriptionimage description

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
46994-29946994-299-86

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
CETYLPYRIDINIUM CHLORIDED9OM4SK49PACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
POLOXAMER 188LQA7B6G8JGIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SODIUM BENZOATEOJ245FE5EUIACT
SUCRALOSE96K6UQ3ZD4IACT
BENZOIC ACID8SKN0B0MIMIACT
FD&C BLUE NO. 1H3R47K3TBDIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
cb496c0f-f966-4aa9-a296-f0c070d85a406a45b4ba-d457-4bd7-a4e1-3128ad7fc1f02023-10-19Warnings, Adverse reactionsExact identifier
spl set id: 6a45b4ba-d457-4bd7-a4e1-3128ad7fc1f0

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.