MedPath

ANTISEPTIC

Best Choice 299.005/299AK-AL Multi Action Alcohol Free Antiseptic Rinse w/CPC

Approved
Approval ID

34f1e92a-be34-4da1-84da-3e8a2a74693b

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 20, 2025

Manufacturers
FDA

Valu Merchandisers.Co

DUNS: 868703513

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

CETYLPYRIDINIUM CHLORIDE

PRODUCT DETAILS

NDC Product Code63941-299
Application Number505G(a)(3)
Marketing CategoryC200263
Route of AdministrationORAL
Effective DateMay 20, 2025
Generic NameCETYLPYRIDINIUM CHLORIDE

INGREDIENTS (10)

SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
BENZOIC ACIDInactive
Code: 8SKN0B0MIM
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
CETYLPYRIDINIUM CHLORIDEActive
Quantity: 0.7 mg in 1 mL
Code: D9OM4SK49P
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
POLOXAMER 188Inactive
Code: LQA7B6G8JG
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 5/20/2025

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

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 5/20/2025

Use

helps control plaque that leads to gingivitis

ADVERSE REACTIONS SECTION

LOINC: 34084-4Updated: 5/20/2025

Best Choice 100% Guaranteed

www.bestchoicebrand.com

PROUDLY DISTRIBUTED BY:

VALU MERCHANDISERS, CO.

5000 KANSAS AVE.

KANSAS CITY, KS 66106

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 5/20/2025

Disclaimers

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

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 5/20/2025

Active ingredient

Cetylpyridinium chloride 0.07%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 5/20/2025

Purpose

Antigingivitis, Antiplaque

WARNINGS SECTION

LOINC: 34071-1Updated: 5/20/2025

Warnings

For this product

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 5/20/2025

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 5/20/2025

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.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 5/20/2025

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 SAFETY INFORMATION

LOINC: 60561-8Updated: 5/20/2025

Other information

  • this rinse is not intended to replace brushing or flossing

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 5/20/2025

Inactive ingredients

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

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 5/20/2025

Questions?

Call 1-800-593-0593

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