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

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code63941-299
Application Number505G(a)(3)
Product Classification
M
Marketing Category
C200263
G
Generic Name
CETYLPYRIDINIUM CHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateMay 20, 2025
FDA Product Classification

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

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.