MedPath

Mint Alcohol Free

WinCo Foods 299.006/299AM MULTI-ACTION ALCOHOL-FREE ANTISEPTIC MOUTH RINSE WITH CPC

Approved
Approval ID

30b50da5-14d0-d0c7-e063-6394a90a091b

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 22, 2025

Manufacturers
FDA

WinCo Foods LLC

DUNS: 056098817

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 Code67091-462
Application Number505G(a)(3)
Product Classification
M
Marketing Category
C200263
G
Generic Name
Cetylpyridinium Chloride
Product Specifications
Route of AdministrationORAL
Effective DateMay 22, 2025
FDA Product Classification

INGREDIENTS (11)

WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
MENTHOL, UNSPECIFIED FORMInactive
Code: L7T10EIP3A
Classification: IACT
POLOXAMER 407Inactive
Code: TUF2IVW3M2
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
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

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 5/22/2025

PRINCIPAL DISPLAY PANEL

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

Compare to the active ingredient in CREST ®Pro-Health

WinCo ®

Foods

ANTISEPTIC

Oral Rinse

Alcohol-Free

ANTIGINGIVITIS/ANTIPLAQUE

MOUTH RINSE

Kills Germs Commonly Associated with Gingivitis

Helps Prevent Plaque

Freshens Breath

No Burn of Alcohol

Fresh Mint

1 L (1.05 QT) 33.8 FL OZ

image descriptionimage description

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 5/22/2025

Use

helps control plaque that leads to gingivitis

ADVERSE REACTIONS SECTION

LOINC: 34084-4Updated: 5/22/2025

ADVERSE REACTIONS SECTION

DISTRIBUTED BY: WINCO FOODS, LLC, BOISE, ID 83704

100% SATISFACTION GUARANTEE

Comments & Questions?

www.wincofoods.com

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 5/22/2025

Disclaimers

*This product is not manufactured or distributed by PROCTER & GAMBLE, owner of the registered trademarks CREST ®Pro-Health ®.

THIS RINSE MAY CAUSE TEMPORARY STAINING TO THE SURFACE OF TEETH.

THIS IS NOT HARMFUL, AND ADEQUATE BRUSHING MAY PREVENT ITS OCCURRENCE.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 5/22/2025

ACTIVE INGREDIENT

Cetylpyridinium chloride 0.07%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 5/22/2025

PURPOSE

Antigingivitis, Antiplaque

WARNINGS SECTION

LOINC: 34071-1Updated: 5/22/2025

Warnings

for this product

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 5/22/2025

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: 5/22/2025

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: 5/22/2025

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: 5/22/2025

Other information

  • this rinse is not intended to replace brushing or flossing

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 5/22/2025

Inactive ingredients

water, glycerin, flavor, menthol, poloxamer 407, sodium saccharin, propylene glycol, sodium benzoate, sucralose, benzoic acid, blue 1

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 5/22/2025

Questions?

Call 800-824-1706 Monday - Friday 9am - 4pm MST

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