MedPath

Antiseptic

Equate 299.005/299AL Multi Action Alcohol Free Antiseptic Rinse w/CPC

Approved
Approval ID

8916fb44-da82-41d5-941a-293ef1d67dd0

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Jun 2, 2025

Manufacturers
FDA

Wal-Mart Stores, Inc

DUNS: 051957769

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 Code49035-299
Application Number505G(a)(3)
Marketing CategoryC200263
Route of AdministrationORAL
Effective DateJune 2, 2025
Generic NameCETYLPYRIDINIUM CHLORIDE

INGREDIENTS (10)

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
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: 6/2/2025

Principal display panel

NDC 49035-299-86

Compare to Crest ® Pro-Health ® Multi-Protection Alcohol Free Rinse Refreshing Clean Mint active ingredient*

equate ™

Multi-Action Antiseptic Oral Rinse

Zesty Mint

Antigingivitis/Antiplaque

Kills germs commonly associated with gingivitis

Helps prevent plaque

Helps prevent gingivitis

Helps keep teeth feeling clean

Freshens breath

No burn of alcohol

ALCOHOL FREE

Made in the USA with domestic and imported ingredients

Factory Certified

33.8 FL OZ (1.05 QT) 1 L

image descriptionimage description

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 6/2/2025

Use

helps control plaque that leads to gingivitis

ADVERSE REACTIONS SECTION

LOINC: 34084-4Updated: 6/2/2025

Adverse reaction

Distributed by Walmart Inc., Bentonville AR, 72716

Statisfaction guaranteed - For questions or comments please call 1-888-287-1915.

Discard Seal, Empty & Replace Cap

PLASTIC BOTTLE

how2recycle.info

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 6/2/2025

Active ingredient

Cetylpyridinium chloride 0.07%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 6/2/2025

Purpose

Antigingivitis, Antiplaque

WARNINGS SECTION

LOINC: 34071-1Updated: 6/2/2025

Warnings

for this product only

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 6/2/2025

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.

OTHER SAFETY INFORMATION

LOINC: 60561-8Updated: 6/2/2025

Other information

  • this rinse is not intended to replace brushing or flossing

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 6/2/2025

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: 6/2/2025

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: 6/2/2025

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 yearsof age: do not use

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 6/2/2025

Inactive ingredients

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

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 6/2/2025

Questions?

Call 1-888-287-1915

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Antiseptic - FDA Approval | MedPath