MedPath

Antigingivitis/Antiplaque

Meijer D00.001/D00AA Alcohol-Free Gum Defense Mouthwash

Approved
Approval ID

ea55487c-a13f-41bd-b952-a7d848480ffa

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 12, 2025

Manufacturers
FDA

Meijer Distribution, INC

DUNS: 006959555

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 Code79481-0900
Application NumberM505G(a)(3)
Product Classification
M
Marketing Category
C200263
G
Generic Name
Cetylpyridinium Chloride
Product Specifications
Route of AdministrationORAL
Effective DateAugust 12, 2025
FDA Product Classification

INGREDIENTS (11)

BENZOIC ACIDInactive
Code: 8SKN0B0MIM
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
ZINC LACTATEInactive
Code: 2GXR25858Y
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
POLOXAMER 407Inactive
Code: TUF2IVW3M2
Classification: IACT
CINNAMALDEHYDEInactive
Code: SR60A3XG0F
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: 8/12/2025

Principal Display Panel

NDC 79481-0900-1

meijer ®

COMPARE TO CREST ®PRO-HEALTH ® GUM AND BREATH ACTIVE INGREDIENT*

Gum Defense Mouthwash

ANTIGINGIVITIS/ANTIPLAQUE

ALCOHOL FREE

SMOOTH MINT

Kills germs that cause bad breath

Helps defend against early signs of gum disease

Helps improve gum hygiene

1 L (1.5 QT) 33.8 FL OZ

image descriptionimage description

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 8/12/2025

Use

helps control plaque that leads to gingivitis

ADVERSE REACTIONS SECTION

LOINC: 34084-4Updated: 8/12/2025

ADVERSE REACTION

DISTRIBUTED BY

MEIJER DISTRIBUTION, INC.

GRAND RAPIDS, MI 49544

www.meijer.com

OUR QUALITY GUARANTEE

The Meijer Family

WWW.MEIJER.COM/SATISFACTION

WARNINGS SECTION

LOINC: 34071-1Updated: 8/12/2025

Warnings

For this product

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 8/12/2025

Active Ingredient

Cetylpyridinium Chloride 0.07%

OTHER SAFETY INFORMATION

LOINC: 60561-8Updated: 8/12/2025

Tamper Evident Statement

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 8/12/2025

Purpose

Antigingivitis, Antiplaque

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 8/12/2025

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: 8/12/2025

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: 8/12/2025

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

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 8/12/2025

Disclaimers

This 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 ® CPC Antiginigivitis/Antiplaque Oral Rinse Gum and Breath Purify Smooth Mint.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 8/12/2025

Inactive ingredients

water, glycerin, flavor, zinc lactate, benzoic acid, sodium saccharin, sucralose, sodium benzoate, poloxamer 407, cinnamal, blue 1

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Antigingivitis/Antiplaque - FDA Drug Approval Details