MedPath

Crest Pro-Health

Crest PRO-HEALTH GUM CARE

Approved
Approval ID

d721e2cb-8f67-3d07-e053-2995a90ae65a

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Jul 31, 2025

Manufacturers
FDA

The Procter & Gamble Manufacturing Company

DUNS: 004238200

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 Code69423-864
Application NumberM022
Product Classification
M
Marketing Category
C200263
G
Generic Name
Cetylpyridinium chloride
Product Specifications
Route of AdministrationORAL
Effective DateJuly 31, 2025
FDA Product Classification

INGREDIENTS (10)

POLOXAMER 407Inactive
Code: TUF2IVW3M2
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
CETYLPYRIDINIUM CHLORIDEActive
Quantity: 0.07 g in 1 mL
Code: D9OM4SK49P
Classification: ACTIB
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
FD&C GREEN NO. 3Inactive
Code: 3P3ONR6O1S
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 2/3/2022

PRINCIPAL DISPLAY PANEL - 1 L Bottle Label

Crest®

Pro Health

CPC ANTIGINGIVITIS/ANTIPLAQUE ORAL RINSE

GUM CARE

NEUTRALIZES PLAQUE GERMS

AROUND THE GUM LINE

COOL WINTERGREEN

• 24 HR Protection*

• Helps prevent and reduce gingivitis

+ Alcohol Free

1 L

(33.8 FL OZ)

Crest Pro Health Gum Care

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 5/9/2011

Uses

  • helps prevent and reduce plaque and gingivitis
  • helps control plaque bacteria that contribute to the development of gingivitis and bleeding gums

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 5/21/2021

DISTR. BY PROCTER & GAMBLE,
CINCINNATI, OH 45202

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 2/3/2022

Active ingredient

Cetylpyridinium chloride 0.07%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 1/11/2018

Purpose

Antigingivitis/antiplaque

WARNINGS SECTION

LOINC: 34071-1Updated: 5/9/2011

Warnings

Ask a dentist ifsymptoms persist or condition worsens after regular use.

**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: 5/9/2011

Directions

  • use after your normal brushing and flossing routine; rinse toothpaste from mouth prior to use
  • adults and children 6 yrs. & 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
  • children under 6 years of age: do not use

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 2/3/2022

Inactive ingredients

water, glycerin, propylene glycol, flavor, poloxamer 407, methylparaben, propylparaben, sodium saccharin, yellow 6, green 3

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 5/9/2011

Questions?

1–800–285–9139

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Crest Pro-Health - FDA Drug Approval Details