MedPath

Crest Pro-Health

Crest PRO-HEALTH ADVANTAGE Rinse

Approved
Approval ID

ddcd56fe-25d6-8195-e053-2a95a90a575a

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 Code69423-893
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)

GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
ZINC LACTATEInactive
Code: 2GXR25858Y
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
POLOXAMER 407Inactive
Code: TUF2IVW3M2
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
CETYLPYRIDINIUM CHLORIDEActive
Quantity: 0.07 g in 1 mL
Code: D9OM4SK49P
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 10/28/2015

Crest Pro Health Advantage Rinse 1L

ALCOHOL FREE

Crest ®
PRO-HEALTH™

ADVANTAGE
CPC ANTIGINGIVITIS/ANTIPLAQUE ORAL MOUTHWASH

99% GERM KILL

AND A HEALTHIER MOUTH*

MULTI-PROTECTION SMOOTH MINT

REDUCES PLAUE BACTERIA

HELPS PREVENT GINGIVITIS

FRESHENS BREATH

1 L (33.8 FL OZ)

Crest Pro Health Advantage Rinse

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: 10/28/2015

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: 10/28/2015

Inactive ingredients

water, glycerin, flavor, zinc lactate, methylparaben, sodium saccharin, sucralose, propylparaben, poloxamer 407, blue 1

OTC - QUESTIONS SECTION

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

Questions?

1–800–285–9139

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