FDA.reportPublic FDA data

Fixodent

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2022-01-20
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 22:13:13

Label at a glance#

ProductFixodent Gum Care
Active ingredientCETYLPYRIDINIUM CHLORIDE
Label structure10 sections

Indications and uses

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

Dosage and administration

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Cetylpyridinium chloride 0.07%

Purpose

OTC - PURPOSE SECTION

Antigingivitis/antiplaque

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

OTC - ASK DOCTOR SECTION

Ask a dentist if symptoms persist or condition worsens after regular use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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 ingredients

INACTIVE INGREDIENT SECTION

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

Questions?

OTC - QUESTIONS SECTION

1–800–214-8871

SPL UNCLASSIFIED SECTION

DISTR. BT PROCTER & GAMBLE,

CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - 250 ML Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ALCOHOL FREE

FRESHENS BREATH

from the makers of

#1

Denture Adhesive Brand

Fixodent®
CPC ANTIGINGIVITIS/ANTIPLAQUE ORAL RINSE

GUM CARE

CLEANS & PROTECTS GUMS

For Partials and Denture Wearers woth Some Natural Teeth

250 mL (8.4FL OZ)

169169

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
37000-16937000-169-36, 37000-169-25, 37000-169-50, 37000-169-01, 37000-169-15

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
POLOXAMER 407TUF2IVW3M2IACT
METHYLPARABENA2I8C7HI9TIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
PROPYLPARABENZ8IX2SC1OHIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
CETYLPYRIDINIUM CHLORIDED9OM4SK49PACTIB
SUCRALOSE96K6UQ3ZD4IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
f8fe293c-46cd-1372-e053-6294a90a67d87bbbd54d-0218-3f61-e053-2a91aa0a02282023-04-10WarningsExact identifier
spl set id: 7bbbd54d-0218-3f61-e053-2a91aa0a0228

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.