FDA.reportPublic FDA data

030 DuoCare™ Clinical Oral Rinse

Manufacturer
Medline Industries, LP
Effective date
2025-10-10
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
daily-update
Hydrated at
2026-07-18 05:10:10

Label at a glance#

ProductDuoCare Clinical Oral Rinse
Active ingredientCETYLPYRIDINIUM CHLORIDE
Label structure10 sections

Indications and uses

helps prevent and reduce plaque that leads to gingivitis and bleeding gums

Dosage and administration

adults and children 12 years of age and older: swish 7 ml of rinse between your teeth for approximately one minute and then spit out. Do not swallow the rinse. Use up to 4 times daily or as directed by dentist or doctor. children 6 years to under 12 years of age: supervise use. children under 6 years of age: consult a dentist or a doctor.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Cetylpyridinium Chloride 0.1%

Purpose

OTC - PURPOSE SECTION

Antigingivitis/Antiplaque

Uses

INDICATIONS & USAGE SECTION

  • helps prevent and reduce plaque that leads to gingivitis and bleeding gums

Warnings

WARNINGS SECTION

Warnings

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • gingivitis, bleeding, or redness persists for more than 2 weeks
  • you have painful or swollen gums, pus from the gum line, loose teeth, or increasing spacing between the teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 12 years of age and older: swish 7 ml of rinse between your teeth for approximately one minute and then spit out. Do not swallow the rinse.
  • Use up to 4 times daily or as directed by dentist or doctor.
  • children 6 years to under 12 years of age: supervise use.
  • children under 6 years of age: consult a dentist or a doctor.

Other information

OTHER SAFETY INFORMATION

  • avoid excessive heat and protect from freezing
  • shield from direct sunlight

Inactive ingredients

INACTIVE INGREDIENT SECTION

citric acid, glycerin, methyl salicylate, poloxamer 407, purified water, sodium citrate, sucralose, supermint

Manufacturing Information

SPL UNCLASSIFIED SECTION

www.medline.com

DuoCare is a trademark of Medline Industries, LP.

Manufactured for:

Medline Industries, LP

Three Lakes Drive, Northfield, IL 60093 USA

1-800-MEDLINE (633-5463)

REF: MDS096316

RECENT MAJOR CHANGES SECTION

  • Dosage and Administration

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

bottle labelbottle label

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeCode 128(01)10193489017083GTIN-14: 10193489017083
GTIN storage (14 digits): 10193489017083		53329-030_bottle_v1.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53329-03053329-030-13, 53329-030-07

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
SUCRALOSE96K6UQ3ZD4IACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
POLOXAMER 407TUF2IVW3M2IACT
GLYCERINPDC6A3C0OXIACT
METHYL SALICYLATELAV5U5022YIACT
SODIUM CITRATE1Q73Q2JULRIACT
WATER059QF0KO0RIACT
CETYLPYRIDINIUM CHLORIDED9OM4SK49PACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
82023-10-16full-release2026-05-31 23:56:49

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
DuoCare Clinical Oral RinseCETYLPYRIDINIUM CHLORIDEMedline Industries, LP98e61cd5-7e29-7066-e053-2a95a90afa212025-10-10WarningsExact identifier
ndc (package): 53329-030-07
ndc (package): 53329-030-13
ndc (product): 53329-030
ndc11 (package): 53329003007
ndc11 (package): 53329003013
spl id: 40d1c70d-8f8c-2334-e063-6394a90a4d35
spl set id: 98e61cd5-7e29-7066-e053-2a95a90afa21

Reported adverse events (FAERS/openFDA)#

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