FDA.reportPublic FDA data

DuoCare Clinical Oral Rinse

Manufacturer
IIMED MEDICAL MEXICANA S DE RL DE CV | Team Technologies
Effective date
2023-10-20
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:23:36

Label at a glance#

ProductDuoCare Clinical Oral Rinse
Active ingredientCETYLPYRIDINIUM CHLORIDE
Label structure8 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

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 the signs 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

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Entire LabelEntire Label

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
83062-03083062-030-13, 83062-030-07
53329-030

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
WATER059QF0KO0RIACT
SUCRALOSE96K6UQ3ZD4IACT
METHYL SALICYLATELAV5U5022YIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
GLYCERINPDC6A3C0OXIACT
SODIUM CITRATE1Q73Q2JULRIACT
POLOXAMER 407TUF2IVW3M2IACT
CETYLPYRIDINIUM CHLORIDED9OM4SK49PACTIB

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 · 2 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 (product): 53329-030
08272b36-9e91-1228-e063-6294a90a90eb07120987-97f3-9b6a-e063-6394a90a6a762023-10-20WarningsExact identifier
spl id: 08272b36-9e91-1228-e063-6294a90a90eb
spl set id: 07120987-97f3-9b6a-e063-6394a90a6a76

Reported adverse events (FAERS/openFDA)#

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