FDA.reportPublic FDA data

PerCara Oral Health Rinse

Manufacturer
LEC Custom Products, Inc
Effective date
2024-01-01
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:07:15

Label at a glance#

ProductPerCara Oral Health Rinse Fresh Mint
Active ingredientCETYLPYRIDINIUM CHLORIDE
Label structure10 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient
Cetylpyridinium chloride 0.07%

OTC - PURPOSE SECTION

Purpose

Antigingivitis

Antiplaque

INDICATIONS & USAGE SECTION

Use helps control plaque that leads to gingivitis.

WARNINGS SECTION

Warning

OTC - STOP USE SECTION

Stop use and ask a dentist if

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

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.

DOSAGE & ADMINISTRATION SECTION

Directions

  • adults and children 6 years & older: rinse for 30 seconds with 20 mL (4 teaspoonfuls) twice a day
  • do not swallow
  • children 6 to Under 12 years of age: supervise use
  • when used after brushing. rinse mouth with water first
  • children under 6 years of age: do not use

OTHER SAFETY INFORMATION

Other Information

this rinse is not intended to replace brushing or flossing

INACTIVE INGREDIENT SECTION

Inactive Ingredients water, glycerin, flavor, poloxamer 188, sodium saccharin, propylene glycol, sodium benzoate, sucralose, benzoic acid, blue 1

SPL UNCLASSIFIED SECTION

Distributed by: LEC Custom Products, Inc. Mississauga, ON. L5S 1B8

Made in Canada

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PERCARA™

FRESH MINT

ORAL HEALTH RINSE

ALCOHOL FREE

KILLS GERMS

FRESHENS BREATH

PREVENTS GINGIVITIS

16.9 FL OZ (500mL)

PerCara Oral Health RinsePerCara Oral Health Rinse

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1100924cetylpyridinium chloride 0.07 % Oral RinsePSN2
1100924cetylpyridinium chloride 0.7 MG/ML MouthwashSCD2
1100924cetylpyridinium chloride 0.07 % Oral RinseSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67933-0321-1PerCara Oral Health RinseFresh Mint500 mL in 1 BOTTLE, PLASTICRINSE5002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67933-0321PERCARA ORAL HEALTH RINSE FRESH MINT (CETYLPYRIDINIUM CHLORIDE) RINSE [LEC CUSTOM PRODUCTS, INC]2Current NDC, Legacy NDC, 1 package rows20240116_bd98c654-218b-15ac-e053-2a95a90a75d1.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67933-032167933-0321-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM BENZOATEOJ245FE5EUIACT
SUCRALOSE96K6UQ3ZD4IACT
WATER059QF0KO0RIACT
BENZOIC ACID8SKN0B0MIMIACT
POLOXAMER 188LQA7B6G8JGIACT
GLYCERINPDC6A3C0OXIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
CETYLPYRIDINIUM CHLORIDED9OM4SK49PACTIB
PROPYLENE GLYCOL6DC9Q167V3IACT

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
PerCara Oral Health Rinse Fresh MintCETYLPYRIDINIUM CHLORIDELEC Custom Products, Incbd98c654-218b-15ac-e053-2a95a90a75d12024-01-01WarningsExact identifier
ndc (package): 67933-0321-1
ndc (product): 67933-0321
ndc11 (package): 67933032101
spl id: 0eb38ee3-e0ad-58f5-e063-6294a90a8d5a
spl set id: bd98c654-218b-15ac-e053-2a95a90a75d1

Reported adverse events (FAERS/openFDA)#

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