FDA.reportPublic FDA data

OptiRinse Plus

Manufacturer
Laboratoires MSP Inc
Effective date
2020-11-06
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:33:08

Label at a glance#

ProductOptiRinse Plus
Active ingredientCETYLPYRIDINIUM CHLORIDE, SODIUM FLUORIDE
Label structure9 sections

Indications and uses

Aids in the prevention of dental cavities Helps prevent and reduce plaque and gingivitis Helps control plaque bacteria that contribute to the development of gingivitis and bleeding gums

Dosage and administration

 Adults and children 6 years of age and older Use once a day after brushing your teeth with a toothpaste Remove cap Pour 10 milliliters into a cap (10 mL mark on inside of cap); do not fill above 10 mL mark Vigorously swish 10 milliliters of rinse between your teeth for 1 minute and then spit out Do not swallow the rinse Do not eat or drink for 30 minutes after rinsing Instruct children 12 years under age in good ...

Label contents#

Full prescribing information#

Active Ingredients (in 10 mL)

OTC - ACTIVE INGREDIENT SECTION

Cetylpyridinum Chloride 0.05%

Sodium Fluoride 0.05% (0.02% w/v fluoride ion)

Purpose

OTC - PURPOSE SECTION

Antigingivitis/antiplaque

Anticavity

Uses

INDICATIONS & USAGE SECTION

  • Aids in the prevention of dental cavities
  • Helps prevent and reduce plaque and gingivitis
  • Helps control plaque bacteria that contribute to the development of gingivitis and bleeding gums

Warnings

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • Keep out of reach of children. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

WARNINGS SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

 Adults and children 6 years of age and older
  • Use once a day after brushing your teeth with a toothpaste
  • Remove cap
  • Pour 10 milliliters into a cap (10 mL mark on inside of cap); do not fill above 10 mL mark
  • Vigorously swish 10 milliliters of rinse between your teeth for 1 minute and then spit out
  • Do not swallow the rinse
  • Do not eat or drink for 30 minutes after rinsing
  • Instruct children 12 years under age in good rinsing habits (to minimize swallowing)
  • Supervise children as necessary until capable of using without supervision 
 Children under 6 years of age Consult a dentist or doctor

Other Information

OTHER SAFETY INFORMATION

  • Store at room temperature (15-30°C)
  • Do not use if safety seal is broken or missing

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Purified Water, Xylitol, Glycerin, Grape Flavor, Poloxamer 407, Bioflavonoids, Sodium Phosphate, Benzoic Acid, Mint Flavor, Red 40

OptiRinse Plus - Grape - 500 mL - NDC 77982-001-01

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

optirinse-500mloptirinse-500ml

OptiRinse Plus

Contains Citrox patented formula

Natural Bioflavinoid Complex

Ideal for Adults & children

00.05% NAF Remineralizing Fluoride Rinse

Grape Flavor

16.9 fl oz (500 ml)

Recommended by Dental Professionals

  • Anti-cavities
  • Anti-gingivitis
  • 10% Xylitol
  • Alcohol free
  • Kills bacteria
  • Lightly flavored
  • Neutral pH

Questions? 1 888 442.7070 or boutique.oralscience.com

Distributed in USA by:

TruLife Distribution, 401 E Las Olas Blvd Suite 1400, Fort Lauderdale,

Floirida USA 33301 / 954.414.0380

X-PUR is a registered trademark of Oral Science Inc.

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2467743cetylpyridinium chloride 0.05 % / sodium fluoride 0.05 % (fluoride ion 0.02 % ) MouthwashPSN2
2467743cetylpyridinium chloride 0.5 MG/ML / sodium fluoride 0.5 MG/ML MouthwashSCD2
2467743cetylpyridinium chloride 0.05 % / sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral RinseSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77982-001-012022-01-28C16284748780-1d6a99b39-987a-a426-e053-dadaa90af4c2OptiRinse Plus

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77982-001-01OptiRinse Plus500 mL in 1 BOTTLELIQUID5002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77982-001OPTIRINSE PLUS (REMINERALIZING FLUORIDE RINSE) LIQUID [LABORATOIRES MSP INC]2Legacy NDC, 1 package rows20201107_003a6c1e-b03a-41c9-8d0a-a2ee762ac7fe.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
77982-00177982-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
CETYLPYRIDINIUM CHLORIDED9OM4SK49PACTIB
SODIUM FLUORIDE8ZYQ1474W7ACTIM
WATER059QF0KO0RIACT
XYLITOLVCQ006KQ1EIACT
GLYCERINPDC6A3C0OXIACT
METHYL ANTHRANILATE981I0C1E5WIACT
POLOXAMER 407TUF2IVW3M2IACT
CITRUS BIOFLAVONOIDSBD70459I50IACT
SODIUM PHOSPHATESE337SVY37IACT
BENZOIC ACID8SKN0B0MIMIACT
PULEGONE4LF2673R3GIACT
FD&C RED NO. 40WZB9127XOAIACT

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
ba492995-a687-43e9-baff-c5f1c3d7b5c2003a6c1e-b03a-41c9-8d0a-a2ee762ac7fe2020-11-06WarningsExact identifier
spl id: ba492995-a687-43e9-baff-c5f1c3d7b5c2
spl set id: 003a6c1e-b03a-41c9-8d0a-a2ee762ac7fe

Reported adverse events (FAERS/openFDA)#

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