X-Pur Opti-Rinse Plus

Manufacturer
Oral Science Inc
Effective date
2022-10-29
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:51:17

Label at a glance#

ProductX-Pur Opti-Rinse Plus
Active ingredientSODIUM FLUORIDE
Label structure10 sections

Dosage and administration

Adults and children 6 years 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 the 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 under 12 years of age in good...

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

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

Purpose

OTC - PURPOSE SECTION

Anticavity

Use

INDICATIONS & USAGE SECTION

aids in the prevention of dental cavities.

Warnings

WARNINGS SECTION

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

Stop use and ask a doctor or dentist if symptoms persist or condition worsens after regular use

OTC - STOP USE SECTION

Stop use and ask a doctor or dentist if symptoms persist or condition worsens after regular use

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 6 years 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 the 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 under 12 years of age in good brushing and rinsing habits (to minimize swallowing)
Supervise children as necessary until capable of using without supervision

  • Children 6 years and under

Consult a dentist or doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, xylitol, glycerin, poloxamer 407, grape flavor, sodium phosphate, bioflavonoids, benzoic acid, cetylpyridinium chloride, mint flavor, red 40

OTHER SAFETY INFORMATION

store at room temperature (59-86°F) do not use if safety seal is broken or missing

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

500 mL NDC: 81359-112-11500 mL NDC: 81359-112-11500 mL NDC: 81359-112-11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
240698sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral RinsePSN4
240698sodium fluoride 0.5 MG/ML MouthwashSCD4
240698sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral RinseSY4

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81359-112-112023-07-28C16284748780-10191ceaa-69e4-198a-e063-dbdaa90aec3eOral Science-Laboratoires MSP- Mouthwash

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81359-112-11X-Pur Opti-Rinse Plus500 mL in 1 BOTTLEMOUTHWASH5004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81359-112X-PUR OPTI-RINSE PLUS (ANTICAVITY FLUORIDE RINSE) MOUTHWASH [ORAL SCIENCE INC]4Legacy NDC, 1 package rows20221030_ba9a4bed-58ac-ecf1-e053-2995a90a0452.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81359-11281359-112-11

Ingredients#

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

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

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
ec2ef9a3-351c-ac2f-e053-2a95a90a0d49ba9a4bed-58ac-ecf1-e053-2995a90a04522022-10-29WarningsExact identifier
spl id: ec2ef9a3-351c-ac2f-e053-2a95a90a0d49
spl set id: ba9a4bed-58ac-ecf1-e053-2995a90a0452

Reported adverse events (FAERS/openFDA)#

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