PCxx NaF RNS Mint

Manufacturer
Ross Healthcare Inc.
Effective date
2017-11-22
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:53:04

Label at a glance#

ProductPCxx NaF RNS Mint
Active ingredientSODIUM FLUORIDE
Label structure7 sections

Label contents#

Full prescribing information#

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
hold bottle upright and squeeze. Fill to FILL LINE
pour out. Only the correct 10 milliliters dose will pour out
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 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.

WARNINGS SECTION

Keep out of reach of children.

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

INACTIVE INGREDIENT SECTION

potassium sorbate, xylitol, sucralose, water

INDICATIONS & USAGE SECTION

Aids in the prevention of dental cavities

OTC - ACTIVE INGREDIENT SECTION

Sodium Fluoride 0.05%

OTC - PURPOSE SECTION

Anticavity

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANELPACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
240698sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral RinsePSN1
240698sodium fluoride 0.5 MG/ML MouthwashSCD1
240698sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral RinseSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
62007-400-162020-01-31C16284748780-19d75b9d0-f355-f424-e053-dadaa90a57cePCxx NaF RNS Mint

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62007-400-16PCxx NaF RNS Mint1 mL in 1 BOTTLE, PLASTICRINSE11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62007-400PCXX NAF RNS MINT (SODIUM FLUOIRDE) RINSE [ROSS HEALTHCARE INC.]1Legacy NDC, 1 package rows20171123_5e95fcb1-0e77-b35e-e053-2a91aa0a20a7.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62007-40062007-400-16

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 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
5e95fcb1-0e78-b35e-e053-2a91aa0a20a75e95fcb1-0e77-b35e-e053-2a91aa0a20a72017-11-22WarningsExact identifier
spl id: 5e95fcb1-0e78-b35e-e053-2a91aa0a20a7
spl set id: 5e95fcb1-0e77-b35e-e053-2a91aa0a20a7

Reported adverse events (FAERS/openFDA)#

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