SALTRAIN CLEAN BREATH

Manufacturer
K.Boeun Pharmaceutical Co.,Ltd.
Effective date
2020-11-10
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:33:25

Label at a glance#

ProductSALTRAIN CLEAN BREATH
Active ingredientSODIUM FLUORIDE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Sodium Flouride

OTC - PURPOSE SECTION

For dental care

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

INDICATIONS & USAGE SECTION

Put an appropriate amount in your mouth, gargle for 30 seconds, spit out, and brush your teeth by brushing

Do not swallow

WARNINGS SECTION

Keep out of reach of children under 6 years old.

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

INACTIVE INGREDIENT SECTION

Concentrated Glycerin, Polyethylene Glycol 1500, Polysorbate 20, Xylitol, Sodium Chloride, I-Menthol, Mentha Oil, Sage Extract, Aloe Extract, Eucalyptus Extract, Water

DOSAGE & ADMINISTRATION SECTION

For dental use only

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
313029sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral RinsePSN1
313029sodium fluoride 0.2 MG/ML MouthwashSCD1
313029sodium fluoride 0.02 % (fluoride ion 0.009 % ) Oral RinseSY1
313029sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral RinseSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
74724-0020-12025-01-30C16284748780-12cef2736-7591-d83d-e063-dadaa90ab31fb3ce98f4-61d0-60b4-e053-2995a90a65a8

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74724-0020-1SALTRAIN CLEAN BREATH15 in 1 BOXMOUTHWASH151
74724-0020-1SALTRAIN CLEAN BREATH12 mL in 1 POUCHMOUTHWASH121

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74724-0020SALTRAIN CLEAN BREATH (SODIUM FLUORIDE) MOUTHWASH [K.BOEUN PHARMACEUTICAL CO.,LTD.]1Legacy NDC, 2 package rows20201112_b3ce98f4-61d0-60b4-e053-2995a90a65a8.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
74724-002074724-0020-1

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
b3ce86fe-6461-7a10-e053-2995a90a5400b3ce98f4-61d0-60b4-e053-2995a90a65a82020-11-10WarningsExact identifier
spl id: b3ce86fe-6461-7a10-e053-2995a90a5400
spl set id: b3ce98f4-61d0-60b4-e053-2995a90a65a8

Reported adverse events (FAERS/openFDA)#

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