FDA.reportPublic FDA data

Euthymol Whitening Purple Corrector

Manufacturer
LG HOUSEHOLD & HEALTH CARE LTD.
Effective date
2025-04-09
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:00:02

Label at a glance#

ProductEuthymol Whitening Purple Corrector
Active ingredientSODIUM FLUORIDE
Label structure8 sections

Dosage and administration

adults and children 2 years of age and older. Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist. do not swallow. to minimize swallowing use a pea-sized amount in children under 6. supervise children's brushing until good habits are established. children under 2 years: ask a dentist.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium Fluoride 0.243%

(0.15% w/v fluoride ion)

Purpose

OTC - PURPOSE SECTION

Anticavity toothpaste

Use

INDICATIONS & USAGE SECTION

helps protect against cavities

WARNINGS SECTION

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children under 6 years of age.

Do not

DOSAGE & ADMINISTRATION SECTION

Do not swallow. If you accidentally swallow more than used for brushing, seek professional assistance or contact a poison control center right away. If an allergic reaction develops, discontinue use immediately.

Directions

INSTRUCTIONS FOR USE SECTION

  • adults and children 2 years of age and older. Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist.
  • do not swallow.
  • to minimize swallowing use a pea-sized amount in children under 6.
  • supervise children's brushing until good habits are established.
  • children under 2 years: ask a dentist.

Inactive ingredients

INACTIVE INGREDIENT SECTION

GLYCERIN, HYDRATED SILICA, SODIUM HEXAMETAPHOSPHATE, WATER, FLAVOR(AROMA), PEG-6, ZINC STEARATE, COCAMIDOPROPYL BETAINE, SODIUM LAURYL SULFATE, TRIPOTASSIUM PHOSPHATE, CARRAGEENAN, POTASSIUM PHOSPHATE, POLOXAMER 407, TITANIUM DIOXIDE, SODIUM SACCHARIN, ALGIN, BLUE 1 LAKE, TOCOPHERYL ACETATE, XANTHAN GUM, SUCRALOSE, RED 33, EUCALYPTUS GLOBULUS LEAF EXTRACT, THYMOL

Questions?

OTC - QUESTIONS SECTION

1-866-993-4709

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BOTTLEBOTTLE

CARTONCARTON

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
416783sodium fluoride 0.24 % ToothpastePSN2
416783sodium fluoride 0.0024 MG/MG ToothpasteSCD2
416783sodium fluoride 0.24 % (fluoride ion 0.13 % ) ToothpasteSY2
416783sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY2
416783sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53208-563-63Euthymol Whitening Purple Corrector106 g in 1 TUBEPASTE, DENTIFRICE1062
53208-563-65Euthymol Whitening Purple Corrector1 in 1 CARTONPASTE, DENTIFRICE12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53208-563EUTHYMOL WHITENING PURPLE CORRECTOR (SODIUM FLUORIDE) PASTE, DENTIFRICE [LG HOUSEHOLD & HEALTH CARE LTD.]2Current NDC, 2 package rows20250501_300303e7-ef8b-7449-e063-6294a90ac811.zip

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53208-56353208-563-63, 53208-563-65

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
NameUNIIKind
POTASSIUM PHOSPHATEB7862WZ632IACT
POLOXAMER 407TUF2IVW3M2IACT
CARRAGEENAN5C69YCD2YJIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
XANTHAN GUMTTV12P4NEEIACT
SUCRALOSE96K6UQ3ZD4IACT
GLYCERINPDC6A3C0OXIACT
SODIUM HEXAMETAPHOSPHATEP1BM4ZH95LIACT
THYMOL3J50XA376EIACT
RED 339DBA0SBB0LIACT
HYDRATED SILICAY6O7T4G8P9IACT
ALGINC269C4G2ZQIACT
BLUE 1 LAKEJ9EQA3S2JMIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
ZINC STEARATEH92E6QA4FVIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
WATER059QF0KO0RIACT
SODIUM SACCHARINSB8ZUX40TYIACT
EUCALYPTUS GLOBULUS LEAFS546YLW6E6IACT
PEG-65655G9Y8AQIACT
SODIUM LAURYL SULFATE368GB5141JIACT
SODIUM FLUORIDE8ZYQ1474W7ACTIB
POTASSIUM PHOSPHATE, TRIBASIC16D59922JUIACT

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Euthymol Whitening Purple CorrectorSODIUM FLUORIDELG HOUSEHOLD & HEALTH CARE LTD.5500686c-d417-c50a-e063-6294a90ac7fa2026-06-24WarningsExact identifier
ndc (product): 53208-563
Euthymol Whitening Purple CorrectorSODIUM FLUORIDELG HOUSEHOLD & HEALTH CARE LTD.369bc785-fb77-a56d-e063-6394a90a2e6b2026-03-24WarningsExact identifier
ndc (package): 53208-563-63
ndc (product): 53208-563
ndc11 (package): 53208056363
Euthymol Whitening Purple CorrectorSODIUM FLUORIDELG HOUSEHOLD & HEALTH CARE LTD.300303e7-ef8b-7449-e063-6294a90ac8112025-04-09WarningsExact identifier
ndc (package): 53208-563-65
ndc (package): 53208-563-63
ndc (product): 53208-563
ndc11 (package): 53208056365
ndc11 (package): 53208056363
spl id: 3259ca3a-5b64-33e3-e063-6294a90af80c
spl set id: 300303e7-ef8b-7449-e063-6294a90ac811

Reported adverse events (FAERS/openFDA)#

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