Doctor EL Black White Tooth

Manufacturer
Dr. EL CO., LTD. | GREEN WONIL CO., LTD.
Effective date
2020-07-02
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:20:00

Label at a glance#

ProductDoctor EL Black White Tooth
Active ingredientSODIUM MONOFLUOROPHOSPHATE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

SODIUM MONOFLUOROPHOSPHATE

OTC - PURPOSE SECTION

For dental care

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

INDICATIONS & USAGE SECTION

Supervise children as necessary until capable of using without Supervision.

Adults and children 6 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician

Children 2 to 6 years: Use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)

Children under 2 years: Ask a dentist or physician

WARNINGS SECTION

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

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

INACTIVE INGREDIENT SECTION

Sorbitol, Water, Hydrated Silica, Silica, Glycerin, Flavor, Sodium Citrate,

Cellulose Gum, Sodium Cocoyl Glutamate, Sodium Lauroyl Sarcosinate,

Menthol, Charcoal Powder.,Carrageenan, Xanthan Gum, Sodium Saccharin,

Sodium Benzoate, Tocopheryl Acetate, Xylitol, Camellia Sinensis Leaf Extract,

Juglans Regia (Walnut) Shell Powder, Sodium Bicarbonate, Calendula Officinalis Extract, Chamomilla Recutita (Matricaria) Extract, Magnolia Officinalis Bark Extract

DOSAGE & ADMINISTRATION SECTION

For dental use only

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2379031sodium monofluorophosphate 0.38 % ToothpastePSN1
2379031sodium monofluorophosphate 0.0038 MG/MG ToothpasteSCD1
2379031sodium monofluorophosphate 0.38 % ToothpasteSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72440-110-012022-07-29C16284748780-1e4f33bdf-9b8d-d8a0-e053-dadaa90a6e4ea9814859-fa3b-47f1-e053-2995a90ad465

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72440-110-01Doctor EL Black White Tooth120 g in 1 TUBEPASTE, DENTIFRICE1201

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72440-110DOCTOR EL BLACK WHITE TOOTH (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [DR. EL CO., LTD.]1Legacy NDC, 1 package rows20200703_a9814859-fa3b-47f1-e053-2995a90ad465.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72440-11072440-110-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
XYLITOLVCQ006KQ1EIACT
WATER059QF0KO0RIACT
SODIUM MONOFLUOROPHOSPHATEC810JCZ56QACTIM

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
a9812e78-1a82-4b6b-e053-2a95a90a4ae9a9814859-fa3b-47f1-e053-2995a90ad4652020-07-02WarningsExact identifier
spl id: a9812e78-1a82-4b6b-e053-2a95a90a4ae9
spl set id: a9814859-fa3b-47f1-e053-2995a90ad465

Reported adverse events (FAERS/openFDA)#

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