Ultra Whitening First Essence

Manufacturer
MIGUHARA
Effective date
2016-02-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:45:09

Label at a glance#

ProductUltra Whitening First Essence
Active ingredientNiacinamide
Label structure8 sections

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient: Niacinamide 2.0%

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Chamomilla Recutita (Matricaria) Flower Water, Glycerin, Dipropylene Glycol, Beta-Glucan, Sodium Hyaluronate, Urtica Dioica (Nettle) Extract, Ecklonia Cava Extract, Camellia Sinensis Leaf Extract, Allium Cepa (Onion) Bulb Extract, 1,2-Hexanediol, Lactobacillus/Punica Granatum Fruit Ferment Extract, accharomyces/Linseed Oil Ferment, Glycosyl Trehalose, PEG-60 Hydrogenated Castor Oil, Piper Methysticum Leaf/Root/Stem Extract, Camellia Sinensis Catechins, Xanthan Gum, Disodium EDTA, Citrus Paradisi (Grapefruit) Peel Oil

PURPOSE

OTC - PURPOSE SECTION

Purpose: Skin Protectant

WARNINGS

WARNINGS SECTION

Warnings:

1. In case of having following symptoms after using this product, stop using it immediately. If the symptoms get worse, you need to consult a dermatologist. 1) In case of having problems such as red spots, swelling, itching or irritation during using this product, 2) In case of having the same symptoms above on the part where you put this product, which is exposed to direct sunlight. 2. Do not use it on the part where you have a scar, eczema or dermatitis. 3. For external use only 4. Keep out of reach of children

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN

Usage

INDICATIONS & USAGE SECTION

Usage: Apply smoothly on the entire face in the morning and night.

Usage

DOSAGE & ADMINISTRATION SECTION

Usage: Apply smoothly on the entire face in the morning and night.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cartonImage of carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1093331niacinamide 2 % Topical CreamPSN1
1093331niacinamide 20 MG/ML Topical CreamSCD1
1093331niacinamide 2 % Topical CreamSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70380-330-012020-01-31C16284748780-19d75b9d0-31f9-f424-e053-dadaa90a57cefd25697f-7305-4329-9b75-0483cfe9b447

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70380-330-01Ultra Whitening First Essence120 mL in 1 CARTONCREAM1201

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70380-330ULTRA WHITENING FIRST ESSENCE (NIACINAMIDE) CREAM [MIGUHARA]1Legacy NDC, 1 package rows20160224_fd25697f-7305-4329-9b75-0483cfe9b447.zip

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70380-33070380-330-01

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
Niacinamide25X51I8RD4ACTIB
CHAMOMILEFGL3685T2XIACT
GlycerinPDC6A3C0OXIACT

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
051a3b49-2bb3-487a-af2e-3eccdc94c42efd25697f-7305-4329-9b75-0483cfe9b4472016-02-24WarningsExact identifier
spl id: 051a3b49-2bb3-487a-af2e-3eccdc94c42e
spl set id: fd25697f-7305-4329-9b75-0483cfe9b447

Reported adverse events (FAERS/openFDA)#

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