Ultra Whitening Ample

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 Ample
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: Anthemis nobilis flower extract, Butylene glycol, Glycerin, Nelumbium speciosum flower extract, Iris versicolor extract, Gnaphalium leontopodium flower extract, Jasminum officinale(Jasmine) flower extract, Lilium candidum flower extract, Rosa centifolia flower extract, Freesia refracta extract, Sodium hyaluronate, Eclipta prostrata extract, Rehmannia glutinosa root extract, Artemisia princeps leaf extract, Portulaca oleracea extract, Glycyrrhiza glabra (Licorice) root extract, Lonicera japonica(Honeysuckle) flower extract, Zanthoxylum piperitum fruit extract, Pulsatilla koreana extract, Citrus paradisi(Grapefruit) fruit extract, Pentapeptide-13, Galactomyces ferment filtrate, Tremella fuciformis (Mushroom) extract, Glycosyl trehalose, Hydrogenated starch hydrolysate, PEG-60 hydrogenated castor oil, Hydroxyethylcellulose, Carbomer, Arginine, Xanthan gum, Gardenia florida fruit extract, Allantoin, Disodium EDTA, Citrus paradisi (Grapefruit) peel oil

PURPOSE

OTC - PURPOSE SECTION

Purpose: Skin Protectant

WARNINGS

WARNINGS SECTION

Warnings:

1. Stop usage immediately if any of the below symptoms occur. Continued use could aggravate symptoms, so it is advisable to consult with a dermatologist immediately. 1) Symptoms include but not limited to: red spots, swelling, itchiness. 2) When having the same symptoms as above due to direct sunlight. 2. Do not apply to areas affected by dermatitis, eczema or wounds. 3. Storage and handling: 1) Tightly close lid after each use. 2 Keep out of reach of children 3) Store in a cool dry area, away from sunlight

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: Take an appropriate amount and evenly apply it on the face along the skin texture.

Usage

DOSAGE & ADMINISTRATION SECTION

Usage: Take an appropriate amount and evenly apply it on the face along the skin texture.

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
70380-320-012020-01-31C16284748780-19d75b9d0-8b3c-f424-e053-dadaa90a57ceb057bfed-f530-487b-99e9-ca6e198e4480

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70380-320-01Ultra Whitening Ample35 mL in 1 CARTONCREAM351

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70380-320ULTRA WHITENING AMPLE (NIACINAMIDE) CREAM [MIGUHARA]1Legacy NDC, 1 package rows20160224_b057bfed-f530-487b-99e9-ca6e198e4480.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
70380-32070380-320-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 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
356500b9-605e-4272-bcae-116d0b581114b057bfed-f530-487b-99e9-ca6e198e44802016-02-24WarningsExact identifier
spl id: 356500b9-605e-4272-bcae-116d0b581114
spl set id: b057bfed-f530-487b-99e9-ca6e198e4480

Reported adverse events (FAERS/openFDA)#

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