Ultra Whitening

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
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: Camellia Sinensis Leaf Extract, Glycerin, Ethylhexyl PalmitateEthylhexyl Palmitate, Dimethicone/Vinyl Dimethicone Crosspolymer /Cyclomethicone/Hydrogenated Lecithin/Alcohol/Aqua, Helianthus Annuus (Sunflower) Seed Oil, Allium Cepa (Onion) Bulb Extract, Beta-Glucan, Ceramide/Phospholipids/Phytosterols/Soybean Glycerides/ Stearyl Alcohol /Behenyl Alcohol, Cetearyl Alcohol, Cyclomethicone, 1,2-Hexanediol, Panthenol, Urtica Dioica (Nettle) Extract, Argania Spinosa Kernel Oil, Sodium Hyaluronate, Beeswax, Butyrospermum Parkii (Shea) Butter, Stearic Acid, Dimethicone, Ecklonia Cava Extract, Tocopheryl Acetate, Arginine, Carbomer, Palmitoyl Dipeptide-7, Xanthan Gum, 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 4. According to supporting evidence that prove its effect. It causes slight papular and uredo, when applying the same contained ingredient medicine.

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 gently apply it on the face

Usage

DOSAGE & ADMINISTRATION SECTION

Usage: Take an appropriate amount and gently apply it on the face

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
70380-340-012020-01-31C16284748780-19d75b9d1-0e5b-f424-e053-dadaa90a57cee9ce1822-bf52-488d-8c5c-794eb5a13a02

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70380-340-01Ultra Whitening50 mL in 1 CARTONCREAM501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70380-340ULTRA WHITENING (NIACINAMIDE) CREAM [MIGUHARA]1Legacy NDC, 1 package rows20160224_e9ce1822-bf52-488d-8c5c-794eb5a13a02.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
70380-34070380-340-01

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
GREEN TEA LEAFW2ZU1RY8B0IACT
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
ab68ef0b-85b0-4c9d-882b-8edbd34efdb9e9ce1822-bf52-488d-8c5c-794eb5a13a022016-02-24WarningsExact identifier
spl id: ab68ef0b-85b0-4c9d-882b-8edbd34efdb9
spl set id: e9ce1822-bf52-488d-8c5c-794eb5a13a02

Reported adverse events (FAERS/openFDA)#

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