FDA.reportPublic FDA data

DR.ALTHEA POWER WHITENING GLUTATHIONE

Manufacturer
Dr. Althea
Effective date
2016-08-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:46:46

Label at a glance#

ProductDR.ALTHEA POWER WHITENING GLUTATHIONE
Active ingredientNIACINAMIDE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

NIACINAMIDE

INACTIVE INGREDIENT SECTION

Water,Butylene Glycol,Glycerin,Dimethicone,Panthenol,Titanium Dioxide (CI 77891),Niacinamide,Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Glutathione, Cyclopentasiloxane,Isohexadecane,Sodium Polyacrylate,Ethylhexyl Stearate,Polysorbate 80,Dimethiconol,Betaine,Triethoxycaprylylsilane,Trideceth-6,Pantolactone,Disodium EDTA,Phenoxyethanol,Chlorphenesin,Caprylyl Glycol,Ethylhexylglycerin,Fragrance

OTC - PURPOSE SECTION

Helps skin whitening

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

keep out of reach of the children

INDICATIONS & USAGE SECTION

Take appropriate amount and apply evenly to skin

WARNINGS SECTION

1. If the following symptoms occur after product use, stop using the product immediately and consult a dermatologist (continuous use can exacerbate the symptoms).
1) Occurrence of red spots, swelling, itchiness, and other skin irritation
2) If the symptoms above occur after the application area is exposed to direct sunlight
2. Do not use on open wounds, eczema, and other skin irritations
3. Precaution for Storage and Handling
1) Close the lid after use
2) Keep out of reach of infants and children
3) Do not to store in a place with high/low temperature and exposed to direct sunlight

DOSAGE & ADMINISTRATION SECTION

for external use only

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

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
70905-0002-12020-01-31C16284748780-19d75b9d0-d012-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70905-0002-1DR.ALTHEA POWER WHITENING GLUTATHIONE50 mL in 1 JARCREAM501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70905-0002DR.ALTHEA POWER WHITENING GLUTATHIONE (NIACINAMIDE) CREAM [DR. ALTHEA]1Legacy NDC, 1 package rows20160812_59fc4d3e-b555-44df-bb1a-60c7a9eac3fd.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
70905-000270905-0002-1

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
WATER059QF0KO0RIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
NIACINAMIDE25X51I8RD4ACTIB

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
39d7a5d2-6797-4c08-e054-00144ff8d46c59fc4d3e-b555-44df-bb1a-60c7a9eac3fd2016-08-12WarningsExact identifier
spl id: 39d7a5d2-6797-4c08-e054-00144ff8d46c
spl set id: 59fc4d3e-b555-44df-bb1a-60c7a9eac3fd

Reported adverse events (FAERS/openFDA)#

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