FDA.reportPublic FDA data

PIONA

Manufacturer
Grand Stream Enterprise, Inc | JIC SKIN KOREA CO.,LTD.
Effective date
2016-12-07
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 22:48:09

Label at a glance#

ProductPIONA
Active ingredientHYDROQUINONE
Label structure7 sections

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

HYDROQUINONE 1.95%...............................................Skin Bleaching

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

ALLANTOIN, ANGELICA GIGAS ROOT, ASIAN GINSENG, BETAINE, BLACK COHOSH, BUTYLENE GLYCOL, CETOSTEARYL ALCOHOL, COPTIS CHINENSIS ROOT, DIMETHICONE, EDETATE DISODIUM ANHYDROUS, FALLOPIA MULTIFLORA ROOT, GARLIC, GLYCERIN, GLYCERYL MONOSTEARATE, GLYCOLIC ACID, GLYCYRRHIZA GLABRA, GREEN TEA LEAF, INDIGOFERA TINCTORIA LEAF, METHYLPARABEN, MINERAL OIL, MORUS ALBA BARK, NIACINAMIDE, OLIVE OIL, PAEONIA LACTIFLORA ROOT, PEG-100 STEARATE, PHELLINUS LINTEUS MYCELIUM, POLYSORBATE 60, PROPYLPARABEN, PUNICA GRANATUM ROOT BARK, RICE GERM, SAFFLOWER, SCUTELLARIA BAICALENSIS ROOT, SESAME SEED, SODIUM ASCORBYL PHOSPHATE, SODIUM BISULFATE, SODIUM LAURYL SULFATE, SODIUM METABISULFITE, SOPHORA FLAVESCENS ROOT, STEARIC ACID, WATER, XANTHAN GUM

INDICATIONS & USAGE

INDICATIONS & USAGE SECTION

Gracually fades skin discolorations such as age spots, freckles and scars.

WARNINGS

WARNINGS SECTION

Sun exposure should be limited by using a sunscreen agent, a sun blocking agent, or protective clothing to cover bleached skin after treatments completed in order to prevent darkening from reoccurring.
Avoid contact with eyes.
Some users of this product may experience a mild ski, irritation. If ski, irritation becomes severe, stop use and consult a doctor.
If pregnant or breast-feeding, ask a health professional before use.
If swallowed, get medical help or contact a Poison Control center right away.

DOSAGE & ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

Adults: apply a small amount as a thin layer on the affected area twice daily, or use as drected by a doctor. If no improvement is seen after 3 months of treatment use of this product should be discontinued.

PURPOSE

OTC - PURPOSE SECTION

Skin Bleaching

PIONA Skin Lightening Body Lotion

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Questions or Comments? 954-731-0165 or piona@grandstreament.com
Formulated in France
Made in Korea
Distributed by: Grand Stream Enterprise, Inc. 2219 NW 29 St., Oakland Park, FL 33311

Label Image
Label Image

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
HYDROQUINONE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d1c9d1af-bddd-448d-86f7-69052b7d5b47Product name120220627
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
85490a6b-2306-6bf2-c51b-eb63537dc2daProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52927-200-012020-01-31C16284748780-19d75b9cf-ecd8-f424-e053-dadaa90a57ce34395fc1-41bf-42b6-b4f0-14d62eeb97b3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52927-200-01PIONA296 mL in 1 TUBELOTION2963

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52927-200PIONA (HYDROQUINONE) LOTION [GRAND STREAM ENTERPRISE, INC]3Legacy NDC, 1 package rows20161209_34395fc1-41bf-42b6-b4f0-14d62eeb97b3.zip

Products#

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

DailyMed product names page 1 of 2 · 43 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52927-20052927-200-01

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 42 matching rows.

Name, UNII, Kind table
NameUNIIKind
HYDROQUINONEXV74C1N1AEACTIB
WATER059QF0KO0RIACT
MINERAL OILT5L8T28FGPIACT
GLYCERINPDC6A3C0OXIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
BETAINE3SCV180C9WIACT
NIACINAMIDE25X51I8RD4IACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
OLIVE OIL6UYK2W1W1EIACT
SODIUM LAURYL SULFATE368GB5141JIACT
POLYSORBATE 60CAL22UVI4MIACT
PEG-100 STEARATEYD01N1999RIACT
DIMETHICONE92RU3N3Y1OIACT
ALLANTOIN344S277G0ZIACT
XANTHAN GUMTTV12P4NEEIACT
SODIUM BISULFATEBU8V88OWIQIACT
SODIUM METABISULFITE4VON5FNS3CIACT
SODIUM ASCORBYL PHOSPHATE836SJG51DRIACT
GLYCYRRHIZA GLABRA2788Z9758HIACT
BLACK COHOSHK73E24S6X9IACT
FALLOPIA MULTIFLORA ROOTAUZ3VD75MCIACT
SESAME SEED7Y1255HVXRIACT
PHELLINUS LINTEUS MYCELIUM40K19XJV3CIACT
ANGELICA GIGAS ROOT32766B2FHXIACT
MORUS ALBA BARK7O71A48NDPIACT
PAEONIA LACTIFLORA ROOT3Z3866YW6PIACT
SOPHORA FLAVESCENS ROOTIYR6K8KQ5KIACT
SCUTELLARIA BAICALENSIS ROOT7J95K7ID2SIACT
PUNICA GRANATUM ROOT BARKCLV24I3T1DIACT
INDIGOFERA TINCTORIA LEAF2K7DF8HZDMIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
COPTIS CHINENSIS ROOTCXS4LJR7ELIACT
GARLICV1V998DC17IACT
ASIAN GINSENGCUQ3A77YXIIACT
RICE GERM7N2B70SFEZIACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLPARABENZ8IX2SC1OHIACT
GLYCOLIC ACID0WT12SX38SIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT

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
56e7d6ee-0c00-46d0-a7fb-2dab60b3199f34395fc1-41bf-42b6-b4f0-14d62eeb97b32016-12-07WarningsExact identifier
spl id: 56e7d6ee-0c00-46d0-a7fb-2dab60b3199f
spl set id: 34395fc1-41bf-42b6-b4f0-14d62eeb97b3

Reported adverse events (FAERS/openFDA)#

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