FDA.reportPublic FDA data

HYDRO H

Manufacturer
General Bio Co., Ltd.
Effective date
2014-12-09
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:41:02

Label at a glance#

ProductHYDRO H
Active ingredientARBUTIN
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

arbutin

INACTIVE INGREDIENT SECTION

water, hyaluronic acid,copper tripeptide-1, tripeptide-29, ginsenosides, etc


OTC - PURPOSE SECTION

skin whitening
skin protectant



OTC - KEEP OUT OF REACH OF CHILDREN SECTION

keep out of reach of the children

INDICATIONS & USAGE SECTION

apply proper amount to the skin


WARNINGS SECTION

・Stop using the product when you have skin problems or the product disagrees with your skin
・Stop using the product immediately and consult a dermatologist if you have redness, swelling, itching or irritation on the skin while or after using the product.
・If the product gets into the eyes, don't rub but rinse with water.
・Don't place the product in any place where it will be subjected to extremely high or low temperatures or direct sunlight.


DOSAGE & ADMINISTRATION SECTION

for external use only

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

package label
package label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69422-5001-12020-01-31C16284748780-19d75b9d0-eacd-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69422-5001-1HYDRO H20 mL in 1 BOTTLESOLUTION201

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69422-5001HYDRO H (ARBUTIN) SOLUTION [GENERAL BIO CO., LTD.]1Legacy NDC, 1 package rows20141209_9c25650d-a3c6-45f0-bff9-3b1d9df46d60.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ARBUTINACTIVE INGREDIENTC5INA23HXF1
ARBUTINACTIVE MOIETYC5INA23HXF1
HYALURONIC ACIDINACTIVE INGREDIENTS270N0TRQY1
PREZATIDE COPPERINACTIVE INGREDIENT6BJQ43T1I91
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69422-500169422-5001-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
ARBUTINC5INA23HXFACTIB
WATER059QF0KO0RIACT
HYALURONIC ACIDS270N0TRQYIACT
PREZATIDE COPPER6BJQ43T1I9IACT

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
61840956-ea63-4855-b862-223d6327a39d9c25650d-a3c6-45f0-bff9-3b1d9df46d602014-12-09WarningsExact identifier
spl id: 61840956-ea63-4855-b862-223d6327a39d
spl set id: 9c25650d-a3c6-45f0-bff9-3b1d9df46d60

Reported adverse events (FAERS/openFDA)#

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