FDA.reportPublic FDA data

Dr Hydrocel Natural pure gel

Manufacturer
MEDICELL CO.,LTD
Effective date
2020-06-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:15:30

Label at a glance#

ProductDr Hydrocel Natural pure gel
Active ingredientALCOHOL
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

alcohol

INACTIVE INGREDIENT SECTION

Water
Glycerin
Carbomer
Lemon Oil
Tromethamine
Aloe Extract (09)
Rosemary Extract
Green Tea Extract
Grapefruit Extract
Tea tree oil

OTC - PURPOSE SECTION

Sterilization of hands and skin

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF THE CHILDREN

INDICATIONS & USAGE SECTION

Apply to clean, dry hands. Apply sufficient amount to thoroughly wet all surfaces of hands and fingers. Rub onto hands until dry.

Supervise children in the use of this product.

WARNINGS SECTION

■ Flammable. Keep away from fire or flame.

■ For external use only.

■ Do not use in eyes.

■ lf swallowed, get medical help promptly.

■ Stop use, ask doctor lf irritation occurs.

■ Keep out of reach of children.

DOSAGE & ADMINISTRATION SECTION

for external use only

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN1
581662ethanol 0.7 ML/ML Topical GelSCD1
581662ethanol 70 % Topical GelSY1
581662ethyl alcohol 70 % Topical GelSY1

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-138809351631381GTIN-13: 8809351631381
EAN-13: 8809351631381
GTIN storage (14 digits): 08809351631381		label.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
75332-0006-12022-01-28C16284748780-1d6a99b39-8c9e-a426-e053-dadaa90af4c2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75332-0006-1Dr Hydrocel Natural pure gel500 mL in 1 BOTTLELIQUID5001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75332-0006DR HYDROCEL NATURAL PURE GEL (ALCOHOL) LIQUID [MEDICELL CO.,LTD]1Legacy NDC, 1 package rows20200601_a6f78b9c-9234-eb0e-e053-2a95a90a0103.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
75332-000675332-0006-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
GREEN TEA LEAFW2ZU1RY8B0IACT
GLYCERINPDC6A3C0OXIACT
GRAPEFRUIT PEEL3582N05Q44IACT
ROSEMARY OIL8LGU7VM393IACT
LEMON OILI9GRO824LLIACT
ALOE VERA LEAFZY81Z83H0XIACT
CARBOMER 9404Q93RCW27EIACT
TEA TREE OILVIF565UC2GIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
TROLAMINE9O3K93S3TKIACT

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
a6f78bdb-f8a7-3d6f-e053-2995a90a71d5a6f78b9c-9234-eb0e-e053-2a95a90a01032020-06-01WarningsExact identifier
spl id: a6f78bdb-f8a7-3d6f-e053-2995a90a71d5
spl set id: a6f78b9c-9234-eb0e-e053-2a95a90a0103

Reported adverse events (FAERS/openFDA)#

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