FDA.reportPublic FDA data

Derma Hand Repair

Manufacturer
Pella Pharmaceuticals Co. Ltd
Effective date
2021-12-02
Label type
HUMAN OTC DRUG LABEL
Version
450
Source
full-release
Hydrated at
2026-05-31 23:45:32

Label at a glance#

ProductDerma Hand Repair
Active ingredientHYALURONIC ACID, DEXPANTHENOL
Label structure14 sections

Dosage and administration

Apply a thin layer of cream several times a day on affected areas after cleaning and drying your hands.

Storage and handling

Store at a temperature below 30 °C.

Label contents#

Full prescribing information#

Forms and presentation

HOW SUPPLIED SECTION

Cream: Tube of 75 g.

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Panthenol

Hyaluronic Acid

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aqua, Oenothera Biennis (Evening primrose) Oil, Glycerin, Cetyl Alcohol, Glyceryl Stearate, Butyrospermum Parkii Butter, Ceteareth-20, Simmondsia Chinensis (Jojoba) Seed Oil, Disodium Phosphate, Benzyl Alcohol, Citric Acid, Potassium Sorbate.

Purpose

OTC - PURPOSE SECTION

Moisturizer

Properties

DESCRIPTION SECTION

Derma Hand Repair cream has a synergistic combination of carefully selected natural oils and is rich in other moisturizing ingredients to promote cell regeneration of the damaged skin of hand.
Derma Hand Repair cream characterize by Non-greasy texture, non­sticky, rapidly absorbed, leaves hands soft and silky.
Paraben free.

Indications

INDICATIONS & USAGE SECTION

Derma Hand Repair nourishes your hands with panthenol, Oenothera Biennis (Evening primrose) Oil and other natural oils that regenerate and strengthen your skin against external influences. Therefore it will smooth and moisturize rough, stressed and damaged hands.

Precautions

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

Warnings

WARNINGS SECTION

  • For external use only
  • Avoid contact with eyes and mucous membrans

Contraindications

CONTRAINDICATIONS SECTION

Hypersensitivity to any of the components.

Side effects

ADVERSE REACTIONS SECTION

There are no known side effects.

Dosage and administration

DOSAGE & ADMINISTRATION SECTION

Apply a thin layer of cream several times a day on affected areas after cleaning and drying your hands.

Storage conditions

STORAGE AND HANDLING SECTION

Store at a temperature below 30 °C.

Primary Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Primary PackagePrimary Package

Secondary Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Secondary PackageSecondary Package

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82160-450-01Derma Hand Repair1 in 1 CARTONCREAM1450
82160-450-01Derma Hand Repair75 g in 1 TUBECREAM75450

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82160-450DERMA HAND REPAIR (PANTHENOL, HYALURONIC ACID) CREAM [PELLA PHARMACEUTICALS CO. LTD]450Legacy NDC, 2 package rows20211209_d22576c4-f88c-2d46-e053-2995a90a1534.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82160-45082160-450-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
GLYCERINPDC6A3C0OXIACT
CETYL ALCOHOL936JST6JCNIACT
SHEA BUTTERK49155WL9YIACT
JOJOBA OIL724GKU717MIACT
BENZYL ALCOHOLLKG8494WBHIACT
HYALURONIC ACIDS270N0TRQYACTIB
WATER059QF0KO0RIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
SODIUM PHOSPHATE, DIBASICGR686LBA74IACT
POTASSIUM SORBATE1VPU26JZZ4IACT
DEXPANTHENOL1O6C93RI7ZACTIB
EVENING PRIMROSE OIL3Q9L08K71NIACT
POLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYIACT

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
d22576c4-f88d-2d46-e053-2995a90a1534d22576c4-f88c-2d46-e053-2995a90a15342021-12-02Warnings, Adverse reactionsExact identifier
spl id: d22576c4-f88d-2d46-e053-2995a90a1534
spl set id: d22576c4-f88c-2d46-e053-2995a90a1534

Reported adverse events (FAERS/openFDA)#

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