Derma Wound-Eaz

Manufacturer
Pella Pharmaceuticals Co. Ltd
Effective date
2024-12-31
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:50:21

Label at a glance#

ProductDerma Wound-Eaz
Active ingredientCETRIMIDE
Label structure16 sections

Dosage and administration

With a clean hand gently apply the cream to the affected area in a layer of about 2 to 3 mm thickness or place the cream on sterile gauze and then apply it to the wound. Apply the cream 2 to 3 times a day or as prescribed by the doctor and the duration of use depends on the improvement of the symptoms.

Storage and handling

Store below 30 ◦ C

Label contents#

Full prescribing information#

Form and Presentation

HOW SUPPLIED SECTION

Cream: Laminated Tube, 25 g

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Cetrimide

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aqua, Paraffinium Liquidium, Cetearyl Alcohol, Petrolatum, Phenyl Trimethicone, Ceteareth-20, Benzyl Alcohol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Hyaluronic Acid, Triethanolamine, Chlorhexidine Digluconate, Disodium EDTA.

Purpose

OTC - PURPOSE SECTION

Wound and scars care cream

Properties

DESCRIPTION SECTION

This product is for the management of wounds and scars, it provides deep skin hydration, accelerates the process of regeneration. It works by softening and flattening raised scars of any kind and is an effective antiseptic with a wide range of activity against micro-organisms, including gram-positive and gram-negative bacteria, fungi, and viruses.

Indications

INDICATIONS & USAGE SECTION

Used for the disinfection and healing of the wounds and burns and to reduce the appearance of scars that result from cuts and grazes, also used for dermatological disorders such as insect bites and stings, minor burns and scalds, sunburn, blisters and sores.

Precaution

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, if accidentally splashed into the eye, the open eye should be irrigated for at least 10 minutes.
- Discontinue use if irritation (redness, pain, etc.) occurs. If skin irritation occurs, consult your physician if the symptoms persist for more than 48 hr.

Contraindications

CONTRAINDICATIONS SECTION

Hypersensitivity to any of the components.

Side Effects

ADVERSE REACTIONS SECTION

Skin irritation.

Pregnancy and Lactation

OTC - PREGNANCY OR BREAST FEEDING SECTION

There are no adequate data from the use of chlorhexidine digluconate and cetrimide in pregnant women.

The potential risk for humans is unknown but is most likely very low since chlorhexidine digluconate and cetrimide are poorly absorbed following topical application.

It is not known whether chlorhexidine digluconate and cetrimide are excreted in breast milk. There are no adequate data from the use of chlorhexidine and cetrimide in breastfeeding women. However, it is unlikely that the products are excreted in breast milk since the products are poorly absorbed. After topical usage of the product, as a general precaution, rinse nipples thoroughly with water before breastfeeding.

Dosage and Administration

DOSAGE & ADMINISTRATION SECTION

With a clean hand gently apply the cream to the affected area in a layer of about 2 to 3 mm thickness or place the cream on sterile gauze and then apply it to the wound.

Apply the cream 2 to 3 times a day or as prescribed by the doctor and the duration of use depends on the improvement of the symptoms.

Interactions

DRUG INTERACTIONS SECTION

The product is incompatible with anionic substances (e.g. soap, toothpaste).

Storage Conditions

STORAGE AND HANDLING SECTION

Store below 30 ◦C

Primary Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Primary PackagePrimary Package

Secondary Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Secondary PackageSecondary Package

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
246065cetrimide 5 % Topical CreamPSN2
246065cetrimide 5 MG/ML Topical CreamSCD2
246065cetrimide 5 % Topical CreamSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
bb6d6c68-649d-4e6d-a1f6-603d969c8f68Product name120160303

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82160-696-01Derma Wound-Eaz1 in 1 CARTONCREAM12
82160-696-01Derma Wound-Eaz25 g in 1 TUBECREAM252

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82160-696DERMA WOUND-EAZ (CETRIMIDE) CREAM [PELLA PHARMACEUTICALS CO. LTD]22 package rows20250101_fea2b4d1-c524-60ee-e053-6294a90ae6fe.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82160-69682160-696-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

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
2a91378f-edcd-7b98-e063-6394a90aba35fea2b4d1-c524-60ee-e053-6294a90ae6fe2024-12-31Warnings, Adverse reactionsExact identifier
spl id: 2a91378f-edcd-7b98-e063-6394a90aba35
spl set id: fea2b4d1-c524-60ee-e053-6294a90ae6fe

Reported adverse events (FAERS/openFDA)#

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