Form And Presentation
Cream: Laminated Tube, 25 g
Derma Wound-eaz
FDA Label NDC 82160-696
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Pella Pharmaceuticals Co. Ltd for the product Derma Wound-eaz (NDC 82160-696). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding form and presentation, active ingredient, inactive ingredients, purpose, properties, indications, precaution, warnings, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Cetrimide
Inactive Ingredients
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
Wound and scars care cream
Properties
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
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
Keep out of reach of children
Warnings
- 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
Hypersensitivity to any of the components.
Side Effects
Skin irritation.
Pregnancy And Lactation
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
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
The product is incompatible with anionic substances (e.g. soap, toothpaste).
Storage Conditions
Store below 30 ◦C
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