FDA Label for Derma Wound-eaz
View Indications, Usage & Precautions
Derma Wound-eaz Product Label
The following document was submitted to the FDA by the labeler of this product Pella Pharmaceuticals Co. Ltd. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Form And Presentation
Cream: Laminated Tube, 25 g
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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