What is biafine?

Biafine is a topical non-steroidal medication available in the United States for treating burns, wounds and irritations. The clinical benefits of Biafine to stimulate all phases of wound healing have been studied in the United States prior to U.S. Food and Drug Administration approval in 2006, and these benefits underscore the heritage of the product's use in France for over 25 years. Biafine contains non-toxic ingredients in an herbal base and its use includes wound management, adjunct to radiation therapy, burn dressings, post-treatment for cosmetic and plastic surgery and dermatology treatments (such as sunburn).


Biafine is manufactured by Laboratoire Medix in France and distributed by Ortho Dermatology (OrthoNeutrogena) in the United States as a prescription topical for wounds and burns. Biafine has been used in France for more than 25 years, and it contains non-toxic and herbal ingredients. It was approved in 2006 for prescription use in the United States. Biafine hydrates skin tissue, adding water to healing tissue, softening scars, promoting the body's antibacterial activity and reducing contamination. It is safe to use Biafine daily, as when changing wound dressings.


Biafine is a topical, water-based emulsion that penetrates the skin to hydrate the underlying tissues. The formulation is an emollient, which softens scarred and dead superficial tissue upon penetration and hydration, to promote healing. Biafine enhances autolytic debridement, which is the body's mechanism to eliminate dead tissue as part of the healing process by enhancing macrophage recruitment to the wound site. A moist dressing and increased macrophage recruitment for natural healing reduce the need to remove dead and scarred tissue surgically. As an emulsion, Biafine also provides a barrier similar to hydrogels which protect the wounds against further bacterial contamination.

Approved Indications

Biafine is used to treat burns, skin irritations, superficial wounds and dryness. Its popularity overseas has been for its hydrating properties and effectiveness on sunburned skin and scrapes. Clinical studies were conducted in the United States for burns, wound healing and radiation.

According to the Biafine package insert, the FDA has approved Biafine for use in full thickness wounds, pressure sores and dermal ulcers (includes lower leg ulcers), superficial wounds, first- and second-degree burns, sunburns, dermal donor and graft site management, radiation dermatitis and minor abrasions.


Wound and burn management involve methods to enhance tissue regeneration and to minimise infection during the healing process. Since autolytic debridement is the preferred method for removing dead and scarred tissue, moist dressings are needed and must be changed daily. Biafine is liberally applied to the skin and covered with a dressing, such as gauze. The dressing is changed every 24 hours, with reapplication of Biafine.


While Biafine is an emulsion, it is non-comedogenic because it stimulates tissue debridement, hydration and regeneration. It promotes antibacterial activity. Initial application may produce a slight tingling sensation from the penetrating properties of the formulation. Biafine has been studied in clinical trials for use after plastic and cosmetic surgery.

Contraindications and Warnings

Biafine is for topical use only and should not be used on bleeding wounds and skin rashes (especially those caused by an allergic reaction). All wounds, burns and irritations should be cleaned before application and bandaging. Biafine is a prescription medication and should be applied as directed by a health care professional, particularly when used as an adjunct to radiation treatment and dermal grafts. Biafine does not contain any sunscreen, because it is applied after prolonged sun exposure.

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