Castor oil; peru balsam is used in wound care management to relieve pain, reduce odor, and promote healing. The formulation contains castor oil (788 mg/gram) and peru balsam (87 mg/gram); the ointment (a prescription only product) has been used for decubital ulcers, varicose ulcers, and dehiscent wounds. Despite the labeled uses, the formulation has not been found by the FDA to be safe or effective for any indication. Castor oil; peru balsam is an FDA unapproved drug. A non-prescription aerosol product has been discontinued from the market.
General Administration Information
For storage information, see the specific product information within the How Supplied section.
Route-Specific Administration
Topical Administration
-Avoid contact with eyes.
-Do not apply to fresh arterial clots.
-Wash hands before and after application.
Cream/Ointment/Lotion Formulations
Ointment:
-Apply as a thin film.
-After use, wound may be left unbandaged or appropriate dressing applied.
-To remove, wash gently with appropriate wound cleanser.
Temporary stinging (skin irritation) may occur with use of castor oil; peru balsam on a sensitive area.
Castor oil; peru balsam is indicated for topical use only. Do not apply to fresh arterial thrombosis, and avoid ocular exposure. In addition, intentional misuse by deliberately concentrating and inhaling the contents of the aerosol formulation may result in harmful, and potentially fatal, effects.
Data are limited regarding use of castor oil; peru balsam during pregnancy. No well-controlled studies have been conducted, and it is unknown if the drug has an adverse effect on the fetus or reproductive system. Castor oil; peru balsam should be used during pregnancy only when clearly needed.
It is unknown whether castor oil; peru balsam is excreted in breast milk. If the product must be applied topically to the breasts, it would be advisable to avoid breast-feeding. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally administered drug, healthcare providers are encouraged to report the adverse effect to the FDA.
The castor oil; peru balsam aerosol formulation is flammable. Avoid heat, flame, and tobacco smoking during and immediately following application of the spray.
For wound management* to promote healing of decubitus ulcer*, varicose ulcer*, and dehiscent wounds*:
Topical dosage (wound care ointment):
Adults, Adolescents and Children: Considered an "unapproved drug product" by the FDA. Apply thin film topically to affected areas at least twice daily, or as often as necessary. Wound may be left unbandaged or appropriate dressing can be applied.
Maximum Dosage Limits:
Maximum dosage information is not available.
Patients with Hepatic Impairment Dosing
Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.
Patients with Renal Impairment Dosing
Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.
*non-FDA-approved indication
There are no drug interactions associated with Castor Oil; Peru Balsam products.
Castor oil; peru balsam is a combination product with antibacterial, blood flow stimulant, and protective barrier activities. The peru balsam component is an effective capillary bed stimulant used to increase circulation in the wound site area. In addition, peru balsam has a mildly bactericidal action. Castor oil is used to improve epithelialization by reducing premature epithelial desiccation and cornification. Also, it can act as a protective covering and aids in the reduction of pain and odor.
Castor oil; peru balsam is applied topically. Pharmacokinetic studies have not been conducted by the manufacturers; significant systemic absorption and effects are not expected with appropriate use.
Affected cytochrome P450 isoenzymes and drug transporters: None