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Xenaderm Ointment Prescribing Information

Package insert / product label
Generic name: balsam peru, castor oil and trypsin
Dosage form: ointment
Drug class: Topical debriding agents

Medically reviewed by Drugs.com. Last updated on Mar 27, 2023.

NDC 0064-3900-60 RX Only
NDC 0064-3900-30


Xenaderm® Ointment
(Balsam Peru, Castor Oil USP/NF and Trypsin USP)

FOR EXTERNAL USE ONLY
PAT. NO. 6,479,060

ACTIVE INGREDIENTS: Each gram contains Trypsin USP NLT 90 USP units, Balsam Peru 87.0 mg, Castor Oil USP/NF 788.0 mg.

INACTIVE INGREDIENTS: Safflower Oil, Aluminum Magnesium Hydroxide Stearate.

ACTION: Balsam Peru is an effective capillary bed stimulant used to increase circulation in the wound site area. Also, Balsam Peru 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. Trypsin is intended for drebridement of eschar and other necrotic tissue. It appears that in many instances removal of wound debris strengthens humoral defense mechanisms sufficiently to retard proliferation of local pathogens.

Indications and Usage for Xenaderm Ointment

To promote healing and the treatment of decubitus ulcers, varicose ulcers and dehiscent wounds.

USES: XENADERM® Ointment is easy to apply and quickly reduces odor frequently accompanying a decubitus ulcer. The wound may be left open or appropriate dressing applied. As a suggestion, keep in mind wounds heal poorly in the presence of hemoglobin or zinc deficiency. XENADERM® Ointment can relieve pain and promote healing.

Warnings

Do not apply to fresh arterial clots. Avoid contact with eyes. Keep out of reach of children. Use only as directed. When applied to a sensitive area, a temporary stinging sensation may be noted.

Xenaderm Ointment Dosage and Administration

Apply a thin film of XENADERM® Ointment a minimum of twice daily or as often as necessary. Wound may be left unbandaged or appropriate dressing applied. To remove, wash gently with appropriate cleanser.

How is Xenaderm Ointment supplied

XENADERM® Ointment is supplied in 60 gram and 30 gram tubes.

Store XENADERM® Ointment between 15-30° C (59-86° F). Avoid freezing.

Marketed by:
Healthpoint, Ltd.
Fort Worth, Texas 76107
1-800-441-8227
www.healthpoint.com

Manufactured by:
DPT Laboratories, Ltd.
San Antonio, Texas 78215

128191-0205

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

e7c2ca2e-figure-01
XENADERM
balsam peru, castor oil and trypsin ointment
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0064-3900
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BALSAM PERU OIL (UNII: DIK0395679) (BALSAM PERU OIL - UNII:DIK0395679) BALSAM PERU OIL87.0 mg in 1 g
CASTOR OIL (UNII: D5340Y2I9G) (CASTOR OIL - UNII:D5340Y2I9G) CASTOR OIL788.0 mg in 1 g
TRYPSIN (UNII: GV54A213NN) (TRYPSIN - UNII:GV54A213NN) TRYPSIN90 [USP'U] in 1 g
Inactive Ingredients
Ingredient NameStrength
SAFFLOWER OIL (UNII: 65UEH262IS)
Product Characteristics
ColorWHITE (OFF-WHITE) Score
ShapeSize
FlavorImprint Code
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0064-3900-3030 g in 1 TUBE
2NDC:0064-3900-6060 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other03/01/2002
Labeler - HEALTHPOINT, LTD (965634504)
Establishment
NameAddressID/FEIBusiness Operations
DPT LABORATORIES, LTD832224526MANUFACTURE

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