Xenaderm Ointment

balsam peru, castor oil and trypsin

Dosage Form: ointment
Xenaderm Ointment

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:

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.

DOSAGE:

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 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

XENADERM  balsam peru, castor oil and trypsin  ointment

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0064-3900 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BALSAM PERU OIL (BALSAM PERU OIL) BALSAM PERU OIL 87.0 mg  in 1 g CASTOR OIL (CASTOR OIL) CASTOR OIL 788.0 mg  in 1 g TRYPSIN (TRYPSIN) TRYPSIN 90 [USP'U]  in 1 g

Inactive Ingredients Ingredient Name Strength SAFFLOWER OIL

Product Characteristics Color WHITE (OFF-WHITE) Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0064-3900-30 30 g In 1 TUBE None 2 0064-3900-60 60 g In 1 TUBE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug other		03/01/2002

Labeler - HEALTHPOINT, LTD (965634504)

Establishment
Name	Address	ID/FEI	Operations
DPT LABORATORIES, LTD		832224526	MANUFACTURE

Revised: 08/2010HEALTHPOINT, LTD

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