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Xenaderm Ointment

Pronunciation

Generic Name: balsam peru, castor oil and trypsin
Dosage Form: ointment

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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.

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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 LABEL Item Code (Source) NDC: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
# Item Code Package Description
1 NDC:0064-3900-30 30 g in 1 TUBE
2 NDC:0064-3900-60 60 g in 1 TUBE
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: 08/2010
 
HEALTHPOINT, LTD



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