Dermulcera Ointment: Package Insert and Label Information

DERMULCERA OINTMENT-
Canton Laboratories

WOUND DRESSING

Rx Only

DESCRIPTION

DERMULCERA™ OINTMENT contains Balsam Peru, Castor Oil USP, Glyceryl Monostearate and White Petrolatum.

ACTION

DERMULCERA™ OINTMENT helps to deodorize and protectively cover pressure wounds (ulcers). DERMULCERA ™ OINTMENT provides a moist wound environment. The moisturizing properties of DERMULCERA™ OINTMENT may also help in the prevention of cracking around the edges of sores.

INDICATIONS

DERMULCERA™ OINTMENT is a wound dressing for topical use in the management of chronic and acute wounds, and dermal ulcers including: pressure ulcers (Stage I-IV), venous stasis ulcers, diabetic ulcers, first and second degree burns, surgical wounds, traumatic wounds, superficial wounds, ulcers resulting from arterial insufficiency and grafted wound/donor sites.

CONTRAINDICATIONS

DERMULCERA™ OINTMENT is contraindicated in persons who have shown hypersensitivity to Balsam Peru, Petrolatum or any of the other ingredients used in this ointment.

USES

DERMULCERA™ OINTMENT is easy to apply and quickly reduces odors frequently accompanying a decubitus ulcer. The wound may be left open or appropriate dressing applied. Please note that wounds generally heal poorly in the presence of hemoglobin or zinc deficiency.

WARNING

FOR EXTERNAL USE ONLY. Do not apply to fresh arterial clots. Avoid contact with eyes. Keep this and all other medications out of reach of children. Keep tightly closed. Use only as directed by a physician. When applied to a sensitive area, a temporary stinging may occur.

USUAL DOSAGE

Apply a thin film of DERMULCERA™ OINTMENT topically a minimum of twice daily or as often as necessary. Wound may be left unbandaged or appropriate dressing can be applied. To remove, wash gently with an appropriate wound cleanser.

HOW SUPPLIED

DERMULCERA™ OINTMENT is supplied as follows:

SIZE N DC NUMBER

60 GRAM TUBE 69437-502-60

STORAGE

Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F). Brief exposure to temperatures up to 40°C (104°F) may be tolerated provided the mean kinetic temperature does not exceed 25°C (77°F); however, such exposure should be minimized. [See USP Controlled Room Temperature]. Protect from freezing. See crimp for lot number and expiration date.

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DERMULCERA OINTMENT
Product Information
Product Type Item Code (Source) NHRIC:69437-502
Route of Administration TOPICAL DEA Schedule
Inactive Ingredients
Ingredient Name Strength
CASTOR OIL
BALSAM PERU
GLYCERYL MONOSTEARATE
PETROLATUM
Packaging
# Item Code Package Description Multilevel Packaging
1 NHRIC:69437-502-60 1 TUBE in 1 CARTON contains a TUBE
1 60 g in 1 TUBE This package is contained within the CARTON (69437-502-60)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Exempt device NAD 06/08/2018
Labeler — Canton Laboratories (079589614)
Establishment
Name Address ID/FEI Operations
Biozone Laboratories, Inc. 962455320 MANUFACTURE, LABEL, PACK

Revised: 05/2019 Canton Laboratories

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