Balsam Peru And Castor Oil () Ointment [Nivagen Pharmaceuticals Llc] -

BALSAM PERU AND CASTOR OIL () OINTMENT [NIVAGEN PHARMACEUTICALS LLC]
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NDC	75834-139-60
Set ID	6d11efdc-6c88-4917-afba-094010b61099
Category	MEDICAL DEVICE
Packager	Nivagen Pharmaceuticals LLC
Generic Name
Product Class
Product Number
Application Number	MGP

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SPL UNCLASSIFIED SECTION

NDC 75834-139-60

Rx Only

Wound Dressing
DESCRIPTION

Balsam Peru & Castor Oil Ointment contains Balsam Peru, Castor Oil USP, Glyceryl Monostearate and White Petrolatum.
ACTION

Balsam Peru & Castor Oil Ointment helps to deodorize and protectively cover pressure wounds (ulcers) and may help with the reduction of pain. Balsam Peru & Castor Oil Ointment provides a moist wound environment conductive to healing. The moisturizing properties of Balsam Peru & Castor Oil Ointment also help in the prevention of cracking around the edges of sores.
INDICATIONS

Balsam Peru & Castor Oil 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

Balsam Peru & Castor Oil Ointment is contraindicated in persons who have shown hypersensitivity to Balsam Peru, Petrolatum or any of the other ingredients used in this ointment.
USES

Balsam Peru & Castor Oil 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 Balsam Peru & Castor Oil 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

Balsam Peru & Castor Oil Ointment is supplied as follows:

SIZE NDC NUMBER
60 GRAM TUBE 75834-139-60

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.
SPL UNCLASSIFIED SECTION

Manufactured for:
Nivagen Pharmaceuticals, Inc.
Sacramento, CA 95827 USA
Toll free number: 1-877-977-0687

Rev. 07/18
PRINCIPAL DISPLAY PANEL - 60 gram Tube Carton

NDC 75834-139-60
Rx only

Balsam Peru
& Castor Oil
Ointment

NIVAGEN
PHARMACEUTICALS

Wound Dressing

Net Wt. 60 grams

SIZE	NDC NUMBER
60 GRAM TUBE	75834-139-60

INGREDIENTS AND APPEARANCE

BALSAM PERU AND CASTOR OIL
dressing, wound and burn, occlusive ointment

Product Information
Product Type	MEDICAL DEVICE	Item Code (Source)	NHRIC:75834-139
Route of Administration	TOPICAL

#	Item Code	Package Description
Packaging
1	NHRIC:75834-139-60	1 in 1 CARTON
1		60 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
Exempt device	NAD	12/14/2018

Labeler - Nivagen Pharmaceuticals LLC (052032418)

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Medic

BALSAM PERU AND CASTOR OIL () OINTMENT [NIVAGEN PHARMACEUTICALS LLC]

STORAGE

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