Label: BALSAM PERU AND CASTOR OIL- ointment
- NHRIC Code(s): 75834-139-60
- Packager: Nivagen Pharmaceuticals LLC
- Category: MEDICAL DEVICE
- DEA Schedule: None
- Marketing Status: Exempt device
Drug Label Information
Updated January 15, 2019
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- DESCRIPTION
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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.
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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
- USES
- WARNING
- USUAL DOSAGE
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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
- PRINCIPAL DISPLAY PANEL - 60 gram Tube Carton
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INGREDIENTS AND APPEARANCE
BALSAM PERU AND CASTOR OIL
dressing, wound and burn, occlusive ointmentProduct Information Product Type MEDICAL DEVICE Item Code (Source) NHRIC:75834-139 Route of Administration TOPICAL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NHRIC:75834-139-60 1 in 1 CARTON 1 60 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Exempt device NAD 12/14/2018 Labeler - Nivagen Pharmaceuticals LLC (052032418)