B and C Ointment by Laser Pharmaceuticals, LLC / Speciality Pharma Manufacturing, LLC B AND C OINTMENT-

B and C Ointment by

Drug Labeling and Warnings

B and C Ointment by is a Other medication manufactured, distributed, or labeled by Laser Pharmaceuticals, LLC, Speciality Pharma Manufacturing, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

B&C Ointment

WOUND DRESSING

Rx Only

DESCRIPTION

B&C OINTMENT contains Balsam Peru, Castor Oil USP, Glyceryl Monostearate and White Petrolatum.

ACTION

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

INDICATIONS

B&C 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

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

USES

B&C 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 B&C 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

B&C OINTMENT is supplied as follows:

SIZE  PRODUCT CODE 

 60 GRAM TUBE        16477-502-60

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

B AND C OINTMENT 
dressing, wound, occlusive

Product Information
Product Type	MEDICAL DEVICE	Item Code (Source)	NHRIC:16477-502
Route of Administration	TOPICAL

Inactive Ingredients
Ingredient Name	Strength
CASTOR OIL (UNII: D5340Y2I9G)
BALSAM PERU (UNII: 8P5F881OCY)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PETROLATUM (UNII: 4T6H12BN9U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:16477-502-60	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	10/26/2021

Labeler - Laser Pharmaceuticals, LLC (614417132)

Establishment
Name	Address	ID/FEI	Business Operations
Speciality Pharma Manufacturing, LLC		013957125	MANUFACTURE, LABEL, PACK