FDA Label for Baciguent
View Indications, Usage & Precautions
Baciguent Product Label
The following document was submitted to the FDA by the labeler of this product Woodward Pharma Services Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Description:
Each gram of ointment contains 500 units of bacitracin in a low melting special base containing White Petrolatum and Mineral Oil.
Clinical Pharmacology:
The antibiotic, bacitracin, exerts a profound action against many gram-positive pathogens, including the common Streptococci and Staphlococci. It is also destructive for certain gram-negative organisms. It is ineffective against fungi.
Indications And Usage:
For the treatment of superficial ocular infections involving the conjunctiva and/or cornea caused by bacitracin susceptible organisms.
Contraindications:
This product should not be used in patients with a history of hypersensitivity to bacitracin.
Precautions:
Baciguent® ophthalmic ointment should not be used in deep-seated ocular infections or in those that are likely to become systemic. The prolonged use of antibiotic containing preparations may result in overgrowth of nonsusceptible organisms particularly fungi. If new infections develop during treatment appropriate antibiotic or chemotherapy should be instituted.
Adverse Reactions:
Bacitracin has such a low incidence of allergenicity that for all practical purposes side reactions are practically non-existent. However, if such reaction should occur, therapy should be discontinued.
To report SUSPECTED ADVERSE REACTIONS, contact Woodward Pharma Services LLC at 1-844-200-7910 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Dosage And Administration:
The ointment should be applied directly into the conjunctival sac 1 to 3 times daily. In blepharitis all scales and crusts should be carefully removed and the ointment then spread uniformly over the lid margins. Patients should be instructed to take appropriate measures to avoid gross contamination of the ointment when applying the ointment directly to the infected eye.
How Supplied:
NDC 69794-880-01 3 – 1 g sterile tamper evident tubes with ophthalmic tip.
NDC 69784-880-35 3.5 g (1/8 oz.) sterile tamper evident tubes with ophthalmic tip.
Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].
Other
Manufactured For
Woodward Pharma Services LLC
Wixom, MI 48393
Rev 11-19
5G000 CJ J1
Package/Label Principal Display Panel – 1 G Label
Rx Only
NDC 69784-880-35
Baciguent®
(Bacitracin Ophthalmic Ointment, USP)
STERILE
NET WT 3.5 g (1/8 oz)
USUAL DOSAGE: Apply 1 to 3 times daily. See package insert for full prescribing information.
Each gram contains: 500 units of bacitracin in a base of white petrolatum and mineral oil.
KEEP TIGHTLY CLOSED
Store at 20° to 25°C (68°-77°F) [see USP Controlled Room Temperature].
KEEP OUT OF REACH OF CHILDREN
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