Bacitracin BACITRACIN PADAGIS US LLC FDA Approved Each gram of ointment contains 500 units of Bacitracin in a low melting special base containing White Petrolatum and Mineral Oil.
Generic: BACITRACIN
Mfr: PADAGIS US LLC FDA Rx Only
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Substance Bacitracin
Route
OPHTHALMIC
Applications
ANDA061212

Drug Facts

Composition & Profile

Strengths
3.5 g
Quantities
35 count
Treats Conditions
Indications And Usage For The Treatment Of Superficial Ocular Infections Involving The Conjunctiva And Or Cornea Caused By Bacitracin Susceptible Organisms

Identifiers & Packaging

Container Type BOX
UNII
58H6RWO52I
Packaging

HOW SUPPLIED: NDC 0574- 4022 -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]. Manufactured for Padagis ® by Jubilant HollisterStier General Partnership Kirkland, Quebec H9H 4J4 Canada 35F00 RC PH2 Rev 02-23; PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 3.5 g Carton NDC 0574-4022-35 Rx Only Bacitracin Ophthalmic Ointment USP NET WT 3.5 g (1/8 oz) STERILE The following image is a placeholder representing the product identifier that is either affixed or imprinted on the drug package label during the packaging operation. Bacitracin Ophthalmic Ointment carton serialization-template

Package Descriptions
  • HOW SUPPLIED: NDC 0574- 4022 -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]. Manufactured for Padagis ® by Jubilant HollisterStier General Partnership Kirkland, Quebec H9H 4J4 Canada 35F00 RC PH2 Rev 02-23
  • PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 3.5 g Carton NDC 0574-4022-35 Rx Only Bacitracin Ophthalmic Ointment USP NET WT 3.5 g (1/8 oz) STERILE The following image is a placeholder representing the product identifier that is either affixed or imprinted on the drug package label during the packaging operation. Bacitracin Ophthalmic Ointment carton serialization-template

Overview

Each gram of ointment contains 500 units of Bacitracin in a low melting special base containing White Petrolatum and Mineral Oil.

Indications & Usage

: For the treatment of superficial ocular infections involving the conjunctiva and/or cornea caused by Bacitracin susceptible organisms.

Dosage & 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.

Warnings & Precautions
No warnings available yet.
Contraindications

: This product should not be used in patients with a history of hypersensitivity to Bacitracin.

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 Padagis ® at 1-866-634-9120 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.


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