Bacitracin Ophthalmic Ointment Usp

Bacitracin Ophthalmic Ointment Usp
SPL v6
SPL
SPL Set ID 6ed2f2bd-9d2f-46af-a44c-95a02ca034de
Route
OPHTHALMIC
Published
Effective Date 2024-10-31
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Bacitracin (500 [USP'U])
Inactive Ingredients
Petrolatum Mineral Oil

Identifiers & Packaging

Marketing Status
ANDA Completed Since 2014-03-10 Until 2016-09-01

Description

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

Indications and Usage

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

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.

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.

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


Medication Information

Indications and Usage

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

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.

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.

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

Description

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

Description:

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

Precautions:

Bacitracin 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.

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

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.

Contraindications:

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

Clinical Pharmacology:

The antibiotic, Bacitracin, exerts a profound action against many gram-positive pathogens, including the common Streptococci and Staphylococci. 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.

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.

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.


Structured Label Content

Description: (DESCRIPTION:)

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

Precautions: (PRECAUTIONS:)

Bacitracin 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.

How Supplied: (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

Adverse Reactions: (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.

Contraindications: (CONTRAINDICATIONS:)

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

Clinical Pharmacology: (CLINICAL PHARMACOLOGY:)

The antibiotic, Bacitracin, exerts a profound action against many gram-positive pathogens, including the common Streptococci and Staphylococci. It is also destructive for certain gram-negative organisms. It is ineffective against fungi.

Indications and Usage: (INDICATIONS AND USAGE:)

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

Dosage and Administration: (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.

Package/label Principal Display Panel – 3.5 G Carton (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.


Advanced Ingredient Data


Raw Label Data

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