NDC 54868-1199 Bacitracin Zinc And Polymyxin B Sulfate

NDC Product Code 54868-1199

NDC 54868-1199-0

Package Description: 1 TUBE in 1 CARTON > 3.5 g in 1 TUBE

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Bacitracin Zinc And Polymyxin B Sulfate with NDC 54868-1199 is a product labeled by Physicians Total Care, Inc.. The generic name of Bacitracin Zinc And Polymyxin B Sulfate is . The product's dosage form is and is administered via form.

Labeler Name: Physicians Total Care, Inc.

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • PETROLATUM (UNII: 4T6H12BN9U)
  • MINERAL OIL (UNII: T5L8T28FGP)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Physicians Total Care, Inc.
Labeler Code: 54868
Start Marketing Date: 11-12-2004 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2017 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: I - INACTIVATED, the listing data was inactivated by the FDA. What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

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Bacitracin Zinc And Polymyxin B Sulfate Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Other

Rx only

Description

Bacitracin Zinc and Polymyxin B Sulfate Ophthalmic Ointment is a
sterile antimicrobial ointment for ophthalmic use.Bacitracin zinc is the zinc salt of bacitracin, a mixture of related cyclic
polypeptides (mainly bacitracin A) produced by the growth of an organism of the
licheniformis group of Bacillus subtilis var Tracy.
It has a potency of not less than 40 bacitracin units per mg. The structural
formula for bacitracin A is:Polymyxin B Sulfate is the sulfate salt of polymyxin B1 and B2 which are produced by the
growth of Bacillus polymyxa (Prazmowski) Migula (Fam.
Bacillaceae). It has a potency of not less than 6,000 polymyxin B units per mg,
calculated on an anhydrous basis. The structural formulae are:Each gram contains: Bacitracin zinc equal to 500 bacitracin units and
polymyxin B sulfate equal to 10,000 polymyxin B units, white petrolatum and
mineral oil.

Clinical Pharmacology

Polymyxin B attacks gram-negative bacilli, including virtually
all strains of Pseudomonas aeruginosa and H influenzae species.Bacitracin is active against most gram-positive bacilli and cocci including
hemolytic streptococci.

Indications And Usage

For the treatment of superficial ocular infections involving the
conjunctiva and/or cornea caused by organisms susceptible to bacitracin zinc and
polymyxin B sulfate.

Contraindications

This product is contraindicated in those individuals who have
shown hypersensitivity to any of its components.

Warnings

Ophthalmic ointments may retard corneal healing.

Precautions

As with other antibiotic preparations, prolonged use may result
in overgrowth of nonsusceptible organisms, including fungi. Appropriate measures
should be taken if this occurs.

Dosage And Administration

Apply the ointment every 3 or 4 hours for 7 to 10 days, depending
on the severity of the infection.

How Supplied

Bacitracin Zinc and Polymyxin B Sulfate ophthalmic ointment USP,
sterile, each gram contains bacitracin zinc equal to 500 bacitracin units and
polymyxin B sulfate equal to 10,000 polymyxin B units, in a tube of 3.5 g (1/8
oz) with ophthalmic tip.NDC 54868-1199-0

Storage

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room
Temperature].Manufactured By: Akorn, Inc.Lake Forest, IL 60045AKP00NRev. 11/08Relabeling of "Additional Barcode Label" by:Physicians Total Care, Inc.Tulsa, OK      74146

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