BACITRACIN - bacitracin ointment 
Physicians Total Care, Inc.

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BACITRACIN
OPHTHALMIC
OINTMENT USP
STERILE

Rx Only

DESCRIPTION:

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

ACTION:

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:

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:

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.

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.

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:

3.5 g (1/8 Oz) sterile tamper proof tubes,  NDC 54868-0649-1.

Fera logo

Manufactured for:

Fera Pharmaceuticals, LLC
Locust Valley, NY 11560

FPBC00N                   Rev. 08/09

Relabeling of "Additional Barcode Label" by:
Physicians Total Care, Inc.
Tulsa, OK       74146

PRINCIPAL DISPLAY PANEL - Carton Label

Rx only

BACITRACIN OPHTHALMIC
OINTMENT USP

STERILE

CONTAINS: 500 units of Bacitracin per gram, White Petrolatum, Mineral Oil.

NET WT 3.5 g (1/8 Oz)

USUAL DOSAGE: 3 applications daily.
See insert for complete information.

KEEP TIGHTLY CLOSED
STORE AT ROOM TEMPERATURE
KEEP OUT OF REACH OF CHILDREN

See crimp of tube for Lot No. & Exp. Date

Bacitracin Carton Label

BACITRACIN 
bacitracin ointment
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:54868-0649(NDC:48102-007-35)
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BACITRACIN (UNII: 58H6RWO52I) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN500 [iU]  in 1 g
Inactive Ingredients
Ingredient NameStrength
MINERAL OIL (UNII: T5L8T28FGP)  
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54868-0649-11 in 1 CARTON
13.5 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA06121204/29/1994
Labeler - Physicians Total Care, Inc. (194123980)
Establishment
NameAddressID/FEIBusiness Operations
Physicians Total Care, Inc.194123980relabel

Revised: 8/2009
Document Id: 1a1f53f2-5434-4359-b1ef-f21bed5084a9
Set id: 2023b121-67d3-499a-ae7f-526cc9bafbc1
Version: 1
Effective Time: 20090826
 
Physicians Total Care, Inc.