BACITRACIN

BACITRACIN — bacitracin ointment
REMEDYREPACK INC.

SPL UNCLASSIFIED

Rx Only

DESCRIPTION

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

MECHANISM OF 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 & 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

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 to BACITRACIN

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 Fera Pharmaceuticals, LLC at (414) 434-6604, Monday — Friday 9am — 5pm EST, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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.

HOW SUPPLIED

NDC 48102-007-13 3 — 1 g sterile tamper evident tubes with ophthalmic tip.

NDC 48102-007-35 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).

SPL UNCLASSIFIED

MM1

Manufactured for:

Fera Pharmaceuticals, LLC
Locust Valley, NY 11560

PF00735A
R1111

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

DRUG: BACITRACIN

GENERIC: BACITRACIN

DOSAGE: OINTMENT

ADMINSTRATION: OPHTHALMIC

NDC: 52125-454-01

ACTIVE INGREDIENT(S):

  • BACITRACIN 500[iU] in 1g

INACTIVE INGREDIENT(S):

  • MINERAL OIL
  • PETROLATUM

PACKAGING: 3.5 g in 1 TUBE

MM2
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MM3
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BACITRACIN
bacitracin ointment
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52125-454(NDC:48102-007)
Route of Administration OPHTHALMIC DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BACITRACIN (BACITRACIN) BACITRACIN 500 [iU] in 1 g
Inactive Ingredients
Ingredient Name Strength
MINERAL OIL
PETROLATUM
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52125-454-01 3.5 g in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA061212 06/10/2013
Labeler — REMEDYREPACK INC. (829572556)

Revised: 06/2013 REMEDYREPACK INC.

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