Bacitracin Polymyxin B

Name: Bacitracin Polymyxin B

Bacitracin Polymyxin B Description

Bacitracin Zinc and Polymyxin B Sulfate Ophthalmic Ointment USP is a sterile antimicrobial ointment formulated 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: ACTIVES: Bacitracin Zinc equal to 500 bacitracin units and Polymyxin B Sulfate equal to 10,000 polymyxin B units; INACTIVES: Mineral Oil and White Petrolatum.

INDlCATlONS 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.

How is Bacitracin Polymyxin B Supplied

Bacitracin Zinc and Polymyxin B Sulfate Ophthalmic Ointment USP is available in tubes with an ophthalmic tip applicator in the following size:

3.5 gram tube - NDC 24208-555-55

DO NOT USE IF CAP AND NECKRING ARE NOT INTACT.

Storage:

Store between 15°-25°C (59°-77°F). KEEP TIGHTLY CLOSED.

KEEP OUT OF REACH OF CHILDREN.

Revised: March 2013

Bausch & Lomb Incorporated
Tampa, FL 33637
©Bausch & Lomb Incorporated

9130701 (Folded)
9130601 (Flat)

Principal display panel

NDC 24208-555-55

Bausch & Lomb

Bacitracin Zinc and

Polymyxin B Sulfate

Ophthalmic

Ointment USP
Sterile

[icon- eye] [icon- ointment] [icon- 3.5 gm]

Net wt. 1/8 oz

(3.5g)

Rx only

BACITRACIN ZINC AND POLYMYXIN B SULFATE 
bacitracin zinc and polymyxin b sulfate ointment
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:24208-555
Route of Administration OPHTHALMIC DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BACITRACIN ZINC (BACITRACIN) BACITRACIN 500 [USP'U]  in 1 g
POLYMYXIN B SULFATE (POLYMYXIN B) POLYMYXIN B 10000 [USP'U]  in 1 g
Inactive Ingredients
Ingredient Name Strength
PETROLATUM  
MINERAL OIL  
Packaging
# Item Code Package Description
1 NDC:24208-555-55 1 TUBE in 1 CARTON
1 3.5 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA064046 04/25/2008
Labeler - Bausch & Lomb Incorporated (196603781)
Establishment
Name Address ID/FEI Operations
Bausch & Lomb Incorporated 079587625 MANUFACTURE(24208-555)
Revised: 11/2013   Bausch & Lomb Incorporated
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