Neomycin and Polymyxin B Sulfates and Bacitracin Zinc (Page 2 of 2)

Nursing Mothers:

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when neomycin and polymyxin B sulfates and bacitracin zinc ophthalmic ointment is administered to a nursing woman.

Pediatric Use:

Safety and effectiveness in pediatric patients have not been established.

ADVERSE REACTIONS:

Adverse reactions have occurred with the anti-infective components of neomycin and polymyxin B sulfates and bacitracin zinc ophthalmic ointment. The exact incidence is not known. Reactions occurring most often are allergic sensitization reactions including itching, swelling, and conjunctival erythema (see WARNINGS). More serious hypersensitivity reactions, including anaphylaxis, have been reported rarely.

Local irritation on instillation has also been reported.

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:

Neomycin and Polymyxin B Sulfates and Bacitracin Zinc Ophthalmic Ointment USP is supplied in a 3.5 g tube with an ophthalmic tip.

Prod. No. 03534

NDC 54868-2971-1

DO NOT USE IF CAP AND NECKRING ARE NOT INTACT.

FOR OPHTHALMIC USE ONLY

Storage:

Store between 15 — 30 degree C. ( 59 — 86 degree F.)
Storage:

Store between 15° — 30°C (59°- 86°F).

KEEP OUT OF REACH OF CHILDREN.

Revised November 2007

Bausch & Lomb Incorporated
Tampa, FL 33637

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

Principal Display Panel

Neomycin and Polymyxin B Sulfates and Bacitracin Zinc Ophthalmic Ointment USP

(Sterile)

Rx only

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

Net wt. 1/8 oz

(3.5g)

Neomycin and Polymyxin B Sulfates and Bacitracin Zinc Ophthalmic Ointment USP (Carton, 3.5 gram -- Bausch & Lomb)
(click image for full-size original)
NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC
neomycin and polymyxin b sulfates and bacitracin zinc ointment
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-2971(NDC:24208-780)
Route of Administration OPHTHALMIC DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NEOMYCIN SULFATE (NEOMYCIN) NEOMYCIN SULFATE 3.5 mg in 1 g
POLYMYXIN B SULFATE (POLYMYXIN B) POLYMYXIN B SULFATE 10000 [USP'U] in 1 g
BACITRACIN ZINC (BACITRACIN) BACITRACIN ZINC 400 [USP'U] in 1 g
Inactive Ingredients
Ingredient Name Strength
MINERAL OIL
PETROLATUM
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-2971-1 1 TUBE (TUBE) in 1 CARTON contains a TUBE
1 3.5 g in 1 TUBE This package is contained within the CARTON (54868-2971-1)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA064064 03/25/1994
Labeler — Physicians Total Care, Inc. (194123980)
Establishment
Name Address ID/FEI Operations
Physicians Total Care, Inc. 194123980 relabel

Revised: 09/2010 Physicians Total Care, Inc.

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