BACIGUENT

BACIGUENT- bacitracin ointment
Woodward Pharma Services LLC

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.

CLINICAL PHARMACOLOGY:

The antibiotic, bacitracin, exerts a profound action against many gram-positive pathogens, including the common Streptococci and Staphlococci. It is also destructive for certain gram-negative organisms. It is ineffective against fungi.

INDICATIONS AND 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:

Baciguent® 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.

To report SUSPECTED ADVERSE REACTIONS, contact Woodward Pharma Services LLC at 1-844-200-7910 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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:

NDC 69784-880-01 3 – 1 g sterile tamper evident tubes with ophthalmic tip.

NDC 69784-880-35 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].

Manufactured For
Woodward Pharma Services LLC
Wixom, MI 48393

Rev 11-19
5G000 CJ J1

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 1 g Label

Rx Only

NDC 69784-880-35

Baciguent®
(Bacitracin Ophthalmic Ointment, USP)

STERILE

NET WT 3.5 g (1/8 oz)

USUAL DOSAGE: Apply 1 to 3 times daily. See package insert for full prescribing information.

Each gram contains: 500 units of bacitracin in a base of white petrolatum and mineral oil.

KEEP TIGHTLY CLOSED

Store at 20° to 25°C (68°-77°F) [see USP Controlled Room Temperature].

KEEP OUT OF REACH OF CHILDREN

Bacitracin Ophthalmic Ointment 1 g Label
(click image for full-size original)
BACIGUENT
bacitracin ointment
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69784-880
Route of Administration OPHTHALMIC DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BACITRACIN (BACITRACIN) BACITRACIN 500 [USP’U] in 1 g
Inactive Ingredients
Ingredient Name Strength
PETROLATUM
MINERAL OIL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69784-880-01 3 TUBE in 1 CARTON contains a TUBE
1 1 g in 1 TUBE This package is contained within the CARTON (69784-880-01)
2 NDC:69784-880-35 1 TUBE in 1 CARTON contains a TUBE
2 3.5 g in 1 TUBE This package is contained within the CARTON (69784-880-35)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA061212 04/15/2020
Labeler — Woodward Pharma Services LLC (026749066)
Registrant — Woodward Pharma Services LLC (026749066)

Revised: 08/2020 Woodward Pharma Services LLC

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