Package insert / prescribing information
Dosage form: ophthalmic ointment
Drug class: Ophthalmic anti-infectives
STERILE Rx Only
DESCRIPTION:
Each gram of ointment has 500 units of Bacitracin in a base made of White Petrolatum and Mineral Oil that doesn’t melt easily.
CLINICAL PHARMACOLOGY:
The antibiotic Bacitracin is very effective against many gram-positive pathogens, such as the common Streptococci and Staphlococci. It can also kill organisms that have gram-negative cells. It doesn’t work against fungi.
INDICATIONS AND USE:
For the treatment of conjunctivitis and/or corneal infections caused by Bacitracin-susceptible organisms that are on the surface of the eye.
CONTRAINDICATIONS:
This product shouldn’t be used on people who have been allergic to Bacitracin in the past.
PRECAUTIONS:
Bacitracin ophthalmic ointment shouldn’t be used for eye infections that are deep or likely to spread to the rest of the body. When antibiotics are used for a long time, non-susceptible organisms, especially fungi, may grow in large numbers. During treatment, if new infections show up, the right antibiotics or chemotherapy should be used.
ADVERSE REACTIONS:
Bacitracin causes allergic reactions in such a small number of people that side effects are almost non-existent. But if such a reaction does happen, the therapy should be stopped.
Contact Perrigo at 1-866-634-9120 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch to report POSSIBLE ADVERSE REACTIONS.
DOSAGE AND ADMINISTRATION:
Put the ointment directly into the conjunctival sac one to three times a day. In blepharitis, all scales and crusts should be carefully removed, and then the ointment should be spread evenly over the lid margins. Patients should be told to take the right steps to keep the ointment from getting too dirty when they put it directly on the infected eye.
HOW SUPPLIED:
NDC 0574-4022-35 3.5 g (1/8 oz) sterile tubes that can’t be opened and have an ophthalmic tip.
Keep at 20°C to 25°C (68°F to 77°F). [see USP Temperature of a Controlled Room].
Made in Canada
Made in Kirkland, Quebec, by Jubilant HollisterStier General Partnership. H9H 4J4 Canada
Perrigo, Allegan, MI 49010 Minneapolis, MN 55427,
35F00 RC J1,
Rev 08-21.
PACKAGE/LABEL MAIN DISPLAY PANEL – 3.5 g Carton
Rx Only, NDC 0574-4022-35
Bacitracin Eye Ointment USP NET WT 3.5 g (1/8 oz)
STERILE
The image below is a placeholder for the product identifier that is either stuck on or printed on the label of the drug package during the packaging process.
| Bacitracin Bacitracin ointment |
| Product Information | |||
|---|---|---|---|
| Product Type | HUMAN PRESCRIPTION DRUG LABEL | Item Code (Source) | NDC:0574-4022 |
| 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 |
| 1 | NDC:0574-4022-01 | 1 TUBE in 1 CARTON |
| 1 | NDC:0574-4022-11 | 1 g in 1 TUBE |
| 2 | NDC:0574-4022-13 | 3 TUBE in 1 CARTON |
| 2 | NDC:0574-4022-11 | 1 g in 1 TUBE |
| 3 | NDC:0574-4022-35 | 1 TUBE in 1 CARTON |
| 3 | 3.5 g in 1 TUBE |
| Marketing Information | |||
|---|---|---|---|
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| ANDA | ANDA061212 | 03/10/2014 |
| Labeler – Padagis US LLC (967694121) |
Padagis US LLC
