Label: ERYTHROMYCIN ointment

Erythromycin Ophthalmic Ointment belongs to the macrolide group of antibiotics. It is basic and readily forms a salt when combined with an acid. The base, as crystals or powder, is slightly soluble in water, moderately soluble in ether, and readily soluble in alcohol or chloroform. Erythromycin ((3R*,4S*,5S*,6R*,7R*,9R*,11R*,12R*,13S*,14R*)-4-[(2,6-dideoxy-3- C-methyl-3- 0-methyl-α-L- ribo-hexopyranosyl)oxy]-14-ethyl-7,12,13-trihydroxy-3,5,7,9,11,13-hexamethyl-6-[[3,4,6-trideoxy-3-(dimethylamino)-ß-D- xylo-hexopyranosyl]oxy]oxacyclotetradecane-2,10-dione) is antibiotic produced from a strain of Streptomyces erythraeus. It has the following structural formula:

Each gram contains Erythromycin USP 5 mg in a sterile ophthalmic base of mineral oil and white petrolatum.

For the treatment of superficial ocular infections involving the conjunctiva and/or cornea caused by organisms susceptible to erythromycin.

For prophylaxis of ophthalmia neonatorum due to N. gonorrhoeaeor C. trachomatis. The effectiveness of erythromycin in the prevention of ophthalmia caused by penicillinase-producing N. gonorrheaeis not established.

For infants born to mothers with clinically apparent gonorrhea, intravenous or intramuscular injections of aqueous crystalline penicillin G should be given; a single dose of 50,000 units for term infants or 20,000 units for infants of low birth weight. Topical prophylaxis alone is inadequate for these infants.

This drug is contraindicated in patients with a history of hypersensitivity to erythromycin.

The most frequently reported adverse reactions are minor ocular irritations, redness, and hypersensitivity reactions.

To report SUSPECTED ADVERSE REACTIONS, contact Perrigo at 1-866-634-9120 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

In the treatment of superficial ocular infections, a ribbon approximately 1 cm in length of Erythromycin Ophthalmic Ointment should be applied directly to the infected structure up to 6 times daily, depending on the severity of the infection. For prophylaxis of neonatal gonococcal or chlamydial conjunctivitis, a ribbon of ointment approximately 1 cm in length should be instilled into each lower conjunctival sac. The ointment should not be flushed from the eye following instillation. A new tube should be used for each infant.

Sterile Erythromycin Ophthalmic Ointment USP, 5 mg/g as follows:

3.5 g (1/8 oz) tamper-evident tubes NDC 0574- 4024-35

24 x 3.5 g (1/8 oz) Hospital-Pak (for hospital use only) NDC 0574- 4024-39

Carton of fifty (50) Unit Dose 1 g tubes NDC 0574- 4024-50

Store at controlled room temperature 15°-30°C (59°-86°F). Avoid excessive heat.

Protect from freezing.

Manufactured For

Perrigo®

Minneapolis, MN 55427

SW700 RC J1 Rev 09-13 A

R1013

Ini 0813

Rx Only

NDC 0574- 4024-35

Erythromycin Ophthalmic Ointment USP

NET WT 3.5 g (1/8 OZ)

STERILE

The following image is a placeholder representing the product identifier that is either affixed or imprinted on the drug package label during the packaging operation.

Rx Only

NDC 0574- 4024-35

Erythromycin Ophthalmic Ointment USP

NET WT 3.5 g (1/8 OZ)

STERILE

The following image is a placeholder representing the product identifier that is either affixed or imprinted on the drug package label during the packaging operation.

HOSPITAL-PAK

Rx Only

NDC 0574- 4024-39

Erythromycin Ophthalmic Ointment USP

STERILE – 5 mg per Gram

For Use in High Volume Neonatal Care

HOSPITAL USE ONLY

24 x 1/8 OZ (3.5 g)

Each gram contains 5 mg of Erythromycin USP in a sterile ophthalmic base of mineral oil and white petrolatum.

The following image is a placeholder representing the product identifier that is either affixed or imprinted on the drug package label during the packaging operation.

Rx Only

NDC 0574- 4024-50

Erythromycin Ophthalmic Ointment USP, 0.5% (5 mg/g)

DO NOT REUSE. ONCE OPENED, DISCARD

STERILE

50 Unit Doses

Sterile Ophthalmic Ointment weighing 1 gram each.

The following image is a placeholder representing the product identifier that is either affixed or imprinted on the drug package label during the packaging operation.