Official product label reference
Erythromycin — A-S Medication Solutions
This page contains 8 source sections for ERYTHROMYCIN, ophthalmic route. Label set 2be16639-b153-407b-b43d-3a2bcf66151e, version 16.
Retrieved 2026-10-02 · openFDA dataset updated 2026-10-02 · Check the current DailyMed label
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Uses described in the label
INDICATIONS AND USAGE 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. gonorrhoeae or C. trachomatis . The effectiveness of erythromycin in the prevention of ophthalmia caused by penicillinase-producing N. gonorrhoeae is 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.
Dosage and administration — label text
DOSAGE AND ADMINISTRATION In the treatment of superficial ocular infections, erythromycin ophthalmic ointment approximately 1 cm in length should be applied directly to the infected eye(s) up to six times daily, depending on the severity of the infection. For prophylaxis of neonatal gonococcal or chlamydial ophthalmia, 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.
Contraindications
CONTRAINDICATIONS This drug is contraindicated in patients with a history of hypersensitivity to erythromycin.
Adverse reactions
ADVERSE REACTIONS The most frequently reported adverse reactions are minor ocular irritations, redness, and hypersensitivity reactions. To report SUSPECTED ADVERSE REACTIONS, contact Bausch & Lomb Incorporated at 1-800-553-5340 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Product description
DESCRIPTION Erythromycin ophthalmic ointment, USP belongs to the macrolide group of antibiotics. The sterile ophthalmic ointment flows freely over the conjunctiva. Erythromycin base, as crystals or powder, is slightly soluble in water, moderately soluble in ether, and readily soluble in alcohol or chloroform. Erythromycin is an antibiotic produced from a strain of Streptomyces erythraeus . It is basic and readily forms a salt when combined with an acid. It has the following structural formula: Molecular Formula: C 37 H 67 NO 13 Mol. Wt. 733.94 Chemical Name: ((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)- β -D- xylo -hexopyranosyl]oxy]oxacyclotetradecane-2,10-dione) Each gram contains: Active: erythromycin USP, 5 mg (0.5%); Inactives: mineral oil and white petrolatum. ChemStructure
Table text from source:
| Molecular Formula: C 37H 67NO 13 | Mol. Wt. 733.94
Clinical pharmacology
CLINICAL PHARMACOLOGY Microbiology Erythromycin inhibits protein synthesis without affecting nucleic acid synthesis. Erythromycin is usually active against the following organisms in vitro and in clinical infections: Streptococcus pyogenes (group A β-hemolytic), Alpha-hemolytic streptococci (viridans group); Staphylococcus aureus, including penicillinase-producing strains (methicillin-resistant staphylococci are uniformly resistant to erythromycin); Streptococcus pneumoniae; Mycoplasma pneumoniae (Eaton Agent, PPLO); Haemophilus influenzae (not all strains of this organism are susceptible at the erythromycin concentrations ordinarily achieved); Treponema pallidum; Corynebacterium diphtheriae; Neisseria gonorrhoeae; Chlamydia trachomatis .
Precautions
PRECAUTIONS General The use of antimicrobial agents may be associated with the overgrowth of non-susceptible organisms including fungi; in such a case, antibiotic administration should be stopped and appropriate measures taken. Information for Patients: Avoid contaminating the applicator tip with material from the eye, fingers, or other source. Carcinogenesis, Mutagenesis, Impairment of Fertility: Two year oral studies conducted in rats with erythromycin did not provide evidence of tumorigenicity. Mutagenicity studies have not been conducted. No evidence of impaired fertility that appeared related to erythromycin was reported in animal studies. Pregnancy: Reproduction studies have been performed in rats, mice, and rabbits using erythromycin and its various salts and esters, at doses that were several multiples of the usual human dose. No evidence of harm to the fetus that appeared related to erythromycin was reported in these studies. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproductive studies are not always predictive of human response, the erythromycins should be used during pregnancy only if clearly needed. Nursing Mothers: Caution should be exercised when erythromycin is administered to a nursing woman. Pediatric Use: See INDICATIONS AND USAGE and DOSAGE AND ADMINISTRATION .
Supply and packaging
HOW SUPPLIED Product: 50090-1484 NDC: 50090-1484-0 3.5 g in a TUBE / 1 in a CARTON
Official sources and product identifiers
- DailyMed — complete source labelVerify the current version and original formatting, including tables and diagrams.
- openFDA — structured source recordMachine-readable label source, linked by the exact label set ID.
- Drugs@FDA application ANDA064067Application history where available; verify the specific product and indication.
Substances listed: ERYTHROMYCIN
RxNorm identifiers: 310149
Package NDC codes
50090-1484-0
Further research and background
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Coverage and corrections
The text is extracted from a US structured product label. Tables are represented as text where supplied; formatting and illustrations may be lost. A missing section does not mean a risk is absent. This reference has not been independently reviewed by a clinician and is not a live safety-alert service.
Source retrieved 2026-10-02. Read the source policy.