FDA label
What is TobraDex used for?
TobraDex contains tobramycin and dexamethasone. The FDA-approved uses below are quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label says: “INDICATIONS AND USAGE: TOBRADEX (tobramycin and dexamethasone ophthalmic ointment) is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists.”
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TobraDex, ointment
Indications and Usage, quoted from the label by Novartis Pharmaceuticals Corporation (NDA050616). Cross-references to other label sections are left out.
INDICATIONS AND USAGE: TOBRADEX (tobramycin and dexamethasone ophthalmic ointment) is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists.
Ocular steroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe where the inherent risk of steroid use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation or thermal burns, or penetration of foreign bodies.
The use of a combination drug with an anti-infective component is indicated where the risk of superficial ocular infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye.
The particular anti-infective drug in this product is active against the following common bacterial eye pathogens:
Staphylococci, including S. aureus and S. epidermidis (coagulase-positive and coagulase-negative), including penicillin-resistant strains.
Streptococci, including some of the Group A-beta-hemolytic species, some nonhemolytic species, and some Streptococcus pneumoniae.
Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae, Enterobacter aerogenes, Proteus mirabilis, Morganella morganii, most Proteus vulgaris strains, Haemophilus influenzae and H. aegyptius, Moraxella lacunata, Acinetobacter calcoaceticus and some Neisseria species.
Source: DailyMed label, set id 7f310e0e-0d3b-493d-b6c4-238493a2a9b9, version 9, effective July 22, 2026. NDC 0078-0876, one of 1 listing for this product.
Questions
What is TobraDex used for?
The FDA label says: “INDICATIONS AND USAGE: TOBRADEX (tobramycin and dexamethasone ophthalmic ointment) is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists.”
What drug class is TobraDex?
FDA lists tobramycin and dexamethasone in the Aminoglycoside Antibacterial and Corticosteroid established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.
More on TobraDex
- Is TobraDex a controlled substance?Federal schedule
- Generic for TobraDexFDA Orange Book
- What is Tobramycin and Dexamethasone used for?FDA label uses
- Is Tobramycin and Dexamethasone a controlled substance?Federal schedule
- Generic for Tobradex STFDA Orange Book
- Aminoglycoside Antibacterials listFDA drug class
- Corticosteroids listFDA drug class
- NDC 0078-0876TobraDex NDC record