Gentamicin sulfate ophthalmic solution, USP is indicated in the topical treatment of ocular bacterial infections including conjunctivitis, keratitis, keratoconjunctivitis, corneal ulcers, blepharitis, blepharoconjunctivitis, acute meibomianitis, and dacryocystitis, caused by susceptible strains of the following microorganisms: Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus...
Instill one or two drops into the affected eye(s) every four hours. In severe infections, dosage may be increased to as much as two drops every hour.
Gentamicin sulfate ophthalmic solution, USP is a sterile, topical anti-infective agent for ophthalmic use.
Gentamicin is obtained from cultures of Micromonospora purpurea. It is a mixture of the sulfate salts of gentamicin C 1, C 2, and C 1A. All three components appear to have similar antimicrobial activity. Gentamicin sulfate occurs as a white to buff powder and is soluble in water and insoluble in alcohol. The structural formula is as follows:
Each mL contains: Active: gentamicin sulfate equivalent to 3 mg (0.3%) gentamicin base. Preservative: benzalkonium chloride. Inactives: edetate disodium; polyvinyl alcohol 1.4%; purified water; sodium chloride; sodium phosphate, dibasic; and hydrochloric acid and/or sodium hydroxide may be added to adjust pH. The solution is an aqueous, buffered solution with a shelf life pH range of 6.5 to 7.5.
Microbiology
Gentamicin sulfate is active in vitro against many strains of the following microorganisms: Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus pneumoniae, Enterobacter aerogenes, Escherichia coli, Haemophilus influenzae, Klebsiella pneumoniae, Neisseria gonorrhoeae, Pseudomonas aeruginosa, and Serratia marcescens.
Gentamicin sulfate ophthalmic solution, USP is indicated in the topical treatment of ocular bacterial infections including conjunctivitis, keratitis, keratoconjunctivitis, corneal ulcers, blepharitis, blepharoconjunctivitis, acute meibomianitis, and dacryocystitis, caused by susceptible strains of the following microorganisms: Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus pneumoniae, Enterobacter aerogenes, Escherichia coli, Haemophilus influenzae, Klebsiella pneumoniae, Neisseria gonorrhoeae, Pseudomonas aeruginosa, and Serratia marcescens.
Gentamicin sulfate ophthalmic solution, USP is contraindicated in patients with known hypersensitivity to any of its components.
NOT FOR INJECTION INTO THE EYE.
Gentamicin sulfate ophthalmic solution, USP is not for injection. It should never be injected subconjunctivally, nor should it be directly introduced into the anterior chamber of the eye.
Prolonged use of topical antibiotics may give rise to overgrowth of nonsusceptible microorganisms, including fungi. Bacterial resistance to gentamicin may also develop. If purulent discharge, inflammation or pain becomes aggravated, the patient should discontinue use of the medication and consult a physician.
If irritation or hypersensitivity to any component of the drug develops, the patient should discontinue use of this preparation and appropriate therapy should be instituted.
To avoid contamination, do not touch tip of container to the eye, eyelid or any surface.
There are no published carcinogenicity or impairment of fertility studies on gentamicin. Aminoglycoside antibiotics have been found to be non-mutagenic.
Gentamicin has been shown to depress body weights, kidney weights and median glomerular counts in newborn rats when administered systemically to pregnant rats in daily doses approximately 500 times the maximum recommended ophthalmic human dose. There are no adequate and well-controlled studies in pregnant women. Gentamicin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Safety and effectiveness in neonates have not been established.
Bacterial and fungal corneal ulcers have developed during treatment with gentamicin ophthalmic preparations.
The most frequently reported adverse reactions are ocular burning and irritation upon drug instillation, non-specific conjunctivitis, conjunctival epithelial defects and conjunctival hyperemia.
Other adverse reactions which have occurred rarely are allergic reactions, thrombocytopenic purpura and hallucinations.
Instill one or two drops into the affected eye(s) every four hours. In severe infections, dosage may be increased to as much as two drops every hour.
Gentamicin sulfate ophthalmic solution, USP 0.3% is supplied sterile in white opaque LDPE plastic bottles and tips with beige high impact polystyrene (HIPS) caps as follows:
Box of 5 mL – NDC 68071-4827-5
Store at or below 25°C (77°F). Avoid exposure to excessive heat (40°C/104°F or above).
Revised: 10/2017
Distributed for: Allergan USA, Inc.
Madison, NJ 07940
©2017 Allergan. All rights reserved.
All trademarks are the property of their respective owners.
Made in the U.S.A.
v1.0USPI188
| Class | Version | Type | Effective |
|---|---|---|---|
| GENTAMICIN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 3b7b3a7a-635f-32a3-0c6c-7ad028e3de91 | Product name | 2 | 20250107 |
| 43025f0d-698c-68da-cec9-ea4261a7ef7a | Product name | 2 | 20250107 |
| d3946667-8212-d1f2-67e1-5643a329bb56 | Product name | 2 | 20200403 |
| 4ce5dce5-e8a7-e4f6-0059-b527e4307477 | Product name | 2 | 20190501 |
| 48b05f5d-d2fc-45ab-76e8-3cb5bd44890d | Product name | 1 | 20140508 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 68071-4827-5 | 2024-06-14 | C162847 | 48780-1 | ba0f9c33-5859-a910-e053-dadaa90a0b85 | GENTAMICIN SULFATE o phthalmic s olution, USP 0.3% s terile |
| 68071-4827-5 | 2023-01-30 | C162847 | 48780-1 | ba0f9c33-5859-a910-e053-dadaa90a0b85 | GENTAMICIN SULFATE o phthalmic s olution, USP 0.3% s terile |
| 68071-4827-5 | 2021-02-17 | C162847 | 48780-1 | ba0f9c33-5859-a910-e053-dadaa90a0b85 | GENTAMICIN SULFATE o phthalmic s olution, USP 0.3% s terile |
| 68071-4827-5 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-5859-a910-e053-dadaa90a0b85 | GENTAMICIN SULFATE o phthalmic s olution, USP 0.3% s terile |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68071-4827-5 | GENTAMICIN SULFATE | 5 mL in 1 BOX | SOLUTION/ DROPS | 5 | 3 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68071-4827 | GENTAMICIN SULFATE SOLUTION/ DROPS [NUCARE PHARMACEUTICALS,INC.] | 3 | Current NDC, Legacy NDC, 1 package rows | 20240616_85424b40-5c2d-421d-e053-2991aa0a7771.zip |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 60758-188-05 | ML - Milliliter | 60758-188 | d155d9ac-d56c-4938-a7d3-39ee324dd1f5 | 1 | 2012-07-24 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 68071-4827 | 68071-4827-5 |
| 60758-188 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| EDETATE DISODIUM | 7FLD91C86K | IACT |
| POLYVINYL ALCOHOL, UNSPECIFIED | 532B59J990 | IACT |
| WATER | 059QF0KO0R | IACT |
| SODIUM CHLORIDE | 451W47IQ8X | IACT |
| SODIUM PHOSPHATE, DIBASIC | GR686LBA74 | IACT |
| BENZALKONIUM CHLORIDE | F5UM2KM3W7 | IACT |
| HYDROCHLORIC ACID | QTT17582CB | IACT |
| SODIUM HYDROXIDE | 55X04QC32I | IACT |
| GENTAMICIN SULFATE | 8X7386QRLV | ACTIM |
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A062452-001 | GENOPTIC | GENTAMICIN SULFATE | EQ 0.3% BASE | SOLUTION/DROPS / OPHTHALMIC | 1984-10-10 |
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A062452-001 | GENOPTIC | EQ 0.3% BASE | SOLUTION/DROPS / OPHTHALMIC | 1984-10-10 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A062452-001 | GENOPTIC | EQ 0.3% BASE | SOLUTION/DROPS / OPHTHALMIC | 1984-10-10 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A062452-001 | GENOPTIC | EQ 0.3% BASE | SOLUTION/DROPS / OPHTHALMIC | 1984-10-10 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A062452-001 | GENOPTIC | EQ 0.3% BASE | SOLUTION/DROPS / OPHTHALMIC | 1984-10-10 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A062452-001 | GENOPTIC | EQ 0.3% BASE | SOLUTION/DROPS / OPHTHALMIC | 1984-10-10 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A062452-001 | GENOPTIC | EQ 0.3% BASE | SOLUTION/DROPS / OPHTHALMIC | 1984-10-10 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A062452-001 | GENOPTIC | EQ 0.3% BASE | SOLUTION/DROPS / OPHTHALMIC | 1984-10-10 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A062452-001 | GENOPTIC | EQ 0.3% BASE | SOLUTION/DROPS / OPHTHALMIC | 1984-10-10 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A062452-001 | GENOPTIC | EQ 0.3% BASE | SOLUTION/DROPS / OPHTHALMIC | 1984-10-10 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A062452-001 | GENOPTIC | EQ 0.3% BASE | SOLUTION/DROPS / OPHTHALMIC | 1984-10-10 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A062452-001 | GENOPTIC | EQ 0.3% BASE | SOLUTION/DROPS / OPHTHALMIC | 1984-10-10 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A062452-001 | GENOPTIC | EQ 0.3% BASE | SOLUTION/DROPS / OPHTHALMIC | 1984-10-10 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A062452-001 | GENOPTIC | EQ 0.3% BASE | SOLUTION/DROPS / OPHTHALMIC | 1984-10-10 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A062452-001 | GENOPTIC | EQ 0.3% BASE | SOLUTION/DROPS / OPHTHALMIC | 1984-10-10 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A062452-001 | GENOPTIC | EQ 0.3% BASE | SOLUTION/DROPS / OPHTHALMIC | 1984-10-10 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A062452-001 | GENOPTIC | EQ 0.3% BASE | SOLUTION/DROPS / OPHTHALMIC | 1984-10-10 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A062452-001 | GENOPTIC | EQ 0.3% BASE | SOLUTION/DROPS / OPHTHALMIC | AT | RS | 1984-10-10 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A062452-001 | GENOPTIC | EQ 0.3% BASE | SOLUTION/DROPS / OPHTHALMIC | AT | RS | 1984-10-10 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A062452-001 | GENOPTIC | EQ 0.3% BASE | SOLUTION/DROPS / OPHTHALMIC | AT | RS | 1984-10-10 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A062452-001 | GENOPTIC | EQ 0.3% BASE | SOLUTION/DROPS / OPHTHALMIC | AT | RS | 1984-10-10 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A062452-001 | GENOPTIC | EQ 0.3% BASE | SOLUTION/DROPS / OPHTHALMIC | AT | RS | 1984-10-10 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A062452-001 | GENOPTIC | EQ 0.3% BASE | SOLUTION/DROPS / OPHTHALMIC | AT | RS | 1984-10-10 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A062452-001 | GENOPTIC | EQ 0.3% BASE | SOLUTION/DROPS / OPHTHALMIC | AT | RS | 1984-10-10 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A062452-001 | GENOPTIC | EQ 0.3% BASE | SOLUTION/DROPS / OPHTHALMIC | AT | RS | 1984-10-10 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A062452-001 | GENOPTIC | EQ 0.3% BASE | SOLUTION/DROPS / OPHTHALMIC | AT | RS | 1984-10-10 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A062452-001 | GENOPTIC | EQ 0.3% BASE | SOLUTION/DROPS / OPHTHALMIC | AT | RS | 1984-10-10 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A062452-001 | GENOPTIC | EQ 0.3% BASE | SOLUTION/DROPS / OPHTHALMIC | AT | RS | 1984-10-10 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A062452-001 | GENOPTIC | EQ 0.3% BASE | SOLUTION/DROPS / OPHTHALMIC | AT | RS | 1984-10-10 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A062452-001 | GENOPTIC | EQ 0.3% BASE | SOLUTION/DROPS / OPHTHALMIC | AT | RS | 1984-10-10 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A062452-001 | GENOPTIC | EQ 0.3% BASE | SOLUTION/DROPS / OPHTHALMIC | 1984-10-10 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A062452-001 | GENOPTIC | EQ 0.3% BASE | SOLUTION/DROPS / OPHTHALMIC | 1984-10-10 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A062452-001 | GENOPTIC | EQ 0.3% BASE | SOLUTION/DROPS / OPHTHALMIC | 1984-10-10 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A062452-001 | GENOPTIC | EQ 0.3% BASE | SOLUTION/DROPS / OPHTHALMIC | 1984-10-10 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A062452-001 | GENOPTIC | EQ 0.3% BASE | SOLUTION/DROPS / OPHTHALMIC | 1984-10-10 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A062452-001 | GENOPTIC | EQ 0.3% BASE | SOLUTION/DROPS / OPHTHALMIC | 1984-10-10 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A062452-001 | GENOPTIC | EQ 0.3% BASE | SOLUTION/DROPS / OPHTHALMIC | 1984-10-10 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A062452-001 | GENOPTIC | EQ 0.3% BASE | SOLUTION/DROPS / OPHTHALMIC | 1984-10-10 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A062452-001 | GENOPTIC | EQ 0.3% BASE | SOLUTION/DROPS / OPHTHALMIC | AT | RS | 1984-10-10 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A062452-001 | GENOPTIC | EQ 0.3% BASE | SOLUTION/DROPS / OPHTHALMIC | AT | RS | 1984-10-10 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A062452-001 | GENOPTIC | EQ 0.3% BASE | SOLUTION/DROPS / OPHTHALMIC | AT | RS | 1984-10-10 | f41ea6bd6efb… |
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A062452-001 | AT | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A062452-001 | AT | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A062452-001 | AT | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A062452-001 | AT | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A062452-001 | AT | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A062452-001 | AT | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A062452-001 | AT | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A062452-001 | AT | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A062452-001 | AT | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A062452-001 | AT | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A062452-001 | AT | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A062452-001 | AT | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A062452-001 | AT | 1 | ea99ee380514… |
| 2023-01-26 05:58 UTC | 2023-01 | A062452-001 | AT | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A062452-001 | AT | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A062452-001 | AT | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A062452-001 | AT | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A062452-001 | AT | 1 | cb3db0bc1861… |
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| GENTAMICIN SULFATE | GENTAMICIN SULFATE | NuCare Pharmaceuticals,Inc. | 85424b40-5c2d-421d-e053-2991aa0a7771 | 2024-06-14 | Warnings, Adverse reactions | 68071-4827-5 68071-4827 68071482705 1ade255c-bb1d-b03f-e063-6294a90a6d78 85424b40-5c2d-421d-e053-2991aa0a7771 |
Adverse event summaries are temporarily unavailable. Other product information remains available.