Gentamicin sulfate ophthalmic ointment is indicated in the topical treatment of ocular bacterial infections including conjunctivitis, keratitis, keratoconjunctivitis, corneal ulcers, blepharitis, blepharonconjunctivitis: acute meibomianitis, and dacryocystitis, caused by susceptible strains of the following microorganisms: Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus pne...
Apply a small amount (approximately 1/2 inch ribbon) of ointment to the affected eye(s) two or three times a day.
Sterile
Rx only
GENTAK ®Gentamicin sulfate is a water soluble antibiotic of the aminoglycoside group.
Gentamicin sulfate ophthalmic ointment is a sterile ointment for ophthalmic use. Each gram contains gentamicin sulfate equivalent to 3 mg gentamicin in a base of white petrolatum and mineral oil, with methylparaben and propylparaben as preservatives.
Gentamicin is obtained from cultures of Micromonospora purpurea.It is a mixture of the sulfate salts of gentamicin C 1C 2, and C 1A. All three components appear to have similar antimicrobial activities. Gentamicin sulfate occurs as a white to buff powder and is soluble in water and insoluble in alcohol. The structural formula is as follows:
Microbiology:Gentamicin sulfate is active in vitroagainst many strains of the following microorganisms:
Gentamicin sulfate ophthalmic ointment is indicated in the topical treatment of ocular bacterial infections including conjunctivitis, keratitis, keratoconjunctivitis, corneal ulcers, blepharitis, blepharonconjunctivitis: acute meibomianitis, and dacryocystitis, caused by susceptible strains of the following microorganisms:
Gentamicin sulfate ophthalmic ointment is con-traindicated in patients with known hypersensitivity to any of the components.
NOT FOR INJECTION INTO THE EYE.
Gentamicin sulfate ophthalmic ointment is not for injection. It should never be injected subconjunctivally, nor should it be directly introduced into the anterior chamber of the eye.
General:Prolonged use of topical antibiotics may give rise to overgrowth of nonsusceptible organisms 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.
Ophthalmic ointments may retard corneal healing.
Information for patients:To avoid contamination, do not touch tip of container to the eye, eyelid or any surface.
Carcinogenesis, Mutagenesis, Impairment of Fertility:There are no published carcinogenicity or impairment of fertility studies on gentamicin. Aminoglycoside antibiotics have been found to be non-mutagenic.
Pregnancy:Pregnancy Category C. 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.
Pediatric Use: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.
Apply a small amount (approximately 1/2 inch ribbon) of ointment to the affected eye(s) two or three times a day.
GENTAK ®Gentamicin sulfate ophthalmic ointment USP, 0.3% is supplied in 3.5 g tube, box of one.
(NDC 17478-284-35)
STORAGE:Store at 2° to 30°C (36° to 86°F).
Akorn
Manufactured by: Akorn, Inc.
Lake Forest, IL 60045
GKO00N Rev. 06/16
Principal Display Panel Text for Container Label:
NDC 17478-284-35 Akorn Logo
Gentak ®
brand of Gentamicin Sulfate
Ophthalmic Ointment USP, 0.3%
(equivalent to 3 mg gentamicin per gram)
Net Wt 3.5 g (1/8 oz) Sterile
Rx only
Principal Display Panel Text for Carton Label:
3.5 g NDC 17478-284-35
Gentak ®
Brand of Gentamicin Sulfate Ophthalmic Ointment USP, 0.3%
(equivalent to 3 mg gentamicin per gram)
Net Wt 3.5 g (1/8 oz.) Sterile Rx only Akorn Logo
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 545236 | GENTAK 0.3 % (3 MG/GM) Ophthalmic Ointment | PSN | 1 |
| 310466 | gentamicin sulfate 0.3 % (3 MG/GM) Ophthalmic Ointment | PSN | 1 |
| 545236 | gentamicin 0.003 MG/MG Ophthalmic Ointment [Gentak] | SBD | 1 |
| 310466 | gentamicin 0.003 MG/MG Ophthalmic Ointment | SCD | 1 |
| 545236 | Gentak 0.003 MG/MG Ophthalmic Ointment | SY | 1 |
| 545236 | Gentak 0.3 % Ophthalmic Ointment | SY | 1 |
| 545236 | Gentak 3 MG per 1 GM Ophthalmic Ointment | SY | 1 |
| 310466 | gentamicin (as gentamicin sulfate) 0.3 % Ophthalmic Ointment | SY | 1 |
| 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 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 67296-0114-1 | Gentak | 3.5 g in 1 TUBE | OINTMENT | 3.5 | 1 | |
| 67296-0114-1 | Gentak | 1 in 1 CARTON | OINTMENT | 1 | 1 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 67296-0114 | GENTAK (GENTAMICIN SULFATE) OINTMENT [REDPHARM DRUG] | 1 | 2 package rows | 20240613_1ab0eecf-5ce2-c2bc-e063-6394a90a744b.zip |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 17478-284-35 | GM - Gram | 17478-284 | 89095929-33e3-404b-a9bc-e49509773ce9 | 1 | 2012-07-24 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 67296-0114 | 67296-0114-1 |
| 17478-284 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| METHYLPARABEN | A2I8C7HI9T | IACT |
| PROPYLPARABEN | Z8IX2SC1OH | IACT |
| PETROLATUM | 4T6H12BN9U | IACT |
| MINERAL OIL | T5L8T28FGP | 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 |
|---|---|---|---|---|---|---|---|
| A064093-001 | GENTAMICIN SULFATE | GENTAMICIN SULFATE | EQ 0.3% BASE | OINTMENT / OPHTHALMIC | 1995-08-31 |
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 | A064093-001 | GENTAMICIN SULFATE | EQ 0.3% BASE | OINTMENT / OPHTHALMIC | 1995-08-31 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A064093-001 | GENTAMICIN SULFATE | EQ 0.3% BASE | OINTMENT / OPHTHALMIC | 1995-08-31 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A064093-001 | GENTAMICIN SULFATE | EQ 0.3% BASE | OINTMENT / OPHTHALMIC | 1995-08-31 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A064093-001 | GENTAMICIN SULFATE | EQ 0.3% BASE | OINTMENT / OPHTHALMIC | 1995-08-31 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A064093-001 | GENTAMICIN SULFATE | EQ 0.3% BASE | OINTMENT / OPHTHALMIC | 1995-08-31 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A064093-001 | GENTAMICIN SULFATE | EQ 0.3% BASE | OINTMENT / OPHTHALMIC | 1995-08-31 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A064093-001 | GENTAMICIN SULFATE | EQ 0.3% BASE | OINTMENT / OPHTHALMIC | 1995-08-31 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A064093-001 | GENTAMICIN SULFATE | EQ 0.3% BASE | OINTMENT / OPHTHALMIC | 1995-08-31 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A064093-001 | GENTAMICIN SULFATE | EQ 0.3% BASE | OINTMENT / OPHTHALMIC | 1995-08-31 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A064093-001 | GENTAMICIN SULFATE | EQ 0.3% BASE | OINTMENT / OPHTHALMIC | 1995-08-31 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A064093-001 | GENTAMICIN SULFATE | EQ 0.3% BASE | OINTMENT / OPHTHALMIC | 1995-08-31 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A064093-001 | GENTAMICIN SULFATE | EQ 0.3% BASE | OINTMENT / OPHTHALMIC | 1995-08-31 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A064093-001 | GENTAMICIN SULFATE | EQ 0.3% BASE | OINTMENT / OPHTHALMIC | 1995-08-31 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A064093-001 | GENTAMICIN SULFATE | EQ 0.3% BASE | OINTMENT / OPHTHALMIC | 1995-08-31 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A064093-001 | GENTAMICIN SULFATE | EQ 0.3% BASE | OINTMENT / OPHTHALMIC | 1995-08-31 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A064093-001 | GENTAMICIN SULFATE | EQ 0.3% BASE | OINTMENT / OPHTHALMIC | 1995-08-31 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A064093-001 | GENTAMICIN SULFATE | EQ 0.3% BASE | OINTMENT / OPHTHALMIC | AT | RS | 1995-08-31 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A064093-001 | GENTAMICIN SULFATE | EQ 0.3% BASE | OINTMENT / OPHTHALMIC | AT | RS | 1995-08-31 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A064093-001 | GENTAMICIN SULFATE | EQ 0.3% BASE | OINTMENT / OPHTHALMIC | AT | RS | 1995-08-31 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A064093-001 | GENTAMICIN SULFATE | EQ 0.3% BASE | OINTMENT / OPHTHALMIC | AT | RS | 1995-08-31 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A064093-001 | GENTAMICIN SULFATE | EQ 0.3% BASE | OINTMENT / OPHTHALMIC | AT | RS | 1995-08-31 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A064093-001 | GENTAMICIN SULFATE | EQ 0.3% BASE | OINTMENT / OPHTHALMIC | AT | RS | 1995-08-31 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A064093-001 | GENTAMICIN SULFATE | EQ 0.3% BASE | OINTMENT / OPHTHALMIC | AT | RS | 1995-08-31 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A064093-001 | GENTAMICIN SULFATE | EQ 0.3% BASE | OINTMENT / OPHTHALMIC | AT | RS | 1995-08-31 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A064093-001 | GENTAMICIN SULFATE | EQ 0.3% BASE | OINTMENT / OPHTHALMIC | AT | RS | 1995-08-31 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A064093-001 | GENTAMICIN SULFATE | EQ 0.3% BASE | OINTMENT / OPHTHALMIC | AT | RS | 1995-08-31 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A064093-001 | GENTAMICIN SULFATE | EQ 0.3% BASE | OINTMENT / OPHTHALMIC | AT | RS | 1995-08-31 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A064093-001 | GENTAMICIN SULFATE | EQ 0.3% BASE | OINTMENT / OPHTHALMIC | AT | RS | 1995-08-31 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A064093-001 | GENTAMICIN SULFATE | EQ 0.3% BASE | OINTMENT / OPHTHALMIC | AT | RS | 1995-08-31 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A064093-001 | GENTAMICIN SULFATE | EQ 0.3% BASE | OINTMENT / OPHTHALMIC | 1995-08-31 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A064093-001 | GENTAMICIN SULFATE | EQ 0.3% BASE | OINTMENT / OPHTHALMIC | 1995-08-31 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A064093-001 | GENTAMICIN SULFATE | EQ 0.3% BASE | OINTMENT / OPHTHALMIC | 1995-08-31 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A064093-001 | GENTAMICIN SULFATE | EQ 0.3% BASE | OINTMENT / OPHTHALMIC | 1995-08-31 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A064093-001 | GENTAMICIN SULFATE | EQ 0.3% BASE | OINTMENT / OPHTHALMIC | 1995-08-31 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A064093-001 | GENTAMICIN SULFATE | EQ 0.3% BASE | OINTMENT / OPHTHALMIC | 1995-08-31 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A064093-001 | GENTAMICIN SULFATE | EQ 0.3% BASE | OINTMENT / OPHTHALMIC | 1995-08-31 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A064093-001 | GENTAMICIN SULFATE | EQ 0.3% BASE | OINTMENT / OPHTHALMIC | 1995-08-31 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A064093-001 | GENTAMICIN SULFATE | EQ 0.3% BASE | OINTMENT / OPHTHALMIC | AT | RS | 1995-08-31 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A064093-001 | GENTAMICIN SULFATE | EQ 0.3% BASE | OINTMENT / OPHTHALMIC | AT | RS | 1995-08-31 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A064093-001 | GENTAMICIN SULFATE | EQ 0.3% BASE | OINTMENT / OPHTHALMIC | AT | RS | 1995-08-31 | f41ea6bd6efb… |
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A064093-001 | AT | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A064093-001 | AT | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A064093-001 | AT | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A064093-001 | AT | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A064093-001 | AT | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A064093-001 | AT | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A064093-001 | AT | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A064093-001 | AT | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A064093-001 | AT | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A064093-001 | AT | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A064093-001 | AT | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A064093-001 | AT | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A064093-001 | AT | 1 | ea99ee380514… |
| 2023-01-26 05:58 UTC | 2023-01 | A064093-001 | AT | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A064093-001 | AT | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A064093-001 | AT | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A064093-001 | AT | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A064093-001 | 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 |
|---|---|---|---|---|---|---|
| 1ab0ecca-26f8-2b1b-e063-6294a90a2bbb | 1ab0eecf-5ce2-c2bc-e063-6394a90a744b | 2024-06-12 | Warnings, Adverse reactions | 1ab0ecca-26f8-2b1b-e063-6294a90a2bbb 1ab0eecf-5ce2-c2bc-e063-6394a90a744b |
Adverse event summaries are temporarily unavailable. Other product information remains available.