Lotemax loteprednol etabonate 5 mg/g Ointment, 1 tube
🆔 Identity & classification
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🏭 Manufacturer & labeler
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🩺 Clinical
- It depends on which product you've been given. Some versions — like Alrex — treat seasonal eye allergies. Eysuvis is used short-term for dry eye disease. Others, like Inveltys and...
- What is loteprednol etabonate actually used for?
- Always wash your hands before touching your eyes or the bottle. Shake the bottle as directed — the shaking instructions are slightly different for each product, so check your label...
- That depends on your condition and which product you're using. For post-surgical use, most products are used for the first two weeks after surgery. Eysuvis for dry eye is approved...
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
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UNII T5L8T28FGP
Mineral oil is a clear, odorless liquid derived from crude oil. It acts as a lubricant and emollient in medications, helping pills slide smoothly during manufacturing and aiding moisture retention in topical products.
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UNII 4T6H12BN9U
Petrolatum is a purified mineral oil-based jelly derived from petroleum. In medicines, it acts as an emollient, lubricant, and moisture barrier to soften skin, reduce friction, and help prevent water loss from formulations.
2 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per g | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · Q2 2026 | $102.67 | $102.67 / 1 g |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Loteprednol Etabonate 5 mg/g 24208-0508-01 | Bausch | 1 bottle | $16.085 | AB | Availability likely | — |
| Loteprednol Etabonate 5 mg/g 72485-0630-05 | ARMAS | 1 bottle | $16.085 | AB | Availability likely | — |
| Loteprednol Etabonate 5 mg/g 82260-0508-01 | Bausch | 1 bottle | $16.085 | AB | Availability likely | — |
| Loteprednol Etabonate 5 mg/g 70244-0036-01 | Sentiss | 1 bottle | $16.085 | AB | Availability likely | — |
| Lotemax 5 mg/g 24208-0503-07 | Bausch | 1 bottle | $49.619 | AB | Availability likely | — |
| Lotemax 5 mg/gthis 24208-0443-01 | Bausch | 1 tube | — | — | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.
Where does this data come from?
💊 Medicaid utilization by pack size
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 24208-0443-01 You're viewing this | 1 TUBE in 1 CARTON (24208-443-01) / 1 g in 1 TUBE | — | — | 2011-04-15 | Active |
| 24208-0443-35 | 1 TUBE in 1 CARTON (24208-443-35) / 3.5 g in 1 TUBE | $99.79 / g | $349.27 | 2011-04-15 | Active |
This pack shows little to no recent Medicaid volume — a different pack size carries most fills. See all packs ↓
Pack size FAQ
What quantity is in NDC 24208-0443-01?
What is the difference between NDC 24208-0443-01 and NDC 24208-0443-35?
What NDC number is used to bill for this package of Lotemax loteprednol etabonate 5 mg/g Ointment?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope. |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
Questions about this listing
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE LOTEMAX ® (loteprednol etabonate ophthalmic ointment) 0.5% ointment is a corticosteroid indicated for the treatment of post-operative inflammation and pain following ocular surgery. LOTEMAX ointment is a corticosteroid indicated for the treatment of post-operative inflammation and pain following ocular surgery. (1)
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Wash hands prior to using LOTEMAX ointment. Apply a small amount (approximately ½ inch ribbon) into the conjunctival sac(s) four times daily beginning 24 hours after surgery and continuing throughout the first 2 weeks of the post-operative period. Apply a small amount (approximately ½ inch ribbon) into the conjunctival sac(s) four times daily beginning 24 hours after surgery and continuing throughout the first 2 weeks of the post-operative period.
( 2 )
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Ophthalmic ointment containing loteprednol etabonate 0.5%. Ophthalmic ointment containing loteprednol etabonate 0.5%. (3)
⛔ Contraindications ▾
4 CONTRAINDICATIONS LOTEMAX ointment, as with other ophthalmic corticosteroids, is contraindicated in most viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures. LOTEMAX ointment, as with other ophthalmic corticosteroids, is contraindicated in most viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures.
( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS • Intraocular Pressure (IOP) Increase : Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision. If this product is used for 10 days or longer, IOP should be monitored even though it may be difficult in children and uncooperative patients. ( 5.1 ) • Cataracts : Use of corticosteroids may result in posterior subcapsular cataract formation.
( 5.2 ) • Delayed Healing : The use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation. In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical steroids. ( 5.3 ) • Bacterial Infections : Prolonged use of corticosteroids may suppress the host response and thus increase the hazard of secondary ocular infections.
In acute purulent conditions, steroids may mask infection or enhance existing infection. ( 5.4 ) • Viral Infections : Employment of a corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution. Use of ocular steroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex).
( 5.5 ) • Fungal Infections : Fungal infections of the cornea are particularly prone to develop coincidentally with long-term local steroid application. Fungus invasion must be considered in any persistent corneal ulceration where a steroid has been used or is in use. ( 5.6 )
5.1Intraocular Pressure (IOP) Increase Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision. Steroids should be used with caution in the presence of glaucoma. If this product is used for 10 days or longer, IOP should be monitored even though it may be difficult in children and uncooperative patients.
5.2Cataracts Use of corticosteroids may result in posterior subcapsular cataract formation.
5.3Delayed Healing The use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation. In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical steroids. The initial prescription and renewal of the medication order beyond 14 days should be made by a physician only after examination of the patient with the aid of magnification such as slit lamp biomicroscopy and, where appropriate, fluorescein staining.
5.4Bacterial Infections Prolonged use of corticosteroids may suppress the host response and thus increase the hazard of secondary ocular infections. In acute purulent conditions, steroids may mask infection or enhance existing infection. If signs and symptoms fail to improve after 2 days, the patient should be re-evaluated.
5.5Viral Infections Employment of a corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution. Use of ocular steroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex).
5.6Fungal Infections Fungal infections of the cornea are particularly prone to develop coincidentally with long-term local steroid application. Fungus invasion must be considered in any persistent corneal ulceration where a steroid has been used or is in use. Fungal culture should be taken when appropriate.
5.7Risk of Contamination Do not touch the eyelid or surrounding areas with the tip of the tube. The cap should remain on the tube when not in use.
5.8Contact Lens Wear Patients should not wear contact lenses during their course of therapy with LOTEMAX ointment.
5.9Topical Ophthalmic Use LOTEMAX is not indicated for intraocular administration.
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS Adverse reactions associated with ophthalmic steroids include elevated intraocular pressure, which may be associated with optic nerve damage, visual acuity and field defects, posterior subcapsular cataract formation, secondary ocular infection from pathogens including herpes simplex, and perforation of the globe where there is thinning of the cornea or sclera. The most common ocular adverse event reported at approximately 25% in subjects in clinical studies with LOTEMAX ointment was anterior chamber inflammation.
Other common adverse events, with an incidence of 4-5%, were conjunctival hyperemia, corneal edema, and eye pain. Many of these events may have been the consequence of the surgical procedure. The only non-ocular adverse event occurring at ≥ 1% was headache (1.5%).
The most common ocular adverse event, reported in approximately 25% of subjects in clinical studies, is anterior chamber inflammation. Other common adverse events, with an incidence of 4-5%, are conjunctival hyperemia, corneal edema, and eye pain. ( 6 ) 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.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Risk Summary There are no adequate and well-controlled studies with loteprednol etabonate in pregnant women. Loteprednol etabonate produced teratogenicity at clinically relevant doses in the rabbit and rat when administered orally during pregnancy. Loteprednol etabonate produced malformations when administered orally to pregnant rabbits at doses ≥ 1.6 times the recommended human ophthalmic dose (RHOD) and to pregnant rats at doses ≥ 41 times the RHOD.
In pregnant rats receiving oral doses of loteprednol etabonate during the period equivalent to the last trimester of pregnancy through lactation in humans, survival of offspring was reduced at doses ≥ 4 times the RHOD. Maternal toxicity was observed in rats at doses ≥ 405 times the RHOD, and a maternal no observed adverse effect level (NOAEL) was established at 41 times the RHOD. The background risk of major birth defects and miscarriage for the indicated population is unknown.
However, the background risk in the U.S. general population of major birth defects is 2 to 4%, and of miscarriage is 15 to 20%, of clinically recognized pregnancies. Data Animal Data Embryofetal studies were conducted in pregnant rabbits administered loteprednol etabonate by oral gavage on gestation Days 6 to 18, to target the period of organogenesis. Loteprednol etabonate produced fetal malformations at doses ≥ 0.1 mg/kg (1.6 times the recommended human ophthalmic dose (RHOD) based on body surface area, assuming 100% absorption).
Spina bifida (including meningocele) was observed at doses ≥ 0.1 mg/kg, and exencephaly and craniofacial malformations were observed at doses ≥ 0.4 mg/kg (6.5 times the RHOD). At 3 mg/kg (49 times the RHOD), loteprednol etabonate was associated with increased incidences of abnormal left common carotid artery, limb flexures, umbilical hernia, scoliosis, and delayed ossification. Abortion and embryofetal lethality (resorption) occurred at doses ≥ 6 mg/kg (97 times the RHOD).
A NOAEL for developmental toxicity was not established in this study. The NOAEL for maternal toxicity in rabbits was 3 mg/kg/day. Embryofetal studies were conducted in pregnant rats administered loteprednol etabonate by oral gavage on gestation Days 6 to 15, to target the period of organogenesis.
Loteprednol etabonate produced fetal malformations, including absent innominate artery at doses ≥ 5 mg/kg (41 times the RHOD); and cleft palate, agnathia, cardiovascular defects, umbilical hernia, decreased fetal body weight and decreased skeletal ossification at doses ≥ 50 mg/kg (410 times the RHOD). Embryofetal lethality (resorption) was observed at 100 mg/kg (811 times the RHOD). The NOAEL for developmental toxicity in rats was 0.5 mg/kg (4 times the RHOD).
Loteprednol etabonate was maternally toxic (reduced body weight gain) at doses of ≥ 50 mg/kg/day. The NOAEL for maternal toxicity was 5 mg/kg. A peri-/postnatal study was conducted in rats administered loteprednol etabonate by oral gavage from gestation Day 15 (start of fetal period) to postnatal Day 21 (the end of lactation period).
At doses ≥ 0.5 mg/kg (4 times the clinical dose), reduced survival was observed in live-born offspring. Doses ≥ 5 mg/kg (41 times the RHOD) caused umbilical hernia/incomplete gastrointestinal tract. Doses ≥ 50 mg/kg (410 times the RHOD) produced maternal toxicity (reduced body weight gain, death), decreased number of live-born offspring, decreased birth weight, and delays in postnatal development.
A developmental NOAEL was not established in this study. The NOAEL for maternal toxicity was 5 mg/kg.
8.2Lactation There are no data on the presence of loteprednol etabonate in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered, along with the mother’s clinical need for LOTEMAX (loteprednol etabonate ophthalmic ointment) 0.5% and any potential adverse effects on the breastfed infant from L…
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary There are no adequate and well-controlled studies with loteprednol etabonate in pregnant women. Loteprednol etabonate produced teratogenicity at clinically relevant doses in the rabbit and rat when administered orally during pregnancy. Loteprednol etabonate produced malformations when administered orally to pregnant rabbits at doses ≥ 1.6 times the recommended human ophthalmic dose (RHOD) and to pregnant rats at doses ≥ 41 times the RHOD.
In pregnant rats receiving oral doses of loteprednol etabonate during the period equivalent to the last trimester of pregnancy through lactation in humans, survival of offspring was reduced at doses ≥ 4 times the RHOD. Maternal toxicity was observed in rats at doses ≥ 405 times the RHOD, and a maternal no observed adverse effect level (NOAEL) was established at 41 times the RHOD. The background risk of major birth defects and miscarriage for the indicated population is unknown.
However, the background risk in the U.S. general population of major birth defects is 2 to 4%, and of miscarriage is 15 to 20%, of clinically recognized pregnancies. Data Animal Data Embryofetal studies were conducted in pregnant rabbits administered loteprednol etabonate by oral gavage on gestation Days 6 to 18, to target the period of organogenesis. Loteprednol etabonate produced fetal malformations at doses ≥ 0.1 mg/kg (1.6 times the recommended human ophthalmic dose (RHOD) based on body surface area, assuming 100% absorption).
Spina bifida (including meningocele) was observed at doses ≥ 0.1 mg/kg, and exencephaly and craniofacial malformations were observed at doses ≥ 0.4 mg/kg (6.5 times the RHOD). At 3 mg/kg (49 times the RHOD), loteprednol etabonate was associated with increased incidences of abnormal left common carotid artery, limb flexures, umbilical hernia, scoliosis, and delayed ossification. Abortion and embryofetal lethality (resorption) occurred at doses ≥ 6 mg/kg (97 times the RHOD).
A NOAEL for developmental toxicity was not established in this study. The NOAEL for maternal toxicity in rabbits was 3 mg/kg/day. Embryofetal studies were conducted in pregnant rats administered loteprednol etabonate by oral gavage on gestation Days 6 to 15, to target the period of organogenesis.
Loteprednol etabonate produced fetal malformations, including absent innominate artery at doses ≥ 5 mg/kg (41 times the RHOD); and cleft palate, agnathia, cardiovascular defects, umbilical hernia, decreased fetal body weight and decreased skeletal ossification at doses ≥ 50 mg/kg (410 times the RHOD). Embryofetal lethality (resorption) was observed at 100 mg/kg (811 times the RHOD). The NOAEL for developmental toxicity in rats was 0.5 mg/kg (4 times the RHOD).
Loteprednol etabonate was maternally toxic (reduced body weight gain) at doses of ≥ 50 mg/kg/day. The NOAEL for maternal toxicity was 5 mg/kg. A peri-/postnatal study was conducted in rats administered loteprednol etabonate by oral gavage from gestation Day 15 (start of fetal period) to postnatal Day 21 (the end of lactation period).
At doses ≥ 0.5 mg/kg (4 times the clinical dose), reduced survival was observed in live-born offspring. Doses ≥ 5 mg/kg (41 times the RHOD) caused umbilical hernia/incomplete gastrointestinal tract. Doses ≥ 50 mg/kg (410 times the RHOD) produced maternal toxicity (reduced body weight gain, death), decreased number of live-born offspring, decreased birth weight, and delays in postnatal development.
A developmental NOAEL was not established in this study. The NOAEL for maternal toxicity was 5 mg/kg.
🧒 Pediatric Use ▾
8.4Pediatric Use Safety and effectiveness in pediatric patients have not been established.
🧓 Geriatric Use ▾
8.5Geriatric Use No overall differences in safety and effectiveness have been observed between elderly and younger adult patients.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Corticosteroids inhibit the inflammatory response to a variety of inciting agents and probably delay or slow healing. They inhibit the edema, fibrin deposition, capillary dilation, leukocyte migration, capillary proliferation, fibroblast proliferation, deposition of collagen, and scar formation associated with inflammation. While glucocorticoids are known to bind to and activate the glucocorticoid receptor, the molecular mechanisms involved in glucocorticoid/glucocorticoid receptor‑dependent modulation of inflammation are not clearly established.
However, corticosteroids are thought to inhibit prostaglandin production through several independent mechanisms.
12.3Pharmacokinetics The systemic exposure to loteprednol etabonate following ocular administration of LOTEMAX ointment has not been studied in humans. However, results from a bioavailability study with LOTEMAX suspension in normal volunteers established that plasma concentrations of loteprednol etabonate and Δ¹ cortienic acid etabonate (PJ 91), its primary, inactive metabolite, were below the limit of quantitation (1 ng/mL) at all sampling times. The results were obtained following the ocular administration of one drop in each eye of 0.5% loteprednol etabonate suspension, 8 times daily for 2 days or 4 times daily for 42 days.
The maximum systemic exposure to loteprednol following administration of the ointment product dosed 4 times daily is not expected to exceed exposures attained with LOTEMAX suspension dosed up to two drops 4 times daily.
🧬 Mechanism of Action ▾
12.1Mechanism of Action Corticosteroids inhibit the inflammatory response to a variety of inciting agents and probably delay or slow healing. They inhibit the edema, fibrin deposition, capillary dilation, leukocyte migration, capillary proliferation, fibroblast proliferation, deposition of collagen, and scar formation associated with inflammation. While glucocorticoids are known to bind to and activate the glucocorticoid receptor, the molecular mechanisms involved in glucocorticoid/glucocorticoid receptor‑dependent modulation of inflammation are not clearly established.
However, corticosteroids are thought to inhibit prostaglandin production through several independent mechanisms.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING LOTEMAX ® (loteprednol etabonate ophthalmic ointment) 0.5% is a sterile ointment supplied in a tin tube with a pink polypropylene cap in the following size: NDC 24208-443-35 3.5 g tube DO NOT USE IF TAMPER-EVIDENT SKIRT IS VISIBLE ON BOTTOM OF CAP. Storage: Store between 15°C to 25°C (59°F to 77°F). After opening, LOTEMAX can be used until the expiration date on the tube.
📋 Description ▾
11 DESCRIPTION LOTEMAX ® (loteprednol etabonate ophthalmic ointment) 0.5% is a sterile, topical corticosteroid for ophthalmic use. Loteprednol etabonate is a white to off-white powder. Loteprednol etabonate is represented by the following structural formula: Chemical name: chloromethyl 17α-[(ethoxycarbonyl)oxy]-11β-hydroxy-3-oxoandrosta-1,4-diene-17β-carboxylate Each gram contains: Active: Loteprednol etabonate 5 mg (0.5%); Inactives: Mineral Oil and White Petrolatum.
CHEM
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Risk of Contamination Advise patients to wash hands prior to using LOTEMAX ointment. Advise patients not to touch the eyelid or surrounding areas with the tip of the tube. The cap should remain on the tube when not in use.
Contact Lens Wear Advise patients not to wear contact lenses during their course of therapy. Risk of Secondary Infection Advise patients to consult a physician if pain, redness, itching or inflammation becomes aggravated [see Warnings and Precautions ( 5.4 )] . Distributed by: Bausch & Lomb Americas Inc.
Bridgewater, NJ 08807 USA Manufactured by: Bausch & Lomb Incorporated Tampa, FL 33637 USA LOTEMAX is a trademark of Bausch & Lomb Incorporated or its affiliates. © 2022 Bausch & Lomb Incorporated or its affiliates 9234905 (Folded) 9234805 (Flat)