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Hydrocortisone

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Active ingredient
Hydrocortisone 10 mg/1 g
Other brand names
Drug class
Corticosteroid
Dosage form
Ointment
Route
Topical
Prescription status
Rx (prescription)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 1975
Label revision date
January 28, 2026
FDA Insert
Prescribing information, PDF file
Active ingredient
Hydrocortisone 10 mg/1 g
Other brand names
Drug class
Corticosteroid
Dosage form
Ointment
Route
Topical
Prescription status
Rx (prescription)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 1975
Label revision date
January 28, 2026
Manufacturer
E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC
Registration number
ANDA080692
NDC root
0168-0020
FDA Insert
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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If you are a consumer or patient please visit this version.

Drug Overview

Hydrocortisone Ointment USP, 1% is a topical medication that contains hydrocortisone, a type of corticosteroid. It is primarily used to relieve inflammation and itching associated with certain skin conditions that respond to corticosteroids. When applied to the skin, hydrocortisone works by reducing inflammation and alleviating discomfort.

This ointment is designed for external use only and is effective in treating various dermatological issues. It is important to note that the absorption of hydrocortisone through the skin can be influenced by factors such as the condition of the skin and the use of occlusive dressings, which can enhance its effectiveness.

Uses

Topical corticosteroids are used to help relieve inflammation and itching associated with certain skin conditions that respond to corticosteroid treatment. If you are experiencing skin issues that cause discomfort, these medications can provide relief from symptoms like redness and irritation.

It's important to note that there are no reported teratogenic effects (which means they do not cause birth defects) or nonteratogenic effects (which refer to other types of harmful effects) associated with these medications. This makes them a safer option for managing your skin concerns.

Dosage and Administration

When using topical corticosteroids, you should apply a thin layer to the affected area three to four times a day. The exact frequency depends on how severe your condition is. For certain skin issues like psoriasis or stubborn conditions, you might also use occlusive dressings, which are coverings that help the medication work better by keeping it in contact with your skin.

However, if you notice any signs of infection, it’s important to stop using the occlusive dressings right away. In that case, you should seek appropriate treatment with antimicrobial therapy (medications that fight infections). Always follow your healthcare provider's instructions for the best results.

What to Avoid

If you have a history of hypersensitivity (allergic reactions) to any ingredients in topical corticosteroids, you should avoid using them. Additionally, if you experience irritation while using these medications, stop using them immediately and seek appropriate treatment.

It's also important to note that if you have a skin infection, you should use the right antifungal or antibacterial treatment first. Only after the infection is under control should you consider resuming the use of topical corticosteroids.

Side Effects

You may experience some local side effects when using this medication, such as burning, itching, irritation, and dryness of the skin. Other possible reactions include folliculitis (inflammation of hair follicles), acne-like eruptions, and changes in skin color. In some cases, you might notice skin thinning, stretch marks, or secondary infections. If you have a history of allergies, be aware that allergic contact dermatitis could also occur.

Systemically, this medication can affect your body's hormone levels, potentially leading to conditions like Cushing's syndrome, which may cause symptoms such as weight gain and high blood sugar levels. Children are particularly sensitive to these effects, with risks including growth delays and signs of increased pressure in the brain, such as headaches. If you notice any irritation or signs of infection, it's important to stop using the medication and consult your healthcare provider for appropriate treatment.

Warnings and Precautions

Using topical corticosteroids can lead to some serious side effects, including issues with your body's hormone regulation (known as HPA axis suppression), symptoms similar to Cushing's syndrome, and increased blood sugar levels. These risks are higher if you use strong steroids over large areas of skin, for long periods, or with occlusive dressings (coverings that trap moisture). If you notice any irritation, stop using the corticosteroid and seek appropriate treatment. If you have a skin infection, make sure to use the right antifungal or antibacterial medication, and stop the corticosteroid if you don’t see improvement quickly.

If you are using a potent topical steroid on a large area or under a dressing, your doctor may want to monitor your hormone levels through tests like the urinary free cortisol test and the ACTH stimulation test. If these tests show signs of hormone suppression, your doctor may suggest reducing the steroid use or switching to a less potent option. Recovery from any hormone issues is usually quick once the medication is stopped, but be aware that some people may experience withdrawal symptoms that could require additional treatment. Children are particularly at risk for these side effects, as they may absorb more of the medication.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, it's important to be aware of the general signs of an overdose, which can include symptoms like extreme drowsiness, confusion, or difficulty breathing. If you suspect an overdose, it is crucial to seek immediate medical help.

In case of an emergency, call your local emergency number or go to the nearest hospital. Always keep medications out of reach of children and follow the prescribed dosage to prevent any potential risks. If you have any concerns or questions about your medication, don’t hesitate to reach out to your healthcare provider for guidance.

Pregnancy Use

Corticosteroids, a type of medication often used to reduce inflammation, may pose risks during pregnancy. Studies in laboratory animals have shown that these drugs can cause developmental issues (teratogenic effects) even at low doses when given systemically. Additionally, more potent corticosteroids have been linked to similar risks when applied to the skin. However, there are no well-controlled studies in pregnant women to confirm these effects from topical use.

Because of these concerns, it is important to use topical corticosteroids during pregnancy only if the potential benefits outweigh the risks to your baby. You should avoid using these medications extensively, in large amounts, or for long periods while pregnant. Always consult your healthcare provider before using any medication during pregnancy to ensure the safety of both you and your baby.

Lactation Use

If you are breastfeeding and considering the use of corticosteroids, it's important to know that while systemically administered corticosteroids (those taken by mouth or injection) do appear in breast milk, the amounts are generally not expected to harm your baby. However, the effects of topical corticosteroids (those applied directly to the skin) on breast milk are not well understood, as it is unclear if they can be absorbed into the bloodstream in significant amounts.

Given this uncertainty, it's wise to be cautious when using topical corticosteroids while nursing. Always consult with your healthcare provider to discuss any medications you are considering and to ensure the safety of both you and your infant.

Pediatric Use

Currently, there is no specific information available regarding the use of this medication in children. This means that if you are considering this treatment for a child, it is important to consult with a healthcare professional for guidance. They can provide you with the best advice tailored to your child's needs and ensure safety. Always prioritize your child's health by seeking expert recommendations.

Geriatric Use

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. If you or a loved one is an older adult, it’s wise to discuss any potential risks or benefits with a healthcare provider. They can help determine the best course of action based on individual health needs and any other medications being taken.

Always keep in mind that older adults may have different responses to medications, so regular monitoring and open communication with your healthcare team are essential for safety and effectiveness.

Renal Impairment

If you have kidney issues, it's important to be aware that corticosteroids are mainly processed in the liver and then removed from your body by the kidneys. Some topical corticosteroids can also be eliminated through bile. When using these medications, especially in large doses or over large areas of skin, you may need to be monitored for potential suppression of the hypothalamic-pituitary-adrenal (HPA) axis, which is a system that helps regulate hormones in your body.

To check for HPA axis suppression, your healthcare provider may perform tests like measuring urinary free cortisol and conducting ACTH stimulation tests. If any suppression is detected, your doctor might suggest reducing the steroid's use, switching to a less potent option, or stopping the medication altogether. The good news is that if you stop using the corticosteroid, your HPA axis function usually recovers quickly and completely.

Hepatic Impairment

If you have liver problems, it's important to be aware that corticosteroids are mainly processed in your liver before being eliminated by your kidneys. Some topical corticosteroids and their breakdown products are also removed from your body through bile. Because of this, if you use topical corticosteroids, especially in large amounts or under a covering, you may need to have your hormone levels monitored. This is to check for a condition called hypothalamic-pituitary-adrenal (HPA) axis suppression, which can occur with systemic absorption of these medications.

If tests show signs of HPA axis suppression, your healthcare provider may suggest reducing the amount you use, changing to a less potent steroid, or stopping the medication altogether. The good news is that if you stop using the corticosteroid, your hormone levels usually return to normal quickly. Always consult your healthcare provider for personalized advice and monitoring.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you.

Always feel free to ask questions and share your complete list of medications and any lab tests you may be undergoing. This way, you can receive the best possible care tailored to your needs.

Storage and Handling

To ensure the best performance and safety of your product, store it at a controlled room temperature between 15° to 30°C (59° to 86°F). This temperature range helps maintain the integrity of the device.

When handling the product, be sure to do so in a clean environment to avoid contamination. Always follow any specific instructions provided for use and disposal to ensure safety and effectiveness.

Additional Information

If you're concerned about the suppression of the hypothalamic-pituitary-adrenal (HPA) axis, certain laboratory tests can help evaluate this condition. The urinary free cortisol test measures the amount of cortisol (a hormone produced by the adrenal glands) in your urine, while the ACTH stimulation test assesses how well your adrenal glands respond to adrenocorticotropic hormone (ACTH). These tests can provide valuable insights into your adrenal function and overall health.

FAQ

What is Hydrocortisone Ointment USP, 1% used for?

Hydrocortisone Ointment USP, 1% is indicated for the relief of inflammatory and pruritic (itchy) manifestations of corticosteroid-responsive dermatoses.

How should I apply Hydrocortisone Ointment?

You should apply a thin film of the ointment to the affected area three or four times a day, depending on the severity of your condition.

Are there any contraindications for using this ointment?

Yes, it is contraindicated for patients with a history of hypersensitivity to any of its components.

What should I do if I experience irritation while using the ointment?

If irritation develops, you should discontinue use and consult your healthcare provider for appropriate therapy.

Can I use Hydrocortisone Ointment during pregnancy?

Topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

What are some local adverse reactions I might experience?

Local adverse reactions may include burning, itching, irritation, dryness, and acneiform eruptions, among others.

What are the systemic effects of using topical corticosteroids?

Systemic absorption can lead to reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, hyperglycemia, and manifestations of Cushing's syndrome.

How should I store Hydrocortisone Ointment?

Store the ointment at controlled room temperature between 15° to 30°C (59° to 86°F).

Is this ointment safe for children?

Children may be more susceptible to systemic toxicity from topical corticosteroids, so caution is advised.

What should I do if I develop a skin infection while using the ointment?

If a skin infection develops, discontinue the use of the ointment and initiate appropriate antimicrobial therapy.

Packaging Info

The table below lists all NDC Code configurations of Hydrocortisone, the U.S. brand-name prescription product. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Hydrocortisone.
Details

FDA Insert (PDF)

This is the full prescribing document for Hydrocortisone, submitted to the U.S. Food and Drug Administration (FDA). It contains official information for healthcare providers, including how to use the medication, possible side effects, and safety warnings.

View FDA-approved insert (PDF)

Description

Hydrocortisone Ointment USP, 1% contains hydrocortisone, which is chemically identified as Pregn-4-ene-3,20-dione, 11,17,21-trihydroxy-, (11ß)-. The molecular formula of hydrocortisone is C21H30O5, and it has a molecular weight of 362.47 g/mol. Each gram of the ointment contains 10 mg of hydrocortisone, USP, formulated in a base that includes white petrolatum and mineral oil.

Uses and Indications

Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations associated with corticosteroid-responsive dermatoses.

There are no teratogenic or nonteratogenic effects reported for this drug.

Dosage and Administration

Topical corticosteroids should be applied to the affected area as a thin film three to four times daily, with the frequency depending on the severity of the condition being treated. For conditions such as psoriasis or other recalcitrant disorders, occlusive dressings may be utilized to enhance the efficacy of the treatment.

In cases where an infection develops, it is imperative to discontinue the use of occlusive dressings immediately and to initiate appropriate antimicrobial therapy to address the infection.

Contraindications

Topical corticosteroids are contraindicated in patients with a history of hypersensitivity to any of the components of the preparation.

In cases of irritation, the use of topical corticosteroids should be discontinued, and appropriate therapy should be initiated. Additionally, in the presence of dermatological infections, the use of an appropriate antifungal or antibacterial agent is required. If a favorable response does not occur promptly, the corticosteroid should be discontinued until the infection is adequately controlled.

Warnings and Precautions

Systemic absorption of topical corticosteroids can lead to reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, as well as manifestations of Cushing's syndrome, hyperglycemia, and glucosuria in certain patients. Factors that may enhance systemic absorption include the use of more potent steroids, application over extensive surface areas, prolonged treatment duration, and the use of occlusive dressings. Should irritation occur, the application of topical corticosteroids must be discontinued, and appropriate therapeutic measures should be initiated.

In cases where dermatological infections are present, it is essential to administer an appropriate antifungal or antibacterial agent. If there is no prompt favorable response, the corticosteroid treatment should be halted until the infection is adequately managed.

Patients receiving high doses of potent topical steroids, particularly when applied to large areas or under occlusive dressings, should undergo periodic evaluations for signs of HPA axis suppression. This can be assessed through urinary free cortisol and ACTH stimulation tests. If evidence of HPA axis suppression is detected, it is advisable to withdraw the corticosteroid, reduce the frequency of application, or consider switching to a less potent steroid. Typically, recovery of HPA axis function occurs rapidly and completely following discontinuation of the corticosteroid. However, in rare instances, withdrawal symptoms may arise, necessitating the use of supplemental systemic corticosteroids.

It is important to note that children may absorb larger amounts of topical corticosteroids relative to their body size, making them more vulnerable to systemic toxicity. Therefore, careful monitoring is warranted in this population.

For monitoring purposes, the following laboratory tests are recommended: urinary free cortisol test and ACTH stimulation test.

Side Effects

Patients may experience a range of local and systemic adverse reactions associated with the use of this medication.

Local adverse reactions are commonly reported and include burning, itching, irritation, and dryness of the skin. Other local effects may consist of folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infections, skin atrophy, striae, and miliaria. In cases where irritation develops, it is recommended that the topical corticosteroid be discontinued and appropriate therapy instituted.

Systemic adverse reactions, although less common, can occur and include reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing's syndrome, hyperglycemia, and glucosuria.

Pediatric patients are noted to have a greater susceptibility to the adverse effects of topical corticosteroids, particularly HPA axis suppression and Cushing's syndrome. Manifestations of adrenal suppression in this population may include linear growth retardation, delayed weight gain, low plasma cortisol levels, and an absence of response to ACTH stimulation. Additionally, signs of intracranial hypertension, such as bulging fontanelles, headaches, and bilateral papilledema, may also be observed in pediatric patients.

It is important to note that signs and symptoms of steroid withdrawal may occur, necessitating the use of supplemental systemic corticosteroids. In the presence of dermatological infections, the use of an appropriate antifungal or antibacterial agent should be initiated. If a favorable response does not occur promptly, the corticosteroid should be discontinued until the infection has been adequately controlled.

Drug Interactions

There are currently no documented drug interactions associated with the use of this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

The table below lists all NDC Code configurations of Hydrocortisone, the U.S. brand-name prescription product. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Hydrocortisone.
Details

Pediatric Use

No pediatric use information is provided in the insert. Therefore, the safety and efficacy of this medication in pediatric patients have not been established. Healthcare professionals should exercise caution when considering this treatment for children, infants, or adolescents, as there are no available data to guide dosing or therapeutic outcomes in these populations.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

Corticosteroids are generally considered teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Additionally, more potent corticosteroids have demonstrated teratogenic effects following dermal application in these animal studies. However, there are no adequate and well-controlled studies in pregnant women to assess the teratogenic effects of topically applied corticosteroids.

Given the potential risks, topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is advised that drugs of this class not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time to minimize any potential adverse fetal outcomes.

Lactation

It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. However, systemically administered corticosteroids are secreted into breast milk in quantities not likely to have a deleterious effect on the breastfed infant.

Caution should be exercised when topical corticosteroids are administered to lactating mothers.

Renal Impairment

Corticosteroids are primarily metabolized in the liver and subsequently excreted by the kidneys. In patients with renal impairment, systemic absorption of topical corticosteroids may lead to reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, necessitating careful monitoring.

Patients receiving large doses of potent topical steroids, especially when applied to extensive areas of the skin or under occlusive dressings, should be periodically evaluated for signs of HPA axis suppression. This evaluation can be conducted using urinary free cortisol and ACTH stimulation tests.

If HPA axis suppression is detected, it is advisable to consider withdrawing the corticosteroid, reducing the frequency of application, or substituting with a less potent steroid. Notably, recovery of HPA axis function is typically prompt and complete following discontinuation of the corticosteroid.

Hepatic Impairment

Patients with hepatic impairment may experience altered metabolism and excretion of corticosteroids, which are primarily metabolized in the liver and excreted by the kidneys. Given that some topical corticosteroids and their metabolites are also excreted via the bile, caution is warranted in this population.

Systemic absorption of topical corticosteroids can lead to reversible hypothalamic-pituitary-adrenal (HPA) axis suppression. Therefore, patients with compromised liver function who are receiving large doses of potent topical steroids, particularly when applied to extensive surface areas or under occlusive dressings, should be monitored periodically for signs of HPA axis suppression. This monitoring can be conducted using urinary free cortisol and ACTH stimulation tests.

In cases where HPA axis suppression is detected, it is recommended to consider withdrawing the corticosteroid, reducing the frequency of application, or substituting with a less potent steroid. Notably, recovery of HPA axis function is typically prompt and complete following the discontinuation of the corticosteroid.

Overdosage

In the absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant and prepared for potential scenarios involving overdose.

Healthcare providers should be aware that the clinical presentation of an overdose may vary significantly depending on the substance involved and the individual patient’s characteristics. Symptoms of overdose can range from mild to severe and may include alterations in consciousness, respiratory distress, cardiovascular instability, and other systemic effects.

In the event of suspected overdosage, immediate medical evaluation is recommended. Healthcare professionals should assess the patient's vital signs and clinical status, and initiate supportive care as necessary. It is crucial to gather a detailed history of the substance involved, including the amount and route of administration, to guide further management.

Management strategies may include activated charcoal administration if the patient presents within a suitable timeframe and is not at risk for aspiration. In cases of severe toxicity, specific antidotes may be indicated, and consultation with a poison control center or a medical toxicologist is advised.

Continuous monitoring of the patient’s condition is essential, as symptoms may evolve over time. Supportive measures, including intravenous fluids and oxygen supplementation, may be required based on the clinical scenario.

In summary, while no specific overdosage information is provided, healthcare professionals should be prepared to respond promptly and effectively to any suspected overdose situation, utilizing appropriate clinical judgment and available resources.

Nonclinical Toxicology

Long-term animal studies have not been conducted to assess the carcinogenic potential or the effects on fertility of topical corticosteroids. Additionally, investigations into the mutagenicity of prednisolone and hydrocortisone have yielded negative results.

Postmarketing Experience

Local adverse reactions associated with topical corticosteroids have been reported infrequently, with an increased incidence noted when occlusive dressings are used. These reactions include burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, and miliaria.

In pediatric populations, cases of hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing's syndrome, and intracranial hypertension have been documented following the use of topical corticosteroids. Manifestations of adrenal suppression in children may present as linear growth retardation, delayed weight gain, low plasma cortisol levels, and an absence of response to ACTH stimulation. Symptoms indicative of intracranial hypertension can include bulging fontanelles, headaches, and bilateral papilledema.

Patient Counseling

Patients should be informed that this medication is to be used strictly as directed by their physician and is intended for external use only. They must be cautioned to avoid contact with the eyes to prevent irritation or injury.

It is essential for patients to understand that this medication should not be used for any condition other than the specific disorder for which it was prescribed. They should be advised against bandaging or covering the treated skin area in a manner that creates an occlusive environment, unless specifically instructed by their physician.

Patients are encouraged to report any signs of local adverse reactions, particularly if they occur under an occlusive dressing, as this may indicate a need for medical evaluation or adjustment of treatment.

For parents of pediatric patients, it is important to advise them against using tight-fitting diapers or plastic pants on a child receiving treatment in the diaper area. Such garments may act as occlusive dressings, potentially leading to increased risk of adverse effects.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It should be stored at a controlled room temperature ranging from 15° to 30°C (59° to 86°F). Care should be taken to ensure that the product is kept within this temperature range to maintain its integrity and efficacy.

Additional Clinical Information

The evaluation of hypothalamic-pituitary-adrenal (HPA) axis suppression in patients may be supported by specific laboratory tests. Clinicians may consider utilizing the urinary free cortisol test and the ACTH stimulation test as part of the assessment process. These tests can provide valuable insights into the functioning of the HPA axis in affected subjects.

FDA Insert (PDF)

This document is the official FDA-approved prescribing information for Hydrocortisone as submitted by E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC. It includes detailed information about indications, dosage, contraindications, warnings, and clinical pharmacology.

View full prescribing information (PDF)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Hydrocortisone, retrieved by a validated AI data-extraction workflow.

All FDA-approved dosage forms and strengths are listed in the Packaging & NDC Codes section above. Regulatory status, pharmacologic class (EPC), and mechanism of action (MoA) were cross-checked against the FDA Orange Book (ANDA080692) and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

Learn more in our Editorial Policy

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Primary FDA sources:

Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.