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Procto-Med Hc

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Active ingredient
Hydrocortisone 25 mg/1 g
Other brand names
Drug class
Corticosteroid
Dosage form
Cream
Route
Topical
Prescription status
Rx (prescription)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2020
Label revision date
January 6, 2026
FDA Insert
Prescribing information, PDF file
Active ingredient
Hydrocortisone 25 mg/1 g
Other brand names
Drug class
Corticosteroid
Dosage form
Cream
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 2020
Label revision date
January 6, 2026
Manufacturer
Leading Pharma, LLC
Registration number
ANDA085025
NDC root
69315-312
FDA Insert
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

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

Drug Overview

Procto-Med HC™ 2.5% is a topical cream that contains hydrocortisone, a type of medication known as a corticosteroid. Each gram of this cream includes 25 mg of hydrocortisone, which is used to help relieve inflammation and itching associated with certain skin conditions. It works by reducing the inflammatory response in the skin, making it effective for treating various dermatological issues that respond to corticosteroids.

This cream is particularly useful for conditions that cause inflammation and itching, known as corticosteroid-responsive dermatosis. When applied to the skin, hydrocortisone can be absorbed and act similarly to corticosteroids taken by other means, helping to alleviate discomfort and promote healing.

Uses

Topical corticosteroids are used to help relieve inflammation and itching associated with certain skin conditions that respond to corticosteroid treatment. These medications can be effective for various skin issues, providing you with comfort and relief from uncomfortable symptoms.

It's important to note that the information provided does not indicate any harmful effects on developing babies (teratogenic effects) or any other non-harmful effects. This means that, based on the available data, these medications are considered safe in that regard.

Dosage and Administration

When using topical corticosteroids, you should apply a thin layer directly to the affected area of your skin. Depending on how severe your condition is, you may need to do this two to four times a day. For certain skin issues like psoriasis or stubborn conditions, you can use occlusive dressings (coverings that keep the medication in contact with the skin) to enhance the treatment's effectiveness.

However, if you notice any signs of infection, such as increased redness, swelling, or pus, you should stop using the occlusive dressings immediately. In that case, it's important to seek appropriate antimicrobial therapy (medications that treat infections) to address the infection properly. Always follow your healthcare provider's instructions for the best results.

What to Avoid

If you have a history of hypersensitivity (an extreme allergic reaction) to any of the ingredients in topical corticosteroids, you should avoid using these medications. It's important to be aware that using them in such cases can lead to serious allergic reactions. Always consult with your healthcare provider if you have any concerns about your allergies or the medications you are considering. Your safety is the top priority, so make sure to discuss any past reactions to medications with your doctor.

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 allergic reactions, skin infections, or thinning of the skin.

Systemically, this medication can affect your body's hormone levels, potentially leading to conditions like Cushing’s syndrome, which can cause weight gain and other symptoms, as well as increased blood sugar levels. If you are using this medication for children, be aware that they may be more prone to these effects, including growth delays and increased pressure in the brain. Signs of steroid withdrawal may also occur, which could require additional treatment.

Warnings and Precautions

It's important to be aware of certain laboratory tests that may be necessary while using this medication. Your doctor may recommend a urinary free cortisol test, which measures the level of cortisol (a hormone) in your urine, and an ACTH stimulation test, which assesses how well your adrenal glands respond to a hormone called ACTH.

While there are no specific warnings or emergency instructions provided, it's always a good practice to stay alert for any unusual symptoms. If you experience any concerning side effects or changes in your health, stop taking the medication and contact your doctor for guidance. Your health and safety are paramount, so don't hesitate to reach out if you have any questions or concerns.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, if you suspect that you or someone else may have taken too much of a medication, it’s important to be aware of potential signs of an overdose. These can include unusual drowsiness, confusion, or difficulty breathing.

If you notice any of these symptoms, or if you are unsure whether an overdose has occurred, seek immediate medical help. You can contact your local emergency services or go to the nearest hospital. Always keep medications out of reach and follow the prescribed dosage to prevent any risks associated with overdosage.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to be aware of the potential risks associated with corticosteroids. These medications are classified as Pregnancy Category C, which means that while they may be necessary for certain conditions, their effects on a developing fetus are not fully understood. Laboratory studies have shown that corticosteroids can cause developmental issues (teratogenic effects) in animals, even at low doses.

Because there are no well-controlled studies in pregnant women regarding the use of topical corticosteroids, you should only use them if your healthcare provider believes the benefits outweigh the risks to your baby. It's also advised to avoid using these medications extensively, in large amounts, or for long periods during pregnancy. Always consult with your healthcare provider before starting or continuing any medication while pregnant.

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 the best options for your situation and ensure the safety of both you and your infant.

Pediatric Use

When using topical corticosteroids (medications applied to the skin) for children, it's important to be aware that they may be more sensitive to side effects than adults. This is due to their larger skin surface area relative to their body weight. In some cases, children can experience serious conditions like adrenal suppression (a decrease in hormone production) and Cushing’s syndrome (a hormonal disorder), as well as increased pressure in the brain.

To minimize risks, you should use the smallest effective amount of topical corticosteroids for your child. Be vigilant for signs of potential side effects, such as slowed growth, delayed weight gain, low cortisol levels, headaches, or bulging fontanelles (the soft spots on a baby’s head). If you notice any of these symptoms, consult your child's healthcare provider promptly. Chronic use of these medications can affect your child's growth and development, so careful management is essential.

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. As you age, your body may process medications differently, which can affect how well they work and the potential for side effects.

If you or a loved one is considering this medication, it’s wise to discuss it with a healthcare provider. They can help determine if any adjustments are needed based on individual health conditions and ensure that the treatment is safe and effective for older adults. Always prioritize open communication with your healthcare team about any concerns or questions you may have.

Renal Impairment

If you have kidney issues, it's important to be aware that corticosteroids, which are often used to treat various conditions, are mainly processed in the liver and then removed from your body by the kidneys. Some of these medications can also be found in bile. If you are using a strong topical corticosteroid over a large area of your skin or under a covering, you may need to have your hormone levels checked. This is because systemic absorption (when the medication enters your bloodstream) can lead to a condition called hypothalamic-pituitary-adrenal (HPA) axis suppression, which affects hormone production.

To ensure your safety, your healthcare provider may recommend monitoring your hormone levels through tests like urinary free cortisol and ACTH stimulation tests. Regular evaluations are crucial to catch any potential issues early, especially if you are on a high dose of these medications.

Hepatic Impairment

If you have liver problems, it's important to be aware that corticosteroids are mainly processed in your liver and then removed from your body through your kidneys. Some topical corticosteroids can also be found in your bile. If you use these medications, especially in large amounts or under a covering, you may need to have your hormone levels checked. This is because they can sometimes affect your body's hormone balance, specifically the hypothalamic-pituitary-adrenal (HPA) axis, which is responsible for regulating stress hormones.

To monitor for any potential issues, your doctor may recommend tests like urinary free cortisol and ACTH stimulation tests. If these tests show that your hormone levels are affected, your doctor might suggest reducing the amount of corticosteroid you use, changing to a less potent option, or stopping the medication altogether. The good news is that if you do experience any hormone suppression, your body usually recovers quickly once the medication is stopped. 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 discuss your full list of medications, including over-the-counter drugs and supplements, as well as any upcoming lab tests. This way, you can avoid any potential issues and receive the best care possible.

Storage and Handling

To ensure the safety and effectiveness of your product, store it at a temperature between 20-25°C (68-77°F), which is considered a controlled room temperature. This helps maintain its quality. Additionally, it's important to keep the product out of the reach of children to prevent any accidental misuse or ingestion.

When handling the product, always ensure that you are in a clean environment to avoid contamination. Following these guidelines will help you use the product safely and effectively.

Additional Information

You may need to undergo certain laboratory tests if you are being evaluated for specific medical conditions. These tests include the urinary free cortisol test, which measures the level of cortisol in your urine, and the ACTH stimulation test, which assesses how well your adrenal glands respond to adrenocorticotropic hormone (ACTH). These tests help your healthcare provider understand your hormone levels and adrenal function better.

FAQ

What is Procto-Med HC™ 2.5%?

Procto-Med HC™ 2.5% is a hydrocortisone cream that contains 25 mg of hydrocortisone per gram in a cream base.

What are the uses of Procto-Med HC™?

It is indicated for the relief of inflammatory and pruritic (itchy) manifestations of corticosteroid-responsive dermatosis.

How should I apply Procto-Med HC™?

Apply a thin film to the affected area two to four times daily, depending on the severity of your condition.

Are there any contraindications for using Procto-Med HC™?

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

What are some local adverse reactions to Procto-Med HC™?

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

What systemic adverse reactions can occur?

Systemic reactions may include reversible hypothalamic-pituitary-adrenal (HPA) axis suppression and hyperglycemia.

Is Procto-Med HC™ safe to use during pregnancy?

Procto-Med HC™ should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus, as it is classified as Pregnancy Category C.

Can Procto-Med HC™ be used while breastfeeding?

Caution should be exercised when using Procto-Med HC™ during breastfeeding, as it is not known if it can be absorbed into breast milk.

What should I do if I develop an infection while using Procto-Med HC™?

If an infection develops, discontinue the use of occlusive dressings and seek appropriate antimicrobial therapy.

How should Procto-Med HC™ be stored?

Store Procto-Med HC™ at 20-25°C (68-77°F) and keep it out of the reach of children.

Packaging Info

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

Packaging configurations for Procto-Med Hc.
Details

FDA Insert (PDF)

This is the full prescribing document for Procto-Med Hc, 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

Each gram of Procto-Med HC 2.5% (Hydrocortisone Cream USP, 2.5%) contains 25 mg of hydrocortisone in a cream base composed of cetyl alcohol, methylparaben, propylene glycol, propylparaben, purified water, sodium lauryl sulfate, and stearyl alcohol. Hydrocortisone is chemically defined as Pregn-4-ene-3,20-dione,11,17,21-trihydroxy-,(11β)-, with a molecular formula of C21H30O5 and a molecular weight of 362.47.

Uses and Indications

Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations associated with corticosteroid-responsive dermatoses. These conditions may include a variety of skin disorders that respond positively to corticosteroid treatment.

There are no teratogenic or nonteratogenic effects reported in the available data.

Dosage and Administration

Topical corticosteroids should be applied to the affected area as a thin film, with a frequency of two to four times daily, depending on the severity of the condition being treated. For patients with psoriasis or other recalcitrant conditions, 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. This contraindication is essential to prevent adverse reactions in susceptible individuals.

Warnings and Precautions

Healthcare professionals should be aware of the following laboratory tests that are essential for the safe use of the medication.

Laboratory Tests

The urinary free cortisol test is recommended to assess cortisol levels in patients. This test is crucial for evaluating adrenal function and diagnosing conditions related to cortisol excess.

Additionally, the ACTH stimulation test is advised to further investigate adrenal insufficiency or hyperfunction. This test helps determine the adrenal glands' response to adrenocorticotropic hormone (ACTH) and is vital for appropriate patient management.

Regular monitoring through these tests is essential to ensure patient safety and to guide therapeutic decisions effectively.

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.

Systemic adverse reactions, while less frequent, can be serious. These include reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria.

In pediatric populations, there is an increased risk of HPA axis suppression and Cushing’s syndrome. Additionally, children may experience intracranial hypertension, which can manifest as bulging fontanelles, headaches, and bilateral papilledema. Signs of adrenal suppression in children may include linear growth retardation, delayed weight gain, low plasma cortisol levels, and an absence of response to ACTH stimulation.

It is important to note that signs and symptoms of steroid withdrawal may occur, necessitating the use of supplemental systemic corticosteroids. Furthermore, children may absorb proportionally larger amounts of topical corticosteroids, making them more susceptible to systemic toxicity.

Drug Interactions

There are currently no documented drug interactions associated with 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 Procto-Med Hc (hydrocortisone), the U.S. brand-name prescription product. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Procto-Med Hc.
Details

Pediatric Use

Pediatric patients may exhibit increased susceptibility to topical corticosteroid-induced hypothalamic-pituitary-adrenal (HPA) axis suppression and Cushing’s syndrome compared to mature patients, primarily due to a larger skin surface area relative to body weight. Reports indicate that HPA axis suppression, Cushing’s syndrome, and intracranial hypertension have occurred in this population following the use of topical corticosteroids.

Manifestations of adrenal suppression in pediatric patients can include linear growth retardation, delayed weight gain, low plasma cortisol levels, and a lack of response to adrenocorticotropic hormone (ACTH) stimulation. Additionally, signs of intracranial hypertension may present as bulging fontanelles, headaches, and bilateral papilledema.

To mitigate these risks, the administration of topical corticosteroids in pediatric patients should be restricted to the minimum amount necessary to achieve an effective therapeutic outcome. It is important to note that chronic corticosteroid therapy may adversely affect the growth and development of pediatric patients.

Geriatric Use

There is no specific information available 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

Pregnancy Category C indicates that corticosteroids may pose risks during pregnancy. Animal studies have demonstrated teratogenic effects associated with systemic administration of corticosteroids at relatively low dosages. Additionally, more potent corticosteroids have shown teratogenicity following dermal application in laboratory animals. 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 prescribed during pregnancy only when the anticipated benefits outweigh the potential risks to the fetus. It is advised that these medications not be used extensively, in large amounts, or for prolonged periods in pregnant patients 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. Therefore, it is essential to monitor these patients for potential HPA axis suppression, particularly when they are receiving large doses of potent topical steroids applied to extensive surface areas or under occlusive dressings. Periodic evaluation for evidence of HPA axis suppression should be conducted using urinary free cortisol and ACTH stimulation tests.

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. Due to the potential for systemic absorption of topical corticosteroids, there is a risk of reversible hypothalamic-pituitary-adrenal (HPA) axis suppression in this population.

It is recommended that patients receiving a large dose of a potent topical steroid, particularly when applied to a large surface area or under an occlusive dressing, 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 advisable to consider withdrawing the corticosteroid, reducing the frequency of application, or substituting 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 regarding the potential risks associated with excessive administration of the medication.

Healthcare providers are advised to monitor patients closely for any signs of adverse effects that may arise from overdosage. Symptoms may vary depending on the medication's pharmacological profile and the individual patient's response.

In the event of suspected overdosage, immediate medical intervention is recommended. Healthcare professionals should initiate supportive care and symptomatic treatment as necessary. It is crucial to consult local poison control centers or relevant medical authorities for guidance on management protocols specific to the medication in question.

Documentation of the incident, including the amount ingested and the time of exposure, is vital for effective treatment and follow-up care. Continuous assessment of the patient's condition will aid in determining the appropriate course of action.

Nonclinical Toxicology

Corticosteroids are classified as Pregnancy Category C, indicating that they are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. More potent corticosteroids have demonstrated teratogenic effects following dermal application in these animals. There are no adequate and well-controlled studies in pregnant women regarding the teratogenic effects of topically applied corticosteroids. Consequently, the use of topical corticosteroids during pregnancy should be considered only if the potential benefits outweigh the potential risks to the fetus. It is advised that drugs within this class not be used extensively on pregnant patients, in large amounts, or for prolonged periods.

Long-term animal studies have not been conducted to assess the carcinogenic potential or the effects on fertility associated with topical corticosteroids. Additionally, studies aimed at determining mutagenicity with 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 patients receiving topical corticosteroids, cases of hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing’s syndrome, and intracranial hypertension have been documented. 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. Symptoms indicative of intracranial hypertension may present as bulging fontanelles, headaches, and bilateral papilledema.

Patient Counseling

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

Healthcare providers should advise patients not to use this medication for any condition other than the one for which it was prescribed. It is important to ensure that patients understand the specific purpose of the treatment.

Patients should be informed that the treated skin area should not be bandaged or covered in a manner that creates an occlusive environment unless specifically directed by their physician. This is crucial to avoid potential complications.

Additionally, patients should be encouraged to report any signs of local adverse reactions, particularly if they occur under occlusive dressings, as this may indicate a need for medical evaluation or adjustment of treatment.

For parents of pediatric patients, it is essential to advise against the use of tight-fitting diapers or plastic pants on children receiving treatment in the diaper area. These garments can create an occlusive dressing, which may lead to adverse effects and should be avoided unless otherwise instructed by a healthcare professional.

Storage and Handling

The product is supplied in accordance with the National Drug Code (NDC) specifications. It should be stored at a temperature range of 20-25°C (68-77°F), adhering to the guidelines set forth by the United States Pharmacopeia (USP) for Controlled Room Temperature.

It is essential to keep the product out of the reach of children to ensure safety. Special handling requirements are not specified; however, standard precautions should be observed during storage and handling to maintain product integrity.

Additional Clinical Information

Patients undergoing treatment may require specific laboratory tests to monitor their condition. The urinary free cortisol test and the ACTH stimulation test are recommended for assessing adrenal function and cortisol levels. Clinicians should consider these tests as part of the overall management strategy for patients.

FDA Insert (PDF)

This document is the official FDA-approved prescribing information for Procto-Med Hc as submitted by Leading Pharma, 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 Procto-Med Hc, 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 (ANDA085025) 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.