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Proctosol-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 2005
Label revision date
July 2, 2025
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 2005
Label revision date
July 2, 2025
Manufacturer
Sun Pharmaceutical Industries, Inc.
Registration number
ANDA088799
NDC root
10631-407
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

Hydrocortisone is a synthetic steroid that is primarily used as an anti-inflammatory and antipruritic agent, meaning it helps reduce inflammation and relieve itching. It is commonly found in topical formulations, such as Proctosol-HC® cream, which is specifically indicated for treating skin conditions that respond to corticosteroids.

When applied to the skin, hydrocortisone works by decreasing the immune response and inflammation, providing relief from various skin irritations and conditions. It is important to use this medication as directed by a healthcare professional to ensure its effectiveness and safety.

Uses

Topical corticosteroids are used to help relieve inflammation and itching associated with certain skin conditions that respond to corticosteroid treatment. These conditions, known as corticosteroid-responsive dermatoses, can cause discomfort and irritation, and using these medications can provide significant relief.

It's important to note that the information provided does not mention any teratogenic effects (which are harmful effects on a developing fetus) or nonteratogenic effects, meaning that there are no known risks of these types associated with the use of topical corticosteroids. Always consult with your healthcare provider for personalized advice and treatment options.

Dosage and Administration

To use this medication effectively, apply a thin layer to the affected area two to four times a day, depending on how severe your condition is. If you have psoriasis or a stubborn skin issue, you can use occlusive dressings (coverings that keep the medication in place) to help manage your symptoms.

However, if you notice any signs of infection, such as increased redness, swelling, or pus, stop using the occlusive dressings immediately. In that case, it's important to seek appropriate treatment with antimicrobial therapy (medications that fight 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 (allergic reactions) to any ingredients in topical corticosteroids, you should avoid using them. If you experience irritation while using these medications, stop using them immediately and seek appropriate treatment. Additionally, if you have a skin infection, it's important to use the right antifungal or antibacterial medication first. Do not continue using the corticosteroid until the infection is properly treated and under control.

Side Effects

You may experience some local side effects, such as burning, itching, irritation, and dryness on 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, there can be more serious effects like reversible suppression of the hypothalamic-pituitary-adrenal (HPA) axis, which can lead to symptoms similar to Cushing's syndrome (a condition caused by excess cortisol), increased blood sugar levels, and glucose in the urine. If you are using this treatment for children, be aware that they may be at higher risk for these systemic effects, including growth delays and increased pressure in the brain. Signs of steroid withdrawal may also occur, which could require additional corticosteroid treatment.

Warnings and Precautions

Using topical corticosteroids can sometimes lead to serious side effects, including suppression of your body's natural hormone production (known as HPA axis suppression), symptoms similar to Cushing's syndrome, high blood sugar levels, and sugar in your urine. This risk increases if you use stronger steroids, apply them over large areas of skin, use them for a long time, or cover them with occlusive dressings (like bandages). If you are using a potent steroid in large amounts or under a dressing, your doctor may recommend tests, such as urinary free cortisol and ACTH stimulation tests, to check your hormone levels.

If you notice any signs of hormone suppression, your doctor may suggest reducing the frequency of use or switching to a less potent steroid. Most people recover quickly and completely after stopping the medication, but some may experience withdrawal symptoms that require additional treatment. Children are particularly at risk for these side effects, as they can absorb more of the medication relative to their body size.

If you experience skin irritation, stop using the corticosteroid and consult your doctor for alternative treatments. Additionally, if you have a skin infection, it's important to treat that with the appropriate antifungal or antibacterial medication before continuing with the corticosteroid. If you do not see improvement in your infection quickly, stop using the corticosteroid until the infection is under control. Always seek emergency help if you experience severe side effects or symptoms.

Overdose

When using topically applied corticosteroids, it's important to know that they can be absorbed into your body in amounts that may lead to systemic effects, which means they can affect your entire system rather than just the area where they are applied.

If you suspect an overdose, look for signs such as unusual fatigue, weight gain, or changes in mood. If you experience any of these symptoms or feel unwell after using a corticosteroid, it’s crucial to seek medical help immediately. Always consult your healthcare provider if you have concerns about your medication or its effects.

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 birth defects (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 (skin-applied) corticosteroids.

Because of these concerns, it’s 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 or planning to breastfeed, it's important to be aware of how corticosteroids may affect you and your baby. While it is unclear whether applying corticosteroids to the skin can lead to enough absorption into your bloodstream to appear in breast milk, systemic (taken into the body) corticosteroids are known to be present in breast milk in amounts that are unlikely to harm your infant.

However, it's wise to be cautious when using topical corticosteroids (medications applied to the skin) 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 baby.

Pediatric Use

When using topical corticosteroids for your child, it's important to be aware that they may be more sensitive to these medications than adults. This is due to their larger skin surface area relative to their body weight. In some cases, children can experience serious side effects, such as adrenal suppression (which affects hormone production) and Cushing's syndrome (a condition caused by excess cortisol). Signs of adrenal suppression may include slower growth, delayed weight gain, and low cortisol levels, while symptoms of increased pressure in the brain can include headaches and bulging fontanelles (the soft spots on a baby's head).

To minimize risks, you should use the smallest amount of topical corticosteroid necessary to effectively treat your child's condition. Long-term use of these medications can potentially interfere with your child's growth and overall development, so it's crucial to follow your healthcare provider's guidance closely.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that if you or a loved one is an older adult considering this medication, it’s important to consult with a healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

Renal Impairment

If you have kidney issues, it's important to be aware that corticosteroids, which are often used to treat various conditions, are primarily processed in the liver and then excreted by the kidneys. When using topical corticosteroids, especially in large amounts or under occlusive dressings (like bandages), you may need to be monitored for potential suppression of the hypothalamic-pituitary-adrenal (HPA) axis, a system that helps regulate hormones in your body.

If signs of HPA axis suppression are observed, your healthcare provider may suggest reducing the frequency of use, switching to a less potent steroid, or stopping the medication altogether. Fortunately, recovery of HPA axis function usually happens quickly and completely once the corticosteroid is discontinued. Additionally, if you are nursing, be cautious, as it’s unclear whether these medications can pass into breast milk, which is something to discuss with your doctor if you have renal impairment.

Hepatic Impairment

If you have liver problems, it's important to be cautious when using corticosteroids, as these medications are mainly processed in the liver. Some topical corticosteroids can be absorbed into your bloodstream, which may lead to a condition called hypothalamic-pituitary-adrenal (HPA) axis suppression. This can affect your body's hormone levels and may require monitoring.

If you are using a strong topical steroid over a large area of skin or under a bandage, your doctor may recommend regular tests, such as urinary free cortisol and ACTH stimulation tests, to check for signs of HPA axis suppression. If any issues are found, your healthcare provider may suggest reducing the dosage, changing to a less potent steroid, or stopping the medication altogether. Fortunately, most people see a quick and complete recovery of their hormone function after discontinuing the steroid. Always discuss your treatment options and any concerns with your healthcare provider.

Drug Interactions

It's important to talk to your healthcare provider about any medications you are taking, even if no specific drug interactions are noted. This ensures that your treatment plan is safe and effective for you.

Additionally, if you're undergoing tests to evaluate your body's hormone response, such as the urinary free cortisol test or the ACTH stimulation test, discussing these with your provider can help you understand their purpose and what the results may mean for your health. Always keep an open line of communication with your healthcare team to ensure the best outcomes.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 20° to 25°C (68° to 77°F). This range is considered a controlled room temperature according to the United States Pharmacopeia (USP). It's important to keep the product protected from freezing, as extreme cold can damage it.

When handling the product, always do so with clean hands and in a clean environment to maintain its integrity. If you have any specific components that come with the product, make sure to follow any additional instructions provided for their safe use and disposal.

Additional Information

If you're concerned about the suppression of your hypothalamic-pituitary-adrenal (HPA) axis, certain tests can help evaluate its function. The urinary free cortisol test measures the level of cortisol in your urine, while the ACTH (adrenocorticotropic hormone) stimulation test assesses how well your adrenal glands respond to ACTH. These tests can provide valuable insights into your adrenal health. If you have questions about these tests or their implications, consider discussing them with your healthcare provider.

FAQ

What is Hydrocortisone?

Hydrocortisone is a synthetic steroid used as an anti-inflammatory and antipruritic agent.

What are the indications for using Hydrocortisone?

Hydrocortisone is indicated for relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

How should I apply Hydrocortisone cream?

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

Are there any contraindications for using Hydrocortisone?

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

What are some common local adverse reactions to Hydrocortisone?

Common local adverse reactions include burning, itching, irritation, and dryness.

What should I do if I experience irritation while using Hydrocortisone?

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

Can Hydrocortisone be used during pregnancy?

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

Is it safe to use Hydrocortisone while breastfeeding?

It is not known if topical Hydrocortisone can be absorbed into breast milk, so caution is advised when administering it to nursing women.

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

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

What are the storage conditions for Hydrocortisone?

Store Hydrocortisone at 20° to 25°C (68° to 77°F) and protect it from freezing.

Packaging Info

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

Packaging configurations for Proctosol-Hc.
Details

FDA Insert (PDF)

This is the full prescribing document for Proctosol-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

Hydrocortisone is a synthetic steroid indicated for its anti-inflammatory and antipruritic properties. The chemical name of hydrocortisone is Pregn-4-ene-3,20-dione, 11,17,21-trihydroxy-, (11β)-, with an empirical formula of C21H30O5 and a molecular weight of 362.47.

Proctosol-HC® 2.5% (Hydrocortisone Cream USP, 2.5%) contains 25 mg of hydrocortisone per gram. The cream is formulated in a base that includes cetyl alcohol, isopropyl palmitate, methylparaben, mineral oil, lanolin alcohol, polyoxyl 40 stearate, polysorbate 60, propylene glycol monostearate, propylene glycol, propylparaben, purified water, sorbic acid, and sorbitan monostearate.

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 noted in the available data.

Dosage and Administration

The medication should be applied to the affected area as a thin film, with frequency ranging from two to four times daily, contingent upon the severity of the condition being treated. For patients with psoriasis or other recalcitrant conditions, occlusive dressings may be utilized to enhance the therapeutic effect.

In the event that an infection develops, the use of occlusive dressings must be discontinued immediately, and appropriate antimicrobial therapy should be initiated 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, it is essential to use an appropriate antifungal or antibacterial agent. If a favorable response is not observed 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, which may manifest as Cushing's syndrome, hyperglycemia, and glucosuria in certain patients. Factors that can enhance systemic absorption include the use of more potent steroids, application over extensive body areas, prolonged treatment duration, and the use of occlusive dressings.

For patients receiving high doses of potent topical steroids applied to large surface areas or under occlusive dressings, periodic evaluation for signs of HPA axis suppression is recommended. This can be accomplished through urinary free cortisol and ACTH stimulation tests. Should evidence of HPA axis suppression be detected, it is advisable to withdraw the corticosteroid, reduce the frequency of application, or switch to a less potent steroid. Typically, recovery of HPA axis function occurs promptly and completely upon discontinuation of the drug; however, in rare cases, signs and symptoms of steroid withdrawal may arise, necessitating the use of supplemental systemic corticosteroids.

Particular caution should be exercised when prescribing topical corticosteroids to children, as they may absorb larger amounts relative to their body size, increasing their risk for systemic toxicity. In instances of irritation, the use of topical corticosteroids should be halted, and appropriate alternative therapies should be initiated.

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

Healthcare professionals should consider the following laboratory tests to assess potential HPA axis suppression: the urinary free cortisol test and the 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.

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

No specific drug interactions have been identified in the available data.

In terms of laboratory test interactions, certain tests may assist in evaluating hypothalamic-pituitary-adrenal (HPA) axis suppression. These tests include the urinary free cortisol test and the ACTH stimulation test. Monitoring these parameters may be beneficial in assessing the impact of treatment on the HPA axis.

Packaging & NDC

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

Packaging configurations for Proctosol-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 adults, primarily due to a higher 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 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

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, 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 deleterious effects on breastfed infants.

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

Additionally, the potential for systemic absorption of topical corticosteroids raises concerns regarding detectable quantities in breast milk, which may be particularly relevant for nursing mothers with renal impairment.

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 into the bile, caution is warranted when administering these medications to this patient population.

Systemic absorption of topical corticosteroids can lead to reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, a condition that may pose additional risks for patients with compromised liver function. For patients receiving a large dose of a potent topical steroid applied to extensive areas of the skin or under occlusive dressings, periodic evaluation for evidence of HPA axis suppression is recommended. This evaluation 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.

Overall, careful monitoring and consideration of dosage adjustments are essential when treating patients with hepatic impairment to mitigate potential systemic effects associated with topical corticosteroids.

Overdosage

Topically applied corticosteroids have the potential to be absorbed in quantities sufficient to elicit systemic effects. Healthcare professionals should be aware that overdosage may occur, particularly with prolonged use or application over large surface areas.

In cases of suspected overdosage, it is essential to monitor the patient for signs of systemic corticosteroid effects. These may include, but are not limited to, symptoms such as adrenal suppression, Cushing's syndrome, and other related endocrine disturbances.

Management of corticosteroid overdosage primarily involves the discontinuation of the topical agent. Supportive care should be provided as necessary, and patients should be monitored closely for any adverse effects. In severe cases, consultation with a specialist in endocrinology may be warranted to address potential complications arising from systemic absorption.

Healthcare professionals are advised to educate patients on the appropriate use of topical corticosteroids, emphasizing adherence to prescribed dosages and application guidelines to minimize the risk of overdosage.

Nonclinical Toxicology

Corticosteroids have been shown to exhibit teratogenic effects in laboratory animals when administered systemically at relatively low dosage levels. Additionally, more potent corticosteroids have demonstrated teratogenicity following dermal application in these animal models. There is a lack of 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 when the potential benefits outweigh the potential risks to the fetus. It is advised that drugs within this class not be used extensively, in large amounts, or for prolonged periods in pregnant patients.

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

Postmarketing Experience

Systemic absorption of topical corticosteroids has been associated with reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, as well as manifestations of Cushing's syndrome, hyperglycemia, and glucosuria in some patients. Reports indicate that pediatric patients receiving topical corticosteroids may experience HPA axis suppression, Cushing's syndrome, and intracranial hypertension. Manifestations of adrenal suppression in this population include linear growth retardation, delayed weight gain, low plasma cortisol levels, and an absence of response to ACTH stimulation. Symptoms of intracranial hypertension reported in pediatric patients include bulging fontanelles, headaches, and bilateral papilledema.

Infrequent local adverse reactions associated with topical corticosteroids have been reported, with a potential increase in frequency 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.

Patient Counseling

Patients should be instructed to use this medication strictly as directed by their physician. It is intended for external use only, and they must avoid contact with the eyes to prevent irritation or injury.

Healthcare providers should emphasize that patients should not use this medication for any condition other than the one for which it was prescribed. This ensures the medication is used safely and effectively.

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 important to prevent potential adverse reactions.

It is crucial for patients to report any signs of local adverse reactions, particularly if they occur under an occlusive dressing. Prompt reporting can help manage any complications that may arise.

For pediatric patients, healthcare providers should advise parents against using tight-fitting diapers or plastic pants on children being treated in the diaper area. These garments can act as occlusive dressings, which may lead to increased risk of adverse effects.

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° to 25°C (68° to 77°F), adhering to the guidelines set forth by the United States Pharmacopeia (USP) for Controlled Room Temperature. It is essential to protect the product from freezing to maintain its integrity and efficacy. Proper handling and storage conditions are crucial to ensure the product remains within the specified temperature range.

Additional Clinical Information

The evaluation of hypothalamic-pituitary-adrenal (HPA) axis suppression in patients may be supported by specific diagnostic tests. Clinicians may consider utilizing the urinary free cortisol test and the ACTH stimulation test to assess HPA axis function effectively.

FDA Insert (PDF)

This document is the official FDA-approved prescribing information for Proctosol-Hc as submitted by Sun Pharmaceutical Industries, Inc.. 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 Proctosol-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 (ANDA088799) 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.