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Hydrocortisone

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Active ingredient
Hydrocortisone 1 g/100 g
Other brand names
Drug class
Corticosteroid
Dosage form
Ointment
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2015
Label revision date
February 29, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Hydrocortisone 1 g/100 g
Other brand names
Drug class
Corticosteroid
Dosage form
Ointment
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2015
Label revision date
February 29, 2024
Manufacturer
TRIFECTA PHARMACEUTICALS USA LLC
Registration number
M017
NDC root
69396-003
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (3 NDCs)
Packaging & NDC Codes (3)

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 medication that provides temporary relief from itching caused by minor skin irritations, inflammation, and rashes. It is commonly used to alleviate discomfort associated with conditions such as eczema, seborrheic dermatitis, psoriasis, insect bites, and reactions to plants like poison ivy, oak, and sumac, as well as irritations from soaps, detergents, cosmetics, and jewelry.

By reducing inflammation and suppressing the immune response in the affected area, hydrocortisone helps to soothe the skin and relieve itching. While it can be effective for these purposes, it's important to use it under the advice and supervision of a doctor for any other uses.

Uses

This product is designed to provide temporary relief from itching caused by various minor skin irritations, inflammation, and rashes. You can use it for conditions such as eczema, seborrheic dermatitis, and psoriasis. It can also help soothe itching from insect bites and reactions to plants like poison ivy, oak, and sumac. Additionally, it may relieve discomfort caused by soaps, detergents, cosmetics, jewelry, and external genital and anal itching.

For any other uses, it's important to consult with your doctor to ensure safety and effectiveness.

Dosage and Administration

To use this medication effectively, start by cleansing the affected area with mild soap and warm water. Make sure to rinse thoroughly when possible. After cleaning, gently dry the area by patting or blotting it with toilet tissue or a soft cloth.

For adults and children aged 12 years and older, you can apply the medication to the affected area up to 3 to 4 times a day. However, if the person is under 12 years old, it’s important not to use this medication without consulting a doctor first. Following these steps will help ensure the best results from your treatment.

What to Avoid

It's important to be aware of specific instructions regarding the use of this medication. If you accidentally swallow it, you should seek medical help or contact a Poison Control Center right away. This is crucial for your safety.

Currently, there are no listed contraindications, controlled substance classifications, or concerns about abuse, misuse, or dependence associated with this medication. However, always follow the guidance provided by your healthcare provider to ensure safe use.

Side Effects

You should be aware that this product is for external use only and should not come into contact with your eyes. It's important not to use it in the rectum with fingers or any devices. If you experience any bleeding, if your condition worsens, or if symptoms last more than 7 days or return shortly after improvement, stop using the product and consult a doctor.

Additionally, do not use this product if you have a vaginal discharge, are treating diaper rash, or if the user is under 2 years old. For those using it for external anal itching, do not exceed the recommended dosage unless directed by a doctor, and consult a doctor if bleeding occurs. If the user is under 12 years of age, please seek medical advice before use.

Warnings and Precautions

This product is for external use only, so be sure to avoid contact with your eyes. Do not insert it into the rectum using fingers or any device. If you experience any bleeding, stop using the product and consult your doctor right away. If your symptoms worsen, persist for more than 7 days, or return after clearing up, seek medical advice. Additionally, do not use this product if you have a vaginal discharge, are treating diaper rash, or if the user is a child under 2 years old. For those using it for external anal itching, do not exceed the recommended dosage unless directed by a doctor, and consult a doctor if the user is under 12 years of age.

If the product is swallowed, seek emergency medical help or contact a Poison Control Center immediately. Always remember to stop using the product and call your doctor if you notice any bleeding.

Overdose

Taking more than the recommended daily dosage of medication can lead to serious health risks. It's important to follow your doctor's instructions carefully and not exceed the dosage unless specifically advised by them.

If you suspect an overdose, look out for signs such as unusual drowsiness, confusion, or difficulty breathing (respiratory depression). If you notice any of these symptoms, seek immediate medical help. Always prioritize your safety and consult a healthcare professional if you have any concerns about your medication.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that there is no specific information available about the use of hydrocortisone ointment during pregnancy. This means that safety concerns, dosage adjustments, or special precautions have not been clearly established.

Before using hydrocortisone ointment, you should consult with your healthcare provider to discuss any potential risks and to ensure that it is appropriate for your situation. Your health and the health of your baby are the top priority, so getting professional advice is essential.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to consult your doctor before using this product. There is a possibility that it may be excreted in breast milk, which means it could potentially affect your baby. Since the effects on nursing infants have not been thoroughly studied, it's best to approach this with caution. Always prioritize your health and your baby's well-being by discussing any concerns with your healthcare provider.

Pediatric Use

It's important to keep this product out of the reach of children. If a child accidentally swallows it, seek medical help or contact a Poison Control Center right away. For children under 2 years old, this product should not be used at all. If your child is under 12 years of age, it's best to consult a doctor before using it.

For those 12 years and older, you can apply the product to the affected area up to 3 to 4 times a day. However, for children under 12, please avoid using it without a doctor's guidance. Always prioritize safety and consult a healthcare professional if you have any questions or concerns.

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, it’s important to consult with a healthcare provider for personalized advice. 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 problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

It's always best to discuss your individual situation with your healthcare provider, who can offer personalized advice and ensure that any medications you take are safe and effective for you.

Hepatic Impairment

If you have liver problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations apply, but you should always consult your healthcare provider for personalized advice. They can help determine the best approach for your treatment and monitor your liver function as needed.

Make sure to keep your doctor informed about your liver health, as they may need to conduct regular tests to ensure your safety while using any medication. Your well-being is a priority, so don't hesitate to ask questions or express any concerns you may have.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking. In this case, there are no specific drug interactions or laboratory test interactions noted, which means that this medication is generally considered safe to use alongside other treatments and tests. However, every individual is different, and your healthcare provider can help ensure that your overall treatment plan is safe and effective for you.

Always remember that even if no interactions are listed, discussing all your medications and any lab tests with your healthcare provider is crucial. This helps to avoid any potential issues and ensures that you receive the best care possible.

Storage and Handling

To ensure the best performance and safety of your product, store it at a controlled room temperature between 15° and 30°C (59° and 86°F). This temperature range helps maintain the product's effectiveness. If you notice that the seal has been broken, do not use the product. Instead, return it to the store where you purchased it for a replacement or refund. Following these guidelines will help you use the product safely and effectively.

Additional Information

You should apply this medication topically to the affected area, using it no more than 3 to 4 times daily if you are an adult or a child aged 12 years and older. If the patient is under 12 years old, consult a doctor before use.

It's important to keep this medication out of the reach of children. If swallowed, seek medical help or contact a Poison Control Center right away. Always read the label directions carefully and keep the carton, as it contains important information.

FAQ

What is hydrocortisone used for?

Hydrocortisone temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to conditions like eczema, psoriasis, and insect bites.

How should I apply hydrocortisone?

Cleanse the affected area with mild soap and warm water, gently dry it, and then apply hydrocortisone to the affected area not more than 3 to 4 times daily for adults and children 12 years and older.

Can children use hydrocortisone?

Children under 12 years of age should not use hydrocortisone without consulting a doctor.

What should I do if I swallow hydrocortisone?

If swallowed, get medical help or contact a Poison Control Center immediately.

Are there any warnings for using hydrocortisone?

Yes, it is for external use only, avoid contact with eyes, and do not use in the rectum. Stop using it and consult a doctor if bleeding occurs or if symptoms worsen.

Is hydrocortisone safe to use during pregnancy?

There is no specific information regarding the use of hydrocortisone during pregnancy; consult a doctor for advice.

What should nursing mothers know before using hydrocortisone?

Nursing mothers should consult a doctor before using hydrocortisone, as there is potential for excretion in breast milk.

How should I store hydrocortisone?

Store hydrocortisone at a controlled room temperature of 15°-30°C (59°-86°F) and do not use it if the seal has been broken.

Packaging Info

Below are the non-prescription pack sizes of Hydrocortisone. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Hydrocortisone.
Details

Drug Information (PDF)

This file contains official product information for Hydrocortisone, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

Hydrocortisone is a corticosteroid with the chemical formula C21H30O5 and a molecular weight of 362.46 g/mol. It is available in various dosage forms, including topical creams, ointments, and injectable solutions. Hydrocortisone appears as a white to off-white crystalline powder, which is odorless and slightly soluble in water. The inactive ingredients may vary depending on the formulation but typically include emulsifiers, preservatives, and stabilizers to ensure product efficacy and stability.

Uses and Indications

This drug is indicated for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to various conditions, including eczema, seborrheic dermatitis, psoriasis, insect bites, and contact with poison ivy, oak, or sumac. It is also effective for itching caused by soaps, detergents, cosmetics, jewelry, and external genital and anal areas.

Other uses of this product should only be undertaken under the advice and supervision of a healthcare professional. There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

The affected area should be cleansed with mild soap and warm water, followed by thorough rinsing when practical. After cleansing, gently dry the area by patting or blotting with toilet tissue or a soft cloth prior to application.

For adults and children aged 12 years and older, the product may be applied to the affected area up to 3 to 4 times daily. For children under 12 years of age, the product is not recommended; consultation with a healthcare professional is advised.

Contraindications

There are no specific contraindications listed for this product. However, it is imperative to seek medical assistance or contact a Poison Control Center immediately if the product is swallowed.

Warnings and Precautions

For external use only; direct contact with the eyes must be avoided. This product should not be administered rectally using fingers, mechanical devices, or applicators. In the event of bleeding, it is imperative to discontinue use and consult a healthcare professional. If the condition worsens, or if symptoms persist beyond 7 days or resolve only to recur within a few days, medical advice should be sought.

Prior to initiating treatment with this product, it is essential to consult a healthcare provider if there is a vaginal discharge, if the product is intended for diaper rash, or if it is to be used on children under 2 years of age. For users experiencing external anal itching, it is crucial not to exceed the recommended daily dosage unless specifically directed by a physician. In cases of bleeding, immediate consultation with a healthcare provider is necessary. Additionally, for children under 12 years of age, a doctor's consultation is required before use.

In the event of accidental ingestion, emergency medical assistance should be sought immediately, or contact a Poison Control Center without delay. If bleeding occurs, the product should be discontinued, and a healthcare professional should be contacted promptly.

Side Effects

Patients using this product should be aware of several important warnings and precautions. The product is intended for external use only and should not come into contact with the eyes. It is crucial that patients do not insert this product into the rectum using fingers, mechanical devices, or applicators.

In the event of bleeding, worsening of the condition, or if symptoms persist for more than 7 days or resolve and then recur within a few days, patients are advised to stop using the product and consult a doctor. Additionally, patients should refrain from using this product if they have a vaginal discharge, before treating diaper rash, or before using it on children under 2 years of age.

For those using the product for external anal itching, it is essential not to exceed the recommended daily dosage unless directed by a healthcare professional. Should bleeding occur, patients must seek medical advice promptly. Furthermore, children under 12 years of age should consult a doctor before use.

Drug Interactions

There are no specific drug interactions reported for this medication. Additionally, no laboratory test interactions have been identified in the available data. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Hydrocortisone. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Hydrocortisone.
Details

Pediatric Use

Pediatric patients should not use this product if they are under 2 years of age. For children under 12 years of age, it is advised to consult a doctor before use. In patients aged 12 years and older, the product may be applied to the affected area no more than 3 to 4 times daily.

Healthcare professionals should ensure that the product is kept out of the reach of children. In the event of accidental ingestion, immediate medical assistance or contact with a Poison Control Center is recommended.

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

There is no specific information available regarding the use of hydrocortisone ointment during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients. It is advisable to weigh the potential benefits against any unknown risks to fetal outcomes. Women of childbearing potential should be counseled accordingly, and alternative treatments may be considered if necessary.

Lactation

Nursing mothers should consult a doctor before using this product. There is a potential for excretion in breast milk, and the effects on a nursing infant are not well studied; therefore, caution is advised.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

Overdosage of the medication can lead to serious health consequences. It is imperative that healthcare professionals adhere to the recommended daily dosage guidelines to mitigate the risk of adverse effects.

In the event of an overdose, the following actions are recommended:

  1. Assessment of Symptoms: Healthcare providers should closely monitor the patient for any signs of overdosage, which may include a range of symptoms depending on the specific medication involved.

  2. Immediate Medical Attention: If an overdose is suspected, it is crucial to seek immediate medical attention. Prompt intervention can significantly improve patient outcomes.

  3. Management Procedures: The management of an overdose may involve supportive care and symptomatic treatment. Specific protocols should be followed based on the medication's pharmacological profile and the severity of the symptoms presented.

It is essential for healthcare professionals to educate patients on the importance of adhering to prescribed dosages and to provide clear instructions regarding the potential risks associated with exceeding the recommended daily dosage.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert.

Patient Counseling

Healthcare providers should advise patients that in the event of accidental ingestion, it is crucial to seek medical assistance or contact a Poison Control Center immediately. This information is essential for ensuring patient safety and prompt intervention in case of an emergency.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which are essential for identification and inventory management. It is crucial to store the product at a controlled room temperature, maintaining a range of 15° to 30°C (59° to 86°F) to ensure its efficacy and safety.

In the event that the seal has been broken, the product should not be used. Instead, it must be returned to the store where it was purchased to ensure proper handling and compliance with safety standards.

Additional Clinical Information

The medication is administered topically, with a recommended application frequency of 3 to 4 times daily for adults and children aged 12 years and older. For children under 12 years of age, consultation with a doctor is advised prior to use.

Clinicians should counsel patients to keep the medication out of reach of children and to seek medical assistance or contact a Poison Control Center immediately if the product is swallowed. Patients are also advised to read all label directions carefully and retain the carton, as it contains important information.

Drug Information (PDF)

This file contains official product information for Hydrocortisone, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (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-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory 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

Last AI update:

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.