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Hydrocortisone

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Active ingredient
Hydrocortisone 1 g/100 g
Other brand names
Drug class
Corticosteroid
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2026
Label revision date
February 10, 2026
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Hydrocortisone 1 g/100 g
Other brand names
Drug class
Corticosteroid
Dosage form
Cream
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 2026
Label revision date
February 10, 2026
Manufacturer
Aldermed Inc.
Registration number
M017
NDC root
87236-004
Drug Information (PDF)
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 cream is a topical medication that temporarily relieves itching associated with minor skin irritations, inflammation, and rashes. It is effective for various conditions, including eczema, psoriasis, and reactions to poison ivy, poison oak, and poison sumac. Additionally, it can help soothe itching from insect bites, detergents, jewelry, cosmetics, soaps, and seborrheic dermatitis.

This cream can also provide temporary relief for external anal and genital itching. While it is useful for these purposes, it's important to use hydrocortisone cream 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, including conditions like eczema, psoriasis, and seborrheic dermatitis. It can also help soothe rashes resulting from contact with poison ivy, poison oak, or poison sumac, as well as itching from insect bites, detergents, jewelry, cosmetics, and soaps.

Additionally, it can relieve external itching in the anal and genital areas. If you have other uses in mind, it's important to consult with your doctor for guidance and supervision.

Dosage and Administration

If you are an adult or a child aged 2 years and older, you can apply the medication to the affected area up to 3 to 4 times a day. For children under 2 years of age, it’s important to consult a doctor before use.

If you are using this medication for anal itching, start by cleaning the affected area with mild soap and warm water, then rinse it thoroughly. After that, gently dry the area by patting or blotting it with bathroom tissue or a soft cloth before applying the medication. If the user is a child under 12, it’s best to consult a doctor before using it for anal itching as well.

What to Avoid

You should avoid using this product in your eyes or for treating diaper rash. If you have a vaginal discharge, do not use it for genital or feminine itching. It's important to stick to the recommended daily dosage and not exceed it unless your doctor advises otherwise. Additionally, do not use this product in the rectum with your fingers or any mechanical device or applicator. Following these guidelines will help ensure your safety and the effectiveness of the treatment.

Side Effects

When using this product, it's important to remember that it is for external use only. If your condition worsens, if symptoms last more than 7 days, or if they clear up and then return within a few days, you should stop using it and consult a doctor. Additionally, if you experience any bleeding while using it for anal itching, seek medical advice immediately.

Before using this product, talk to your doctor if you are currently using any other hydrocortisone product. There are no specific adverse reactions mentioned, but it's always best to stay informed and cautious.

Warnings and Precautions

This product is for external use only. If you accidentally swallow it, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

You should stop using this product and call your doctor if your condition worsens, if symptoms last longer than 7 days, or if symptoms improve and then return within a few days. Additionally, if you experience any bleeding while using it for anal itching, discontinue use and consult your doctor.

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

If you are pregnant or planning to become pregnant, it's important to know that the safety of hydrocortisone cream during pregnancy has not been established. You should consult your doctor before using this medication, as there may be potential risks to your fetus. It is recommended to use hydrocortisone cream only if it is clearly needed and if the benefits outweigh any risks.

Additionally, dosage adjustments may be necessary, so it's essential to seek guidance from your healthcare provider. Always use this medication with caution and under medical supervision during your pregnancy to ensure the best outcomes for you and your baby.

Lactation Use

If you are breastfeeding and considering the use of hydrocortisone cream, you can feel reassured that there are no specific warnings or recommendations against its use for nursing mothers. Additionally, there is no information indicating that hydrocortisone cream is passed into breast milk or poses any risk to your infant.

As always, if you have any concerns or questions about using medications while breastfeeding, it's a good idea to consult with your healthcare provider for personalized advice.

Pediatric Use

If your child is under 2 years old, it's important to consult a doctor before using this medication. For children aged 2 years and older, you can apply it to the affected area up to 3 to 4 times a day. However, if your child is under 12 and experiencing anal itching, please check with a doctor before using this product to ensure it's safe and appropriate for their needs. Always prioritize your child's health by seeking professional advice when necessary.

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 before starting the medication. 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 the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to change based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment is safe and effective, especially if you have any concerns about your kidney health.

Hepatic Impairment

If you have liver problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or precautions related to your condition. This means that there are no tailored recommendations for how the medication may affect you differently due to your liver health.

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your specific situation. They can help determine the best approach based on your liver function and overall health.

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 tests you might be undergoing. This way, you can avoid any potential issues and ensure the best possible care.

Storage and Handling

To ensure the best use of your product, store it at room temperature. It's important to check the packaging before use; do not use the product if the seal is torn, cut, or opened, as this indicates it may have been tampered with. For your reference, you can find the lot number and expiry date on the sachet or carton, so be sure to check these details to ensure the product is still safe to use.

Additional Information

You can apply this medication to the affected area for adults and children aged 2 years and older up to 3 to 4 times a day. If the patient is under 2 years of age, it's important to consult a doctor before use. There are no additional details available regarding laboratory tests, abuse potential, or patient counseling information.

FAQ

What is Hydrocortisone Cream used for?

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

How should I use Hydrocortisone Cream?

Adults and children 2 years of age and older should apply it to the affected area not more than 3 to 4 times daily. For children under 2 years, consult a doctor.

Are there any contraindications for using Hydrocortisone Cream?

Do not use it in the eyes, for diaper rash, or for genital itching if you have a vaginal discharge. Also, do not use it in the rectum with fingers or any device.

What should I do if my condition worsens?

Stop using Hydrocortisone Cream and consult a doctor if your condition worsens, symptoms persist for more than 7 days, or if bleeding occurs when used for anal itching.

Is Hydrocortisone Cream safe to use during pregnancy?

The safety of Hydrocortisone Cream during pregnancy has not been established. Consult a doctor before use if you are pregnant or planning to become pregnant.

What precautions should I take when using Hydrocortisone Cream?

Use it only as directed and consult a doctor for other uses. If swallowed, seek medical help immediately.

Can I use Hydrocortisone Cream for anal itching?

Yes, it temporarily relieves external anal itching, but cleanse the area thoroughly before application and consult a doctor for children under 12.

Packaging Info

Below are the non-prescription pack sizes of Hydrocortisone (hydrocortisone cream 1%). 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

No description information is available for the drug.

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, psoriasis, poison ivy, poison oak, poison sumac, insect bites, and reactions to detergents, jewelry, cosmetics, soaps, and seborrheic dermatitis. Additionally, it is indicated for the temporary relief of external anal and genital itching.

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

For adults and children aged 2 years and older, the recommended application is to the affected area not more than 3 to 4 times daily. For children under 2 years of age, it is advised to consult a physician prior to use.

In cases of anal itching, it is essential to first cleanse the affected area with mild soap and warm water, ensuring a thorough rinse. After cleansing, gently dry the area by patting or blotting with bathroom tissue or a soft cloth before applying the medication.

For children under 12 years of age, consultation with a healthcare professional is recommended before using the product for anal itching.

Contraindications

Use of this product is contraindicated in the following situations:

  • Application in the eyes is prohibited due to potential harm.

  • The product should not be used for diaper rash, as it is not indicated for this condition.

  • It is contraindicated for genital or feminine itching in the presence of vaginal discharge, as this may indicate an underlying condition requiring different management.

  • Exceeding the recommended daily dosage is not advised unless specifically directed by a healthcare professional, to avoid potential adverse effects.

  • The product must not be administered rectally using fingers or any mechanical device or applicator, as this may lead to complications.

Warnings and Precautions

For external use only. Healthcare professionals should advise patients to avoid ingestion of the product. In the event of accidental swallowing, immediate medical assistance should be sought by contacting a Poison Control Center at 1-800-222-1222.

Patients should be instructed to discontinue use and consult a healthcare provider if their condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. Additionally, if any bleeding occurs while using the product for anal itching, patients must stop using it and seek medical advice.

No specific laboratory tests are recommended for monitoring during the use of this product. However, vigilance in monitoring patient responses and adherence to the outlined precautions is essential for safe and effective use.

Side Effects

Patients should be aware that the product is intended for external use only. It is important to stop use and consult a doctor if the condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. Additionally, patients should discontinue use and seek medical advice if bleeding occurs when the product is used for anal itching.

Before using this product, patients are advised to consult a doctor if they are currently using any other hydrocortisone product. No specific adverse reactions have been reported in clinical trials or postmarketing experiences.

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

Below are the non-prescription pack sizes of Hydrocortisone (hydrocortisone cream 1%). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Hydrocortisone.
Details

Pediatric Use

Pediatric patients under 2 years of age should consult a healthcare professional prior to use. For children aged 2 years and older, the medication may be applied to the affected area no more than 3 to 4 times daily. Additionally, it is advised that children under 12 years of age consult a doctor before using the product for anal itching.

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 potential adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

The safety of hydrocortisone cream during pregnancy has not been established. Pregnant patients or those planning to become pregnant should consult a healthcare provider before use. There may be potential risks to the fetus; therefore, hydrocortisone cream should only be used if clearly needed and if the benefits outweigh the risks.

Dosage adjustments may be necessary, and it is essential for healthcare providers to offer guidance on appropriate dosing. Special precautions should be taken, and the use of hydrocortisone cream during pregnancy should occur with caution and under medical supervision.

Lactation

There are no specific warnings or recommendations regarding the use of hydrocortisone cream in lactating mothers. Additionally, there is no information available about the potential for excretion of hydrocortisone in breast milk or any associated risks to breastfed infants.

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

There is currently no specific information available regarding overdosage for this medication. Healthcare professionals are advised to monitor patients closely for any signs of adverse effects or symptoms that may arise from excessive dosing.

In the event of suspected overdosage, it is recommended that healthcare providers initiate supportive care and symptomatic treatment as necessary. Patients should be evaluated for potential complications, and appropriate interventions should be implemented based on clinical judgment.

For further guidance, healthcare professionals may refer to established protocols for managing drug overdosage or consult a poison control center.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the compound in these areas.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of the product. Notably, allergic reactions, including anaphylaxis, and skin irritation have been reported. Additional adverse reactions include burning, itching, and dryness at the application site.

Furthermore, cases of secondary infections have been noted in patients using hydrocortisone cream. There have also been reports of systemic effects, such as adrenal suppression, particularly with prolonged use or application over large areas of the body. These events were reported voluntarily or through surveillance programs.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 if the product is swallowed. It is important to inform patients that the product should not be used in the eyes or for diaper rash. Additionally, patients should be cautioned against using the product for genital or feminine itching if they have a vaginal discharge.

Providers should emphasize the importance of adhering to the recommended daily dosage and advise patients not to exceed this dosage unless directed by a physician. Patients must be informed that the product should not be used rectally with fingers or any mechanical device or applicator.

Patients should be instructed to discontinue use and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. They should also be advised to stop use and seek medical advice if bleeding occurs when the product is used for anal itching.

Finally, healthcare providers should recommend that patients consult a doctor before using this product if they are currently using any other hydrocortisone product.

Storage and Handling

The product is supplied in tamper-evident packaging. It is essential to inspect the seal before use; do not use if the seal is torn, cut, or opened. The product should be stored at room temperature. For specific lot numbers and expiry dates, please refer to the sachet or carton.

Additional Clinical Information

For patients aged 2 years and older, the medication should be applied to the affected area no more than 3 to 4 times daily. For children under 2 years of age, it is advised to consult a doctor before use. No further information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

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.

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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.