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Hydrocortisone

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Active ingredient
Hydrocortisone 0.5 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 2001
Label revision date
July 3, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Hydrocortisone 0.5 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 2001
Label revision date
July 3, 2025
Manufacturer
Sun Pharmaceutical Industries, Inc.
Registration number
M017
NDC root
51672-2010
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 ½% is a cream designed to provide temporary relief from itching associated with minor skin irritations and rashes. It is particularly effective for conditions such as eczema, insect bites, and reactions to plants like poison ivy, as well as irritations caused by soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis, and external genital and anal itching.

This cream works as an antipruritic (anti-itch) agent, helping to soothe discomfort and reduce the urge to scratch. While it can be beneficial for various skin issues, it's important to use it under the advice and supervision of a doctor for any other uses.

Uses

You can use this product for temporary relief from itching caused by various minor skin irritations and rashes. This includes conditions like eczema, insect bites, and reactions to plants such as poison ivy, poison oak, or poison sumac. It can also help with irritation from soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis, and even external genital and anal itching.

For any other uses, it's important to consult with your doctor for advice and supervision.

Dosage and Administration

If you are an adult or a child aged 2 years and older, you can apply this medication to the affected area up to 3 to 4 times a day. However, if your child is under 2 years old, it’s important not to use this product without first consulting a doctor.

For those dealing with external anal itching, adults should start by gently cleansing the affected area with mild soap and warm water, making sure to rinse thoroughly. After cleaning, gently dry the area by patting or blotting it with toilet tissue or a soft cloth before applying the medication. If your child is under 12 years old, please consult a doctor before use.

What to Avoid

You should avoid using this product in your eyes or inserting it into the rectum with fingers or any devices. If your condition worsens, lasts more than 7 days, or clears up only to return within a few days, stop using the product and consult your doctor. It's important not to start any other hydrocortisone product without your doctor's advice.

While using this product, make sure to consult your doctor if you feel the need to exceed the recommended dosage. This helps prevent misuse and ensures your safety.

Side Effects

When using this product, it's important to be aware of some potential side effects and warnings. This product is for external use only and should not be applied in or around the eyes, nor should it be inserted into the rectum using fingers or any devices. If you experience a vaginal discharge, rectal bleeding, or diaper rash, consult a doctor before use.

You should also stop using the product and seek medical advice if your condition worsens, does not improve after 7 days, or if it clears up and then returns shortly after. Additionally, if the product is swallowed, seek medical help or contact a Poison Control Center immediately. Always follow the recommended dosage and consult a doctor if you have any concerns.

Warnings and Precautions

This product is for external use only, so please avoid contact with your eyes and do not insert it into the rectum using fingers or any devices. Before using this product, it's important to consult your doctor if you have any vaginal discharge, rectal bleeding, or diaper rash.

While using this product, be sure to follow the recommended dosage and consult your doctor if you feel the need to exceed it. You should stop using the product and contact your doctor if your condition worsens, does not improve after 7 days, or clears up only to return within a few days. Avoid using any other hydrocortisone product without first speaking to your doctor.

Keep this product out of reach of children. If it is swallowed, seek medical help or contact a Poison Control Center immediately.

Overdose

If you or someone else has swallowed a medication and you suspect an overdose, it’s important to act quickly. Contact a medical professional or call a Poison Control Center immediately for guidance. They can provide you with the necessary steps to take based on the specific situation.

Signs of an overdose can vary, but they may include unusual symptoms that are not typical for the medication. If you notice any concerning changes in behavior or health, don’t hesitate to seek immediate medical attention. Your safety is the top priority, so getting help quickly can make a significant difference.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that there are no specific guidelines or safety concerns mentioned about using hydrocortisone cream during pregnancy. This means that the information available does not indicate any need for dosage changes or special precautions when using this cream. However, as with any medication, it's always best to consult with your healthcare provider before starting or continuing any treatment during pregnancy to ensure it is safe for you and your baby.

Lactation Use

If you are breastfeeding, you can use hydrocortisone cream without specific warnings or recommendations against it. The information available does not indicate any concerns about the cream being passed into breast milk or posing risks to your baby. However, it's always a good idea to consult with your healthcare provider if you have any questions or concerns about using medications while nursing.

Pediatric Use

If your child is under 2 years old, it's important not to use this medication without first consulting a doctor. For children aged 2 years and older, you can apply the medication to the affected area, but make sure to do this no more than 3 to 4 times a day. If your child is under 12 years old, it's best to check with a doctor before using the medication to ensure it's safe and appropriate for them. Always prioritize your child's health and seek professional advice when needed.

Geriatric Use

While there is no specific information about the use of this medication in older adults, it’s important to remember that each person’s health needs can vary. Since the insert does not mention any age-related dosage adjustments, safety concerns, or special precautions for elderly patients, you should always consult with a healthcare provider before starting any new medication. They can help ensure that the treatment is appropriate for your individual health situation and any other medications you may be taking.

Renal Impairment

If you have kidney problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or safety considerations for your condition. This means that there are no tailored guidelines for how this medication should be used if you have renal impairment (kidney issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your health situation. They can help you understand how to manage your treatment effectively while considering your kidney health.

Hepatic Impairment

If you have liver problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication may affect you if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to discuss any concerns regarding your liver health and how it may relate to your treatment. They can help ensure that you receive the safest and most effective care.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking, even if there are no specific drug interactions or laboratory test interactions noted for your treatment. This ensures that your healthcare team can monitor your health effectively and make informed decisions about your care.

Always feel free to ask questions and share any other medications or supplements you might be using. This way, you can work together to ensure your treatment is safe and effective.

Storage and Handling

To ensure the best quality and safety of your product, store it at room temperature. It's important to check the carton or tube crimp for the lot number and expiration date, as this information helps you confirm the product's validity and safety for use.

Always handle the product with care, and make sure to follow any additional instructions provided to maintain its integrity. Proper storage and attention to these details will help you use the product effectively and safely.

Additional Information

You can apply this product to the affected area 3 to 4 times daily if you are an adult or a child aged 2 years and older. If you are treating external anal itching, it's best to first cleanse the area with mild soap and warm water, rinse thoroughly, and gently dry it by patting or blotting with toilet tissue or a soft cloth before applying the product.

FAQ

What is Hydrocortisone ½% used for?

Hydrocortisone ½% cream is used for temporary relief of itching associated with minor skin irritations and rashes, including conditions like eczema, insect bites, and poison ivy.

How should I apply Hydrocortisone ½%?

For adults and children 2 years and older, apply to the affected area not more than 3 to 4 times daily. Children under 2 years should not use it without consulting a doctor.

Are there any warnings for using this product?

Yes, do not use Hydrocortisone ½% in the eyes or insert it into the rectum. It is for external use only.

What should I do if my condition worsens?

Stop using the product and consult a doctor if your condition worsens, persists for more than 7 days, or clears up and occurs again within a few days.

Can I use this product if I am pregnant or nursing?

There are no specific warnings or recommendations regarding the use of Hydrocortisone cream during pregnancy or nursing mentioned in the provided information.

What should I do if I accidentally swallow the cream?

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

How should I store Hydrocortisone ½%?

Store the cream at room temperature and check the carton or tube crimp for the lot number and expiration date.

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 ½% is a topical cream formulated for antipruritic (anti-itch) purposes. This preparation contains hydrocortisone as the active ingredient, complemented by aloe to enhance skin soothing properties. The product is presented in a net weight of 1 oz (28.4 g).

Uses and Indications

This drug is indicated for the temporary relief of itching associated with minor skin irritations and rashes due to various conditions, including eczema, insect bites, poison ivy, poison oak, or poison sumac, as well as reactions to soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis, and external genital and anal itching.

Other uses of this product should only be undertaken under the advice and supervision of a healthcare professional.

Dosage and Administration

For adults and children aged 2 years and older, the product should be applied to the affected area no more than 3 to 4 times daily. For external anal itching in adults, it is recommended to cleanse the affected area with mild soap and warm water, followed by thorough rinsing. After cleansing, the area should be gently dried by patting or blotting with toilet tissue or a soft cloth prior to the application of the product.

The use of this product is not advised for children under 2 years of age; consultation with a doctor is required. Additionally, for children under 12 years of age, it is also recommended to consult a doctor before use.

Contraindications

This product is contraindicated for use in the eyes and for rectal administration via fingers, mechanical devices, or applicators.

If the condition worsens, persists for more than 7 days, or resolves and recurs within a few days, discontinue use and consult a healthcare professional. The use of any other hydrocortisone product should not be initiated without medical consultation.

Additionally, prior to exceeding the recommended dosage, a healthcare professional should be consulted.

Warnings and Precautions

This product is intended for external use only. It is imperative that the product is not applied in or around the eyes, nor should it be administered rectally using fingers, mechanical devices, or applicators.

Healthcare professionals should advise patients to consult a physician prior to use if they are experiencing any of the following conditions: vaginal discharge, rectal bleeding, or diaper rash. These conditions may require further evaluation and management.

During the use of this product, it is crucial to adhere to the recommended dosage. Patients should be instructed to seek medical advice before exceeding the prescribed amount.

Patients must discontinue use and consult a healthcare provider if any of the following occur: the condition worsens, persists for more than seven days, or resolves only to recur within a few days. It is essential that patients do not initiate the use of any other hydrocortisone products without prior consultation with a physician.

To ensure safety, this product should be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center should be made without delay.

Side Effects

Patients should be aware that this product is for external use only and should not be applied in or around the eyes, nor should it be administered rectally using fingers or any mechanical device or applicator.

Before using this product, patients are advised to consult a doctor if they have a vaginal discharge, rectal bleeding, or diaper rash. While using this product, it is important to adhere to the recommended dosage and to seek medical advice before exceeding it.

Patients should discontinue use and consult a doctor if their condition worsens, persists for more than 7 days, or if the condition clears up and recurs within a few days. It is also recommended that patients do not begin using any other hydrocortisone product without prior consultation with a healthcare professional.

In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center immediately.

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions with laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the current information.

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 under 2 years of age should not use this medication and must consult a doctor prior to use. For children aged 2 years and older, the recommended application is to the affected area no more than 3 to 4 times daily. Additionally, pediatric patients under 12 years of age are advised to consult a doctor before using this product.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, as the prescribing information does not provide any age considerations, dosage adjustments, safety concerns, or special precautions for this population.

Healthcare providers should exercise clinical judgment when prescribing this medication to geriatric patients, considering the absence of data specific to this demographic. Monitoring for efficacy and safety in elderly patients is advised, given the potential for variability in drug response and the presence of comorbidities that may affect treatment outcomes.

Pregnancy

There are no specific statements regarding the use of hydrocortisone cream 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 appropriate.

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 drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be prudent in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there is no available information regarding dosage adjustments, special monitoring requirements, or precautions 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 warranted based on clinical judgment.

Overdosage

In the event of an overdosage, immediate medical intervention is crucial. If the substance is ingested, it is imperative to seek medical assistance or contact a Poison Control Center without delay.

Healthcare professionals should be aware that prompt action can significantly influence the outcome of an overdosage situation. Symptoms of overdosage may vary depending on the specific substance involved; therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous evaluation and appropriate interventions should be implemented based on the clinical presentation and severity of symptoms.

In all cases of suspected overdosage, the involvement of poison control experts is recommended to guide the management and ensure the best possible care for the patient.

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 use of the compound in these contexts.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. In the event of swallowing the product, patients should seek medical help or contact a Poison Control Center immediately.

Patients should be informed that this product is not intended for use in the eyes and should not be administered rectally using fingers, mechanical devices, or applicators. They should be instructed to stop using the product and consult a doctor if their condition worsens, persists for more than 7 days, or if the condition clears up and recurs within a few days. It is important to note that patients should not begin using any other hydrocortisone product without first consulting a doctor.

When using this product, patients should be cautioned against exceeding the recommended dosage and should consult a doctor prior to doing so. Additionally, patients should be advised to seek medical advice before use if they experience vaginal discharge, rectal bleeding, or have a diaper rash.

Storage and Handling

The product is supplied in various packaging configurations, with specific NDC numbers available for identification. It should be stored at room temperature to maintain its efficacy and integrity. Healthcare professionals are advised to refer to the carton or tube crimp for the lot number and expiration date to ensure proper tracking and usage.

Additional Clinical Information

For patients aged 2 years and older, the product should be applied to the affected area no more than 3 to 4 times daily. In cases of external anal itching, it is recommended that adults cleanse the affected area with mild soap and warm water, rinse thoroughly, and gently dry by patting or blotting with toilet tissue or a soft cloth prior to application.

No additional 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.

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.