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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 1989
Label revision date
May 27, 2025
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 1989
Label revision date
May 27, 2025
Manufacturer
Sun Pharmaceutical Industries, Inc.
Registration number
M017
NDC root
51672-2018
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 is a topical ointment available in a 1% concentration, designed to provide temporary relief from itching associated with minor skin irritations and rashes. It works as an antipruritic (anti-itch) agent, making it effective for conditions such as eczema, insect bites, and reactions to plants like poison ivy, poison oak, or poison sumac. Additionally, it can help soothe irritation caused by soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis, and external genital and anal itching.

This ointment is labeled as "Maximum Strength" and comes in a 1 oz (28.4 g) package. While it is useful for various skin issues, it's important to consult a doctor for any other uses beyond those mentioned.

Uses

This product is designed to provide temporary relief from itching caused by various minor skin irritations and rashes. You can use it for conditions like eczema, insect bites, and reactions to plants such as poison ivy, poison oak, or poison sumac. It can also help soothe itching 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 to ensure it's appropriate for your situation.

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. For those dealing with external anal itching, it’s important to first clean the 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 product.

If your child is under 2 years old, do not use this medication without consulting a doctor. Additionally, if your child is under 12 years of age, it’s best to check with a doctor before use to ensure safety and proper guidance.

What to Avoid

It's important to use this product safely. You should not use it in your eyes or insert it into the rectum using fingers or any mechanical device or applicator. These actions can lead to serious complications.

Additionally, keep this product out of reach of children. If a child accidentally swallows it, seek medical help or contact a Poison Control Center immediately. Always prioritize safety to avoid misuse or potential harm.

Side Effects

When using this product, it's important to be aware of potential side effects. You should stop using it and consult a doctor if your condition worsens, persists for more than 7 days, or clears up only to return within a few days. Additionally, if you experience any vaginal discharge, rectal bleeding, or diaper rash, it's advisable to speak with a healthcare professional before using the product.

Remember, this product is for external use only and should not be applied in or around the eyes, or inserted into the rectum using fingers or any devices. Keep it out of reach of children, and if swallowed, seek medical help or contact a Poison Control Center immediately. Always follow the recommended dosage and consult a doctor if you feel the need to exceed it.

Warnings and Precautions

This product is for external use only, so please avoid using it in your eyes or inserting it into the rectum with fingers or any devices. Before using this product, it's important to consult your doctor if you have a vaginal discharge, rectal bleeding, or diaper rash.

While using this product, make sure not to exceed the recommended dosage without consulting your doctor. If your condition worsens, lasts more than 7 days, or clears up only to return within a few days, stop using the product and contact your doctor. Do not start any other hydrocortisone product without medical advice.

Keep this product out of reach of children. If 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 drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms, seek immediate medical attention. Remember, it’s always better to be safe and get help if you think an overdose has occurred.

Pregnancy Use

You can use hydrocortisone ointment during pregnancy without specific warnings or precautions mentioned in the information provided. There are no indications that this product is contraindicated (not recommended) for pregnant individuals, nor are there any noted risks to the fetus associated with its use. Additionally, you do not need to make any dosage modifications or take special precautions while using this ointment during your pregnancy.

As always, it's a good idea to consult with your healthcare provider before starting any new medication to ensure it’s appropriate for your individual situation.

Lactation Use

If you are breastfeeding and considering the use of hydrocortisone ointment, 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 ointment is passed into breast milk or poses any risk to your infant.

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

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

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 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 may affect you if your kidneys are not functioning properly.

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your kidney health. They can help monitor your condition and make any necessary adjustments to your treatment plan.

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 should be used if you have hepatic impairment (issues with liver function).

Before starting any new medication, including this one, you should discuss your liver health with your healthcare provider. They can help determine the best approach for your treatment and ensure your safety.

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 the medication may not have known conflicts with other drugs or tests. However, every individual is different, and your healthcare provider can help ensure that your treatment plan is safe and effective for you.

Always discuss any changes in your medications or upcoming lab tests with your healthcare provider to avoid any potential issues and to get the best care possible.

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. If you have any questions about the product's use or safety, don't hesitate to reach out for more information.

Additional Information

You should apply this product to the affected area no more than 3 to 4 times a day if you are an adult or a child aged 2 years and older. If you are dealing with external anal itching, it's recommended 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?

Hydrocortisone is a 1% concentration ointment used for temporary relief of itching associated with minor skin irritations and rashes.

What conditions can Hydrocortisone help relieve?

It can relieve itching from conditions such as eczema, insect bites, poison ivy, and rashes caused by soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis, and external genital and anal itching.

How should I use Hydrocortisone?

Apply Hydrocortisone to the affected area not more than 3 to 4 times daily for adults and children 2 years and older. For external anal itching, cleanse the area before application.

Are there any age restrictions for using Hydrocortisone?

Do not use Hydrocortisone on children under 2 years of age without consulting a doctor. Children under 12 years should also consult a doctor before use.

What should I avoid while using Hydrocortisone?

Do not use Hydrocortisone in the eyes or insert it into the rectum using fingers or any device. Keep it out of reach of children.

What should I do if my condition worsens?

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

Is Hydrocortisone safe to use during pregnancy or while nursing?

The insert does not provide specific warnings or precautions regarding the use of Hydrocortisone during pregnancy or lactation.

What are the side effects of Hydrocortisone?

Side effects are not specifically mentioned, but you should stop use and consult a doctor if your condition worsens or does not improve.

How should I store Hydrocortisone?

Store Hydrocortisone 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 1% is an ointment formulated for topical application. It serves as an antipruritic agent, effectively alleviating itching associated with various dermatological conditions. The product is packaged in a net weight of 1 ounce (28.4 grams).

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. There are no teratogenic or nonteratogenic effects associated with this drug.

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. In cases of external anal itching, it is recommended that adults first cleanse the affected area with mild soap and warm water, ensuring 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 recommended for children under 2 years of age; consultation with a doctor is advised. Additionally, for children under 12 years of age, it is also recommended to consult a doctor before use.

Contraindications

Use of this product is contraindicated in the following situations:

The product should not be applied to the eyes, as this may lead to irritation or injury. Additionally, it is contraindicated for rectal administration using fingers, mechanical devices, or applicators due to the risk of injury or improper use.

This product must 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 is advised.

Warnings and Precautions

For external use only. This product is contraindicated for use in the eyes and should not be administered rectally, either by fingers or any mechanical device or applicator.

Healthcare professionals should advise patients to consult a doctor prior to use if they experience any of the following conditions: vaginal discharge, rectal bleeding, or diaper rash.

During the use of this product, it is imperative to adhere to the recommended dosage. Patients should be cautioned against exceeding this dosage without prior consultation with a healthcare provider.

Patients must be instructed to discontinue use and seek medical advice if their condition worsens, persists for more than 7 days, or if the condition resolves and then recurs within a few days. It is essential that patients do not initiate the use of any other hydrocortisone product without first consulting a healthcare professional.

Additionally, 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 using this product should be aware that it is intended for external use only. It is contraindicated for use in the eyes and should not be administered rectally, either by fingers or any mechanical device or applicator.

Before using this product, patients are advised to consult a healthcare professional if they have a vaginal discharge, rectal bleeding, or diaper rash. While using the product, it is important to adhere to the recommended dosage; exceeding this dosage should be discussed with a doctor.

Patients should discontinue use and seek medical advice if their condition worsens, persists for more than 7 days, or if the condition resolves and then recurs within a few days. It is also recommended that patients do not initiate the use of any other hydrocortisone product without prior consultation with a healthcare provider.

Additionally, 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.

Drug Interactions

There are no specific drug interactions or laboratory test interactions identified in the available data. Therefore, no dosage adjustments or monitoring recommendations are necessary at this time.

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, children under 12 years of age are advised to consult a doctor before using this product.

Geriatric Use

There is no specific information available regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. It is advisable to monitor these patients closely for any potential adverse effects or changes in efficacy.

Pregnancy

Hydrocortisone ointment is not associated with specific warnings or precautions for use during pregnancy. The prescribing information does not indicate any contraindications for pregnant patients or outline any risks to the fetus associated with its use. Additionally, there are no recommended dosage modifications or special precautions for individuals who are pregnant. Healthcare professionals should consider the overall clinical context when prescribing this medication to women of childbearing potential.

Lactation

There are no specific warnings or recommendations regarding the use of hydrocortisone ointment 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 patients with reduced kidney function, as the lack of data necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients, although specific recommendations are not provided.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this medication. Consequently, there are no 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 prescribing information.

Overdosage

In the event of an overdosage, immediate medical assistance is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical help or contact a Poison Control Center without delay.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and evaluation are recommended to ensure patient safety and effective resolution of any complications arising from the overdosage.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available in the insert.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children. In the event of accidental ingestion, patients should seek medical assistance 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, whether by fingers or any mechanical device or applicator.

Healthcare providers should instruct patients to discontinue use and consult a doctor if their condition worsens, persists for more than 7 days, or if the condition improves and then recurs within a few days. Patients should also be cautioned against starting any other hydrocortisone product without prior consultation with a healthcare professional.

When using this product, patients should be advised to consult a doctor before exceeding the recommended dosage. Additionally, patients should be encouraged 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. For traceability, the lot number and expiration date can be found on the carton or the crimp of the tube. Proper handling is essential to ensure the product remains within the recommended storage conditions.

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.