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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 2011
Label revision date
January 14, 2026
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 2011
Label revision date
January 14, 2026
Manufacturer
Padagis Israel Pharmaceuticals Ltd
Registration number
M017
NDC root
45802-276
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 1% is a maximum strength anti-itch ointment designed to provide temporary relief from itching caused by minor skin irritations, inflammation, and rashes. It is effective for various conditions, including eczema, psoriasis, poison ivy, oak, sumac, insect bites, and reactions to detergents, jewelry, cosmetics, soaps, and seborrheic dermatitis. Additionally, it can help relieve external anal and genital itching.

This ointment works by reducing inflammation and soothing the skin, helping you feel more comfortable. Its water-resistant formula also helps protect the skin, making it a reliable option for managing itchiness and irritation.

Uses

This product is designed to provide temporary relief from itching caused by various minor skin irritations, including conditions like eczema and psoriasis, as well as reactions to poison ivy, oak, and sumac. It can also help soothe itching from insect bites, detergents, jewelry, cosmetics, soaps, and seborrheic dermatitis.

In addition to these uses, it can temporarily relieve itching in the external anal and genital areas. If you have other uses in mind, it's best to consult with your doctor for advice and supervision.

Dosage and Administration

If you're dealing with itching from skin irritation, inflammation, or rashes, you can apply the medication to the affected area up to 3 to 4 times a day if you are an adult or a child aged 2 years and older. However, if your child is under 2 years old, it's important to consult a doctor before use.

For external itching around the anal and genital areas, adults should 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. You can then apply the medication to the affected area, again up to 3 to 4 times daily. If the person needing treatment is under 12 years old, please consult a doctor for guidance.

What to Avoid

It's important to use this product safely and effectively. You should not use it for treating diaper rash or in the genital area if you have a vaginal discharge—please consult your doctor in these cases. Additionally, avoid contact with your eyes and do not exceed the recommended dosage unless directed by your healthcare provider. Never insert the product directly into the rectum using your fingers or any device.

Be mindful that this product may have potential for misuse or dependence (a condition where you rely on a substance). Always follow the instructions carefully to ensure your safety and well-being.

Side Effects

When using this product, it's important to be aware of some potential side effects and precautions. You should avoid contact with your eyes and not use it more than directed unless advised by a doctor. If you notice that your condition worsens, experience rectal bleeding, or if symptoms persist for more than 7 days or return shortly after improvement, stop using the product and consult a doctor.

Additionally, this product is for external use only and should not be used for diaper rash or in the genital area if you have a vaginal discharge without consulting a doctor first. Keep it out of reach of children, and if swallowed, seek medical help or contact a Poison Control Center immediately.

Warnings and Precautions

This product is for external use only, so please avoid using it on areas like diaper rashes or the genital area if you have a vaginal discharge—consult your doctor in these cases. When applying, be careful not to get it in your eyes, and only use the amount directed by your doctor. Do not insert it into the rectum using fingers or any devices.

If your condition worsens, you experience rectal bleeding, or your symptoms last more than 7 days (or improve and then return), stop using the product and contact your doctor. Additionally, 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 too much of a medication, it’s important to seek medical help immediately. You can do this by contacting a Poison Control Center or going to the nearest emergency room. Acting quickly can make a significant difference in the outcome.

Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms, don’t hesitate to get help right away. Remember, it’s always better to be safe and seek assistance if you suspect an overdose.

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 any special precautions related to its use in pregnant individuals 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 safe for you and your baby. Always prioritize open communication with your doctor about any medications you are considering during pregnancy.

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, the information available does not indicate any concerns about the ointment being passed into breast milk or posing any risk to your infant.

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

Pediatric Use

If your child is under 2 years old, it's important not to use this medication without consulting a doctor first. For children aged 2 years and older, you can apply the medication to the affected area up to 3 to 4 times a day. However, if your child is under 12 years old and is experiencing external anal or genital itching, you should also seek advice from a doctor before using the product. Always prioritize your child's safety and well-being by following these guidelines.

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 there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations for the medication do not include special monitoring or safety considerations tailored for patients with 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 kidney health. They can provide guidance based on your individual situation.

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 differently due to your liver health.

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver condition and the use of this medication. They can help ensure that you receive the safest and most effective treatment.

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 share your complete list of medications and any recent lab tests to avoid any potential issues. Your health and safety should always come first.

Storage and Handling

To ensure the best performance of your product, store it at a temperature between 20°-25°C (68°-77°F). This temperature range helps maintain its effectiveness and safety.

When handling the product, be sure to do so in a clean environment to avoid contamination. Always follow any specific instructions provided for use and disposal to ensure safety and compliance.

Additional Information

You should apply this medication topically to the affected area, using it no more than 3 to 4 times daily. This applies to both adults and children aged 2 years and older. If you are treating external anal and genital itching, adults should also follow the same application frequency. Always ensure you are using the medication as directed for the best results.

FAQ

What is Hydrocortisone 1% used for?

Hydrocortisone 1% is a maximum strength anti-itch ointment that temporarily relieves itching associated with minor skin irritations, inflammation, and rashes, including conditions like eczema, psoriasis, and insect bites.

How should I use Hydrocortisone 1%?

For adults and children 2 years and older, apply to the affected area not more than 3 to 4 times daily. For external anal and genital itching, clean the area first and then apply the ointment.

Are there any contraindications for using this product?

Do not use Hydrocortisone 1% for the treatment of diaper rash or in the genital area if you have a vaginal discharge. Always consult a doctor for these conditions.

What should I do if my condition worsens?

Stop using the product and ask a doctor if your condition worsens, if rectal bleeding occurs, or if symptoms persist for more than 7 days.

Is Hydrocortisone 1% safe for children?

Children under 2 years of age should not use this product without consulting a doctor. For children under 12 years, consult a doctor for external anal and genital itching.

What precautions should I take when using this product?

Avoid contact with the eyes, do not use more than directed unless advised by a doctor, and do not apply directly into the rectum.

How should I store Hydrocortisone 1%?

Store the ointment at a temperature between 20°-25°C (68°-77°F).

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

No description information is available for the specified 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, oak, sumac, insect bites, detergents, jewelry, cosmetics, soaps, and seborrheic dermatitis. Additionally, it provides temporary relief for 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 the treatment of itching associated with skin irritation, inflammation, and rashes, the recommended dosage for adults and children aged 2 years and older is to apply the medication to the affected area no more than 3 to 4 times daily. For children under 2 years of age, the use of this medication is not recommended; consultation with a physician is advised.

In cases of external anal and genital itching in adults, it is recommended to first clean 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 application. The medication should then be applied to the affected area no more than 3 to 4 times daily. For children under 12 years of age, it is advisable to consult a physician before use.

Contraindications

The product is contraindicated for the treatment of diaper rash; consultation with a healthcare professional is advised. Additionally, it should not be applied in the genital area if there is a vaginal discharge; again, a healthcare professional should be consulted.

Contact with the eyes must be avoided. The product should not be used in excess of the directed dosage unless specifically instructed by a healthcare provider. Direct application into the rectum using fingers or any mechanical device or applicator is also contraindicated.

Warnings and Precautions

For external use only. This product is not intended for the treatment of diaper rash; healthcare professionals should advise patients to consult a doctor for such conditions. Additionally, it should not be applied in the genital area if there is a vaginal discharge; again, a consultation with a healthcare provider is recommended.

When using this product, it is imperative to avoid contact with the eyes. Patients should adhere strictly to the recommended dosage and should not exceed the directed amount unless specifically instructed by a healthcare professional. Furthermore, the product should not be inserted directly into the rectum using fingers or any mechanical device or applicator.

Patients must be advised to discontinue use and seek medical advice if any of the following occur: worsening of the condition, rectal bleeding, or if symptoms persist for more than 7 days. If symptoms resolve and then recur within a few days, patients should refrain from using any other hydrocortisone products without first consulting a doctor.

It is essential to keep this product 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 the treatment of diaper rash and should not be applied in the genital area if there is a vaginal discharge; in such cases, consultation with a healthcare provider is advised.

During the use of this product, patients should avoid contact with the eyes and adhere strictly to the recommended dosage. It is important not to exceed the directed use unless specifically instructed by a healthcare professional. Additionally, patients should refrain from inserting the product directly into the rectum using fingers or any mechanical device or applicator.

Patients are advised to discontinue use and seek medical advice if any of the following occur: worsening of the condition, rectal bleeding, or if symptoms persist for more than 7 days. If symptoms resolve and then recur within a few days, patients should not resume use of any other hydrocortisone product without consulting a doctor.

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 currently no documented drug interactions associated with the use of 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. 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; caregivers are advised to consult a doctor for guidance. For children aged 2 years and older, the medication may be applied to the affected area no more than 3 to 4 times daily. In children under 12 years of age, it is recommended to seek medical advice before using the product for external anal and genital 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 adverse effects or changes in therapeutic response, 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

There are no specific warnings or recommendations regarding the use of hydrocortisone ointment in lactating mothers. Additionally, there are no statements concerning the potential for excretion of hydrocortisone in breast milk or any associated risks to breastfed infants during the use of this medication.

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 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 prescribing information.

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 should include supportive care and symptomatic treatment as necessary. Continuous evaluation of the patient's condition is recommended to address any complications that may arise.

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 safety profile in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center if the product is swallowed. It is important to inform patients that this product is not intended for the treatment of diaper rash and that they should consult a doctor for appropriate alternatives.

Patients should be cautioned against using the product in the genital area if they have a vaginal discharge, and they should be encouraged to seek medical advice in such cases. Providers should instruct patients to discontinue use and consult a doctor if their condition worsens or if rectal bleeding occurs.

Additionally, patients should be informed that if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days, they should stop using the product and consult a doctor before using any other hydrocortisone product.

While using this product, patients should be advised to avoid contact with the eyes and to adhere strictly to the directed dosage, refraining from using more than recommended unless instructed by a healthcare professional. Furthermore, patients should be cautioned against inserting the product directly into the rectum using fingers or any mechanical device or applicator.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It should be stored at a controlled room temperature of 20° to 25°C (68° to 77°F). Care should be taken to ensure that the product is kept within this temperature range to maintain its integrity and efficacy.

Additional Clinical Information

The medication is administered topically, with the recommended application frequency for adults and children aged 2 years and older being no more than 3 to 4 times daily to the affected area. For external anal and genital itching, adults should also apply to the affected area no more than 3 to 4 times daily. There is no additional information 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.