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Hydrocortisone 1%

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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
March 12, 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
March 12, 2026
Manufacturer
ProStat First Aid
Registration number
M017
NDC root
58228-7030
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 designed to provide temporary relief from itching caused by minor skin irritations and rashes. It is particularly effective for external feminine, genital, and anal itching, helping to soothe discomfort and promote healing.

While hydrocortisone cream can be beneficial for these specific uses, it's important to consult with a doctor for any other applications to ensure safe and appropriate use.

Uses

You can use this product for temporary relief from itching caused by minor skin irritations and rashes. It is also effective for external itching in feminine, genital, and anal areas. However, 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 the medication to the affected area up to 3 to 4 times a day. Before applying, it’s best to clean the area with mild soap and warm water, then rinse thoroughly. After that, gently dry the area by patting or blotting it with toilet tissue or a soft cloth.

If your child is under 2 years old, do not use this medication without consulting a doctor. Additionally, if you are treating external or anal itching in children under 12 years, it’s important to ask a doctor for guidance before use.

What to Avoid

It's important to be cautious when using this product. You should not use it for treating diaper rash without first consulting a doctor. Additionally, avoid using it alongside any other Hydrocortisone products unless directed by a healthcare professional. If you experience a vaginal discharge, please consult a doctor before use.

If your condition worsens, symptoms last longer than 7 days, or if symptoms improve and then return within a few days, stop using the product and seek medical advice. You should also stop using it if you notice rectal bleeding. While using this product, keep it away from your eyes, do not exceed the recommended dosage unless advised by a doctor, and avoid inserting it into the rectum with fingers or any devices.

Side Effects

This product is intended for external use only. You should stop using it and consult a doctor if your condition worsens, if symptoms last longer than 7 days, or if your symptoms improve and then come back within a few days. Additionally, if you experience rectal bleeding, seek medical advice immediately. It's important not to start using any other hydrocortisone product without consulting a healthcare professional.

Warnings and Precautions

This product is for external use only, so please avoid using it on any internal areas. Keep it out of reach of children, and if it is swallowed, seek medical help or contact a Poison Control Center right away.

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 come back within a few days. Additionally, if you experience rectal bleeding, it’s important to seek medical advice immediately.

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 has not been established. Before using this medication, you should consult your doctor to discuss any potential risks and whether it is appropriate for your situation.

Additionally, dosage adjustments may be necessary, so it's crucial to seek guidance from a healthcare provider. If you do use hydrocortisone cream during pregnancy, it should only be done under the advice of a healthcare professional and only if it is clearly needed. Your health and the health of your baby are the top priority, so always communicate openly with your healthcare team.

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 not to use this medication without consulting a doctor first. For children under 12 who are experiencing itching in the anal or genital areas, you should also seek advice from a healthcare professional before using it.

For children aged 2 years and older, you can apply the medication to the affected area, but be sure to limit the application to no more than 3 to 4 times a day. Always follow these guidelines to ensure your child's safety and well-being.

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 change based on renal impairment. However, it’s always best to consult with your healthcare provider about your kidney health and any medications you are taking. They can provide personalized advice and ensure that your treatment is safe and effective for you.

Hepatic Impairment

If you have liver problems, it's important to know that the information provided does not include any specific guidelines about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no established recommendations for how your liver health might affect the use of this medication.

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and appropriate for your liver health. They can help you understand how to manage your condition while considering any medications you may need.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. Currently, there are no specific drug interactions or laboratory test interactions noted for this medication. However, every individual’s health situation is unique, and your provider can help ensure that your treatment plan is safe and effective for you. Always feel free to ask questions and share all the medications and supplements you are using to avoid any potential issues.

Storage and Handling

To ensure the safety and effectiveness of your product, store it at a controlled room temperature between 20°-25°C (68°-77°F). It's important to keep it away from excessive heat and humidity, as these conditions can affect its quality. Always check the packaging before use; do not use the product if the packet is torn, cut, or opened, as this indicates it may have been tampered with.

By following these simple storage and handling guidelines, you can help maintain the integrity of the product and ensure it works as intended.

Additional Information

For adults and children aged 2 years and older, you should apply the medication to the affected area no more than 3 to 4 times a day. If the patient is under 2 years old, do not use this medication without consulting a doctor first. There are no additional details available regarding laboratory tests, abuse potential, or patient counseling.

FAQ

What is Hydrocortisone Cream used for?

Hydrocortisone Cream is used for temporary relief of itching associated with minor skin irritations and rashes, including external feminine, genital, and anal itching.

How should I apply 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 of age, do not use and ask a doctor.

Are there any contraindications for using Hydrocortisone Cream?

Yes, consult a doctor before use if you have a vaginal discharge, are treating diaper rash, or are using any other Hydrocortisone product.

What should I do if my symptoms worsen?

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

Is it safe to use Hydrocortisone Cream 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.

Can I use Hydrocortisone Cream while breastfeeding?

There are no specific warnings or recommendations regarding the use of Hydrocortisone Cream in nursing mothers mentioned in the insert.

What precautions should I take when using Hydrocortisone Cream?

Avoid contact with the eyes, do not exceed the recommended dosage, and keep the product out of reach of children.

How should I store Hydrocortisone Cream?

Store at controlled room temperature between 20°-25°C (68°-77°F) and avoid excessive heat and humidity.

Packaging Info

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

Packaging configurations for Hydrocortisone 1%.
Details

Drug Information (PDF)

This file contains official product information for Hydrocortisone 1%, 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 and rashes. It is also indicated for external feminine, genital, and anal itching.

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

Dosage and Administration

Adults and children aged 2 years and older are instructed to apply the medication to the affected area no more than 3 to 4 times daily. For optimal results in adults experiencing external and anal itching, it is recommended to first clean the affected area with mild soap and warm water, followed by thorough rinsing. The area should then be gently dried by patting or blotting with toilet tissue or a soft cloth prior to application of the medication.

For children under 2 years of age, the use of this medication is not advised; consultation with a healthcare professional is necessary. Additionally, for external anal and genital itching in children under 12 years of age, it is essential to seek guidance from a doctor before use.

Contraindications

Use of this product is contraindicated in the following situations:

  • Treatment of diaper rash should only be undertaken after consulting a doctor.

  • Concurrent use with any other hydrocortisone product is contraindicated unless a doctor has been consulted.

  • Patients presenting with vaginal discharge should seek medical advice prior to use.

Additionally, if conditions worsen, symptoms persist for more than 7 days, or symptoms resolve and then reappear within a few days, the use of this product should be discontinued and a doctor consulted. Rectal bleeding is also a contraindication for use.

Warnings and Precautions

For external use only. It is imperative that this product is kept out of the reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact a Poison Control Center without delay.

Healthcare professionals should advise patients to discontinue use and consult a physician if any of the following occur: worsening of conditions, persistence of symptoms beyond 7 days, or if symptoms resolve and then reappear within a few days. Patients should also be instructed to refrain from using any other hydrocortisone products during this time. Additionally, if rectal bleeding is observed, it is crucial to stop using the product and seek medical advice promptly.

No specific laboratory tests are recommended for monitoring the use of this product.

Side Effects

For external use only. Patients are advised to discontinue use and consult a healthcare professional if conditions worsen, if symptoms persist for more than 7 days, or if symptoms resolve and then reappear within a few days. Additionally, patients should seek medical advice if rectal bleeding occurs.

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 1% (hydrocortisone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Hydrocortisone 1%.
Details

Pediatric Use

Pediatric patients under 2 years of age should not use this medication without consulting a doctor. For the treatment of external anal and genital itching, children under 12 years of age are advised to seek medical advice prior to use. For those aged 2 years and older, the medication may be applied to the affected area no more than 3 to 4 times daily.

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

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 using this medication. Dosage adjustments may be necessary, and it is essential to seek guidance from a healthcare professional regarding appropriate use. Hydrocortisone cream should only be used during pregnancy if clearly needed and under the advice of a healthcare provider to ensure the safety of both the mother and the developing fetus.

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

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in clinical trials for this medication. Consequently, there is no information available regarding dosage adjustments, special monitoring, 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, as the lack of data may impact the safety and efficacy of treatment in this population. Regular monitoring of liver function may be warranted based on clinical judgment.

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 the clinical presentation.

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 use of the compound in these contexts.

Postmarketing Experience

Postmarketing experience has indicated that the use of hydrocortisone cream may be associated with several adverse reactions. Reports have included instances of skin irritation, allergic reactions, and other hypersensitivity reactions. These events were reported voluntarily or identified through surveillance programs.

Patient Counseling

Healthcare providers should advise patients to keep this product out of the reach of children. Instruct patients that if the product is swallowed, they should seek medical help or contact a Poison Control Center immediately.

For patients using this product for the treatment of diaper rash, it is important to recommend consulting a doctor prior to use. Additionally, patients should be informed not to use this product in conjunction with any other hydrocortisone product unless they have first consulted a doctor.

Patients experiencing vaginal discharge should also be advised to consult a doctor. Healthcare providers should instruct patients to discontinue use and seek medical advice if conditions worsen, if symptoms persist for more than 7 days, or if symptoms clear up and then reappear within a few days. Patients should not begin use of any other hydrocortisone product without consulting a healthcare provider.

It is crucial to inform patients to seek medical attention if rectal bleeding occurs. While using this product, patients should be cautioned to avoid contact with the eyes. Providers should emphasize the importance of not exceeding the recommended daily dosage unless directed by a doctor.

Finally, patients should be advised against inserting this product into the rectum using fingers or any mechanical device or applicator.

Storage and Handling

The product is supplied in tamper-evident packaging. It is essential to inspect the packaging prior to use; do not utilize the product if the packet is torn, cut, or opened.

For optimal storage, the product should be maintained at a controlled room temperature between 20°-25°C (68°-77°F). It is important to avoid exposure to excessive heat and humidity to ensure the integrity and efficacy of the product.

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. It is contraindicated for use in children under 2 years of age, and clinicians are advised to consult a doctor in such cases. 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 1%, 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 1%, 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.