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Hydrocortisone

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Active ingredient
Hydrocortisone 10 mg/1 g
Other brand names
Drug class
Corticosteroid
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2026
Label revision date
February 23, 2026
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Hydrocortisone 10 mg/1 g
Other brand names
Drug class
Corticosteroid
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2026
Label revision date
February 23, 2026
Manufacturer
Sportpharm LLC
Registration number
M017
NDC root
85766-166
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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

This medication provides temporary relief from itching caused by minor skin irritations, inflammation, and rashes. It can be helpful for conditions such as eczema, insect bites, and reactions to plants like poison ivy, poison oak, and poison sumac. Additionally, it may alleviate discomfort from soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis, and scrapes.

While this product is effective for these uses, it's important to consult with a doctor for any other applications. Always ensure you are using it as directed to achieve the best results.

Uses

This product is designed to provide temporary relief from itching caused by various minor skin irritations, inflammation, and rashes. You can use it for conditions such as eczema, insect bites, and reactions to plants like poison ivy, poison oak, and poison sumac. It can also help soothe irritation from soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis, and scrapes.

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

Dosage and Administration

If you are an adult or a child aged 2 years and older, you can apply this medication to the affected area 3 to 4 times a day. For children under 12 years old experiencing external anal itching, it's important to consult a doctor before use. If your child is under 2 years old, do not use this product without first speaking to a doctor.

For adults dealing with external anal itching, it's best to start by cleaning the affected area. Use mild soap and warm water, then rinse thoroughly. You can also use a suitable cleansing pad to help with this. After cleaning, gently dry the area by patting or blotting it with toilet tissue or a soft cloth before applying the medication. This preparation helps ensure the product works effectively.

What to Avoid

It's important to use this medication safely. You should not use it for treating diaper rash, and you should avoid using it alongside any other Hydrocortisone product unless you have first consulted with your doctor. Additionally, if you experience vaginal discharge, please consult your doctor before using this medication. Following these guidelines will help ensure your safety and the effectiveness of your treatment.

Side Effects

You should be aware that this product is for external use only. It is not intended for treating diaper rash, and you should avoid using it with any other Hydrocortisone product unless you have consulted a doctor. If you experience vaginal discharge, it's important to speak with a healthcare professional.

If your condition worsens, lasts more than 7 days, or clears and then comes back within a few days, you should stop using the product and consult a doctor. Additionally, if you notice any bleeding, seek medical advice. In case of accidental swallowing, get medical help or contact a Poison Control Center immediately.

Warnings and Precautions

This product is for external use only, so please avoid applying it to areas like diaper rash. If you have vaginal discharge, it's important to consult a doctor before using this product. Additionally, do not use it alongside any other Hydrocortisone product unless you have spoken with your doctor first.

You should stop using this product and contact your doctor if your condition worsens, lasts more than 7 days, or if it clears up and then comes back within a few days. If you notice any bleeding while using it, seek medical advice immediately. Always keep this product out of reach of children, and if it is swallowed, get medical help or contact a Poison Control Center right away.

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 assistance. They can provide guidance on what to do next.

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 help. Your safety is the top priority, so getting prompt care is essential.

Pregnancy Use

When it comes to using this product during pregnancy, there is no specific information available about its safety or potential risks to you or your developing baby. The insert does not indicate whether the product is contraindicated (not recommended) for pregnant individuals, nor does it mention any necessary dosage adjustments or special precautions for use during this time.

As always, it's important to consult with your healthcare provider before using any medication or product while pregnant 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 particular precautions or considerations for nursing mothers regarding this cream.

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

Pediatric Use

When using this medication for children aged 2 years and older, you can apply it to the affected area 3 to 4 times a day. However, if your child is under 12 years old and is experiencing external anal itching, it's important to consult a doctor before use. For children under 2 years of age, you should not use this medication without first speaking to a doctor. Always prioritize your child's safety and seek professional advice when needed.

Geriatric Use

While there is no specific information about how this medication should be used by older adults, it’s important to approach any new treatment with caution. If you or a loved one is an older adult, it’s always a good idea to discuss any medications with a healthcare provider. They can help determine the best approach, considering any unique health needs or conditions.

Since there are no dosage adjustments or special precautions mentioned for elderly patients, your healthcare provider will be the best resource for ensuring safety and effectiveness. Always keep them informed about any other medications or health issues to avoid potential interactions or complications.

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 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 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 health conditions you have to receive the best care possible.

Storage and Handling

To ensure the best performance and safety of your product, store it at room temperature and avoid freezing it. It's important to keep the packaging intact; do not use any packets that are opened or torn, as this indicates they may have been tampered with or compromised.

By following these simple storage and handling guidelines, you can help maintain the integrity of the product and ensure its effectiveness when you need it. Always check the packaging before use to ensure it is sealed properly.

Additional Information

For adults and children aged 2 years and older, apply the product to the affected area 3 to 4 times daily. If you are treating a child under 12 years for external anal itching, it's best to consult a doctor first. For children under 2 years, do not use the product without consulting a doctor. Adults should cleanse the affected area with mild soap and warm water, rinsing thoroughly, or by using a suitable cleansing pad before gently drying the area with toilet tissue or a soft cloth prior to application.

FAQ

What is the primary use of this product?

This product is used for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to conditions like eczema, insect bites, and poison ivy.

How should I apply this product?

For adults and children aged 2 years and older, apply to the affected area 3 to 4 times daily. For children under 2 years, consult a doctor before use.

Are there any contraindications for using this product?

Do not use this product for diaper rash, with any other Hydrocortisone product without consulting a doctor, or if you have vaginal discharge.

What should I do if my condition worsens?

Stop use and consult a doctor if your condition worsens, lasts more than 7 days, or if bleeding occurs.

Is this product safe for use during pregnancy?

The insert does not provide specific information regarding the use of this product during pregnancy, so consult a doctor for advice.

What should I do if I accidentally swallow this product?

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

Can children use this product?

Children under 12 years should consult a doctor for external anal itching, and children under 2 years should not use it without consulting a doctor.

How should I store this product?

Store at room temperature and do not freeze. Ensure the packaging is intact before use.

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 resulting from various conditions, including but not limited to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis, and scrapes.

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 recommended application frequency is 3 to 4 times daily to the affected area. Prior to application, adults should cleanse the affected area with mild soap and warm water, ensuring thorough rinsing. Alternatively, the area may be cleansed by patting or blotting with an appropriate cleansing pad. After cleansing, the area should be gently dried by patting or blotting with toilet tissue or a soft cloth before applying the product.

For children under 12 years of age experiencing external anal itching, it is advised to consult a healthcare professional before use. The product is not recommended for children under 2 years of age; consultation with a doctor is necessary in such cases.

Contraindications

The product is contraindicated in the following situations:

Use is not recommended for the treatment of diaper rash. Additionally, concurrent use with any other Hydrocortisone product is contraindicated unless a healthcare professional has been consulted. The product should not be used in patients presenting with vaginal discharge; medical consultation is advised in such cases.

Warnings and Precautions

For external use only. This product is contraindicated for the treatment of diaper rash. It should not be used in conjunction with any other Hydrocortisone product unless a healthcare professional has been consulted. In cases of vaginal discharge, it is imperative to seek medical advice prior to use.

Healthcare professionals should advise patients to discontinue use and consult a doctor if the condition worsens, persists for more than 7 days, or if symptoms resolve and then recur within a few days. Additionally, patients should be instructed to stop use if any bleeding occurs or if they begin using another Hydrocortisone product without prior consultation with a healthcare provider.

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 used in conjunction with any other Hydrocortisone product without prior consultation with a healthcare professional.

Patients are advised to discontinue use and seek medical advice if their condition worsens, persists for more than 7 days, or if symptoms clear and then recur within a few days. Additionally, if any bleeding occurs, patients should stop use and consult a doctor.

In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

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

Packaging configurations for Hydrocortisone.
Details

Pediatric Use

Pediatric patients aged 2 years and older may apply the medication to the affected area 3 to 4 times daily. For children under 12 years of age experiencing external anal itching, it is advised to consult a doctor prior to use. The medication is contraindicated in children under 2 years of age; consultation with a doctor is necessary for this age group.

Geriatric Use

There is no specific information 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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

The available prescribing information does not provide specific data regarding the use of this product during pregnancy. There are no contraindications noted for pregnant patients, nor are there any associated risks to the fetus identified in the available literature. Additionally, no dosage modifications or special precautions for use during pregnancy have been specified. Healthcare professionals should consider the lack of data when prescribing this product to women of childbearing potential and weigh the potential benefits against any unknown risks.

Lactation

There are no specific warnings or recommendations regarding the use of hydrocortisone cream in lactating mothers. Additionally, there are no specific considerations or precautions related to lactation mentioned in the provided text. Therefore, healthcare professionals may consider the use of hydrocortisone cream in nursing mothers without specific concerns for breastfed infants.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data may impact the drug's efficacy and safety profile in this population. Regular monitoring of renal function is advisable to ensure patient safety.

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 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 limits the assessment of potential risks associated with the compound in these areas.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. It is important to inform patients that if the medication is swallowed, they should seek medical help or contact a Poison Control Center immediately. This guidance is crucial to ensure the safety and well-being of patients and to mitigate any potential risks associated with accidental ingestion.

Storage and Handling

The product is supplied in tamper-evident packaging. It is essential to avoid using any packets that are opened or torn.

For optimal storage, the product should be kept at room temperature. It is important to note that freezing the product is not permitted, as it may compromise its integrity and effectiveness.

Additional Clinical Information

For patients aged 2 years and older, the recommended administration of the product is to apply it to the affected area 3 to 4 times daily. For children under 12 years of age experiencing external anal itching, it is advised to consult a doctor prior to use. The product is not recommended for children under 2 years of age without medical consultation.

Clinicians should instruct adult patients to cleanse the affected area with mild soap and warm water, rinsing thoroughly or patting with an appropriate cleansing pad before application. It is important to gently dry the area by patting or blotting with toilet tissue or a soft cloth prior to using the product.

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

Last AI update:

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.