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Maximum Strength Hydrocortisone Cream

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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 2016
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
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 2016
Label revision date
January 14, 2026
Manufacturer
Walgreens
Registration number
M017
NDC root
0363-0638
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

This medication is designed to provide temporary relief from itching caused by minor skin irritations, inflammation, and rashes. You may find it helpful for various conditions, including eczema, insect bites, and reactions to plants like poison ivy, poison oak, and poison sumac. It can also be used for itching related to soaps, jewelry, detergents, cosmetics, psoriasis, and seborrheic dermatitis, as well as for external genital, feminine, and anal itching.

For any other uses, it's important to consult with a doctor to ensure it's appropriate for your situation.

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 like eczema, insect bites, and reactions to plants such as poison ivy, poison oak, and poison sumac. It can also help with irritation from soaps, jewelry, detergents, cosmetics, psoriasis, and seborrheic dermatitis. Additionally, it is effective for external genital, feminine, and anal itching.

If you have other uses in mind, it's important to consult with your doctor for advice and supervision.

Dosage and Administration

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

If you are dealing with external anal itching, start by cleaning the affected area with mild soap and warm water. Make sure to rinse thoroughly and gently dry the area by patting or blotting it with toilet tissue or a soft cloth before applying the medication. If the person needing treatment is a child under 12 years old, please consult a doctor for guidance.

What to Avoid

It's important to be cautious when using this medication. You should not use it for external feminine itching if you have a vaginal discharge; in this case, it's best to consult a doctor. Additionally, do not use this medication for treating diaper rash without first speaking to a healthcare professional.

Always prioritize your health and safety by following these guidelines. If you have any questions or concerns about your symptoms or the appropriate treatment, don't hesitate to reach out to your doctor for advice.

Side Effects

It's important to use this product only on the skin and not for any other purpose. If you notice that your symptoms last longer than 7 days, worsen, or improve only to return after a few days, you should stop using the product and consult your doctor. Additionally, if you experience any rectal bleeding, seek medical attention immediately.

Warnings and Precautions

This product is intended for external use only. If you accidentally swallow it, seek medical help or contact a Poison Control Center immediately.

You should not use this product for external feminine itching if you have a vaginal discharge or for treating diaper rash; in these cases, please consult your doctor. If your symptoms persist for more than 7 days, worsen, clear up and then return within a few days, or if you experience rectal bleeding, stop using the product and contact your doctor right away.

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 during pregnancy has not been established. You should consult your doctor before using this medication, as there may be potential risks to your fetus that are not clearly defined.

If your healthcare provider determines that hydrocortisone is necessary, they may recommend dosage adjustments to ensure your safety and that of your baby. Always use this medication only if it is clearly needed and if the benefits outweigh the risks. Your health and the health of your baby are the top priority, so open communication with your healthcare provider is essential.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of this product while nursing. This means that, based on the available information, it is considered safe for you to use without concerns about affecting your milk production or your nursing infant. Always consult with your healthcare provider if you have any questions or concerns about your specific situation.

Pediatric Use

When using this medication for children, it's important to follow specific guidelines. For children aged 2 years and older, you can apply it to the affected area no more than 3 to 4 times a day. However, if your child is under 2 years old, you should not use this medication without first consulting a doctor.

If your child is experiencing external anal itching and is under 12 years old, it's best to consult a doctor before using this product. Always prioritize your child's safety 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, it’s important to consult with a healthcare provider before starting the medication. 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 your medication dosage may need to be adjusted. This is because your kidneys may not process the medication as effectively. Regular monitoring of your renal function tests is essential to ensure your kidneys are working properly. If you have decreased creatinine clearance (a measure of how well your kidneys filter waste), your healthcare provider may recommend a reduced dose of your medication to avoid potential complications. Always discuss any concerns with your doctor to ensure your treatment is safe and effective.

Hepatic Impairment

If you have liver problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or precautions related to your condition. This means that there are no tailored recommendations for how the medication may affect you differently due to your liver health.

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your specific situation. They can help determine the best approach based on your liver function and overall health.

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 in a cool, dry place where the temperature does not exceed 30°C (86°F). It's important to protect it from freezing, as extreme temperatures can affect its effectiveness.

Before using the product, make sure to read all the label directions carefully. Keeping the carton is also a good idea, as it contains important information that you may need later. By following these guidelines, you can help ensure safe and effective use.

Additional Information

You should apply this medication topically to the affected area, using it 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 treating external anal itching, it's best to clean the area with mild soap and warm water, rinse thoroughly, and gently dry it before applying the product. If your child is under 2 years old, do not use this medication without consulting a doctor, and if your child is under 12, it's advisable to consult a doctor as well.

Before using this medication, make sure to read all the label directions carefully. It's also a good idea to keep the carton, as it contains important information you may need.

FAQ

What is the drug indicated for?

The drug is indicated for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes.

What specific conditions can this drug treat?

It can treat conditions such as eczema, insect bites, poison ivy, poison oak, poison sumac, and more.

Can this drug be used for external genital or anal itching?

Yes, the drug is indicated for external genital, feminine, and anal itching.

What should I do if I have a vaginal discharge?

Do not use this drug for external feminine itching if you have a vaginal discharge; consult a doctor.

What is the recommended dosage for adults and children over 2 years?

Apply to the affected area not more than 3 to 4 times daily.

Is this drug safe for children under 2 years of age?

No, do not use this drug for children under 2 years; consult a doctor.

What should I do if symptoms last for more than 7 days?

Stop use and ask a doctor if symptoms last for more than 7 days or if the condition worsens.

What precautions should I take during pregnancy?

Consult a doctor before use if pregnant or planning to become pregnant, as the safety of this drug during pregnancy has not been established.

How should I store this drug?

Store at a temperature not to exceed 30°C (86°F) and protect from freezing.

Packaging Info

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

Packaging configurations for Maximum Strength Hydrocortisone Cream.
Details

Drug Information (PDF)

This file contains official product information for Maximum Strength Hydrocortisone Cream, 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 but not limited to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, jewelry, detergents, cosmetics, psoriasis, and seborrheic dermatitis. Additionally, it is indicated for external genital, feminine, and anal itching.

Other uses of this product should be undertaken only 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. For children under 2 years of age, the product is not recommended; consultation with a healthcare professional is advised.

In cases of external anal itching, it is recommended that adults first clean the affected area with mild soap and warm water. The area should be rinsed thoroughly and gently dried by patting or blotting with toilet tissue or a soft cloth prior to the application of the product. For children under 12 years of age, consultation with a healthcare professional is also recommended before use.

Contraindications

Use is contraindicated in the following situations:

External feminine itching should not be treated if there is a vaginal discharge; consultation with a healthcare professional is advised. Additionally, the product is contraindicated for the treatment of diaper rash, and a healthcare professional should be consulted in such cases.

Warnings and Precautions

For external use only. In the event of accidental ingestion, immediate medical assistance should be sought, or contact a Poison Control Center without delay.

This product is contraindicated for use in cases of external feminine itching accompanied by vaginal discharge; healthcare professionals should advise patients to consult a doctor in such instances. Additionally, it is not recommended for the treatment of diaper rash, and a consultation with a healthcare provider is necessary before use in this context.

Patients should be instructed to discontinue use and seek medical advice if symptoms persist for more than 7 days, if the condition worsens, if symptoms resolve only to recur within a few days, or if rectal bleeding occurs. Prompt consultation with a healthcare professional is essential under these circumstances to ensure appropriate management and care.

Side Effects

For external use only. Patients are advised to discontinue use and consult a healthcare professional if symptoms persist for more than 7 days, if the condition worsens, if symptoms resolve and then recur within a few days, or if rectal bleeding occurs.

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 Maximum Strength Hydrocortisone Cream (hydrocortisone cream). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Maximum Strength Hydrocortisone Cream.
Details

Pediatric Use

Pediatric patients aged 2 years and older may 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, and a consultation with a doctor is advised. Additionally, for the treatment of external anal itching, it is recommended that children under 12 years of age consult a doctor prior to use.

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 during pregnancy has not been established. Pregnant patients or those planning to become pregnant should consult a healthcare provider before use. Potential risks to the fetus are not clearly defined; therefore, caution is advised when considering treatment. Dosage adjustments may be necessary, and it is essential for healthcare providers to evaluate the need for hydrocortisone on a case-by-case basis. Use of this medication should only occur if clearly needed, and the benefits must outweigh the risks involved.

Lactation

There are no specific warnings or recommendations regarding the use of this product by lactating mothers. Additionally, there are no specific warnings or recommendations related to lactation in the provided information.

Renal Impairment

Patients with renal impairment may require dosage adjustments to ensure safety and efficacy. It is essential to monitor renal function tests in these individuals to assess their kidney status. Additionally, a reduced dose should be considered for patients with decreased creatinine clearance to mitigate the risk of adverse effects associated with impaired renal function.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of 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 and consider the overall clinical context when prescribing this medication to patients with hepatic impairment.

Overdosage

In the absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant regarding the potential for overdose with this medication. In cases where an overdose is suspected, immediate medical attention should be sought.

Healthcare providers are advised to monitor patients closely for any signs or symptoms that may indicate an overdose. These may include, but are not limited to, altered mental status, cardiovascular instability, or gastrointestinal disturbances.

Management of an overdose should be tailored to the individual patient and may involve supportive care, symptomatic treatment, and, if applicable, the use of specific antidotes. It is crucial to consult local poison control guidelines and the product's prescribing information for detailed management protocols.

In summary, while specific overdosage data is not available, healthcare professionals should exercise caution and be prepared to act swiftly in the event of an overdose scenario.

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 identified the following adverse reactions reported voluntarily or through surveillance programs: skin irritation, allergic contact dermatitis, and other hypersensitivity reactions. These events have been documented in the context of routine pharmacovigilance activities.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center if the product is swallowed.

Patients experiencing external feminine itching accompanied by vaginal discharge should be instructed to consult a doctor for further evaluation and appropriate management.

For those considering the product for the treatment of diaper rash, it is essential to recommend that they consult a healthcare professional prior to use to ensure proper treatment.

Additionally, patients should be informed that if their symptoms persist for more than 7 days, worsen, resolve and then recur within a few days, or if they experience rectal bleeding, they must promptly consult a doctor for further assessment and care.

Storage and Handling

The product is supplied in a carton that contains essential information for proper use. It is crucial for healthcare professionals to read all label directions before administering the medication.

For optimal storage, the product should be maintained at a temperature not exceeding 30°C (86°F) and must be protected from freezing to ensure its efficacy and safety.

Additional Clinical Information

Patients should apply the topical medication to the affected area no more than 3 to 4 times daily. For adults experiencing external anal itching, it is recommended to clean the 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. The product is not indicated for use in children under 2 years of age, and those under 12 years should consult a doctor before use.

Clinicians should advise patients to read all label directions before using the medication and to retain the carton, as it contains important information. No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Maximum Strength Hydrocortisone Cream, 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 Maximum Strength Hydrocortisone Cream, 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.