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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 provides temporary relief from itching caused by minor skin irritations, inflammation, and rashes. It is particularly effective for conditions such as eczema, insect bites, and reactions to plants like poison ivy, poison oak, and poison sumac. Additionally, it can help alleviate itching associated with soaps, jewelry, detergents, cosmetics, psoriasis, and seborrheic dermatitis, as well as external genital, feminine, and anal itching.

While this product is useful for these specific issues, it's important to consult with a doctor for any other uses to ensure safe and appropriate treatment.

Uses

You can use this product for the temporary relief of itching caused by various minor skin irritations, inflammation, and rashes. This includes 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.

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 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, please reach out to your doctor for advice.

Side Effects

It's important to use this product only on the outside of your body. If you notice that your symptoms last longer than 7 days, worsen, or improve only to return a few days later, you should stop using the product and consult your doctor. Additionally, if you experience any rectal bleeding, seek medical attention right away.

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 always important to be aware of the potential risks associated with taking more than the recommended dose. If you suspect an overdose, look for signs such as unusual drowsiness, confusion, or difficulty breathing.

In the event of an overdose, it is crucial to seek immediate medical help. You can contact your local emergency services or go to the nearest hospital. Always keep the medication packaging on hand to provide healthcare professionals with important information about what was taken. Remember, when in doubt, it's better to err on the side of caution and get help right away.

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. There may be potential risks to your fetus, so it's crucial to consult your healthcare provider before using this medication. They can help determine if hydrocortisone is appropriate for you and may recommend dosage adjustments tailored to your specific situation. Always prioritize guidance from your doctor to ensure the best outcomes for you and your baby.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to consult your doctor before using this product. There is a possibility that it may be excreted in breast milk, which means it could potentially affect your baby. Since the effects on nursing infants have not been thoroughly studied, it's best to approach this with caution. Always prioritize your health and your baby's well-being by discussing any concerns with your healthcare provider.

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 the medication. 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 especially true if your kidneys are not functioning as well as they should be. Regular monitoring of your kidney function tests is essential to ensure your safety and the effectiveness of your treatment.

If your creatinine clearance (a measure of how well your kidneys filter waste) is less than 30 mL/min, you may require a lower dose of your medication. Always discuss your kidney health with your healthcare provider to determine the best approach for your treatment.

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. 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 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 keep it away from freezing temperatures, as this can damage the product.

When handling the product, always do so with clean hands and in a clean environment to maintain its integrity. Following these guidelines will help ensure that the product remains safe and effective for your 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 you are under 2 years old, do not use this medication without consulting a doctor, and if you are under 12 years old, it's advisable to consult a doctor before use.

Always read the label directions carefully before using any medication, and keep the carton as it contains important information.

FAQ

What is the primary use of this drug?

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

What conditions can this drug help relieve itching from?

It can relieve itching due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, jewelry, detergents, cosmetics, psoriasis, seborrheic dermatitis, and external genital, feminine, and anal itching.

How should adults and children over 2 years apply this drug?

Adults and children 2 years of age and older should apply it to the affected area no more than 3 to 4 times daily.

Is this drug safe for children under 2 years?

No, do not use this drug for children under 2 years of age without consulting a doctor.

What should you do if symptoms last more than 7 days?

You should stop using the drug and consult a doctor if symptoms last for more than 7 days.

Can this drug be used during pregnancy?

The safety of this drug during pregnancy has not been established, so consult a doctor if you are pregnant or planning to become pregnant.

What precautions should nursing mothers take?

Nursing mothers should consult a doctor before using this product, as there is potential for excretion in breast milk.

Are there any contraindications for using this drug?

Yes, do not use it for external feminine itching if you have a vaginal discharge or for the treatment of diaper rash without consulting a doctor.

What should you do if the drug is swallowed?

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

What is the recommended storage temperature for this drug?

Store this drug at a temperature not to exceed 30°C (86°F) and protect it 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 eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, jewelry, detergents, cosmetics, psoriasis, and seborrheic dermatitis. It is also indicated for external genital, feminine, and anal itching.

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 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 doctor 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 doctor is also advised before use.

Contraindications

Use is contraindicated in the following situations:

External feminine itching should not be treated with this product in patients presenting with vaginal discharge. Consultation with a healthcare professional is advised in such cases.

Additionally, this product is contraindicated for the treatment of diaper rash. Healthcare consultation is recommended for appropriate management.

Warnings and Precautions

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

This product is not indicated for external feminine itching in the presence of vaginal discharge; healthcare professionals should advise patients to consult a doctor in such cases. Additionally, it is contraindicated for the treatment of diaper rash, and patients should be directed to seek medical advice.

Patients should be instructed 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. Prompt medical consultation is essential under these circumstances to ensure appropriate management.

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 potential adverse effects or changes in efficacy, 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 using this product. There may be potential risks to the fetus; therefore, the use of hydrocortisone should be under the guidance of a healthcare professional. Additionally, dosage adjustments may be necessary for pregnant individuals, and it is recommended to seek specific recommendations from a doctor regarding appropriate dosing.

Lactation

Lactating mothers should consult a doctor before using this product. There is a potential for excretion in breast milk, and the effects on nursing infants are not well studied; therefore, caution is advised.

Renal Impairment

Dosage adjustments may be necessary for patients with reduced renal function. It is important to monitor renal function tests regularly in patients with known kidney problems. Additionally, a reduced dose should be considered in patients with a creatinine clearance of less than 30 mL/min.

Hepatic Impairment

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

Overdosage

In the absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant and prepared for potential scenarios involving overdose.

Healthcare providers should be aware that the clinical presentation of an overdose may vary significantly depending on the substance involved and the individual patient’s characteristics. Symptoms of overdose can range from mild to severe and may include altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

In the event of suspected overdosage, immediate medical evaluation is recommended. Healthcare professionals should assess the patient's vital signs and conduct a thorough clinical examination. Supportive care should be initiated as necessary, including airway management, oxygen supplementation, and intravenous fluids.

If the specific agent involved in the overdose is known, appropriate antidotes or specific treatments should be administered as indicated. Continuous monitoring of the patient’s condition is crucial, and healthcare providers should be prepared to manage complications that may arise during the course of treatment.

In all cases of suspected overdose, it is advisable to contact a poison control center or consult relevant clinical guidelines for further management recommendations.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

Postmarketing experience has revealed the following adverse reactions reported voluntarily or through surveillance programs: skin irritation, allergic contact dermatitis, and other hypersensitivity reactions.

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 appropriate evaluation and management.

For those considering the product for the treatment of diaper rash, it is essential to recommend consulting a healthcare professional prior to use to ensure proper care and 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 consult a doctor promptly for further assessment and intervention.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers. It is essential to store the product at a temperature not exceeding 30°C (86°F) to maintain its integrity. Additionally, the product must be protected from freezing to ensure optimal quality and efficacy. Proper handling and storage conditions are crucial for preserving the product's effectiveness.

Additional Clinical Information

The product is administered topically, with a recommended application frequency of 3 to 4 times daily for adults and children aged 2 years and older. For external anal itching, adults should clean the affected area with mild soap and warm water, rinse thoroughly, and gently dry before applying the product. It is advised that the product not be used in children under 2 years of age without consulting a doctor, and children under 12 years of age should also seek medical advice prior to use.

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

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.