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Maximum Strength Hydrocortisone

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Active ingredient
Hydrocortisone 1 g/100 g
Other brand names
Drug class
Corticosteroid
Dosage form
Ointment
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2016
Label revision date
January 15, 2026
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Hydrocortisone 1 g/100 g
Other brand names
Drug class
Corticosteroid
Dosage form
Ointment
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2016
Label revision date
January 15, 2026
Manufacturer
Walgreens
Registration number
M017
NDC root
0363-0230
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 safety and effectiveness.

Uses

You can use this product for temporary relief from 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 gently cleaning the affected area with mild soap and warm water. Make sure to rinse thoroughly and then gently dry the area by patting or blotting it with toilet tissue or a soft cloth before applying the medication. If the person is under 12 years of age, 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 for external use only, so please avoid swallowing it. If you accidentally ingest it, seek medical help or contact a Poison Control Center immediately.

You should stop using this product and consult your doctor if your symptoms persist for more than 7 days, worsen, improve and then return within a few days, or if you experience rectal bleeding. It's important to take these precautions seriously to ensure your safety and well-being.

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 signs of an overdose, which can include unusual drowsiness, confusion, or difficulty breathing. If you suspect that you or someone else may have taken too much of a medication, it’s crucial to seek immediate medical help.

In case of an overdose, contact your local emergency services or go to the nearest hospital. Having the medication packaging or information on hand can help medical professionals provide the best care. Always remember that when it comes to medications, it’s better to be safe and get help if you have any concerns.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the safety of hydrocortisone ointment during pregnancy has not been established. There may be potential risks to your fetus, so you should consult your doctor before using this medication. It's essential to use it only if clearly needed and under the supervision of a healthcare provider.

Additionally, dosage adjustments may be necessary for pregnant individuals, so be sure to discuss your specific situation with a healthcare professional. Always prioritize your health and the health of your baby by seeking guidance before using any medication during pregnancy.

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 the ingredients may pass into your breast milk, which could affect your nursing infant. Therefore, exercising caution while using this product during breastfeeding is highly recommended to ensure the safety and well-being of both you and your baby.

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 up to 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.

Additionally, if your child is experiencing external anal itching and is under 12 years old, it's best to consult a doctor before using the product. Always prioritize your child's safety and seek professional advice when needed.

Geriatric Use

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. As you age, your body may process medications differently, and factors like kidney function (renal impairment) and changes in cognition can affect how well a drug works or how safe it is for you.

If you or a loved one is considering this medication, it’s wise to discuss it with a healthcare provider. They can help determine the best approach, taking into account any unique health needs or concerns that may arise with age. Always prioritize open communication with your doctor 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. Your healthcare provider will likely monitor your renal function tests, which help assess how well your kidneys are working.

If you have decreased creatinine clearance (a measure of kidney function), your doctor may recommend a reduced dose of your medication to ensure your safety and effectiveness of treatment. Always communicate openly with your healthcare team about your kidney health to receive the best care possible.

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 or how your liver health should be considered when taking it.

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 you understand how to manage your liver health 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. 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 safety and effectiveness of your product, store it in a cool, dry place where the temperature does not exceed 30°C (86°F). This helps maintain its quality and performance. Before using the medication, be sure to read all label directions carefully. It's also a good idea to keep the carton, as it contains important information that you may need later.

Handling your product safely is crucial. Always follow the instructions provided to avoid any mishaps. By taking these precautions, you can help ensure that you use the product correctly and safely.

Additional Information

You should apply this medication to the affected area 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 the patient is a child under 12 years old, 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 provides temporary relief of itching associated with minor skin irritations, inflammation, and rashes.

What conditions can this drug help with?

It is indicated for 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 use this drug?

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

Can children under 2 years use this drug?

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

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

Stop use and ask a doctor if symptoms last for more than 7 days, if the condition worsens, or if symptoms clear up and occur again in a few days.

Is this drug safe to use during pregnancy?

The safety of this drug during pregnancy has not been established, and it should only be used under the guidance of a healthcare provider.

What precautions should nursing mothers take?

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

What should you avoid while using this drug?

Avoid contact with the eyes and do not use for external feminine itching if you have a vaginal discharge or for the treatment of diaper rash without consulting a doctor.

What are the storage instructions for this drug?

Store the drug at a temperature not to exceed 30°C (86°F).

Packaging Info

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

Packaging configurations for Maximum Strength Hydrocortisone.
Details

Drug Information (PDF)

This file contains official product information for Maximum Strength 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 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. These include eczema, insect bites, poison ivy, poison oak, poison sumac, and reactions to soaps, jewelry, detergents, and cosmetics. Additionally, it is indicated for the relief of itching related to psoriasis and seborrheic dermatitis, as well as 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. 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. This product is not intended for ingestion. In the event of accidental swallowing, it is imperative to seek medical assistance or contact a Poison Control Center immediately.

Healthcare professionals should advise patients to discontinue use and consult a physician under the following circumstances: 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 in these situations to ensure appropriate management and care.

Side Effects

For external use only. Patients should discontinue use and consult a doctor 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 (hydrocortisone ointment). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Maximum Strength Hydrocortisone.
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

There is no specific information available 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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

The safety of hydrocortisone ointment during pregnancy has not been established. Pregnant patients or those planning to become pregnant should consult a healthcare provider prior to use. There may be potential risks to the fetus associated with the use of this medication; therefore, it is essential that its use occurs under the guidance of a healthcare professional.

Dosage adjustments may be necessary for pregnant individuals, and healthcare providers should be consulted for specific recommendations. Special precautions should be taken to use hydrocortisone ointment only if clearly needed and under the supervision of a healthcare provider during pregnancy.

Lactation

Lactating mothers should consult a doctor before using this product. There is a potential for excretion in breast milk, and caution is advised when using this product while breastfeeding.

Renal Impairment

Patients with renal impairment may require dosage adjustments to ensure safety and efficacy. It is essential to monitor renal function tests in individuals with kidney problems to assess their renal 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 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 available information.

Overdosage

There is currently no specific information available regarding overdosage for this medication. In the absence of documented overdosage data, healthcare professionals are advised to exercise caution and monitor patients closely for any unusual symptoms or adverse effects that may arise following administration.

In the event of suspected overdosage, it is recommended that healthcare providers initiate supportive care and symptomatic treatment as necessary. Continuous monitoring of vital signs and clinical status is essential to ensure patient safety.

Healthcare professionals should also consider consulting a poison control center or relevant toxicology resources for guidance on management strategies tailored to the specific circumstances of the overdosage event.

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

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

Patients should be advised to keep this medication out of reach of children to prevent accidental ingestion. In the event of swallowing the medication, they should seek medical help or contact a Poison Control Center immediately.

Healthcare providers should inform patients that this medication is not intended for external feminine itching if they have a vaginal discharge and that they should consult a doctor in such cases. Additionally, patients should be cautioned against using this medication for the treatment of diaper rash and should seek medical advice if they have any concerns.

Patients must be instructed to stop using the medication and consult a doctor if their 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 in these situations to ensure appropriate care.

Storage and Handling

The product is supplied in packaging that includes important information, which should be retained for reference. It is essential to read all label directions prior to use.

For optimal storage, the product must be kept at a temperature not exceeding 30°C (86°F). Proper handling and adherence to these storage conditions are crucial to maintain the integrity and efficacy of the medication.

Additional Clinical Information

Patients aged 2 years and older are advised to apply the product to the affected area no more than 3 to 4 times daily. For adults experiencing external anal itching, it is recommended to clean the affected 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. For children under 12 years of age, consultation with a doctor is necessary before use.

Clinicians should counsel patients to read all label directions carefully and retain the carton, as it contains important information regarding the product. 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, 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, 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.