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Maximum Strength Hydrocortisone Cream with Aloe

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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
0363-0620
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. It can be helpful for various conditions, including eczema, insect bites, and reactions to plants like poison ivy, poison oak, and poison sumac. Additionally, it may alleviate itching related to soaps, jewelry, detergents, cosmetics, psoriasis, seborrheic dermatitis, and external genital, feminine, and anal itching.

While this product can be effective for these issues, it's important to use it under the guidance of a healthcare professional for any other uses.

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 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 a 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, as this could indicate a more serious condition that requires medical attention. Additionally, do not use it for treating diaper rash; consulting a doctor is recommended in both cases.

Always prioritize your health by seeking professional advice if you're unsure about your symptoms or the appropriate treatment. Remember, using this medication incorrectly can lead to complications, so it's best to consult with a healthcare provider for guidance.

Side Effects

This product is intended for external use only. You should stop using it and consult a doctor if your symptoms last longer than 7 days, if your condition worsens, or if your symptoms improve and then return after a few days. Additionally, if you experience rectal bleeding, it’s important to 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 signs of an overdose, which can include symptoms like extreme 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, do not wait for symptoms to appear. Contact your local emergency services or go to the nearest hospital right away. Always keep medications out of reach and follow the prescribed dosage to prevent any potential risks. If you have any concerns or questions about your medication, don’t hesitate to talk to your healthcare provider.

Pregnancy Use

While there are no specific statements regarding the use of hydrocortisone cream during pregnancy, the information provided does not indicate any safety concerns, contraindications, or special precautions for pregnant individuals. Additionally, there are no recommended dosage modifications for those who are pregnant.

If you are considering using hydrocortisone cream while pregnant, it is always a good idea to consult with your healthcare provider to ensure it is appropriate for your situation.

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. Additionally, there is no information available about whether this product is passed into breast milk or if it poses any risk to your infant. Always consult with your healthcare provider if you have any concerns or questions about medications while breastfeeding.

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. If you or a loved one is an older adult, be sure to discuss any potential risks or concerns with your healthcare provider. They can help determine the best approach for your individual health needs, especially since older adults may have different responses to medications compared to younger individuals. Always keep an open line of communication with your doctor about any changes in health or medication effects.

Renal Impairment

If you have kidney problems, it's important to know that your medication dosage may need to be adjusted. 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, a reduced dose may be necessary. Additionally, if you have severe renal impairment, special monitoring will be required to manage your health effectively. Always consult your healthcare provider for personalized advice and adjustments based on your kidney function.

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 may affect you differently due to your liver health.

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver function and how it relates to your treatment. They can help ensure that your medication is safe and effective for you.

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 feel free to ask questions and share your complete list of medications and any tests you might be undergoing. This way, you can avoid any potential issues and receive the best care possible.

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 device, always do so with care to maintain its integrity. Following these storage and handling 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 daily if you are an adult or a child aged 2 years and older. If you are under 2 years old, do not use this product without consulting a doctor. For external anal itching, it's recommended to clean the area with mild soap and warm water, rinse thoroughly, and gently dry it before applying the medication. If you are a child under 12 years old, please 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 this drug used for?

This drug is indicated for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes, including conditions like eczema, insect bites, and poison ivy.

Who should not use this drug?

Do not use this drug for external feminine itching if you have a vaginal discharge or for the treatment of diaper rash without consulting a doctor.

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

Adults and children 2 years of age and older should apply the drug to the affected area not more than 3 to 4 times daily.

What should I do if symptoms last 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 insert does not provide specific statements regarding the use of this drug during pregnancy, and no safety concerns are mentioned.

Can nursing mothers use this product?

There are no specific warnings or recommendations regarding the use of this product in nursing mothers.

What should I do if I accidentally swallow this drug?

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

What precautions should I take when using this drug?

Avoid contact with the eyes and do not use any other hydrocortisone product unless directed by a doctor.

What are the storage conditions for this drug?

Store the 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 with Aloe (hydrocortisone cream). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Maximum Strength Hydrocortisone Cream with Aloe.
Details

Drug Information (PDF)

This file contains official product information for Maximum Strength Hydrocortisone Cream with Aloe, 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 the Poison Control Center should be contacted without delay.

This product is contraindicated for use in cases of external feminine itching accompanied by vaginal discharge. Healthcare professionals are advised to consult a physician prior to use in such circumstances. Additionally, this product should not be utilized for the treatment of diaper rash; a consultation with a healthcare provider is recommended in these cases.

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 reoccur within a few days, or if rectal bleeding is observed. Prompt consultation with a healthcare professional is essential under these conditions 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 the use of this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

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

Packaging configurations for Maximum Strength Hydrocortisone Cream with Aloe.
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

There are no specific statements regarding the use of hydrocortisone cream during pregnancy in the provided information. The insert does not mention any safety concerns, contraindications, or special precautions regarding the use of this product during pregnancy. Additionally, there are no dosage modifications indicated for pregnant individuals. As such, healthcare professionals should consider the absence of specific data when advising pregnant patients on the use of hydrocortisone cream.

Lactation

There are no specific warnings or recommendations regarding the use of this product in nursing mothers. Additionally, there is no information available about the potential for excretion in breast milk or any associated risks to breastfed infants during lactation.

Renal Impairment

Dosage adjustments may be necessary for patients with reduced renal function. Regular monitoring of renal function tests is recommended for patients with known kidney problems. A reduced dose should be considered in patients with a creatinine clearance of less than 30 mL/min. Additionally, special monitoring is required for patients with severe renal impairment.

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, as the lack of data may impact the safety and efficacy of treatment in this population. Regular monitoring of liver function may be warranted based on clinical judgment.

Overdosage

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 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, which may include airway management, intravenous fluids, and monitoring of vital parameters.

If specific antidotes or treatments are available for the substance involved, they should be administered according to established protocols. Consultation with a poison control center or toxicology expert may also be warranted to guide management decisions.

It is crucial to document all findings and interventions in the patient's medical record and to report any adverse events to the appropriate regulatory authorities as required.

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

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 consulting a healthcare professional prior to use to ensure proper treatment and care.

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 various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a temperature not exceeding 30°C (86°F) to maintain its integrity and efficacy. Additionally, the product must be protected from freezing to prevent any potential degradation. Proper handling and storage conditions are crucial to ensure the product remains safe and effective for use.

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 children under 2 years, consultation with a doctor is advised prior to use. In cases of external anal itching, adults should clean the affected area with mild soap and warm water, rinse thoroughly, and gently dry before applying the product. Clinicians should also advise that children under 12 years of age consult a doctor before use.

Patients are encouraged to read all label directions carefully before using the medication and to retain the carton, as it contains important information.

Drug Information (PDF)

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

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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.