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Hydrocortisone

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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)
Marketed in the U.S.
Since 2026
Label revision date
February 10, 2026
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
Marketed in the U.S.
Since 2026
Label revision date
February 10, 2026
Manufacturer
Aldermed Inc.
Registration number
M017
NDC root
87236-003

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Drug Overview

Hydrocortisone Cream 1 with Aloe Vera is a topical medication designed to temporarily relieve itching caused by minor skin irritations, inflammation, and rashes. It is effective for various conditions, including eczema, psoriasis, and reactions to poison ivy, poison oak, and poison sumac. Additionally, it can help soothe itching from insect bites, detergents, jewelry, cosmetics, soaps, and seborrheic dermatitis. This cream is also used to alleviate external anal and genital itching.

While Hydrocortisone Cream can provide relief for these skin issues, it's important to use it under the advice and supervision of a doctor for any other uses.

Uses

This product is designed to provide temporary relief from itching caused by various minor skin irritations, including conditions like eczema, psoriasis, and rashes from poison ivy, poison oak, and poison sumac. It can also help soothe itching from insect bites, reactions to detergents, jewelry, cosmetics, soaps, and seborrheic dermatitis.

In addition to skin irritations, this product can temporarily relieve itching in external anal and genital areas. For any other uses, it's important to consult with your doctor for guidance and supervision.

Dosage and Administration

If you're dealing with itching from skin irritation, inflammation, or rashes, you can apply the medication to the affected area up to 3 to 4 times a day if you are an adult or a child aged 2 years and older. However, if your child is under 2 years old, it's best to consult a doctor before using it.

For external itching around the anal and genital areas, adults should first clean the area with mild soap and warm water, making sure to rinse thoroughly. After cleaning, gently dry the area by patting it with toilet tissue or a soft cloth. You can then apply the medication to the affected area, again up to 3 to 4 times daily. If the person needing treatment is under 12 years old, please consult a doctor for guidance.

What to Avoid

You should avoid using this product in the genital area if you have a vaginal discharge; it's important to consult a doctor in this case. Additionally, do not use it for treating diaper rash without medical advice. Always keep the product away from your eyes, and follow the usage instructions carefully—do not exceed the recommended amount unless directed by a healthcare professional. Lastly, avoid inserting the product directly into the rectum using fingers or any devices. If you have any questions or concerns, please reach out to your doctor for guidance.

Side Effects

It's important to use this product only on the skin and not for any other purposes. If your condition worsens, if symptoms last longer than 7 days, or if they improve and then return within a few days, you should stop using the product and consult a doctor. Additionally, if you experience rectal bleeding, seek medical advice immediately. Avoid starting any other hydrocortisone products without first discussing it with your healthcare provider.

Warnings and Precautions

This product is for external use only, so please avoid applying it to any internal areas. If you have a vaginal discharge, do not use it in the genital area and consult your doctor. Additionally, it is not intended for treating diaper rash; please speak with a healthcare professional if you need guidance.

You should stop using this product and contact your doctor if your condition worsens, if symptoms last longer than 7 days, or if they improve and then return within a few days. Also, seek medical advice if you experience any rectal bleeding. If the product is swallowed, it’s important to get emergency help immediately or contact a Poison Control Center at 1-800-222-1222.

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, you should call your local emergency number or go to the nearest hospital. Always keep your medications in a safe place 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 there is no specific information available about the use of Hydrocortisone Cream 1% with Aloe during pregnancy. This means that safety concerns, dosage adjustments, or special precautions have not been clearly established.

Before using this cream, it’s a good idea to consult with your healthcare provider to discuss any potential risks and to ensure that it is safe for you and your baby. Always prioritize open communication with your doctor regarding any medications you consider during pregnancy.

Lactation Use

If you are breastfeeding and considering the use of hydrocortisone cream, you can feel reassured that there are no specific warnings or recommendations against its use for nursing mothers. Additionally, there is no information indicating that hydrocortisone cream is passed into breast milk or poses any risk to your infant while you are breastfeeding.

As always, if you have any concerns or questions about using this cream or any medication while nursing, it's a good idea to consult with your healthcare provider for personalized advice.

Pediatric Use

If your child is experiencing itching from skin irritation, inflammation, or rashes, you can apply the treatment to the affected area up to 3 to 4 times a day for children aged 2 years and older. However, if your child is under 2 years old, it's important to consult a doctor before using the product.

For external anal and genital itching, adults should clean the area with mild soap and warm water, then gently dry it before applying the treatment. If your child is under 12 years old, please ask a doctor for guidance before use. Always prioritize your child's safety and well-being by seeking 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 considering this medication, it’s important to consult with a healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken.

Always keep in mind that older adults may have different responses to medications, so discussing any concerns with a doctor is essential for ensuring safety and effectiveness.

Renal Impairment

If you have kidney problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to change based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective for your specific situation. They can help monitor your kidney health and make any necessary adjustments to your medications.

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 is different, and your healthcare provider can help ensure that your treatment is safe and effective based on your unique health needs. 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 use of your product, start by carefully opening it: unscrew the cap and pull the tab to remove the foil seal. It's important to store the product at room temperature, ideally between 20°-25°C (68-77°F). This helps maintain its effectiveness.

Always check the crimp of the tube or the carton for the lot number and expiration date, as this information is crucial for safety and quality. Proper handling and storage will help you use the product safely and effectively.

Additional Information

You can use this medication topically to relieve itching caused by skin irritation, inflammation, and rashes. For both adults and children aged 2 years and older, apply it to the affected area no more than 3 to 4 times a day. If you're dealing with external anal and genital itching, adults should also apply it to the affected area up to 3 to 4 times daily. Always follow the recommended application frequency for the best results.

FAQ

What is Hydrocortisone Cream 1 with Aloe Vera used for?

It temporarily relieves itching associated with minor skin irritations, inflammation, and rashes.

What conditions can Hydrocortisone Cream relieve itching from?

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

How should I apply Hydrocortisone Cream?

For adults and children 2 years and older, apply to the affected area not more than 3 to 4 times daily. For children under 2 years, consult a doctor.

Are there any precautions I should take when using this cream?

Avoid contact with eyes, do not use more than directed unless advised by a doctor, and do not apply directly into the rectum.

Can I use Hydrocortisone Cream for diaper rash?

No, do not use it for the treatment of diaper rash; consult a doctor instead.

What should I do if my condition worsens or does not improve?

Stop use and ask a doctor if your condition worsens, symptoms persist for more than 7 days, or if rectal bleeding occurs.

Is it safe to use Hydrocortisone Cream during pregnancy or while breastfeeding?

There is no specific information regarding its use during pregnancy or breastfeeding, so consult a doctor for advice.

What should I do if I accidentally swallow Hydrocortisone Cream?

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

Packaging Info

Below are the non-prescription pack sizes of Hydrocortisone (hydrocortisone cream 1%). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Hydrocortisone.
Details

Drug Information (PDF)

This file contains official product information for Hydrocortisone, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

No description information is available for the 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, psoriasis, poison ivy, poison oak, poison sumac, insect bites, detergents, jewelry, cosmetics, soaps, and seborrheic dermatitis. Additionally, it provides temporary relief for external anal and genital 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 the treatment of itching associated with skin irritation, inflammation, and rashes, the recommended dosage for adults and children aged 2 years and older is to apply the medication to the affected area no more than 3 to 4 times daily. For children under 2 years of age, it is advised to consult a physician prior to use.

In cases of external anal and genital itching in adults, it is recommended to first clean the affected area with mild soap and warm water, ensuring thorough rinsing. After cleansing, the area should be gently dried by patting or blotting with toilet tissue or a soft cloth. The medication should then be applied to the affected area, not exceeding 3 to 4 applications per day. For children under 12 years of age, consultation with a physician is also recommended before use.

Contraindications

Use is contraindicated in the following situations:

The product should not be applied to the genital area in the presence of vaginal discharge; medical consultation is advised. Additionally, it is contraindicated for the treatment of diaper rash, and a healthcare professional should be consulted in such cases.

Contact with the eyes must be avoided. The product should not be used in excess of the directed dosage unless specifically instructed by a physician. Furthermore, direct application into the rectum using fingers, mechanical devices, or applicators is prohibited.

Warnings and Precautions

For external use only. This product is not intended for internal use and should be applied solely to the skin as directed.

General precautions must be observed when using this product. It is contraindicated for use in the genital area if there is a vaginal discharge; in such cases, consultation with a healthcare professional is advised. Additionally, this product should not be used for the treatment of diaper rash without prior consultation with a doctor.

Healthcare professionals should instruct patients to discontinue use and seek medical advice if any of the following occur: the condition worsens, symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. Patients should also be advised against using any other hydrocortisone products unless directed by a healthcare provider. Immediate medical attention is required if rectal bleeding occurs.

In the event of accidental ingestion, it is imperative to seek emergency medical assistance or contact a Poison Control Center immediately at 1-800-222-1222.

Side Effects

For external use only. Patients should discontinue use and consult a doctor if the condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. Additionally, patients should not begin the use of any other hydrocortisone product without first consulting a healthcare professional. Rectal bleeding is another serious condition that necessitates immediate medical attention.

Drug Interactions

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

Packaging & NDC

Below are the non-prescription pack sizes of Hydrocortisone (hydrocortisone cream 1%). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Hydrocortisone.
Details

Pediatric Use

Pediatric patients aged 2 years and older may use the medication for the relief of itching associated with skin irritation, inflammation, and rashes. The recommended application is to the affected area not more than 3 to 4 times daily. For children under 2 years of age, consultation with a doctor is advised prior to use.

In cases of external anal and genital itching, adults are instructed to clean the affected area with mild soap and warm water, rinse thoroughly, and gently dry before application. This medication should also be applied to the affected area not more than 3 to 4 times daily. For children under 12 years of age, it is recommended to seek medical advice before 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

There is no specific information available regarding the use of Hydrocortisone Cream 1% with Aloe during pregnancy. As such, the safety of this medication in pregnant patients has not been established, and there are no known dosage modifications or special precautions recommended for its use in this population. Healthcare professionals should weigh the potential benefits against any unknown risks when considering the use of this medication in pregnant patients. Women of childbearing potential should be advised to discuss their pregnancy status and any potential risks with their healthcare provider before using this product.

Lactation

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

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

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 in these patients to ensure safety and therapeutic effectiveness.

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

No postmarketing experience details are provided in the insert.

Patient Counseling

Patients should be advised to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 if the product is swallowed. It is important to inform patients to consult a doctor if they experience a vaginal discharge in the genital area or if they are considering using the product for the treatment of diaper rash.

Healthcare providers should instruct patients to monitor their condition closely. If symptoms worsen, persist for more than 7 days, or if symptoms clear up and then recur within a few days, patients should refrain from using any other hydrocortisone product unless directed by a doctor. Patients should also be made aware that rectal bleeding is a serious concern and requires immediate medical attention.

Patients must be cautioned to avoid contact with the eyes and to adhere strictly to the recommended dosage. They should not use the product more than directed unless specifically instructed to do so by a healthcare professional. Additionally, patients should be informed that the product should not be inserted directly into the rectum using fingers, mechanical devices, or applicators.

Storage and Handling

The product is supplied in a tube format, with specific instructions for opening: the cap should be unscrewed, and the tab should be pulled to remove the foil seal. It is essential to store the product at room temperature, within the range of 20°-25°C (68-77°F). For traceability, the lot number and expiration date can be found on the crimp of the tube or the carton.

Additional Clinical Information

The medication is administered topically for the treatment of itching associated with skin irritation, inflammation, and rashes in patients aged 2 years and older. It is recommended that the affected area be treated no more than 3 to 4 times daily. For external anal and genital itching in adults, the same frequency of application is advised.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Hydrocortisone, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Hydrocortisone, retrieved by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

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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.