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Hydrocortisone

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Active ingredient
Hydrocortisone 10 mg/1 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 2024
Label revision date
September 25, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Hydrocortisone 10 mg/1 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 2024
Label revision date
September 25, 2025
Manufacturer
Walgreens Company
Registration number
M017
NDC root
0363-9981
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

Hydrocortisone Cream 1% is a topical medication designed to provide temporary relief from itching associated with minor skin irritations, inflammation, and rashes. It can be effective for conditions such as eczema, psoriasis, and reactions to poison ivy, oak, or sumac, as well as insect bites and irritations caused by detergents, jewelry, cosmetics, soaps, and seborrheic dermatitis. Additionally, it can help relieve external anal and genital itching.

This cream works by reducing inflammation and soothing the skin, making it a helpful option for managing discomfort from various skin issues. However, it's important to use it as directed and consult a doctor 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, psoriasis, and reactions to poison ivy, oak, or sumac. It also helps soothe itching from insect bites, as well as irritations caused by detergents, jewelry, cosmetics, soaps, and seborrheic dermatitis.

Additionally, this product can relieve external itching in the anal and genital areas. If you have other uses in mind, it's best to consult with your doctor for advice 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 important to consult a doctor before use.

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 or blotting 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 or for treating diaper rash—please consult a doctor in these cases. If your condition worsens, symptoms last longer than 7 days, or if they clear up and then return within a few days, stop using the product and talk to your doctor. Additionally, if you experience rectal bleeding, seek medical advice immediately.

While using this product, be careful to avoid contact with your eyes. Only use it as directed; do not exceed the recommended dosage unless your doctor advises otherwise. It's also important not to insert the product directly into the rectum using your fingers or any device.

Side Effects

When using this product, it's important to be aware of some potential side effects and warnings. You should avoid contact with your eyes and not use it more than directed unless advised by a doctor. If you experience worsening symptoms, if your condition persists for more than 7 days, or if you notice rectal bleeding, stop using the product and consult a doctor. Additionally, do not use this product in the genital area if you have a vaginal discharge or for treating diaper rash without consulting a healthcare professional.

If the product is swallowed, seek medical help or contact a Poison Control Center immediately. Remember, this product is for external use only.

Warnings and Precautions

This product is for external use only, so please avoid applying it to the genital area if you have a vaginal discharge or for treating diaper rash—consult your doctor in these cases. Be careful to keep it away from your eyes, and do not use more than the recommended amount unless your doctor advises otherwise. It's important not to insert the product directly into the rectum using fingers or any devices.

If your condition worsens, if symptoms last longer than 7 days, or if they improve and then return within a few days, stop using the product and consult your doctor. Additionally, if you experience rectal bleeding, stop use immediately and seek medical advice. Always keep this product out of reach of children, and if swallowed, seek medical help or contact a Poison Control Center right away.

Overdose

It's important to keep this medication out of reach of children. If a child accidentally swallows it, you should seek medical help immediately or contact a Poison Control Center.

In case of an overdose, you may notice signs such as unusual drowsiness, confusion, or difficulty breathing. If you or someone else experiences these symptoms, it's crucial to get emergency assistance right away. Always prioritize safety and act quickly if an overdose is suspected.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the safety of hydrocortisone cream during pregnancy has not been established. You should consult your doctor before using this medication, as there may be potential risks to your fetus. Your healthcare provider can help determine if the benefits of using hydrocortisone cream outweigh the risks in your specific situation.

Additionally, dosage adjustments may be necessary for pregnant individuals, so it's essential to seek your doctor's recommendations. Always use this cream only if it is clearly needed and under the guidance of a healthcare professional.

Lactation Use

When it comes to breastfeeding, it's important to be aware that there are no specific guidelines or statements regarding nursing mothers or lactation (the process of producing milk). This means that if you are breastfeeding, you may not find detailed information about how certain medications or treatments could affect you or your baby.

If you have concerns about breastfeeding while taking any medication, it's always best to consult with your healthcare provider for personalized advice and to ensure the safety of both you and your infant.

Pediatric Use

If your child is under 2 years old, it's important to consult a doctor before using this medication. For children under 12 years, you should also check with a doctor if the treatment is for external anal and genital itching.

For children aged 2 years and older, you can apply the medication to the affected area, but be sure not to exceed 3 to 4 applications per day. Always follow these guidelines to ensure your child's safety and well-being.

Geriatric Use

While there is no specific information about the use of Hydrocortisone Cream in older adults, it's important to approach its use with caution. Since the drug insert does not mention any dosage adjustments or safety concerns for elderly patients, you should consult with a healthcare provider before using this cream. They can help determine if it's appropriate for you or your loved one, considering any unique health needs or conditions that may be present. Always prioritize safety and seek professional advice when introducing new medications.

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 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 if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to discuss any concerns regarding your liver health and how it may relate to your treatment. They can help ensure that you receive the safest and most effective care.

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 health conditions you have to receive the best care possible.

Storage and Handling

To ensure the safety and effectiveness of your product, it's important to store it properly. Keep the product in a cool, dry place at a temperature between 20° to 25°C (68° to 77°F). Always check the carton or the crimp on the tube for the lot number and expiration date to ensure you are using a valid product.

When handling the product, be cautious and inspect the packaging. Do not use it if the pull tab seal on the tube has been removed, as this indicates that the product may have been tampered with. Following these guidelines will help you use the product safely and effectively.

Additional Information

The medication is applied topically, meaning it is used on the skin. It's important to keep this product out of reach of children. If a child accidentally swallows it, seek medical help or contact a Poison Control Center immediately for assistance.

FAQ

What is Hydrocortisone Cream 1% used for?

Hydrocortisone Cream 1% is used to temporarily relieve itching associated with minor skin irritations, inflammation, and rashes due to conditions like eczema, psoriasis, and insect bites.

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, and do not apply directly into the rectum. Consult a doctor if you have a vaginal discharge or are treating diaper rash.

What should I do if my condition worsens?

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?

The safety of Hydrocortisone Cream during pregnancy has not been established. Consult a doctor before use if you are pregnant or planning to become pregnant.

What should I do if I accidentally swallow the cream?

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

How should I store Hydrocortisone Cream?

Store the cream between 20° to 25°C (68° to 77°F) and do not use if the pull tab seal on the tube has been removed.

Packaging Info

Below are the non-prescription pack sizes of Hydrocortisone. 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, oak, 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 no more than 3 to 4 times daily. For children under 12 years of age, consultation with a physician is also recommended before use.

Contraindications

Use of this product is contraindicated in the following situations:

  • Application in the genital area is not recommended for patients with vaginal discharge; consultation with a healthcare professional is advised.

  • The product should not be used for the treatment of diaper rash without prior consultation with a healthcare professional.

Patients should discontinue use and seek medical advice if any of the following occur:

  • The condition worsens or symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. Do not initiate use of any other hydrocortisone product without consulting a healthcare professional.

  • Rectal bleeding is observed.

While using this product, it is essential to avoid contact with the eyes, adhere to the directed dosage unless otherwise instructed by a healthcare professional, and refrain from inserting the product directly into the rectum using fingers or any mechanical device or applicator.

Warnings and Precautions

This product is intended for external use only. It is imperative that healthcare professionals advise patients against using this product in the genital area if they are experiencing vaginal discharge; consultation with a physician is recommended in such cases. Additionally, this product should not be utilized for the treatment of diaper rash without prior medical consultation.

Healthcare providers should instruct patients to avoid contact with the eyes while using this product. It is crucial that patients adhere to the recommended dosage and refrain from exceeding the directed amount unless specifically instructed by a physician.

Patients must be cautioned against inserting the product directly into the rectum using fingers or any mechanical device or applicator. Should the patient's condition worsen, or if symptoms persist beyond 7 days, or if symptoms resolve and then recur within a few days, they should discontinue use and consult a healthcare professional. Furthermore, if rectal bleeding occurs, patients should stop using the product and seek medical advice.

To ensure safety, this product should be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center should be made without delay.

Side Effects

Patients using this product should be aware that it is intended for external use only. It is contraindicated for use in the genital area if a vaginal discharge is present, and patients are advised to consult a doctor in such cases. Additionally, the product should not be used for the treatment of diaper rash without prior consultation with a healthcare professional.

While using this product, patients should avoid contact with the eyes and adhere strictly to the recommended dosage. It is important not to exceed the directed use unless specifically instructed by a doctor. The product should not be administered directly into the rectum using fingers or any mechanical device or applicator.

Patients are advised to discontinue use and seek medical advice if the condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. Furthermore, if rectal bleeding occurs, patients should stop using the product and consult a healthcare provider.

In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center immediately.

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. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Hydrocortisone.
Details

Pediatric Use

Pediatric patients under 2 years of age should consult a healthcare professional before use. For children under 12 years of age, it is advised to seek medical guidance for the treatment of external anal and genital itching.

For pediatric patients aged 2 years and older, the medication may be applied to the affected area no more than 3 to 4 times daily.

Geriatric Use

Elderly patients may not have specific information regarding the use of Hydrocortisone Cream, including dosage adjustments, safety concerns, or special precautions. As such, healthcare providers should exercise caution when prescribing this medication to geriatric patients.

Due to the lack of available data, it is advisable for clinicians to closely monitor elderly patients for any potential adverse effects or changes in therapeutic response. Individual patient factors, including comorbidities and concurrent medications, should be considered when determining the appropriateness of Hydrocortisone Cream for this population.

Pregnancy

The safety of hydrocortisone cream 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; therefore, the use of hydrocortisone cream should be under the guidance of a healthcare professional.

Dosage adjustments may be necessary for pregnant individuals, and it is essential to seek recommendations from a doctor regarding appropriate dosing. Special precautions should be taken, and hydrocortisone cream should only be used if clearly needed, with a careful consideration of whether the benefits outweigh the risks during pregnancy.

Lactation

There are no specific statements regarding the use of this medication in lactating mothers or its effects on breastfed infants. Healthcare professionals should consider the absence of data when advising lactating mothers about the use of this medication.

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 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

In the event of an overdosage, it is imperative to keep the product out of reach of children. Should ingestion occur, immediate medical assistance is required. Healthcare professionals are advised to contact a Poison Control Center without delay to ensure appropriate management and intervention.

Prompt action is crucial in mitigating potential adverse effects associated with overdosage. The symptoms may vary depending on the specific substance involved, and healthcare providers should be prepared to assess and manage any clinical manifestations that arise.

In summary, vigilance in preventing access to the product by children and swift response to any incidents of ingestion are essential components of effective overdosage management.

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

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children. In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center immediately.

Patients should be informed not to use this product in the genital area if they have a vaginal discharge and to consult a doctor in such cases. Additionally, it is important to communicate that this product is not intended for the treatment of diaper rash, and patients should seek medical advice if they have such a condition.

Patients should be instructed to stop using the product and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. They should also be cautioned against using any other hydrocortisone products without prior consultation with a healthcare professional.

If patients experience rectal bleeding, they should discontinue use and seek medical advice. It is essential to remind patients to avoid contact with their eyes while using this product.

Patients should be advised not to exceed the recommended dosage unless directed by a healthcare provider. Furthermore, they should be informed not to insert the product directly into the rectum using fingers or any mechanical device or applicator.

Storage and Handling

The product is supplied in a tamper-evident tube. It is essential to refrain from using the product if the pull tab seal on the tube has been removed.

For optimal storage, the product should be maintained at a temperature range of 20° to 25°C (68° to 77°F). Users are advised to check the carton or the tube crimp for the lot number and expiration date to ensure product integrity and safety.

Additional Clinical Information

The route of administration for the medication is topical. Clinicians should advise patients to keep the product out of reach of children. In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center immediately. No further information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

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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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.