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Hydrocortisone

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Active ingredient
Hydrocortisone 1 mg/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 2025
Label revision date
March 3, 2026
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Hydrocortisone 1 mg/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 2025
Label revision date
March 3, 2026
Manufacturer
PHARMACY CHOICE INC
Registration number
M017
NDC root
87228-2010
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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 used to relieve itching caused by skin irritation, inflammation, and rashes. It is suitable for adults and children aged 2 years and older, and can be applied to the affected area up to 3 to 4 times daily. For children under 2 years of age, it is important to consult a doctor before use.

Additionally, it can be used for external anal and genital itching in adults, where it is recommended to cleanse the area with mild soap and warm water before application. Always ensure the area is gently dried before applying the medication. If you have any questions or concerns about its use, especially for children under 12, it's best to consult a healthcare professional.

Uses

You can use this medication to help relieve itching caused by skin irritation, inflammation, and rashes. It is also effective for alleviating external anal and genital itching in adults.

Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) associated with this medication, making it a safer option for those concerned about such risks.

Dosage and Administration

When using this medication, it's important to avoid contact with your eyes to prevent irritation or damage. Always follow the dosage instructions provided; do not use more than directed unless your doctor advises you to do so.

Additionally, please refrain from inserting the medication directly into the rectum using your fingers or any mechanical device or applicator. This ensures safe and effective use of the product while minimizing the risk of complications. If you have any questions or concerns about how to use this medication, don't hesitate to reach out to your healthcare provider for guidance.

What to Avoid

It's important to be cautious when using this medication. You should not apply it to the genital area if you have a vaginal discharge, and it's also advised not to use it for diaper rash without first consulting your doctor.

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 medication and speak with your doctor. Additionally, if you experience any rectal bleeding, seek medical advice immediately. Always prioritize your health and safety by following these guidelines.

Side Effects

This product is intended for external use only. You should stop using it and consult a doctor if your condition worsens, if your symptoms last longer than 7 days, or if they improve and then return within a few days. Additionally, seek medical advice if you experience any rectal bleeding.

Warnings and Precautions

This product is for external use only, so please avoid swallowing it. If you accidentally swallow it, seek emergency medical help immediately or contact the Poison Control Center at 1-800-222-1222.

You should stop using this product and call your doctor if your condition worsens, if your symptoms last more than 7 days, or if they improve and then return within a few days. Additionally, if you experience any rectal bleeding, it’s important to stop use and consult your doctor right away. Please do not start using any other hydrocortisone product without first discussing it with your healthcare provider.

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 services 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

When considering the use of Hydrocortisone 1% cream during pregnancy, it's important to note that the drug insert does not provide specific information about its safety, dosage adjustments, or any special precautions for pregnant individuals. This means that there are no established guidelines or known risks associated with its use in pregnancy.

If you are pregnant or planning to become pregnant, it's always best to consult with your healthcare provider before using any medication, including over-the-counter creams like Hydrocortisone. They can help you weigh the potential benefits and risks based on your individual health needs.

Lactation Use

If you are breastfeeding and considering the use of hydrocortisone 1% cream, you can feel reassured that there are no specific warnings or recommendations against its use for nursing mothers. Additionally, the information available does not indicate any concerns about the cream being passed into breast milk or posing any risk to your infant.

As always, it's a good idea to consult with your healthcare provider if you have any questions or concerns about using any medication while breastfeeding.

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 can also apply the treatment up to 3 to 4 times daily. But for children under 12 years of age, you should seek advice from a doctor before use. Always prioritize your child's safety and consult a healthcare professional if you have any concerns.

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 prioritize open communication with your healthcare team to ensure safe and effective treatment.

Renal Impairment

If you have kidney problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that there are no special monitoring requirements or safety considerations outlined for patients like you with renal impairment (kidney issues).

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can provide guidance tailored to your specific situation.

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. 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 lab tests you may be undergoing. This way, you can receive the best possible care tailored to your needs.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 20° - 25°C (68° - 77°F). It's important to check the carton or tube crimp for the lot number and expiration date, as this information helps you keep track of the product's safety and effectiveness.

When handling the product, always do so with clean hands and in a clean environment to maintain its integrity. If you have any questions about disposal or specific handling instructions, please refer to the product packaging or consult a healthcare professional for guidance.

Additional Information

No further information is available.

FAQ

What is the drug indicated for?

The drug is indicated for itching of skin irritation, inflammation, and rashes, as well as for external anal and genital itching in adults.

How should I apply the drug?

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

What should I do before applying the drug for external anal and genital itching?

When practical, cleanse the affected area with mild soap and warm water, rinse thoroughly, and gently dry by patting or blotting before applying.

Are there any contraindications for using this drug?

Do not use in the genital area if you have a vaginal discharge or for the treatment of diaper rash without consulting a doctor.

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 this drug safe to use during pregnancy?

There is no specific information regarding the use of this drug during pregnancy, so consult your doctor for advice.

Can nursing mothers use this drug?

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

What should I do if I accidentally swallow the drug?

If swallowed, get medical help or contact Poison Control Center right away at 1-800-222-1222.

How should I store this drug?

Store the drug between 20° - 25°C (68° - 77°F).

What should I avoid while using this drug?

Avoid contact with eyes and do not use more than directed unless told to do so by a doctor.

Packaging Info

Below are the non-prescription pack sizes of Hydrocortisone (hydrocortisone 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 specified drug.

Uses and Indications

This drug is indicated for the relief of itching associated with skin irritation, inflammation, and rashes. It is also indicated for the treatment of external anal and genital itching in adults.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Healthcare professionals should instruct patients to avoid contact with the eyes during the administration of this medication. It is essential to adhere strictly to the prescribed dosage and not exceed the recommended amount unless directed by a physician.

Patients should be advised against inserting the medication directly into the rectum using fingers, mechanical devices, or applicators, as this may lead to complications or ineffective treatment. Proper administration techniques should be emphasized to ensure safety and efficacy.

Contraindications

Use is contraindicated in the following situations:

The product should not be applied to the genital area in patients with a vaginal discharge due to the potential for exacerbating the condition. Additionally, it is contraindicated for the treatment of diaper rash unless a healthcare professional has been consulted, as improper use may lead to complications.

Patients should discontinue use and seek medical advice if the condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. Rectal bleeding is also a reason to stop use and consult a doctor.

Warnings and Precautions

For external use only. It is imperative that healthcare professionals advise patients to adhere strictly to this guideline to prevent unintended ingestion or misuse of the product.

In the event of accidental ingestion, immediate medical assistance is required. Patients should be instructed to seek emergency medical help or contact the Poison Control Center at 1-800-222-1222 without delay.

Healthcare providers should monitor patients closely and advise them to discontinue use and consult a physician if any of the following conditions arise: worsening of the condition being treated, persistence of symptoms beyond 7 days, or recurrence of symptoms after initial improvement. It is crucial that patients refrain from using any other hydrocortisone products unless directed by a healthcare professional.

Additionally, patients should be informed to seek medical attention if rectal bleeding occurs, as this may indicate a serious underlying condition that requires further evaluation.

Side Effects

For external use only. Patients are advised to discontinue use and consult a healthcare professional 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 seek medical attention 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 Hydrocortisone (hydrocortisone 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 apply the medication to the affected area for itching associated with skin irritation, inflammation, and rashes, not exceeding 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 may apply the medication to the affected area up to 3 to 4 times daily. However, for children under 12 years of age, it is recommended to seek a doctor's advice before application.

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 1% cream during pregnancy, including safety concerns, dosage modifications, or special precautions. As such, the available data does not provide sufficient information to assess the potential risks or benefits of this medication in pregnant patients. Healthcare professionals should consider the lack of specific guidance and weigh the potential risks versus benefits when prescribing this medication to women of childbearing potential. It is advisable to monitor for any adverse effects in both the mother and fetus if Hydrocortisone 1% cream is used during pregnancy.

Lactation

There are no specific warnings or recommendations regarding the use of hydrocortisone 1% cream in lactating mothers. Additionally, there is no information available concerning 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 based on clinical judgment.

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. If symptoms of overdosage are observed, appropriate interventions should be implemented based on the patient's condition.

Healthcare professionals should also consider contacting a poison control center or a medical toxicologist for guidance on management strategies tailored to the specific situation. It is crucial to document any overdosage incidents thoroughly and report them to the relevant regulatory authorities as part of ongoing pharmacovigilance efforts.

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 reactions, and contact dermatitis. 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 the Poison Control Center at 1-800-222-1222 if the product is swallowed. It is important to inform patients that the product should not be applied to the genital area if they have a vaginal discharge. Additionally, patients should be cautioned against using the product for the treatment of diaper rash and should consult a doctor for appropriate alternatives.

Patients should be instructed to discontinue use and consult a healthcare professional if their condition worsens. They should also be advised to stop using the product and seek medical advice if symptoms persist for more than 7 days, or if symptoms improve and then recur within a few days. It is essential to inform patients not to begin the use of any other hydrocortisone product without first consulting a doctor.

Furthermore, patients should be made aware that they must stop use and contact a healthcare provider if they experience rectal bleeding. Finally, any other uses of this product should only be undertaken with the advice and supervision of a healthcare professional.

Storage and Handling

The product is supplied in various packaging configurations, with specific NDC numbers available for identification. It should be stored at a temperature range of 20° to 25°C (68° to 77°F) to ensure optimal stability and efficacy.

Healthcare professionals are advised to check the carton or tube crimp for the lot number and expiration date, which are essential for tracking and inventory management. Proper handling and storage conditions are crucial to maintain the integrity of the product.

Additional Clinical Information

No further data are available.

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.

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.