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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)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 1989
Label revision date
July 7, 2025
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 1989
Label revision date
July 7, 2025
Manufacturer
Sun Pharmaceutical Industries, Inc.
Registration number
M017
NDC root
51672-2063
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 is a topical cream designed to provide temporary relief from itching caused by minor skin irritations and rashes. It contains 1% hydrocortisone, which is an anti-itch medication, and is formulated with 12 moisturizers to help soothe the skin. This cream can be used for various conditions, including eczema, insect bites, poison ivy, poison oak, and reactions to soaps, detergents, cosmetics, and jewelry.

When applied, hydrocortisone works by reducing inflammation and alleviating discomfort, making it a helpful option for managing symptoms associated with skin conditions like seborrheic dermatitis and psoriasis, as well as external genital and anal itching. For any other uses, it's important to consult with a doctor for guidance.

Uses

This product is designed to provide temporary relief from itching caused by various minor skin irritations and rashes. You can use it for conditions like eczema, insect bites, and reactions to plants such as poison ivy, poison oak, or poison sumac. It can also help soothe itching from soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis, and even external genital and anal itching.

For any other uses, it's important to consult with your doctor to ensure it's appropriate for your situation.

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. However, if your child is under 2 years old, you should not use this product and should consult a doctor instead.

For treating external anal itching, adults should first clean the affected area with mild soap and warm water, making sure to rinse it thoroughly. After cleaning, gently dry the area by patting or blotting it with toilet tissue or a soft cloth before applying the medication. If your child is under 12 years old, it's important to consult a doctor before use.

What to Avoid

You should avoid using this product in your eyes or inserting it into the rectum with fingers or any devices. If your condition worsens, lasts more than seven days, or clears up only to return within a few days, stop using the product and consult a doctor. It's important not to start any other hydrocortisone product without medical advice.

While using this product, please consult your doctor if you feel the need to exceed the recommended dosage. This ensures your safety and helps prevent potential misuse or dependence (a condition where you may feel unable to stop using a substance).

Side Effects

When using this product, it's important to be aware of some potential side effects and warnings. This product is for external use only and should not be applied to the eyes or inserted into the rectum using fingers or any devices. If you experience a vaginal discharge, rectal bleeding, or diaper rash, consult a doctor before using it.

You should also stop using the product and seek medical advice if your condition worsens, does not improve after 7 days, or clears up only to return within a few days. Additionally, if the product is swallowed, seek medical help or contact a Poison Control Center immediately. Always follow the recommended dosage and consult a doctor if you have any concerns.

Warnings and Precautions

This product is intended for external use only, so please avoid contact with your eyes and do not insert it into the rectum using fingers or any devices. Before using this product, it's important to consult your doctor if you have any vaginal discharge, rectal bleeding, or diaper rash.

While using this product, be sure to follow the recommended dosage. If your condition worsens, does not improve after 7 days, or clears up only to return within a few days, stop using it and contact your doctor. Additionally, keep this product out of reach of children. If swallowed, seek medical help or contact a Poison Control Center immediately.

Overdose

If you or someone else has swallowed too much of this medication, it’s important to seek medical help immediately. You can do this by contacting a Poison Control Center or going to the nearest emergency room.

Signs of an overdose can vary, but they may include unusual symptoms that are not typical for you. If you notice anything concerning, don’t hesitate to reach out for help. Remember, acting quickly can make a significant difference in ensuring safety and health.

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 Plus 12 Moisturizers during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions related to its use while pregnant have not been established.

Before using this product, it’s advisable to consult with your healthcare provider to discuss any potential risks and to ensure that you are making the best choice for your health and your baby's health.

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, the information provided does not mention any concerns about the product being excreted in breast milk, which means it is not expected to affect your milk supply or your nursing infant. Always consult with your healthcare provider if you have any questions or concerns 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 under 12 years old, it's best to check with a doctor before use to ensure it's safe and appropriate for them. Always prioritize your child's health and safety 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 healthcare providers may not have tailored guidelines for elderly patients.

If you or a loved one is an older adult considering this medication, it’s important to discuss any potential risks and benefits with your healthcare provider. They can help determine the best approach based on individual health needs and circumstances.

Renal Impairment

If you have kidney problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or safety considerations for your condition. This means that there are no tailored guidelines for how this medication should be used if you have renal impairment (kidney issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your health situation. They can help you understand how to manage your treatment effectively while considering your kidney health.

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).

Before starting any new medication, including this one, you should discuss your liver health with your healthcare provider. They can help determine the best approach for your treatment and ensure your safety.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking, even if there are no specific drug interactions or laboratory test interactions noted for your treatment. This ensures that your healthcare team can monitor your health effectively and make informed decisions about your care.

Always feel free to ask questions and share any other medications or supplements you may be using. This helps to create a comprehensive picture of your health and ensures your safety while receiving treatment.

Storage and Handling

To ensure the best performance of your product, store it at room temperature. It's important to check the carton or tube crimp for the lot number and expiration date, as this information helps you confirm the product's safety and effectiveness.

When handling the product, always do so with care to maintain its integrity. Following these simple storage and handling guidelines will help you use the product safely and effectively.

Additional Information

You should apply this product to the affected area no more than 3 to 4 times a day if you are an adult or a child aged 2 years and older. If you are dealing with external anal itching, it's recommended to first cleanse the area with mild soap and warm water, rinse thoroughly, and then gently dry it by patting or blotting with toilet tissue or a soft cloth before applying the product.

FAQ

What is Hydrocortisone used for?

Hydrocortisone is used for temporary relief of itching associated with minor skin irritations and rashes, including conditions like eczema, insect bites, and poison ivy.

How should I apply Hydrocortisone?

For adults and children 2 years and older, apply to the affected area not more than 3 to 4 times daily. Children under 2 years should not use it without consulting a doctor.

Are there any side effects of using Hydrocortisone?

If your condition worsens, persists for more than 7 days, or clears up and occurs again within a few days, stop use and consult a doctor.

Can I use Hydrocortisone on my face or near my eyes?

No, do not use Hydrocortisone in the eyes or by putting it into the rectum using fingers or any device.

What should I do if I swallow Hydrocortisone?

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

Is Hydrocortisone safe to use during pregnancy?

There is no specific information regarding the use of Hydrocortisone during pregnancy in the provided text, so consult your doctor.

What should I do if my symptoms do not improve?

If your symptoms do not improve or worsen, consult a doctor before using any other hydrocortisone product.

How should I store Hydrocortisone?

Store Hydrocortisone at room temperature and check the carton or tube crimp for the lot number and expiration date.

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

Hydrocortisone 1% is a topical cream formulated for antipruritic (anti-itch) purposes. Each 1 oz (28.4 g) tube contains hydrocortisone as the active ingredient, complemented by a blend of 12 moisturizers to enhance skin hydration and comfort. The cream is designed for local application to alleviate itching and irritation associated with various dermatological conditions.

Uses and Indications

This drug is indicated for the temporary relief of itching associated with minor skin irritations and rashes due to various conditions, including eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis, and external genital and anal itching.

Other uses of this product should only be undertaken under the advice and supervision of a healthcare professional.

Dosage and Administration

For adults and children aged 2 years and older, the recommended application frequency is to apply the product to the affected area no more than 3 to 4 times daily. For children under 2 years of age, the product should not be used without consulting a doctor.

In cases of external anal itching, it is advised that adults first cleanse 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 prior to the application of the product.

For children under 12 years of age, consultation with a doctor is recommended before use.

Contraindications

This product is contraindicated for use in the eyes and for rectal administration via fingers, mechanical devices, or applicators.

If the condition worsens, persists for more than 7 days, or resolves and recurs within a few days, discontinue use and consult a healthcare professional. The use of any other hydrocortisone product should not be initiated without prior consultation with a doctor.

Additionally, it is advised to consult a healthcare professional before exceeding the recommended dosage.

Warnings and Precautions

This product is intended for external use only. It is imperative that the product is not applied in or around the eyes, nor should it be administered rectally using fingers, mechanical devices, or applicators.

Healthcare professionals should advise patients to consult a physician prior to use if they are experiencing any of the following conditions: vaginal discharge, rectal bleeding, or diaper rash. These conditions may require further evaluation and management.

During the use of this product, it is crucial to adhere to the recommended dosage. Patients should be instructed to seek medical advice before exceeding the prescribed amount.

Patients must discontinue use and consult a healthcare provider if any of the following occur: the condition worsens, persists for more than 7 days, or resolves only to recur within a few days. It is essential that patients do not initiate the use of any other hydrocortisone products without prior consultation with a physician.

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 eyes and should not be administered rectally, either by fingers or any mechanical device or applicator.

Before using this product, patients are advised to consult a doctor if they have a vaginal discharge, rectal bleeding, or diaper rash. During the use of this product, it is important to adhere to the recommended dosage; exceeding this dosage may require consultation with a healthcare professional.

Patients should discontinue use and seek medical advice if their condition worsens, persists for more than 7 days, or if the condition resolves and then recurs within a few days. It is also recommended that patients do not initiate the use of any other hydrocortisone product without prior consultation with a doctor.

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

Drug Interactions

There are no specific drug interactions or laboratory test interactions identified in the available data. Therefore, no recommendations for dosage adjustments or monitoring are necessary 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 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 healthcare professional is advised. Additionally, for children under 12 years of age, it is important to consult a doctor prior to use.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

There is no specific information available regarding the use of Hydrocortisone Plus 12 Moisturizers during pregnancy. As such, the safety of this product in pregnant patients has not been established. Healthcare professionals should consider the lack of data when prescribing this product to women of childbearing potential and weigh the potential benefits against any unknown risks to fetal outcomes. It is advisable to exercise caution and discuss any concerns with patients who are pregnant or planning to become pregnant.

Lactation

There are no specific warnings or recommendations regarding the use of this product by nursing mothers. Additionally, there are no considerations or precautions mentioned concerning lactation or the potential for excretion in breast milk.

Renal Impairment

Patients with renal impairment have not been specifically studied in relation to dosage adjustments, special monitoring, or safety considerations for this medication. As such, there is no available information regarding the use of this drug in individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing this medication to patients with renal impairment.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to 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 prescribing information.

Overdosage

In the event of an overdosage, immediate medical assistance is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical help or contact a Poison Control Center without delay.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and evaluation are recommended to ensure patient safety and effective resolution of any complications arising from the overdosage.

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 use of the compound in these contexts.

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 to prevent accidental ingestion. In the event of swallowing the product, patients should seek medical help or contact a Poison Control Center immediately.

Patients should be informed that this product is not intended for use in the eyes and should not be administered rectally using fingers, mechanical devices, or applicators. They should be instructed to stop using the product and consult a doctor if their condition worsens, persists for more than 7 days, or if the condition clears up and then recurs within a few days. It is important to note that patients should not begin using any other hydrocortisone product without first consulting a doctor.

When using this product, patients should be cautioned to consult a doctor before exceeding the recommended dosage. Additionally, patients should be advised to seek medical advice before use if they experience vaginal discharge, rectal bleeding, or have a diaper rash.

Storage and Handling

The product is supplied in various packaging configurations, with specific NDC numbers available for identification. It should be stored at room temperature to maintain its efficacy. Healthcare professionals are advised to check the carton or tube crimp for the lot number and expiration date to ensure proper tracking and usage.

Additional Clinical Information

For patients aged 2 years and older, the product should be applied to the affected area no more than 3 to 4 times daily. In cases of external anal itching, it is recommended that adults cleanse the affected area with mild soap and warm water, rinse thoroughly, and gently dry by patting or blotting with toilet tissue or a soft cloth prior to application.

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.

Learn more in our Editorial Policy

Last AI update:

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.