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Hydrocortisone 1%

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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 2024
Label revision date
June 4, 2024
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 2024
Label revision date
June 4, 2024
Manufacturer
Chain Drug Marketing Association Inc.
Registration number
M017
NDC root
83324-047
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 Max Strength is a topical medication designed to provide temporary relief from itching caused by minor skin irritations, inflammation, and rashes. It is commonly used for conditions such as eczema (a chronic skin condition that causes inflammation and irritation), seborrheic dermatitis (a skin disorder that causes scaly patches), psoriasis (a skin disease that causes red, itchy scaly patches), insect bites, and reactions to plants like poison ivy, oak, and sumac, as well as irritations from soaps, detergents, cosmetics, and jewelry.

This cream works by reducing inflammation and alleviating discomfort in the affected areas. While it can be effective for these common skin issues, it's important to use it under the guidance of a healthcare professional for any other uses.

Uses

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

For any other uses, it’s important to consult with your doctor to ensure safety and effectiveness.

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. Before applying, it’s best to clean the area with mild soap and warm water, rinsing thoroughly. Alternatively, you can gently pat or blot the area with toilet tissue or a soft cloth.

If you are caring for a child under 2 years old, do not use this product without consulting a doctor first. Additionally, if a child under 12 years old is experiencing external anal itching, it’s important to speak with a doctor before using this medication.

What to Avoid

It's important to use this product safely and effectively. You should not start using any other hydrocortisone product without first consulting your doctor. Additionally, make sure to follow the recommended daily dosage closely; exceeding this dosage is not advised unless your doctor specifically instructs you to do so, especially for conditions like external genital, feminine, and anal itching.

Also, please avoid inserting this product into the rectum using your fingers or any medicated device or applicator, as this can lead to complications. 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 or if your symptoms last longer than 7 days. If your symptoms improve and then return within a few days, discontinue use and do not start any other hydrocortisone product unless your doctor advises you to do so.

Warnings and Precautions

This product is for external use only, so please avoid using it for diaper rash or for external genital itching if you have a vaginal discharge; in these cases, consult your doctor. Always keep this product out of the reach of children. If it is swallowed, seek medical help or contact a Poison Control Center right away.

You should stop using this product and call your doctor if your condition worsens, if symptoms last longer than 7 days, or if symptoms improve and then return within a few days. Do not start using any other hydrocortisone product without your doctor's guidance.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While there are no specific signs or symptoms listed for an overdose, you should be aware of general warning signs such as extreme drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms or feel something is wrong, seek medical help right away.

In case of an overdose, contact your local emergency services or go to the nearest hospital. It's always better to be safe and get checked by a healthcare professional if you have any concerns about your health. Remember, timely intervention can make a significant difference.

Pregnancy Use

This product is intended for external use only, so it's important to avoid using it for diaper rash. If you experience external genital itching and have a vaginal discharge, please consult your doctor for guidance. If you have children under 2 years old, do not use this product without consulting a doctor, and for children under 12 years old, especially for external and anal itching, it's best to seek medical advice as well.

While the provided information does not specify any particular risks or safety concerns related to pregnancy, it's always wise to consult your healthcare provider before using any new product during pregnancy. They can help ensure that you make safe choices for both you and your baby.

Lactation Use

If you are breastfeeding, it's important to consult your doctor before using this product. There is a possibility that it may be excreted in breast milk, which means it could potentially affect your nursing infant. Therefore, exercising caution while using this product during breastfeeding is highly recommended. Always prioritize your health and your baby's well-being by discussing any concerns with your healthcare provider.

Pediatric Use

If your child is under 2 years old, it's important not to use this medication without first consulting a doctor. For children aged 2 years and older, you can apply the medication to the affected area up to 3 to 4 times a day. However, if your child is under 12 years old and is experiencing external anal itching, please consult a doctor before use. Always prioritize your child's safety and seek professional advice when needed.

Geriatric Use

While there is no specific information about the use of Hydrocortisone 1% 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 your needs and ensure that it is used safely, considering any other medications or health conditions you may have. Always prioritize open communication with your healthcare team to address any concerns you might have.

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 differently due to your liver health.

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

Drug Interactions

It's important to talk to your healthcare provider before starting any new hydrocortisone product. This ensures that you avoid any potential complications or interactions with your current medications. Your doctor can help you understand the best options for your health needs.

While there are no specific interactions with laboratory tests mentioned, maintaining open communication with your healthcare team about all medications and tests is crucial for your safety and well-being. Always consult your doctor to make informed decisions about your treatment.

Storage and Handling

To ensure the best performance of your product, store it at a controlled room temperature between 20° and 25°C (68° and 77°F). This temperature range helps maintain the integrity and effectiveness of the device.

When handling the product, make sure to do so in a clean environment to avoid contamination. Always follow any specific instructions provided for safe use and disposal to ensure your safety and the safety of others.

Additional Information

You should apply this medication topically to the affected area, and it can be used by adults and children aged 2 years and older. Make sure to apply it no more than 3 to 4 times a day for best results. There are no additional details available regarding laboratory tests, abuse potential, or patient counseling.

FAQ

What is Hydrocortisone Cream Max Strength used for?

Hydrocortisone Cream Max Strength is used for temporary relief of itching associated with minor skin irritations, inflammation, and rashes.

What conditions can Hydrocortisone Cream treat?

It is indicated for conditions such as eczema, seborrheic dermatitis, psoriasis, insect bites, poison ivy, and irritation from soaps, detergents, cosmetics, and jewelry.

How should I apply Hydrocortisone Cream?

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

Can children under 2 years use this cream?

No, children under 2 years of age should not use this product and should consult a doctor.

What should I do if my symptoms persist?

If symptoms persist for more than 7 days or worsen, stop using the product and consult a doctor.

Is this product safe to use during pregnancy?

There is no specific information regarding the use of this product during pregnancy; consult a doctor for advice.

What precautions should I take when using this cream?

Keep it out of reach of children, and if swallowed, seek medical help or contact a Poison Control Center immediately.

Can I use this cream for diaper rash?

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

What should I do if I have a vaginal discharge?

If you have a vaginal discharge, do not use this cream for external genital itching and consult a doctor.

How should I store Hydrocortisone Cream?

Store the cream at controlled room temperature between 20°-25°C (68°-77°F).

Packaging Info

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

Packaging configurations for Hydrocortisone 1%.
Details

Drug Information (PDF)

This file contains official product information for Hydrocortisone 1%, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

99260 QC Hydrocortisone Cream is a topical formulation containing hydrocortisone as the active ingredient. This cream is designed for dermatological use and is available in a maximum strength concentration. The product is packaged in a 1-ounce container. The formulation is intended for the management of inflammatory skin conditions.

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, seborrheic dermatitis, psoriasis, insect bites, and contact with poison ivy, oak, or sumac. It is also effective for itching resulting from exposure to soaps, detergents, cosmetics, jewelry, and external feminine genital and anal areas.

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

No teratogenic or nonteratogenic effects have been reported.

Dosage and Administration

For adults and children aged 2 years and older, the product should be applied to the affected area no more than 3 to 4 times daily. Prior to application for external and anal itching, it is recommended that the affected area be cleansed with mild soap and warm water, followed by thorough rinsing or gentle patting with toilet tissue or a soft cloth.

For children under 2 years of age, the product should not be used without consulting a doctor. Additionally, for children under 12 years of age experiencing external anal itching, it is advised to consult a doctor before use.

Contraindications

The use of this product is contraindicated in the following situations:

Patients should not initiate the use of any other hydrocortisone product without prior consultation with a healthcare professional. Additionally, exceeding the recommended daily dosage is contraindicated unless specifically directed by a physician, particularly for external genital, feminine, and anal itching. The product should not be administered rectally using fingers or any medicated device or applicator.

Warnings and Precautions

For external use only. This product is not intended for the treatment of diaper rash; healthcare professionals should advise patients to consult a doctor for appropriate management. Additionally, it is contraindicated for use in cases of external genital itching accompanied by vaginal discharge; a consultation with a healthcare provider is recommended in such instances.

General precautions must be observed to ensure safety. This product should be kept out of the reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

Patients should be instructed to discontinue use and consult a doctor if any of the following occur: the condition worsens, symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. Under no circumstances should patients initiate the use of any other hydrocortisone product without prior medical advice.

In cases of ingestion, it is imperative to seek emergency medical help or contact a Poison Control Center immediately.

Side Effects

For external use only. Patients are advised to discontinue use and consult a doctor if conditions worsen or if symptoms persist for more than 7 days. Additionally, if symptoms clear up and then recur within a few days, patients should stop using this product and refrain from starting any other hydrocortisone product unless directed by a healthcare professional.

Drug Interactions

The initiation of any hydrocortisone product should be preceded by consultation with a healthcare professional. This precaution is essential to avoid potential adverse effects or interactions with other medications.

No specific drug or laboratory test interactions have been identified in the available data. Therefore, routine monitoring or dosage adjustments related to drug interactions are not indicated at this time.

Packaging & NDC

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

Packaging configurations for Hydrocortisone 1%.
Details

Pediatric Use

Pediatric patients under 2 years of age should not use this medication and must consult a doctor for guidance. For children aged 2 years and older, the recommended application is to the affected area no more than 3 to 4 times daily. Additionally, pediatric patients under 12 years of age experiencing external anal itching are advised to consult a doctor before use.

Geriatric Use

There is no specific information regarding the use of Hydrocortisone 1% cream in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as the absence of data necessitates careful consideration of individual patient factors and potential risks. Monitoring for efficacy and adverse effects is recommended in this population, given the lack of established guidelines for geriatric use.

Pregnancy

Pregnant patients should be aware that this product is intended for external use only. It is not recommended for the treatment of diaper rash; consultation with a healthcare provider is advised in such cases. For external genital itching, if there is a presence of vaginal discharge, pregnant patients should also seek medical advice prior to use.

There are no specific statements regarding the use of this product during pregnancy, nor are there contraindications or safety concerns explicitly mentioned in the available data. However, as a precaution, it is advisable for women of childbearing potential to consult with their healthcare provider before using this product, particularly if they have any underlying conditions or concerns.

Additionally, this product is not recommended for use in children under 2 years of age, and for external and anal itching in children under 12 years of age, consultation with a doctor is necessary.

Lactation

Lactating mothers should consult a doctor before using this product. There is a potential for excretion in breast milk, and caution is advised when using this product while breastfeeding.

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 absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution when administering the medication. It is essential to monitor patients closely for any signs of adverse effects or symptoms that may arise from excessive dosing.

In the event of suspected overdosage, immediate medical attention should be sought. Healthcare providers should implement supportive measures as necessary, which may include symptomatic treatment and monitoring of vital signs.

Due to the lack of detailed overdosage information, it is recommended that healthcare professionals refer to established clinical guidelines and protocols for managing overdose situations relevant to the specific medication in question. Additionally, contacting a poison control center may provide further guidance on appropriate management strategies.

Continued vigilance and patient assessment are crucial in mitigating potential risks associated with 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 compound in these areas.

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

Patients should be instructed to discontinue use and consult a doctor if their condition worsens. Additionally, if symptoms persist for more than 7 days or if symptoms clear up and then recur within a few days, patients should stop using the product and refrain from starting any other hydrocortisone product unless directed by a healthcare professional.

While using this product, patients must be cautioned to avoid contact with the eyes. It is important to inform patients that they should not initiate the use of any other hydrocortisone product without prior consultation with a doctor.

For patients using this product for external genital, feminine, and anal itching, they should not exceed the recommended daily dosage unless specifically directed by a healthcare provider. In cases of bleeding, patients should stop use immediately and seek medical advice.

Finally, patients should be informed that this product should not be inserted into the rectum using fingers or any medicated device or applicator.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It should be stored at a controlled room temperature of 20°-25°C (68°-77°F) to maintain its integrity and efficacy. Proper container requirements must be adhered to, ensuring that the product is kept in a suitable environment. Special handling needs should be observed to prevent any compromise to the product's quality.

Additional Clinical Information

The medication is administered topically, with a recommended application frequency of 3 to 4 times daily for adults and children aged 2 years and older, specifically to the affected area. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Hydrocortisone 1%, 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 1%, 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.