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Hydrocortisone

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This product has been discontinued

Active ingredient
Hydrocortisone 1 g/100 g
Other brand names
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2010
Label revision date
January 10, 2011
Active ingredient
Hydrocortisone 1 g/100 g
Other brand names
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2010
Label revision date
January 10, 2011
Manufacturer
Neopharm Co,. Ltd
Registration number
part348
NDC root
51141-0002

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Drug Overview

Hydrocortisone is a medication that temporarily relieves itching caused by minor skin irritations, inflammation, and rashes. It works by reducing the itch sensation, making it helpful for conditions such as psoriasis, seborrheic dermatitis, and reactions to poison ivy, oak, or sumac, as well as insect bites.

If you are experiencing discomfort from these skin issues, hydrocortisone may provide relief. However, for any other uses or if you have specific concerns, it's best to consult with a doctor.

Uses

This product is designed to temporarily relieve itching caused by minor skin irritations, inflammation, and rashes. You might find it helpful if you're dealing with conditions like psoriasis, seborrheic dermatitis, or reactions to poison ivy, oak, or sumac. It can also provide relief from itching due to insect bites.

If you have other skin issues or concerns, it's a good idea to consult with your doctor for further advice.

Dosage and Administration

You should apply the medication to the affected area no more than 3 to 4 times each day. If you're using it for external anal itching, it's a good idea to clean the area first with mild soap and warm water when possible. This helps ensure the medication works effectively and keeps the area clean. Remember to follow these guidelines to get the best results from your treatment.

What to Avoid

You can feel confident using this medication, as there are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with it. This means that, based on the available information, there are no known reasons that would prevent you from taking this medication safely. Always remember to follow your healthcare provider's instructions and reach out to them if you have any questions or concerns about your treatment.

Side Effects

It's important to use this product only on the skin and avoid contact with your eyes. You should not apply it directly into the rectum using fingers or any devices, and it is not recommended for treating diaper rash without consulting a doctor. Always follow these guidelines to ensure safe use.

Warnings and Precautions

This product is for external use only, so please avoid using it in or near your eyes. Do not insert it directly into the rectum using fingers or any devices, and do not use it for diaper rash without consulting a doctor first.

To ensure safety, keep this product out of reach of children. If it is swallowed, seek medical help immediately or contact Poison Control for assistance.

If you experience any concerning symptoms or have questions about your use of this product, it’s important to stop using it and reach out to your doctor for guidance.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While there is no specific information available about the effects of an overdose for this medication, you should be aware of general signs that may indicate a problem. These can include unusual drowsiness, confusion, or difficulty breathing.

If you notice any of these symptoms or if you believe you have taken too much of the medication, seek medical help right away. Contact your healthcare provider or go to the nearest emergency room. It's always better to be safe and get checked out if you have any concerns about your health.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that there is currently no information available about the use of Hydrocortisone HC cream 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 cream, you should consult with your healthcare provider to discuss any potential risks and to ensure that you are making the best choice for your health and the health of your baby.

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 should consult with your healthcare provider for personalized advice and to discuss any medications or treatments you may be considering. They can help you understand any potential effects on your milk production or your baby's health. Always prioritize open communication with your healthcare team to ensure the best outcomes for you and your infant.

Pediatric Use

It's important to keep this medication out of reach of children to ensure their safety. If your child accidentally swallows it, seek medical help immediately or contact Poison Control for guidance.

Additionally, this medication should not be used for treating diaper rash. If you have concerns about your child's skin condition, it's best to consult with a doctor for appropriate advice.

Geriatric Use

While there is no specific information about how this medication should be used by older adults, it’s important to approach any new treatment with caution. Since older adults may have different health needs and may be taking multiple medications, it’s always a good idea to discuss any concerns with your healthcare provider. They can help determine the best approach for you, considering any potential interactions or side effects.

If you or a loved one is an older adult, make sure to keep your doctor informed about all medications being taken and any changes in health. This way, you can ensure safe and effective treatment tailored to your individual needs.

Renal Impairment

If you have kidney problems, it's important to know that there are no specific guidelines, dosage adjustments, or monitoring requirements mentioned for your condition in the provided information. This means that the standard recommendations for medication use may apply to you, but it's always best to consult with your healthcare provider for personalized advice. They can help ensure that any treatment you receive is safe and effective based on 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).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your liver health. They can help monitor your condition and make any necessary adjustments to your treatment plan.

Drug Interactions

It's great to know that there are no reported interactions between this medication and other drugs or laboratory tests. However, it's still very important to discuss all medications you are taking, including over-the-counter drugs and supplements, with your healthcare provider. This ensures that your treatment is safe and effective, and helps avoid any potential issues.

Always keep your healthcare provider informed about any changes in your health or medications, as they can provide personalized advice tailored to your specific situation. Your safety and well-being are the top priority!

Storage and Handling

To ensure the safety and effectiveness of your product, store it at room temperature. It's important to keep it out of reach of children to prevent any accidental use. Once you open the product, please remember to discard it after use to maintain safety and hygiene. Following these simple guidelines will help you use the product safely and effectively.

Additional Information

You should apply the medication topically to the affected area, using it no more than 3 to 4 times a day. There are no additional details available regarding laboratory tests, abuse potential, or patient counseling.

FAQ

What is hydrocortisone used for?

Hydrocortisone temporarily relieves itching associated with minor skin irritation, inflammation, and rashes due to conditions like psoriasis, seborrheic dermatitis, poison ivy, oak, sumac, and insect bites.

How should I apply hydrocortisone?

You should apply hydrocortisone to the affected area not more than 3 to 4 times daily.

Are there any warnings for using hydrocortisone?

Yes, hydrocortisone is for external use only. Do not use it in or near the eyes, or for diaper rash without consulting a doctor.

What should I do if I swallow hydrocortisone?

If swallowed, you should get medical help or contact a Poison Control center immediately.

Is hydrocortisone safe to use during pregnancy?

There is no specific information regarding the safety of hydrocortisone use during pregnancy in the provided text.

Can I use hydrocortisone if I am nursing?

The provided text does not contain specific statements regarding the use of hydrocortisone by nursing mothers.

How should I store hydrocortisone?

You should store hydrocortisone at room temperature and keep it out of reach of children. Discard it after opening.

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 is a corticosteroid with the chemical formula C21H30O5 and a molecular weight of 362.46 g/mol. It is available in various dosage forms, including topical creams, ointments, and injectable solutions. Hydrocortisone appears as a white to off-white crystalline powder, which is odorless and slightly soluble in water. The compound is utilized for its anti-inflammatory and immunosuppressive properties in the treatment of various conditions.

Uses and Indications

This drug is indicated for the temporary relief of itching associated with minor skin irritation, inflammation, and rashes due to various conditions, including psoriasis, seborrheic dermatitis, poison ivy, oak, sumac, and insect bites.

For any other uses of this product, healthcare professionals are advised to consult a physician.

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

Dosage and Administration

The medication should be applied to the affected area no more than 3 to 4 times daily. For the treatment of external anal itching, it is advisable to clean the area with mild soap and warm water when practical prior to application. This preparation step may enhance the effectiveness of the treatment.

Contraindications

There are no contraindications associated with the use of this product. It is not classified as a controlled substance, and there are no identified risks of abuse, misuse, or dependence.

Warnings and Precautions

For external use only. This product is contraindicated for application in or near the eyes. It should not be administered rectally, either by direct insertion with fingers or through the use of any mechanical device or applicator. Additionally, it is not intended for use in treating diaper rash; consultation with a healthcare professional is advised in such cases.

General precautions must be observed to ensure safety. The product should be kept out of reach of children. In the event of accidental ingestion, it is imperative to seek medical assistance immediately or contact a Poison Control Center.

Emergency medical help should be sought if the product is swallowed. Healthcare professionals should advise patients to discontinue use and consult their physician if any adverse reactions occur, although specific instructions for cessation were not provided in the available information.

Side Effects

Patients should be aware that the product is intended for external use only. It is contraindicated for use in or near the eyes, and it should not be applied directly into the rectum using fingers, mechanical devices, or applicators. Additionally, the product is not recommended for use in the treatment of diaper rash; patients are advised to consult a healthcare professional in such cases.

These warnings are critical to ensure the safe and effective use of the product, and adherence to these guidelines is essential to avoid potential adverse reactions.

Drug Interactions

No drug interactions or drug and laboratory test interactions have been identified in the available data. Therefore, no specific 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 should be monitored closely, as the product must be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with Poison Control is advised. This product is not indicated for use in treating diaper rash; consultation with a healthcare professional is recommended for appropriate management in such cases.

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 currently no information available regarding the use of Hydrocortisone HC cream during pregnancy, including safety concerns, dosage modifications, or any special precautions that should be taken. Healthcare professionals should consider this lack of data when prescribing this medication to pregnant patients. It is advisable to weigh the potential benefits against any unknown risks to fetal outcomes. Women of childbearing potential should be counseled accordingly.

Lactation

There are no specific statements regarding the use of this medication in nursing mothers or its effects on lactation. Additionally, there is no available data on the excretion of this medication in breast milk or its potential effects on breastfed infants. Healthcare professionals should consider the absence of information when advising lactating mothers about the use of this medication.

Renal Impairment

There is no information available regarding renal impairment, including dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of specific guidance when treating patients with renal impairment.

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 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 the medication out of reach of children to prevent accidental ingestion. It is important to emphasize that if the medication is swallowed, patients should seek medical help immediately or contact a Poison Control Center for assistance. This guidance is crucial to ensure the safety and well-being of patients and their families.

Storage and Handling

The product is supplied in a configuration that ensures optimal usability. It should be stored at room temperature, away from direct sunlight and moisture. To maintain safety, it is essential to keep the product out of reach of children. Once opened, the product must be discarded to ensure proper safety and efficacy.

Additional Clinical Information

The medication is administered topically, with application to the affected area not exceeding 3 to 4 times daily. 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, 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.