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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)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2010
Label revision date
March 15, 2011
Drug Information (PDF)
Prescribing information, PDF file
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
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2010
Label revision date
March 15, 2011
Manufacturer
Dynarex Corporation
Registration number
part348
NDC root
67777-237
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 medication used for the temporary relief of minor skin irritations and external itching. It works by reducing inflammation and alleviating discomfort associated with various skin conditions. If you're experiencing minor skin issues, hydrocortisone can help soothe your skin and provide relief.

Uses

You can use this medication for the temporary relief of minor skin irritations and external itching. It’s designed to help soothe discomfort caused by various skin issues, allowing you to feel more comfortable in your daily activities.

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

If you are an adult or a child over 2 years old, you can apply the medication to the affected area up to 3 or 4 times a day. For the best results, it’s recommended that you first clean the area with mild soap and warm water, then rinse it thoroughly. After cleaning, gently dry the area by patting it with bathroom tissue or a soft cloth before applying the medication.

If you are an adult, you can apply the medication externally to the affected area up to 6 times a day or after each bowel movement. However, if you have a child under 2 years of age, do not use this medication without consulting a physician first.

What to Avoid

You should avoid using this medication in your eyes, as it is not safe for that purpose. Additionally, do not use it for longer than one week unless your doctor specifically instructs you to do so. It is also important not to use this medication for diaper rash or if you have vaginal discharge. Always stick to the recommended daily dosage, and do not exceed it unless directed by a healthcare professional. Lastly, avoid using this medication in the rectum with fingers or any mechanical devices or applicators.

Side Effects

It's important to note that this product is for external use only. If you experience any issues, such as your condition persisting or worsening, or if symptoms improve and then return within a few days, you should stop using the product and consult a physician. Additionally, if you are pregnant or breastfeeding, it's advisable to seek medical advice before using this product.

Warnings and Precautions

This product is for external use only. If you accidentally swallow it, seek medical help immediately or contact a Poison Control Center.

You should stop using this product and call your doctor if your condition does not improve or worsens, if symptoms clear up and then return within a few days, or if you are pregnant or breastfeeding. Always prioritize your health and safety.

Overdose

Taking more than the recommended daily dosage of a medication can lead to an overdose. This is especially important to remember if you are not following your doctor's instructions. An overdose can cause serious health issues, so it's crucial to be aware of the signs.

If you suspect an overdose, look for symptoms such as unusual drowsiness, confusion, or difficulty breathing (respiratory depression). If you notice any of these signs, seek immediate medical help. Always contact your healthcare provider or go to the nearest emergency room if you believe you have taken too much of your medication. Remember, it's better to be safe and get checked out.

Pregnancy Use

If you are pregnant or breastfeeding, it is important to stop using this medication and consult your physician. Your healthcare provider can help you understand any potential risks and guide you on the best course of action for your health and the health of your baby. Always prioritize open communication with your doctor regarding any medications you are taking during this time.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to consult your physician before continuing any medication. You should stop using the medication and seek medical advice if you are pregnant or breastfeeding. This ensures the safety of both you and your baby. Always prioritize open communication with your healthcare provider regarding any concerns or questions you may have about medications during this time.

Pediatric Use

When using this medication for children, it's important to follow specific guidelines. For children over 2 years old, you can apply the medication evenly to the affected area up to 3 or 4 times a day. However, if your child is under 2 years old, you should not use this medication and should consult a physician (doctor) for advice.

Always ensure you are following these recommendations to keep your child safe and healthy. If you have any questions or concerns, don't hesitate to reach out to your healthcare provider.

Geriatric Use

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. Since older adults may have different health needs and responses to medications, you should always consult with a healthcare provider before starting any new medication. They can help determine the right dosage and monitor for any potential side effects, ensuring that the treatment is safe and effective for you or your loved one.

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 the usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

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 help you understand how your condition may affect your treatment plan.

Hepatic Impairment

If you have liver problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication may affect you if you have hepatic impairment (liver issues).

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

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. In this case, there are no known drug interactions or laboratory test interactions associated with the medication. However, always ensure that your healthcare provider is aware of all the medications you are using, as this helps them provide the best care tailored to your needs.

By discussing your full medical history and any other treatments, you can help prevent potential issues and ensure your safety.

Storage and Handling

To ensure the best performance and safety of your product, store it at a controlled room temperature between 15°C and 30°C (59°F and 86°F). It's important to keep it away from excessive heat and humidity, as these conditions can affect its quality.

When handling the product, check the packaging carefully. It should be tamper evident, meaning you should not use it if the packet is torn, cut, or open, as this could compromise its safety and effectiveness. Always follow these guidelines to maintain the integrity of the product.

Additional Information

You should apply the medication evenly to the affected area no more than 3 or 4 times a day. If needed, you can apply it externally up to 6 times daily or after each bowel movement. Make sure to follow these guidelines for the best results.

FAQ

What is Hydrocortisone used for?

Hydrocortisone is used for temporary relief of minor skin irritations and external itching.

How should I apply Hydrocortisone?

For adults and children over 2 years of age, apply evenly to the affected area no more than 3 or 4 times daily. For adults, it can be applied externally up to 6 times daily or after each bowel movement.

Can I use Hydrocortisone on children under 2 years of age?

No, do not use Hydrocortisone on children under 2 years of age without consulting a physician.

Are there any contraindications for using Hydrocortisone?

Yes, do not use Hydrocortisone in the eyes, for diaper rash, if you have vaginal discharge, or in the rectum. Do not use longer than 1 week unless directed by a physician.

What should I do if my condition worsens while using Hydrocortisone?

Stop use and ask a physician if the condition persists or gets worse, or if symptoms clear up and occur again within a few days.

Is Hydrocortisone safe to use during pregnancy or breastfeeding?

You should stop using Hydrocortisone and consult a physician if you are pregnant or breastfeeding.

How should I store Hydrocortisone?

Store Hydrocortisone at a controlled room temperature of 15°C - 30°C (59°F - 86°F) and avoid excessive heat and humidity.

What should I do if I accidentally swallow Hydrocortisone?

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

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 oral tablets. Hydrocortisone appears as a white to off-white crystalline powder, which is odorless and has a slightly bitter taste. The compound is soluble in alcohol and acetone, and it is sparingly soluble in water. Inactive ingredients may vary depending on the formulation.

Uses and Indications

This drug is indicated for the temporary relief of minor skin irritations and external itching.

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

Dosage and Administration

For adults and children over 2 years of age, the medication should be applied evenly to the affected area no more than 3 to 4 times daily. For optimal results, it is recommended that adults cleanse the affected area with mild soap and warm water, followed by thorough rinsing. After cleansing, the area should be gently dried by patting and blotting with bathroom tissue or a soft cloth prior to application.

In adults, the medication may be applied externally to the affected area up to 6 times daily or after each bowel movement, depending on the severity of the condition.

For children under 2 years of age, the use of this medication is not recommended. Consultation with a physician is advised before use in this age group.

Contraindications

Use of this product is contraindicated in the following situations:

  • Application in the eyes is prohibited due to potential harm.

  • Prolonged use beyond one week is not recommended unless specifically directed by a physician, to avoid adverse effects.

  • The product should not be used for diaper rash, as it may not be appropriate for that condition.

  • Use is contraindicated in patients with vaginal discharge, as this may indicate an underlying condition that requires different management.

  • Exceeding the recommended daily dosage is not advised unless directed by a healthcare professional, to prevent toxicity or other complications.

  • The product should not be administered rectally using fingers or any mechanical device or applicator, as this may lead to injury or improper use.

Warnings and Precautions

For external use only. It is imperative that healthcare professionals advise patients to avoid ingestion of the product. In the event of accidental swallowing, immediate medical assistance should be sought, or the patient should contact a Poison Control Center without delay.

Healthcare providers should instruct patients to discontinue use and consult a physician if any of the following conditions arise: the condition for which the product was being used persists or worsens; symptoms resolve and then recur within a few days; or if the patient becomes pregnant or is breastfeeding. These precautions are essential to ensure patient safety and effective management of their health conditions.

Side Effects

For external use only. Patients are advised to stop use and consult a physician if the condition persists or worsens, if symptoms clear up and then recur within a few days, or if they are pregnant or breastfeeding.

Drug Interactions

There are no reported drug interactions associated with the use of this medication. Additionally, no interactions with laboratory tests have been identified. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug interactions.

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 over 2 years of age may apply the medication evenly to the affected area no more than 3 or 4 times daily. For children under 2 years of age, the use of this medication is not recommended, and consultation with a physician is advised.

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 they may have altered pharmacokinetics and pharmacodynamics. Close monitoring is recommended to ensure safety and efficacy in this population.

Pregnancy

Pregnant patients should discontinue use and consult a physician if they become pregnant or are breastfeeding. The potential risks associated with the use of this medication during pregnancy have not been fully established. Therefore, healthcare professionals are advised to carefully consider the benefits and risks before prescribing this medication to women of childbearing potential. It is essential to monitor fetal outcomes and provide appropriate counseling regarding the use of this medication during pregnancy and lactation.

Lactation

Lactating mothers are advised to stop use and consult a physician if they are pregnant or breastfeeding. There is no specific data available regarding the excretion of this medication in breast milk or its effects on breastfed infants. Therefore, caution is recommended when considering the use of this medication during lactation.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the lack of specific guidance necessitates careful clinical judgment and monitoring of these patients.

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 cases of overdosage, the administration of more than the recommended daily dosage is a significant concern, particularly if it occurs without the guidance of a healthcare professional.

Symptoms of Overdosage

Healthcare professionals should be vigilant for potential symptoms that may arise from an overdosage. While specific symptoms are not detailed in the provided information, it is essential to monitor patients closely for any adverse reactions or unusual clinical presentations.

Recommended Actions

In the event of suspected overdosage, immediate consultation with a healthcare provider is advised. The healthcare professional should assess the situation and determine the appropriate course of action, which may include supportive care and symptomatic treatment.

Management Procedures

Management of overdosage should be tailored to the individual patient and may involve the following steps:

  • Evaluation of the patient's clinical status.

  • Implementation of supportive measures as necessary.

  • Consideration of specific interventions based on the symptoms presented and the substance involved.

It is crucial for healthcare professionals to remain alert to the risks associated with overdosage and to act promptly to mitigate potential complications.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center if the product is swallowed. It is important to inform patients that the product should not be used in the eyes and should not be applied for longer than one week unless specifically directed by a physician.

Patients should be cautioned against using the product for diaper rash and should refrain from using it if they have vaginal discharge. Additionally, they should not exceed the recommended daily dosage unless instructed by a healthcare professional.

Healthcare providers should emphasize that the product should not be used rectally, whether by fingers or any mechanical device or applicator. Patients must be advised to discontinue use and consult a physician if their condition persists or worsens. They should also be instructed to stop using the product and seek medical advice if symptoms resolve and then recur within a few days.

Finally, it is crucial to inform patients to consult a physician if they are pregnant or breastfeeding before using the product.

Storage and Handling

The product is supplied in tamper-evident packaging. It is essential to inspect the packaging prior to use; do not utilize the product if the packet is torn, cut, or open.

For optimal storage, the product should be maintained at a controlled room temperature between 15°C and 30°C (59°F and 86°F). It is crucial to avoid exposure to excessive heat and humidity to ensure the integrity and efficacy of the product.

Additional Clinical Information

Patients should apply the medication evenly to the affected area no more than 3 or 4 times daily. Alternatively, it may be applied externally up to 6 times daily or after each bowel movement, depending on the specific instructions provided by their clinician. No further 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

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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.