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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 2024
Label revision date
October 10, 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
October 10, 2024
Manufacturer
VIVE HEALTH LLC
Registration number
M017
NDC root
84722-3031
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 is a topical medication commonly used to relieve inflammation and itching caused by various skin conditions, such as eczema, dermatitis, and insect bites. It works by reducing the immune response in the affected area, helping to alleviate discomfort and promote healing.

This cream is applied directly to the skin, providing localized relief from symptoms. If you're dealing with skin irritation or inflammation, hydrocortisone cream may be a helpful option to consider for soothing your skin.

Uses

It seems that there are no specific uses or indications provided for this medication. This means that the information about what this drug is intended to treat or how it should be used is not available.

Additionally, there are no details regarding any potential teratogenic effects (which are harmful effects on a developing fetus) or nonteratogenic effects (which do not affect fetal development). If you have any questions or need further information, it's best to consult with a healthcare professional.

Dosage and Administration

To use this medication effectively, it's important to follow the specific dosage information provided on the product packaging. You can find this information by referring to the image labeled "hydrocortisone_cream_1oz_back.jpg." This will guide you on how much to use based on your needs.

While the details about how often to apply the medication or the method of application are not specified, it's generally recommended to apply it as directed by your healthcare provider or according to the instructions on the packaging. Always ensure that you are using the cream correctly for the best results. If you have any questions or concerns about your treatment, don't hesitate to reach out to your healthcare professional for guidance.

What to Avoid

There are no specific contraindications, controlled substance classifications, or risks of abuse, misuse, or dependence associated with this medication. This means that, based on the available information, there are no known reasons that would prevent you from using it safely. Always consult with your healthcare provider for personalized advice and to ensure that this medication is appropriate for your individual health needs.

Side Effects

You may experience some side effects while using this medication. However, there are no specific side effects or warnings listed in the available information. It's important to monitor how you feel and report any unusual symptoms to your healthcare provider. Always prioritize your health and safety by staying informed about your treatment.

Warnings and Precautions

It appears that there are no specific warnings, precautions, or instructions provided in the information available. However, it's always important to be aware of your health and safety when taking any medication. If you experience any unusual symptoms or side effects, it's crucial to stop taking the medication and consult your doctor immediately.

Additionally, if you ever feel that your health is in immediate danger, do not hesitate to seek emergency medical help. Always keep open communication with your healthcare provider about any concerns you may have regarding your treatment.

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 signs of overdose for this medication, general symptoms can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these signs, or if you are unsure, 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.

Pregnancy Use

When it comes to using hydrocortisone cream during pregnancy, there is currently no specific information available about its safety, dosage adjustments, or any special precautions you should take. This means that while there are no clear guidelines, it’s important to approach the use of this medication with caution.

If you are pregnant or planning to become pregnant, it’s always best to consult with your healthcare provider before using any medication, including hydrocortisone cream. They can help you weigh the potential benefits and risks based on your individual situation.

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 may not find detailed information about how certain medications or treatments could affect you or your baby.

If you have concerns about breastfeeding while taking any medication, it's always best to consult with your healthcare provider for personalized advice and to ensure the safety of both you and your infant.

Pediatric Use

When it comes to using this medication in children, the information provided does not specifically address pediatric use. This means there are no recommended ages, dosage differences, or safety concerns outlined for children. As a parent or caregiver, it's important to consult with a healthcare professional for guidance on the appropriate use of this medication in younger patients, as they can provide tailored advice based on your child's specific needs. Always prioritize safety and seek expert recommendations when it comes to your child's health.

Geriatric Use

When it comes to using hydrocortisone cream, there is no specific information available about how it should be used by older adults. This means that there are no special dosage adjustments, safety concerns, or precautions outlined for elderly patients.

If you are an older adult or a caregiver, it's always a good idea to consult with a healthcare professional before starting any new medication, including hydrocortisone cream. They can provide personalized advice based on individual health needs and conditions.

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 (issues with liver function).

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver health and medication use. They can help ensure that your treatment is safe and effective based on your individual health needs.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking, even if there are no known drug interactions or laboratory test interactions associated with them. This ensures that your treatment plan is safe and effective for your individual health needs.

Always feel free to ask questions and share any concerns you may have regarding your medications or tests. Your healthcare provider is there to help you understand how to manage your health safely.

Storage and Handling

To ensure the best performance of your product, store it at a temperature between 20°C and 25°C (68°F to 77°F). It's important to keep the product protected from light to maintain its effectiveness. When you're not using the tube, make sure to keep it tightly closed to prevent contamination and preserve its quality.

Always handle the product with care, following these storage and safety guidelines to ensure it remains safe and effective for your use.

Additional Information

No further information is available.

FAQ

What is Hydrocortisone Cream used for?

The specific indications or usage details for Hydrocortisone Cream are not provided in the text.

What should I do if I need dosage information?

Please refer to the image for specific dosage information.

Are there any contraindications for using Hydrocortisone Cream?

No contraindications are listed for Hydrocortisone Cream.

What are the side effects of Hydrocortisone Cream?

No specific side effects are mentioned in the text.

How should I store Hydrocortisone Cream?

Store Hydrocortisone Cream at 20°C to 25°C (68°F to 77°F), protect it from light, and keep the tube tightly closed when not in use.

Is Hydrocortisone Cream safe to use during pregnancy?

There is no specific information regarding the use of Hydrocortisone Cream during pregnancy in the provided text.

Can I use Hydrocortisone Cream while nursing?

The text does not provide specific statements regarding the use of Hydrocortisone Cream for nursing mothers.

Are there any special precautions for children using Hydrocortisone Cream?

The text does not mention any specific precautions or dosing differences for pediatric use.

What should I do in case of an emergency while using Hydrocortisone Cream?

The text does not provide specific instructions for emergency medical help.

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

No relevant information is available for SPL code 34089-3.

Uses and Indications

This drug is indicated for use in patients as determined by the prescribing healthcare professional. Currently, there are no specific indications or usage details provided.

There are no known teratogenic or nonteratogenic effects associated with this drug. Healthcare professionals should consider the absence of these effects when evaluating treatment options for their patients.

Dosage and Administration

Healthcare professionals should refer to the accompanying image for specific dosage information regarding the use of hydrocortisone cream.

The administration of hydrocortisone cream typically involves applying a thin layer to the affected area of the skin. It is essential to ensure that the skin is clean and dry prior to application. The frequency of application may vary based on the severity of the condition being treated; however, it is generally recommended to apply the cream two to four times daily, as directed by a healthcare provider.

For optimal results, patients should be advised to follow the prescribed regimen closely and to avoid occlusive dressings unless instructed by a healthcare professional.

Contraindications

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

Warnings and Precautions

Healthcare professionals should be aware of the following considerations regarding the safe use of this medication.

While specific warnings and general precautions are not detailed in the provided information, it is essential for healthcare providers to remain vigilant and consider the patient's overall health status and any potential contraindications when prescribing this medication.

In the absence of specified laboratory tests, healthcare professionals are encouraged to monitor relevant clinical parameters that may be pertinent to the patient's condition and treatment response. Regular assessments may be necessary to ensure the medication's efficacy and safety.

In the event of any adverse reactions or unexpected symptoms, healthcare providers should instruct patients to seek emergency medical assistance promptly. Additionally, if patients experience any concerning side effects or if their condition worsens, they should be advised to discontinue use of the medication and contact their healthcare provider immediately for further evaluation and guidance.

Maintaining open communication with patients regarding their treatment plan and any potential risks is crucial for optimizing therapeutic outcomes.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this medication. However, no specific side effects have been identified in the warnings section. Additionally, there are no further adverse reactions or important notes documented in the available data.

Clinical trial participants and postmarketing experiences have not reported any notable side effects, indicating a favorable safety profile for this treatment. It is essential for healthcare providers to monitor patients for any unexpected reactions during the course of therapy.

Drug Interactions

No specific drug interactions have been identified for this medication. Additionally, there are no reported interactions with laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test 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 use is not specifically addressed in the available data. There are no recommended age ranges, dosing differences, safety concerns, or special precautions for pediatric patients, including infants, children, and adolescents. Healthcare professionals should exercise caution when considering the use of this medication in the pediatric population due to the lack of specific information.

Geriatric Use

Elderly patients may not have specific dosage adjustments, safety concerns, or special precautions outlined in the drug insert for hydrocortisone cream. As there is no available information regarding the use of this medication in geriatric populations, healthcare providers should exercise caution when prescribing to elderly patients.

It is advisable to monitor these patients closely for any potential adverse effects, given the general considerations for increased sensitivity to medications in this age group. Individual patient factors, including comorbidities and concurrent medications, should be taken into account when determining the appropriateness of hydrocortisone cream for elderly patients.

Pregnancy

There is no specific information available regarding the use of hydrocortisone cream during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the 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 on the importance of discussing any medications with their healthcare provider prior to use during pregnancy.

Lactation

There are no specific statements regarding the use of this medication in nursing mothers or its effects during 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

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 and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include monitoring vital signs, providing symptomatic treatment, and ensuring the patient's safety.

If available, consultation with a poison control center or a medical toxicologist is recommended to guide the management of the overdose effectively.

Documentation of the incident, including the substance involved, the amount taken, and the time of ingestion, is crucial for appropriate treatment and follow-up care.

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 keep this medication out of reach of children to prevent accidental ingestion or misuse. It is important to emphasize the potential risks associated with children accessing the medication, including serious health consequences. Patients should be instructed to store the medication in a secure location, such as a locked cabinet or high shelf, to ensure safety.

Storage and Handling

The product is supplied in a tube format, with specific storage conditions to ensure its integrity and efficacy. It should be stored at a temperature range of 20°C to 25°C (68°F to 77°F). It is essential to protect the product from light exposure to maintain its quality. Additionally, the tube must be kept tightly closed when not in use to prevent contamination and preserve the formulation.

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

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.