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Fifthpulse Hydrocortisone 4oz

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Active ingredient
Hydrocortisone 1 g/100 g
Other brand names
Drug class
Corticosteroid
Dosage form
Ointment
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2025
Label revision date
July 15, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Hydrocortisone 1 g/100 g
Other brand names
Drug class
Corticosteroid
Dosage form
Ointment
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 2025
Label revision date
July 15, 2025
Manufacturer
Front Pharmaceutical PLC
Registration number
M004
NDC root
69571-015
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 commonly used to relieve inflammation and itching caused by various skin conditions. It is available in a topical form, such as creams or ointments, and is often applied directly to the affected area to help reduce symptoms. This medication works by mimicking the effects of cortisol, a hormone produced by your adrenal glands, which plays a key role in managing inflammation in the body.

If you are experiencing skin irritation or conditions that cause discomfort, hydrocortisone may be a helpful option to consider for soothing relief. Always consult with a healthcare professional to ensure it is appropriate for your specific needs.

Uses

It seems that there are no specific uses or indications provided for this medication. Additionally, there are no mentions of teratogenic effects (which refer to substances that can cause developmental abnormalities in a fetus) or nonteratogenic effects. If you have any questions or need further information about this medication, please consult your healthcare provider for personalized advice.

Dosage and Administration

To use FifthPulse Hydrocortisone, please refer to the accompanying image for specific dosage information. This will guide you on how much of the medication you should take or apply.

Unfortunately, the information provided does not include details about how to administer the medication, such as the method (like whether it should be taken orally or applied topically) or how often you should use it. It's important to follow the instructions in the image closely to ensure you are using the medication correctly. If you have any questions or need further clarification, consider reaching out to a healthcare professional for assistance.

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, you can use it without concerns about these particular issues. However, 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 can feel reassured that there are no specific side effects or adverse reactions listed for this medication. This means that, based on the available information, it is considered to have a favorable safety profile. However, as with any medication, it's always a good idea to discuss any concerns or questions with your healthcare provider.

Warnings and Precautions

It's important to be aware of certain warnings when using this medication. If you experience any unusual symptoms or reactions, you should stop taking the medication and call your doctor immediately.

While there are no specific general precautions or laboratory tests mentioned, it's always a good idea to discuss your complete medical history and any other medications you are taking with your healthcare provider to ensure safety. If you have any concerns or experience severe side effects, seek emergency medical help right away.

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 concerned about a possible overdose, seek medical help right away.

In case of an overdose, contacting your local emergency services or going to the nearest hospital is crucial. Always keep the medication packaging with you, as it can help healthcare professionals understand what you've taken. Remember, it's better to be safe and get checked out if you have any doubts about your health.

Pregnancy Use

When it comes to using FIFTHPULSE HYDROCORTISONE during pregnancy, there are no specific guidelines or safety concerns mentioned in the available information. This means that there are no known dosage adjustments or special precautions that you need to be aware of while pregnant.

However, it's always important to consult with your healthcare provider before starting or continuing any medication during pregnancy. They can provide personalized advice based on your health needs and circumstances.

Lactation Use

If you are breastfeeding, you can use hydrocortisone ointment without specific warnings or recommendations against it. The information available does not indicate any concerns regarding its use while nursing or during lactation (the period when you produce breast milk).

However, as with any medication, it's always a good idea to consult with your healthcare provider if you have any questions or concerns about using hydrocortisone ointment while breastfeeding. They can provide personalized advice based on your situation.

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 may have different needs compared to adults. Always prioritize your child's safety and well-being by seeking expert advice.

Geriatric Use

When it comes to using FIFTHPULSE HYDROCORTISONE, there is no specific information available about how it should be adjusted or used differently for older adults. This means that, as an older adult or caregiver, you should be aware that there are no special dosage recommendations or safety precautions outlined for this medication in the drug insert.

It's always a good idea to discuss any concerns or questions with your healthcare provider, especially regarding how this medication may affect you or your loved one. 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 there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations apply, but you should always consult your healthcare provider for personalized advice. They can help determine the best approach for your treatment and monitor your liver function as needed.

Make sure to keep your doctor informed about your liver health, as they may want to conduct regular tests to ensure your safety while using any medication. Your well-being is a priority, so don't hesitate to ask questions or express any concerns you may have.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking. In this case, there are no specific drug interactions or laboratory test interactions noted, which means that this medication is generally considered safe to use alongside other treatments and tests. However, every individual is different, and your healthcare provider can help ensure that your overall treatment plan is safe and effective for you. Always feel free to ask questions and share any concerns you may have regarding your medications or tests.

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 protect it from light to maintain its effectiveness. When you're not using the product, make sure to keep the tube tightly closed to prevent contamination. Remember to discard the product after opening to ensure safety and efficacy. Following these guidelines will help you use the product safely and effectively.

Additional Information

No further information is available.

FAQ

What is Hydrocortisone?

Hydrocortisone is a medication available as FifthPulse Hydrocortisone in a 4oz tube.

What are the indications for using Hydrocortisone?

No specific indications or usage details are provided for Hydrocortisone.

What should I know about the dosage of Hydrocortisone?

For specific dosage information, please refer to the image labeled 'FifthPulse Hydrocortisone 4oz.jpg.'

Are there any contraindications for Hydrocortisone?

There are no contraindications listed for Hydrocortisone.

What are the storage instructions for Hydrocortisone?

Store Hydrocortisone 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 safe to use during pregnancy?

The provided text does not include specific information regarding the use of Hydrocortisone during pregnancy.

Can nursing mothers use Hydrocortisone?

There are no specific warnings or recommendations regarding the use of Hydrocortisone in nursing mothers mentioned.

What should I do if I experience side effects from Hydrocortisone?

The text does not list specific side effects, but you should consult your doctor if you have concerns.

Packaging Info

Below are the non-prescription pack sizes of Fifthpulse Hydrocortisone 4oz (hydrocortisone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Fifthpulse Hydrocortisone 4oz.
Details

Drug Information (PDF)

This file contains official product information for Fifthpulse Hydrocortisone 4oz, 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 a chemical name of hydrocortisone. It appears as a white to off-white crystalline powder. The formulation includes several inactive ingredients: citric acid, sodium citrate, sodium chloride, and water for injection.

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

The prescribing information for FifthPulse Hydrocortisone should be consulted for specific dosage details, as outlined in the accompanying image.

Healthcare professionals are advised to follow the recommended dosing guidelines as indicated. The route of administration, method of application, and frequency of dosing are not specified in the provided information. It is essential to refer to the product's prescribing information for comprehensive instructions on administration techniques and any necessary preparation steps.

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

The use of this medication is associated with specific warnings that healthcare professionals must consider.

Warnings Healthcare providers should remain vigilant regarding the potential risks associated with this medication. It is imperative to assess each patient's individual health status and history to mitigate any adverse effects.

General Precautions While no specific general precautions have been outlined, it is advisable for healthcare professionals to exercise caution and conduct thorough evaluations of patients prior to prescribing this medication. Continuous monitoring of the patient's response to treatment is recommended to ensure safety and efficacy.

Laboratory Tests Currently, there are no specific laboratory tests recommended for monitoring the use of this medication. However, healthcare professionals should remain attentive to any emerging guidelines or recommendations that may arise.

Emergency Medical Help In the event of severe adverse reactions or complications, immediate medical assistance should be sought. Healthcare providers should educate patients on recognizing signs that necessitate urgent care.

Discontinuation of Treatment Patients should be instructed to discontinue use and contact their healthcare provider if they experience any concerning symptoms or side effects. Regular follow-up and communication between the patient and provider are essential for safe medication management.

Side Effects

In the evaluation of adverse reactions associated with the use of this product, no specific side effects have been identified in the warnings section. Additionally, the review of clinical data and postmarketing experiences has not revealed any notable adverse reactions. Therefore, healthcare professionals should be aware that, based on the current information available, there are no documented adverse reactions linked to this treatment.

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 Fifthpulse Hydrocortisone 4oz (hydrocortisone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Fifthpulse Hydrocortisone 4oz.
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

There is no specific information regarding the use of FIFTHPULSE HYDROCORTISONE 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. Monitoring for potential adverse effects is recommended, given the lack of targeted studies in this population.

Pregnancy

There are no specific statements regarding the use of FIFTHPULSE HYDROCORTISONE 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. The potential risks and benefits should be carefully evaluated, and alternative treatments may be considered based on the clinical scenario. Women of childbearing potential should be counseled regarding the absence of established safety data in pregnancy.

Lactation

There are no specific warnings or recommendations regarding the use of hydrocortisone ointment in lactating mothers. Additionally, no information is provided concerning the excretion of hydrocortisone in breast milk or its effects on breastfed infants. Therefore, healthcare professionals may consider the use of hydrocortisone ointment in nursing mothers on a case-by-case basis, taking into account the clinical situation and the potential benefits versus risks.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the text. Therefore, healthcare professionals should exercise caution and consider individual patient factors when prescribing to this population. Regular assessment of renal function may be warranted to ensure safe and effective use of the medication in patients with reduced kidney function.

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 maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

Additionally, it is recommended to consult local poison control centers or relevant toxicology resources for guidance on specific management protocols and antidotes, if applicable.

Documentation of the incident, including the amount and timing of the substance taken, is crucial for effective treatment and follow-up care.

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 question. Further studies may be necessary to elucidate these aspects of nonclinical 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 necessity of proper storage and handling to ensure the safety of young individuals.

Storage and Handling

The product is supplied in a tube format, with specific storage and handling requirements 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) and must be protected from light exposure. To maintain the product's quality, the tube should be kept tightly closed when not in use. Additionally, it is important to discard the product after opening to prevent any potential degradation or contamination.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Fifthpulse Hydrocortisone 4oz, 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 Fifthpulse Hydrocortisone 4oz, 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.