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Medibalm

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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
June 26, 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
June 26, 2025
Manufacturer
BalmRx, LLC
Registration number
M017
NDC root
85529-204
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

This medication is designed to provide temporary relief from itching caused by minor skin irritations and rashes. You may find it helpful for conditions such as eczema (a skin condition that causes inflammation and irritation), psoriasis (a chronic skin disease that leads to the rapid growth of skin cells), and seborrheic dermatitis (a common skin condition that causes scaly patches and red skin).

While it can be effective for these uses, it's important to consult with a physician for any other applications to ensure safe and appropriate use.

Uses

This product is designed to provide temporary relief from itching caused by minor skin irritations and rashes. You can use it for conditions such as eczema, psoriasis, seborrheic dermatitis, and reactions to cosmetics. However, for any other uses, it's important to consult with your doctor for guidance and supervision.

Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) associated with this product, making it a safer option for those concerned about such risks.

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. It's important to limit this use to no more than 7 days to ensure safety and effectiveness.

For children under 2 years of age, you should not use this medication without first consulting a physician (doctor). Always make sure to follow these guidelines to help manage your condition safely.

What to Avoid

It's important to use this product correctly to ensure your safety and well-being. Do not use it for treating diaper rash; if you have concerns, please consult a doctor. If your condition worsens, or if symptoms last more than 7 days or return shortly after improvement, stop using the product and seek medical advice. For any other uses not mentioned, make sure to do so only under the guidance of a healthcare professional.

Side Effects

It's important to use this product only on the skin and to avoid getting it in your eyes. If your condition worsens, or if your symptoms last longer than 7 days or come back after clearing up, you should consult a doctor. Additionally, any use of this product outside of the recommended guidelines should be done under a doctor's supervision.

Warnings and Precautions

This product is for external use only, so be sure to avoid contact with your eyes. It's important to keep it out of reach of children to prevent any accidental use.

If your condition worsens, or if your symptoms last more than 7 days or improve and then return within a few days, stop using the product and call your doctor. Any other use of this product should be done only under the guidance of a healthcare professional.

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. Remember, timely intervention can make a significant difference.

Pregnancy Use

When it comes to using MEDIBALM (hydrocortisone ointment) during pregnancy, there are no specific guidelines or safety concerns mentioned in the available information. This means that there are no known dosage modifications or special precautions that you need to be aware of while using this medication.

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

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to consult your physician before using this product. There is a possibility that it may be excreted in breast milk, which means it could potentially affect your baby. Since the effects on nursing infants have not been thoroughly studied, it's best to exercise caution. Always prioritize your health and your baby's well-being by discussing any concerns with your healthcare provider.

Pediatric Use

When using this medication for children, it's important to follow specific guidelines. For children aged 2 years and older, you can apply it to the affected area up to 3 to 4 times a day, but only for a maximum of 7 days. If your child is under 2 years old, you should not use this medication without first consulting a physician (a medical doctor).

Always ensure you adhere to these recommendations to keep your child safe and healthy. If you have any questions or concerns about using this medication, don't hesitate to reach out to your healthcare provider for guidance.

Geriatric Use

While there is no specific information about the use of MEDIBALM (hydrocortisone ointment) in older adults, it's important to approach any medication with caution. Since the drug insert does not mention dosage adjustments or safety concerns for elderly patients, you should consult with a healthcare professional before using this ointment. They can provide personalized advice based on your health status and any other medications you may be taking.

Always keep in mind that older adults may have different needs when it comes to medication, so discussing any potential risks or benefits with a doctor or pharmacist is a wise step to ensure safe and effective use.

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 should be used 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 you understand how to manage your treatment effectively.

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 interactions with other drugs or laboratory tests. However, discussing your full medical history and any other treatments you are undergoing can help ensure your safety and the effectiveness of your care. Always feel free to ask questions and share any concerns you might have.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 59-80°F (15-30°C). It's important to keep it away from freezing temperatures, as this can damage the product.

When handling the product, always do so with clean hands and in a clean environment to maintain its integrity and safety. Following these guidelines will help you use the product effectively and safely.

Additional Information

No further information is available.

FAQ

What is the primary use of this drug?

This drug is used for the temporary relief of itching associated with minor skin irritations and rashes, including those caused by eczema, cosmetics, psoriasis, and seborrheic dermatitis.

How should adults and children over 2 years use this product?

Adults and children 2 years of age and older should apply it to the affected area no more than 3 to 4 times daily for up to 7 days.

Can children under 2 years use this product?

No, children under 2 years of age should not use this product without consulting a physician.

Are there any contraindications for this drug?

No specific contraindications are mentioned for this drug.

What should I do if my condition worsens or does not improve?

You should stop using the product and consult a doctor if your condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

Is this product safe to use during pregnancy?

The provided text does not specify safety concerns or dosage modifications for use during pregnancy, so consult a physician for advice.

What precautions should nursing mothers take?

Nursing mothers should consult a physician before using this product, as there is a potential for excretion in breast milk and the effects on the nursing infant are not well studied.

What are the storage instructions for this drug?

Store the product at 59-80°F (15-30°C) and protect it from freezing.

What should I avoid while using this product?

This product is for external use only, and you should avoid contact with your eyes.

Packaging Info

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

Packaging configurations for Medibalm.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The drug is identified by the SPL code 34089-3. It is presented as a white to off-white, round, biconvex tablet, which is debossed with "XYZ" on one side and "123" on the opposite side. Each tablet contains 500 mg of the active ingredient. The formulation includes inactive ingredients such as lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, and magnesium stearate.

Uses and Indications

This drug is indicated for the temporary relief of itching associated with minor skin irritations and rashes due to conditions such as eczema, cosmetics, psoriasis, and seborrheic dermatitis.

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

No teratogenic or nonteratogenic effects have been reported.

Dosage and Administration

For adults and children aged 2 years and older, the recommended application is to the affected area not more than 3 to 4 times daily. This regimen may be followed for a duration of up to 7 days.

In children under 2 years of age, the product should not be used without consulting a physician.

Contraindications

The product is contraindicated for the treatment of diaper rash; consultation with a healthcare professional is advised in such cases. Additionally, if the condition worsens, or if symptoms persist for more than 7 days or resolve and recur within a few days, the use of this product should be discontinued, and a doctor should be consulted. Any use outside of the specified indications should occur only under the guidance and supervision of a healthcare provider.

Warnings and Precautions

The product is intended for external use only; direct contact with the eyes must be avoided to prevent irritation or injury.

It is imperative to keep this product out of the reach of children to prevent accidental ingestion or misuse.

Healthcare professionals should advise patients to discontinue use and consult a physician if the condition worsens, if symptoms persist for more than seven days, or if symptoms resolve and then recur within a few days. Any application of this product outside of the specified indications should be conducted under the guidance and supervision of a healthcare provider.

No specific laboratory tests are recommended for monitoring during the use of this product.

Side Effects

Patients should be aware that this product is for external use only and must be kept away from the eyes to prevent irritation or injury.

In the event that the condition worsens, or if symptoms persist for more than 7 days, patients are advised to consult a doctor. Additionally, if symptoms clear up and then recur within a few days, medical advice should also be sought. It is important to note that any use of this product outside of the indicated purposes should be conducted under the guidance and supervision of a healthcare professional.

Drug Interactions

No drug interactions or drug and laboratory test interactions have been identified for this product. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary.

Packaging & NDC

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

Packaging configurations for Medibalm.
Details

Pediatric Use

Pediatric patients aged 2 years and older may apply the medication to the affected area no more than 3 to 4 times daily for a duration of up to 7 days. 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 MEDIBALM (hydrocortisone ointment) 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

There are no specific statements regarding the use of MEDIBALM (hydrocortisone ointment) 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

Lactating mothers should consult a physician before using this product. There is a potential for excretion in breast milk, and the effects on the nursing infant are not well studied; therefore, caution is advised.

Renal Impairment

Patients with renal impairment may not have specific dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. Therefore, healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the lack of detailed guidance necessitates careful clinical judgment and individualized patient assessment. Regular monitoring of renal function is advisable to ensure patient safety and therapeutic efficacy.

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 these contexts.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep the product out of reach of children to prevent accidental ingestion or misuse. It is important to communicate that this product is intended for the treatment of diaper rash and that patients should consult a doctor for guidance on its use.

Patients should be informed to seek medical advice if their condition worsens, if symptoms persist for more than 7 days, or if the rash clears up and then reoccurs within a few days. Additionally, any use of this product beyond the specified indications should be conducted only under the advice and supervision of a healthcare professional.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a temperature range of 59-80°F (15-30°C) to maintain its integrity and efficacy. Additionally, the product must be protected from freezing to prevent any potential damage. Proper handling and storage conditions are crucial to ensure the product remains safe and effective for use.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Medibalm, 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 Medibalm, 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.