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Medi-Cortisone

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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 1995
Label revision date
September 24, 2012
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 1995
Label revision date
September 24, 2012
Manufacturer
Medicine Shoppe International Inc
Registration number
part348
NDC root
49614-404
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

Medi-Cortisone™ is a 1% hydrocortisone cream designed to provide temporary relief from itching associated with various minor skin irritations and rashes. This includes conditions such as eczema, insect bites, and reactions to plants like poison ivy, as well as irritations caused by soaps, detergents, cosmetics, jewelry, and skin conditions like seborrheic dermatitis and psoriasis.

The cream works as an antipruritic (anti-itch) agent, helping to soothe discomfort and reduce the urge to scratch. While it can be effective for these common skin issues, it's important to use it under the advice and supervision of a doctor for any other uses.

Uses

This product is designed to provide temporary relief from itching caused by various minor skin irritations and rashes. You can use it for conditions such as eczema, insect bites, and reactions to plants like poison ivy, poison oak, or poison sumac. It can also help soothe itching from soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis, and even external genital and anal itching.

For any other uses, it's important to consult with your doctor to ensure it's appropriate for your situation.

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. Before applying, it's best to clean the area gently with mild soap and warm water, then rinse it thoroughly. After cleaning, make sure to dry the area by patting or blotting it with toilet tissue or a soft cloth.

If you have a child under 2 years old, do not use this product without consulting a doctor. Additionally, if the user is a child under 12 years of age, it's important to speak with a doctor before use to ensure safety and proper guidance.

What to Avoid

You should be aware of several important guidelines when using this product. First, it is for external use only, so do not apply it to your eyes or use it rectally with fingers or any devices. If your condition worsens, lasts more than seven days, or clears up only to return within a few days, stop using the product and consult a doctor. It's also essential to talk to your doctor before using any other hydrocortisone product in these situations.

Additionally, if you have a vaginal discharge, rectal bleeding, or diaper rash, please consult a doctor before using this product. Always follow the recommended dosage and avoid exceeding it without medical advice.

Side Effects

You should be aware that this product is for external use only and should not be applied in or around the eyes, nor should it be inserted into the rectum using fingers or any devices. Before using it, consult a doctor if you have a vaginal discharge, rectal bleeding, or diaper rash.

If your condition worsens, does not improve after 7 days, or clears up only to return within a few days, stop using the product and seek medical advice. Additionally, keep this product out of reach of children; if swallowed, seek medical help or contact a Poison Control Center immediately.

Warnings and Precautions

This product is for external use only, so please avoid using it in your eyes or inserting it into the rectum with fingers or any devices. Before using this product, consult your doctor if you have any vaginal discharge, rectal bleeding, or diaper rash. It's also important to talk to your doctor if you think you might need to use more than the recommended amount.

You should stop using this product and contact your doctor if your condition worsens, does not improve after 7 days, or clears up only to return within a few days. Avoid starting any other hydrocortisone product without consulting your doctor first. Keep this product out of reach of children, and if it is swallowed, seek medical help or contact a Poison Control Center immediately.

Overdose

If you or someone else has swallowed too much of a medication, it’s important to seek medical help immediately. You can do this by contacting a Poison Control Center or going to the nearest emergency room. Acting quickly can make a significant difference in the outcome.

Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms, don’t hesitate to get help right away. Remember, it’s always better to be safe and seek assistance if you suspect an overdose.

Pregnancy Use

When it comes to using this product during pregnancy, there are no specific guidelines or safety concerns mentioned. This means that the information available does not indicate any known risks associated with its use while pregnant. Additionally, there are no recommended changes to the dosage for pregnant individuals, nor are there any special precautions outlined for use during this time.

As always, it's important to consult with your healthcare provider before starting any new medication or treatment during pregnancy to ensure it is safe for you and your baby.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of this product while nursing. This means that, according to the information available, it is considered safe for you to use without concerns about potential effects on your milk production or the nursing infant.

Additionally, there are no indications that this product is excreted in breast milk, which further supports its use during lactation. Always consult with your healthcare provider if you have any questions or concerns about medications while breastfeeding.

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. However, if your child is under 2 years old, you should not use this medication without first consulting a doctor. Additionally, if your child is under 12 years old, it's best to check with a doctor before use to ensure safety and proper dosage. Always prioritize your child's health by seeking professional advice when needed.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available regarding its use. This means that there are no special dosage adjustments, safety concerns, or precautions outlined for elderly patients.

As always, it's important for you or your caregiver to discuss any medications with your healthcare provider, especially if you have any underlying health conditions or are taking other medications. Your doctor can help ensure that any treatment plan is safe and effective for your individual needs.

Renal Impairment

If you have kidney problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or safety considerations for your condition. This means that there are no tailored guidelines for how this medication should be used if you have renal impairment (kidney issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your health situation. They can help determine the best course of action based on your kidney function and overall 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 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 you are taking. In this case, there are no specific drug interactions or laboratory test interactions noted, which means that the medication is generally considered safe to use with other drugs and tests. However, every individual is different, and your healthcare provider can help ensure that your treatment plan is safe and effective for you.

Always remember that discussing your full list of medications and any lab tests with your healthcare provider is crucial. This way, you can avoid any potential issues and receive the best care tailored to your needs.

Storage and Handling

To ensure the best quality and safety of your product, store it at room temperature. It's important to check the carton or tube crimp for the lot number and expiration date, as this information helps you confirm the product's validity and safety for use.

Always handle the product with care, and make sure to follow any additional instructions provided to maintain its integrity. Proper storage and handling are key to ensuring that you can use the product effectively and safely.

Additional Information

You can apply this product to the affected area 3 to 4 times a day if you are an adult or a child aged 2 years and older. If you are dealing with external anal itching, it's best to first cleanse the area with mild soap and warm water, rinse thoroughly, and then gently dry it by patting or blotting with toilet tissue or a soft cloth before applying the product.

FAQ

What is Medi-Cortisone™?

Medi-Cortisone™ is a 1% hydrocortisone cream used for temporary relief of itching associated with minor skin irritations and rashes.

What conditions can Medi-Cortisone™ help relieve?

It can help relieve itching from conditions such as eczema, insect bites, poison ivy, and more.

How should I use Medi-Cortisone™?

Apply to the affected area not more than 3 to 4 times daily for adults and children 2 years and older. For children under 2, consult a doctor.

Are there any contraindications for using Medi-Cortisone™?

Yes, do not use it in the eyes or insert it into the rectum.

What should I do if my condition worsens while using this product?

Stop use and consult a doctor if your condition gets worse, persists for more than 7 days, or recurs after clearing.

Is Medi-Cortisone™ safe to use during pregnancy?

There are no specific statements regarding its use during pregnancy, so consult a doctor before use.

What should I do if I accidentally swallow Medi-Cortisone™?

Keep it out of reach of children and seek medical help or contact a Poison Control Center immediately if swallowed.

Can I use Medi-Cortisone™ for diaper rash?

Consult a doctor before use if you have a diaper rash.

How should I store Medi-Cortisone™?

Store at room temperature and check the carton or tube crimp for the lot number and expiration date.

Packaging Info

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

Packaging configurations for Medi-Cortisone.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Medi-Cortisone™ is a maximum strength hydrocortisone cream formulated at a concentration of 1%. It is indicated for its antipruritic properties, effectively alleviating itching associated with various skin conditions. The product is presented in a cream dosage form, with a net weight of 1 oz (28.4 g). The National Drug Code (NDC) for this formulation is 49614-404-10.

Uses and Indications

This drug is indicated for the temporary relief of itching associated with minor skin irritations and rashes due to various conditions, including eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, seborrheic dermatitis, psoriasis, and external genital and anal itching.

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

Dosage and Administration

For adults and children aged 2 years and older, the product should be applied to the affected area no more than 3 to 4 times daily. Prior to application, it is recommended that the affected area be cleansed with mild soap and warm water, followed by thorough rinsing. The area should then be gently dried by patting or blotting with toilet tissue or a soft cloth before applying the product.

For children under 2 years of age, the product is not recommended, and consultation with a healthcare professional is advised. Additionally, for children under 12 years of age, it is also recommended to consult a doctor prior to use.

Contraindications

The product is contraindicated for use in the eyes. It should not be administered rectally, either manually or with any mechanical device or applicator. This product is intended for external use only.

Healthcare professionals should advise patients to discontinue use and consult a doctor if the condition worsens, persists for more than 7 days, or resolves and recurs within a few days. Patients should not initiate the use of any other hydrocortisone product without prior consultation with a healthcare provider.

Additionally, it is recommended that patients consult a doctor before using this product if they have a vaginal discharge, rectal bleeding, or diaper rash. Caution should be exercised to avoid exceeding the recommended dosage without medical advice.

Warnings and Precautions

For external use only. This product is contraindicated for use in the eyes and should not be administered rectally, either by fingers or any mechanical device or applicator.

Healthcare professionals should advise patients to consult a physician prior to use if they experience any of the following conditions: vaginal discharge, rectal bleeding, or diaper rash. It is also important to remind patients to seek medical advice before exceeding the recommended dosage of this product.

Patients should be instructed to discontinue use and consult a healthcare provider if any of the following occur: the condition worsens, persists for more than 7 days, or resolves and then recurs within a few days. Patients should refrain from using any other hydrocortisone products without prior consultation with a physician.

To ensure safety, this product must be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center should be made without delay.

Side Effects

Patients using this product should be aware of several important warnings and potential adverse reactions. This product is intended for external use only and should not be applied in the eyes or introduced into the rectum using fingers, mechanical devices, or applicators.

Before using this product, patients are advised to consult a healthcare professional if they experience vaginal discharge, rectal bleeding, or diaper rash. If the condition worsens, persists for more than 7 days, or resolves only to recur within a few days, patients should discontinue use and seek medical advice. It is also recommended that patients refrain from using any other hydrocortisone products without prior consultation with a healthcare provider.

In addition, it is crucial to keep this product out of reach of children. In the event of accidental ingestion, patients should seek immediate medical assistance or contact a Poison Control Center.

Drug Interactions

There are no specific drug interactions or laboratory test interactions identified in the available data. Therefore, no recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

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

Packaging configurations for Medi-Cortisone.
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 children under 2 years of age, the medication is not recommended, and a consultation with a doctor is advised. Additionally, for children under 12 years of age, it is also recommended to consult a doctor prior to use.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, as the prescribing information does not provide any age-related considerations. There are no recommended dosage adjustments or safety concerns outlined for geriatric patients. Additionally, no special precautions are indicated for this population. Healthcare providers should exercise clinical judgment when prescribing this medication to elderly patients, considering individual patient factors and overall health status.

Pregnancy

There are no specific statements regarding the use of this product during pregnancy. Additionally, no safety concerns related to pregnancy have been identified in the available data. There are no recommended dosage modifications for pregnant individuals, nor are there any special precautions regarding the use of this product during pregnancy. Healthcare professionals should consider the absence of data when advising pregnant patients or women of childbearing potential.

Lactation

There are no specific warnings or recommendations regarding the use of this product by lactating mothers. Additionally, there is no information available concerning the potential for excretion in breast milk or any effects on breastfed infants.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of data necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients, although specific recommendations are not provided.

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 event of an overdosage, immediate medical intervention is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical assistance or contact a Poison Control Center without delay.

Prompt action is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and evaluation are recommended to ensure patient safety and effective resolution of any complications arising from the overdosage.

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 product out of reach of children. In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center immediately.

Patients should be informed that this product is for external use only and must not be applied in or around the eyes. It is important to emphasize that the product should not be used rectally, whether by fingers or any mechanical device or applicator.

Patients should be instructed to discontinue use and consult a doctor if their condition worsens, persists for more than 7 days, or if the condition improves and then recurs within a few days. They should also be cautioned against starting any other hydrocortisone product without prior consultation with a healthcare professional.

When using this product, patients should be advised to consult a doctor before exceeding the recommended dosage. Additionally, patients should be encouraged to seek medical advice before use if they experience vaginal discharge, rectal bleeding, or have a diaper rash.

Storage and Handling

The product is supplied in various packaging configurations, with specific NDC numbers available for identification. It should be stored at room temperature to maintain its efficacy. Healthcare professionals are advised to check the carton or tube crimp for the lot number and expiration date to ensure proper tracking and usage.

Additional Clinical Information

Patients aged 2 years and older are advised to apply the product to the affected area no more than 3 to 4 times daily. For adults experiencing external anal itching, it is recommended to cleanse the affected area with mild soap and warm water, rinse thoroughly, and gently dry by patting or blotting with toilet tissue or a soft cloth prior to application.

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 Medi-Cortisone, 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 Medi-Cortisone, 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.