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Medi-First Hydrocortisone, Medi-First Plus Hydrocortisone

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This product has been discontinued

Active ingredient
Hydrocortisone 10 mg/1 g
Other brand names
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2020
Label revision date
August 10, 2023
Active ingredient
Hydrocortisone 10 mg/1 g
Other brand names
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2020
Label revision date
August 10, 2023
Manufacturer
Unifirst First Aid Corporation
Registration number
part348
NDC roots
47682-611, 47682-633

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If you are a consumer or patient please visit this version.

Drug Overview

Medi-First® 1% Hydrocortisone Cream is a topical medication designed to provide temporary relief from itching caused by minor skin irritations, inflammation, and rashes. This cream can also be used for external genital, feminine, and anal itching, helping to soothe discomfort in these sensitive areas.

It's important to note that while this cream is effective for these specific uses, any other applications should be done only under the advice and supervision of a doctor.

Uses

You can use this product for temporary relief from itching caused by minor skin irritations, inflammation, and rashes. It is also effective for alleviating itching in external genital areas, as well as feminine and anal itching.

If you have other uses in mind for this product, it's important to consult with your doctor first 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 the medication to the affected area up to 3 to 4 times a day. For children under 2 years old, it’s important not to use this medication without consulting a doctor first.

If you are dealing with external anal and genital itching, start by gently cleaning the affected area with mild soap and warm water, then rinse it thoroughly. After cleaning, make sure to dry the area gently by patting or blotting it with toilet tissue or a soft cloth before applying the medication. If the person needing treatment is under 12 years old, be sure to ask a doctor for guidance.

What to Avoid

It's important to use this medication safely. You should not use it for treating diaper rash or in combination with any other Hydrocortisone product unless you've consulted your doctor. If you have a vaginal discharge, please speak with your doctor before using this product.

Additionally, avoid inserting this medication into the rectum using your fingers, a mechanical device, or an applicator. Always follow the recommended daily dosage and do not exceed it unless directed by your doctor. Your health and safety are paramount, so please adhere to these guidelines.

Side Effects

When using this product, it's important to be aware of some potential side effects and warnings. You should only use it externally and avoid contact with your eyes. If you experience any worsening of your condition, if symptoms last more than 7 days, or if symptoms improve and then come back shortly after, stop using the product and consult your doctor. Additionally, if you notice any rectal bleeding, seek medical advice immediately.

Do not use this product for diaper rash or in combination with other hydrocortisone products without consulting a doctor first. It's also crucial not to insert the product into the rectum using fingers or any devices. Always follow the recommended dosage unless directed otherwise by your healthcare provider.

Warnings and Precautions

This product is for external use only, so please avoid applying it to any internal areas. It’s important not to use it for diaper rash or in combination with other hydrocortisone products unless you have spoken with your doctor. If you notice any vaginal discharge, consult your doctor before using this product.

If you accidentally swallow this medication, seek emergency medical help or contact a Poison Control Center immediately. You should also stop using the product and call your doctor if your condition worsens, if symptoms last longer than 7 days, or if symptoms improve and then come back within a few days. Additionally, if you experience rectal bleeding, stop use and reach out to your doctor 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 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

If you are pregnant or planning to become pregnant, it's important to be cautious about certain medications. You should avoid using this medication if you have a vaginal discharge and consult your doctor for guidance. Additionally, if you have children under 2 years old, do not use this medication without first speaking to a healthcare professional. For children under 12 years of age, it's advisable to consult a doctor before use as well. Always prioritize safety and seek medical advice when it comes to medication during pregnancy and for young children.

Lactation Use

If you are breastfeeding, it's important to know that there is no specific information available regarding the use of this medication while nursing. This means that the effects on breast milk production and your nursing infant are not clearly defined.

As always, it's best to consult with your healthcare provider about any medications you are considering while breastfeeding to ensure the safety and well-being of both you and your baby.

Pediatric Use

If you have a child who is 2 years old or older, you can apply the medication to the affected area up to 3 to 4 times a day. However, if your child is under 2 years old, it's important not to use this medication without first consulting a doctor. Additionally, for children under 12 years of age, you should also check with a doctor before use to ensure it's safe and appropriate for them. 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 about dosage adjustments, safety concerns, or special precautions. This means that if you or a loved one is an older adult considering this medication, it’s important to consult with a healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

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 may affect you if you have hepatic impairment (liver issues).

Before starting any new medication, including this one, you should discuss your liver health with your healthcare provider. They can help determine the best approach for your treatment and ensure your safety.

Drug Interactions

It's important to be cautious when using hydrocortisone. You should not use it alongside any other hydrocortisone products unless you have first consulted with your doctor. This is crucial to avoid potential complications and ensure your treatment is safe and effective.

While there are no specific laboratory test interactions noted, it's always a good practice to discuss all medications and any upcoming tests with your healthcare provider. They can help you understand how your treatments may interact and ensure you receive the best care possible.

Storage and Handling

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

When handling the product, check that the packaging is intact. Do not use it if the packet is torn, cut, or opened, as this indicates that it may have been tampered with. Following these guidelines will help you use the product safely and effectively.

Additional Information

No further information is available.

FAQ

What is Medi-First® 1% Hydrocortisone Cream used for?

Medi-First® 1% Hydrocortisone Cream is used for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes.

Who can use this cream?

Adults and children 2 years of age and older can use this cream, but children under 2 years should not use it without consulting a doctor.

How should I apply the cream?

Apply the cream to the affected area not more than 3 to 4 times daily, and for external anal and genital itching, clean the area with mild soap and warm water before applying.

Are there any contraindications for using this cream?

Yes, do not use it for the treatment of diaper rash, with any other Hydrocortisone product without consulting a doctor, or if you have a vaginal discharge.

What should I do if my condition worsens?

If your condition worsens, symptoms persist for more than 7 days, or if rectal bleeding occurs, stop using the cream and consult a doctor.

What are the storage instructions for this cream?

Store the cream at room temperature between 59° to 86° F (15° to 30° C) and avoid excessive heat and humidity.

Is there any specific advice for nursing mothers?

No specific information is provided regarding the use of this cream by nursing mothers.

Packaging Info

Below are the non-prescription pack sizes of Medi-First Hydrocortisone, Medi-First Plus Hydrocortisone (1 % hydrocortisone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Medi-First Hydrocortisone, Medi-First Plus Hydrocortisone.
Details

Uses and Indications

This drug is indicated for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes. It is also indicated for the relief of external genital, feminine, and anal itching.

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

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. For external anal and genital itching in adults, it is advised to first clean the affected area with mild soap and warm water, ensuring thorough rinsing. After cleansing, gently dry the area by patting or blotting with toilet tissue or a soft cloth prior to application.

For children under 2 years of age, the product should not be used without consulting a doctor. Additionally, for children under 12 years of age, it is recommended to seek medical advice before use.

Contraindications

The product is contraindicated in the following situations:

Use is not recommended for the treatment of diaper rash. Additionally, the product should not be used in conjunction with any other Hydrocortisone product without prior consultation with a healthcare professional. Patients presenting with vaginal discharge should seek medical advice before use.

Furthermore, the product must not be administered rectally using fingers, mechanical devices, or applicators. Exceeding the recommended daily dosage is contraindicated unless directed by a physician.

Warnings and Precautions

For external use only. This product is not intended for the treatment of diaper rash. Healthcare professionals should advise patients against using this product in conjunction with any other hydrocortisone product unless they have consulted a physician. Additionally, patients should be cautioned not to use this product if they have a vaginal discharge and should seek medical advice in such cases.

In the event of accidental ingestion, it is imperative to seek emergency medical assistance or contact a Poison Control Center immediately.

Patients should be instructed to discontinue use and contact their healthcare provider if any of the following occur: the condition worsens, symptoms persist for more than 7 days, or if symptoms resolve and then reappear within a few days. Furthermore, if rectal bleeding occurs, patients must stop using the product and consult their doctor without delay.

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

Side Effects

Patients using this product may experience various adverse reactions. It is important to note that this product is for external use only and should not be used for the treatment of diaper rash. Additionally, patients should not use this product in conjunction with any other hydrocortisone product without prior consultation with a healthcare professional.

During the use of this product, patients are advised to avoid contact with the eyes and to refrain from inserting the product into the rectum using fingers, mechanical devices, or applicators. Patients should adhere to the recommended daily dosage and should not exceed it unless directed by a healthcare provider.

Patients should discontinue use and consult a doctor if the condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then reappear within a few days. Furthermore, if rectal bleeding occurs, patients should seek medical advice immediately.

Drug Interactions

The concurrent use of this product with any other Hydrocortisone formulation is contraindicated unless a healthcare professional has been consulted. This precaution is essential to avoid potential additive effects or complications associated with corticosteroid therapy.

No specific interactions with laboratory tests have been identified in the available data. Therefore, routine monitoring of laboratory parameters is not indicated in relation to this product.

Packaging & NDC

Below are the non-prescription pack sizes of Medi-First Hydrocortisone, Medi-First Plus Hydrocortisone (1 % hydrocortisone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Medi-First Hydrocortisone, Medi-First Plus Hydrocortisone.
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 consultation with a healthcare professional is advised. Additionally, for children under 12 years of age, it is recommended to seek medical advice before use.

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 individual responses may vary. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

Pregnant patients should not use this medication if they have a vaginal discharge and are advised to consult a healthcare professional. The safety of this medication in pregnant women has not been established, and its use is not recommended without medical guidance.

Additionally, this medication is contraindicated in children under 2 years of age, and caution is advised for use in children under 12 years of age, necessitating consultation with a healthcare provider. The potential risks and benefits should be carefully considered in these populations.

Lactation

There is no specific information available regarding the use of this medication in nursing mothers or its effects on lactation. Additionally, there are no data on the excretion of this medication in human breast milk or its potential effects on breastfed infants. Healthcare professionals should consider the lack 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 this medication. Consequently, there are no 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 prescribing 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 specific postmarketing experience details are available in the extracted data. As such, there are no reported adverse events or case reports to summarize.

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 this product is not intended for the treatment of diaper rash.

Patients should be cautioned against using this product in conjunction with any other Hydrocortisone products unless they have first consulted with a healthcare professional. Additionally, patients should be instructed not to use the product if they have a vaginal discharge and to consult a doctor in such cases.

Healthcare providers should emphasize the importance of discontinuing use and consulting a doctor if the patient's condition worsens, if symptoms persist for more than 7 days, or if symptoms improve and then reappear within a few days. Patients should also be advised to stop use and seek medical advice if rectal bleeding occurs.

While using this product, patients should be reminded to avoid contact with the eyes. They should also be instructed not to insert the product into the rectum using fingers, mechanical devices, or applicators. Furthermore, patients should be cautioned not to exceed the recommended daily dosage unless directed by a healthcare professional.

Storage and Handling

The product is supplied in tamper-evident packaging. It is essential to inspect the packaging prior to use; do not utilize any packets that are torn, cut, or opened.

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

Additional Clinical Information

No further data are available.

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-First Hydrocortisone, Medi-First Plus 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.