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Alumier Md Intensive Recovery

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Active ingredient
Hydrocortisone 10 mg/1 mL
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 2022
Label revision date
August 6, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Hydrocortisone 10 mg/1 mL
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 2022
Label revision date
August 6, 2025
Manufacturer
Alumier Labs
Registration number
M017
NDC root
69473-017
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 minor skin irritations, rashes, itching, and redness. It is commonly used for conditions such as eczema, insect bites, and reactions to poison ivy, poison oak, and poison sumac. Additionally, it can help with contact dermatitis, which may be caused by soaps, detergents, cosmetics, or jewelry, as well as seborrheic dermatitis and psoriasis.

Approved for use in adults and children aged 2 years and older, this treatment aims to soothe your skin and alleviate discomfort associated with these common skin issues.

Uses

You can use this medication for the temporary relief of minor skin irritations, rashes, itching, and redness if you or your child is 2 years of age or older. It is effective for various conditions, including eczema, insect bites, and reactions to poison ivy, poison oak, or poison sumac. Additionally, it can help with contact dermatitis, which may occur from exposure to soaps, detergents, cosmetics, or jewelry, as well as seborrheic dermatitis and psoriasis.

This treatment is designed to provide comfort and alleviate symptoms associated with these skin issues, helping you feel better quickly.

Dosage and Administration

If you are an adult or a child aged 2 years and older, you can apply this medication sparingly to the affected area. It’s important to do this no more than three to four times a day. Make sure to follow this guideline to ensure safe and effective use.

If the person needing treatment is under 2 years old, do not use this medication without first consulting a physician (doctor). Always prioritize safety and seek professional advice when it comes to young children.

What to Avoid

It's important to use this medication safely. You should not use it for treating diaper rash unless your doctor specifically advises you to do so. If your condition worsens, persists for more than 7 days, or clears up only to return shortly after, stop using the product and consult your doctor. Additionally, avoid using any other hydrocortisone products unless directed by your physician.

Be cautious to keep the medication away from your eyes, as it should not be used in or around that area. Following these guidelines will help ensure your safety and the effectiveness of your treatment.

Side Effects

When using this product, it's important to remember that it is for external use only. Avoid contact with your eyes, and do not apply it in or around the eye area. If your condition worsens, persists for more than 7 days, or clears up and then returns within a few days, stop using the product and consult a doctor. Additionally, do not use it for diaper rash unless advised by a physician.

Keep this product out of reach of children. If it is swallowed, seek immediate medical assistance or contact a Poison Control Center.

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 unless your doctor specifically advises you to do so. When using this product, be careful to keep it away from your eyes, as contact can cause irritation.

If your condition worsens, or if symptoms last longer than 7 days or return shortly after improvement, stop using the product and consult your doctor. Additionally, do not start using any other hydrocortisone product without your physician's guidance.

Keep this product out of reach of children. If it is swallowed, seek immediate medical assistance by calling a Poison Control Centre or going to the nearest emergency room.

Overdose

If you or someone else has swallowed too much of a medication, it’s important to act quickly. Call a Poison Control Centre or seek medical help immediately. Signs of an overdose can vary, but they may include unusual symptoms that are not typical for the medication.

Remember, getting prompt assistance is crucial. Don’t hesitate to reach out for help if you suspect an overdose has occurred. Your safety and well-being are the top priority.

Pregnancy Use

If you are pregnant or breastfeeding, it’s important to consult your physician before using this medication. This ensures that you receive the best advice tailored to your specific situation. Additionally, you should avoid using this medication for treating diaper rash unless specifically directed by a healthcare professional. Always prioritize your health and the health of your baby by seeking guidance from your doctor.

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. Additionally, there is no information available about whether this product is excreted in breast milk or any potential risks to your infant. Always consult with your healthcare provider if you have any concerns or questions about medications while breastfeeding.

Pediatric Use

You can use this medication to help relieve minor skin irritations, rashes, itching, and redness caused by conditions like eczema, insect bites, and poison ivy in children aged 2 years and older. It's important to apply it sparingly to the affected area, no more than three to four times a day.

However, you should avoid using this medication on children under 2 years old. If your child is younger than this age, it's best to consult a physician (doctor) for advice. Always prioritize your child's safety and well-being when considering any treatment.

Geriatric Use

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. Since older adults may have different health needs and may be taking multiple medications, it’s always a good idea to consult with a healthcare provider before starting any new medication. They can help ensure that the treatment is safe and appropriate for your individual health situation.

If you or a loved one is an older adult, be sure to discuss any concerns about potential side effects or interactions with other medications you may be taking. Your healthcare provider can provide guidance tailored to your specific needs.

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).

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 talk to your healthcare provider before starting any new medications, especially if you're considering using another hydrocortisone product. Your doctor can guide you on the safe use of these medications to avoid any potential issues.

Currently, there are no specific interactions with laboratory tests mentioned, but it's always a good practice to keep your healthcare provider informed about all the medications you are taking. This way, they can help ensure your treatment is safe and effective.

Storage and Handling

To ensure your product remains safe and effective, always check that the security seal is intact before use. If the seal is broken or missing, do not use the product, as this may compromise its safety and effectiveness. Proper handling is crucial, so make sure to store the product in a secure location to prevent any tampering or damage. Following these guidelines will help you use the product safely and effectively.

Additional Information

No further information is available.

FAQ

What is the drug used for?

The drug is used for the temporary relief of minor skin irritations, rashes, itching, and redness due to conditions like eczema, insect bites, and poison ivy.

Who can use this drug?

It is approved for use in adults and children 2 years of age and older.

How should I apply the drug?

You should apply it sparingly to the affected area not more than three to four times daily.

Are there any contraindications for this drug?

Do not use it for the treatment of diaper rash, except on the advice of a physician.

What should I do if my condition worsens?

Stop use and ask a doctor if your condition worsens or if symptoms persist for more than 7 days.

Is this drug safe during pregnancy or breastfeeding?

Consult a physician before use if you are pregnant or breastfeeding, as there are no specific warnings provided.

What precautions should I take when using this drug?

Avoid contact with eyes and do not use in or around the eyes.

What should I do if the drug is swallowed?

Keep it out of reach of children. If swallowed, call a Poison Control Centre or get medical help right away.

Can I use other hydrocortisone products while using this drug?

Do not begin use of any other hydrocortisone product unless directed by a physician.

Packaging Info

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

Packaging configurations for Alumier Md Intensive Recovery.
Details

Drug Information (PDF)

This file contains official product information for Alumier Md Intensive Recovery, 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 the temporary relief of minor skin irritations, rashes, itching, and redness in adults and children aged 2 years and older. The specific conditions for which this drug is indicated include eczema, insect bites, poison ivy, poison oak, poison sumac, contact dermatitis (including reactions caused by soaps, detergents, cosmetics, and/or jewelry), seborrheic dermatitis, and psoriasis.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Adults and children aged 2 years and older are instructed to apply the medication sparingly to the affected area, not exceeding three to four applications per day. It is imperative that this medication is not used on children under 2 years of age without prior consultation with a physician.

Contraindications

The product is contraindicated for the treatment of diaper rash unless specifically advised by a physician.

Additionally, it is essential to discontinue use and consult a healthcare professional if the condition worsens, if symptoms persist for more than 7 days, or if the rash clears and recurs within a few days. The initiation of any other hydrocortisone product should only occur under the direction of a physician.

Contact with the eyes should be avoided; the product must not be used in or around the eyes.

Warnings and Precautions

For external use only. This product is not intended for the treatment of diaper rash unless specifically advised by a physician. Healthcare professionals should instruct patients to avoid contact with the eyes during application and to refrain from using the product in or around the eye area.

Patients are advised to discontinue use and consult a physician if the condition worsens, if symptoms persist for more than 7 days, or if the condition clears up and recurs within a few days. It is important to note that patients should not initiate the use of any other hydrocortisone product without prior consultation with a healthcare provider.

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 by contacting a Poison Control Centre or seeking emergency medical help.

Side Effects

Patients should be aware that this product is for external use only. It is contraindicated for the treatment of diaper rash unless specifically advised by a physician.

While using this product, patients should avoid contact with the eyes and should not apply it in or around the eye area. If the condition worsens, or if symptoms persist for more than 7 days, or if the condition clears up and then recurs within a few days, patients are advised to stop use and consult a doctor. Additionally, patients should not initiate the use of any other hydrocortisone product unless directed by a physician.

It is important to keep this product out of the reach of children. In the event of accidental ingestion, patients should contact a Poison Control Centre or seek medical assistance immediately.

Drug Interactions

The initiation of any additional hydrocortisone product should only occur under the guidance of a physician. This precaution is essential to avoid potential adverse effects or interactions that may arise from concurrent use.

No specific drug or laboratory test interactions have been identified in the available data. Therefore, routine monitoring or dosage adjustments related to drug interactions are not indicated at this time.

Packaging & NDC

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

Packaging configurations for Alumier Md Intensive Recovery.
Details

Pediatric Use

Pediatric patients aged 2 years and older may use this medication for the temporary relief of minor skin irritations, rashes, itching, and redness associated with conditions such as eczema, insect bites, poison ivy, poison oak, poison sumac, contact dermatitis, seborrheic dermatitis, and psoriasis. The recommended application is sparingly to the affected area, not exceeding three to four times daily.

Caution is advised as this medication is not indicated for use in children under 2 years of age; a physician should be consulted for this age group.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any potential adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

Pregnant patients should not use this medication for the treatment of diaper rash unless advised by a physician. It is essential for women of childbearing potential to consult a healthcare professional prior to using this medication if they are pregnant or breastfeeding. The potential risks and benefits should be carefully evaluated in these populations to ensure the safety of both the mother and the fetus.

Lactation

There are no specific warnings or recommendations regarding the use of this product in nursing mothers. Additionally, there is no information available concerning the potential for excretion in breast milk or any associated risks to breastfed infants.

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 established dosage adjustments, special monitoring requirements, or precautions 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 outlined in the prescribing information.

Overdosage

In the event of an overdosage, immediate action is crucial. If the substance is swallowed, it is imperative to contact a Poison Control Centre or seek medical assistance without delay.

Healthcare professionals should be aware that timely intervention can significantly impact the outcome of an overdosage situation. Symptoms may vary depending on the specific substance involved, and monitoring for any adverse effects is essential.

Management procedures should include a thorough assessment of the patient's condition, including vital signs and any presenting symptoms. Supportive care may be necessary, and specific treatment protocols should be followed as per established guidelines for the substance in question.

In all cases of suspected overdosage, the involvement of poison control and emergency medical services is recommended to ensure appropriate care and intervention.

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

Serious adverse reaction events associated with the use of this product may be reported to Alumier Labs Inc. at 550 Cochituate Road, Suite 25, Framingham, MA 01701. Reports can be made voluntarily or through surveillance programs, contributing to the ongoing assessment of the product's safety profile.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children. Instruct patients that if the product is swallowed, they should call a Poison Control Centre or seek medical assistance immediately.

Patients should be informed that this product is not intended for the treatment of diaper rash unless specifically recommended by a physician. It is important to emphasize that if the patient's condition worsens, or if symptoms persist for more than 7 days, they should stop using the product and consult a doctor. Additionally, patients should be cautioned against starting any other hydrocortisone product without the guidance of a physician.

While using this product, patients must be advised to avoid contact with the eyes and to refrain from using it in or around the eye area.

Storage and Handling

The product is supplied in packaging that includes a security seal. It is imperative that the product not be used if the security seal is broken or missing, as this may compromise the integrity of the product.

For optimal storage and handling, the product should be kept in a controlled environment. Specific temperature ranges and container requirements are not provided; however, general best practices for pharmaceutical storage should be followed to ensure product stability and efficacy.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Alumier Md Intensive Recovery, 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 Alumier Md Intensive Recovery, 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.