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Elixircortirelief

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Active ingredient
Hydrocortisone 1 g/100 g
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 2025
Label revision date
December 2, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Hydrocortisone 1 g/100 g
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 2025
Label revision date
December 2, 2025
Manufacturer
ELIXIR HEALTHCARE USA, LLC.
Registration number
M017
NDC root
84546-0005
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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 Cream 1% is an anti-itch cream designed to provide temporary relief from minor skin irritations, itching, and rashes. It is commonly used for conditions such as eczema, insect bites, and reactions to plants like poison ivy, poison oak, and poison sumac, as well as irritations caused by soaps, detergents, cosmetics, and jewelry. This cream can also be applied for external genital, feminine, and anal itching, helping to soothe discomfort in these sensitive areas.

Uses

You can use this medication for the temporary relief of minor skin irritations, itching, and rashes caused by various conditions. These include eczema, insect bites, and reactions to plants like poison ivy, poison oak, and poison sumac. It can also help soothe irritation from soaps, detergents, cosmetics, and even jewellery. Additionally, if you're experiencing external genital, feminine, or anal itching, this medication may provide relief.

It's important to note that there are no reported teratogenic effects (which means it doesn't cause birth defects) associated with this medication.

Dosage and Administration

If you are an adult or a child over 2 years old, you can apply the medication to the affected area up to 3 to 4 times a day. For the best results, it’s recommended that you first clean the area with mild soap and warm water, then rinse it thoroughly. After gently drying the area by patting it with bathroom tissue or a soft cloth, you can apply the medication.

If you are an adult, you may apply the medication externally up to 6 times a day or after each bowel movement. Remember to discard any used pads after application, and do not flush them down the toilet. If your child is under 2 years old, it’s important not to use this medication without consulting a doctor first.

What to Avoid

It's important to use this medication safely. You should not use it in your eyes, for treating diaper rash, or if you have vaginal discharge. Additionally, make sure to stick to the recommended dosage and avoid taking more than what is advised, as exceeding this can lead to serious issues, including dependence (a condition where your body becomes reliant on a substance).

Always prioritize your health and safety by following these guidelines closely. If you have any questions or concerns about using this medication, please consult your healthcare provider.

Side Effects

This product is intended for external use only. If your condition worsens, or if symptoms last more than 7 days or improve and then return within a few days, you should stop using it and consult a doctor. Additionally, if you are pregnant or breastfeeding, it's important to talk to your doctor before using this product.

Warnings and Precautions

This product is for external use only, so please avoid swallowing it. If you accidentally swallow it, seek medical help immediately or contact a Poison Control Center.

If your condition worsens, or if your symptoms last longer than 7 days or come back after clearing up, stop using the product and call your doctor for further advice. Your health and safety are important, so don’t hesitate to reach out for help if you need it.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, it's important to be aware of the general signs of an overdose, which can include symptoms like extreme drowsiness, confusion, or difficulty breathing. If you suspect an overdose, it is crucial to seek immediate medical attention.

In case of an emergency, call your local emergency services or go to the nearest hospital. Always keep your medications in their original packaging and follow the prescribed dosage to minimize the risk of an overdose. If you have any concerns or questions about your medication, don’t hesitate to reach out to your healthcare provider for guidance.

Pregnancy Use

If you are pregnant or breastfeeding, it’s important to consult your doctor before using this medication. Your healthcare provider can help you understand any potential risks and ensure that you make the safest choices for you and your baby. Always prioritize open communication with your doctor regarding any medications you may be considering during this time.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to consult your doctor before using any medication. This is to ensure that it is safe for you and your baby. Your healthcare provider can help you understand any potential risks and make informed decisions about your health and your baby's well-being. Always prioritize open communication with your doctor regarding your breastfeeding status when considering new treatments.

Pediatric Use

When using this medication for children, it's important to follow specific guidelines. For children over 2 years old, you can apply the medication evenly 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 and should consult a doctor for advice.

Always ensure you are following these recommendations to keep your child safe and healthy. If you have any questions or concerns, don't hesitate to reach out to a healthcare professional.

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, it’s important to consult with a healthcare provider before starting the medication. 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 there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations for the medication do not include special monitoring or safety considerations tailored for patients with renal impairment (kidney issues).

Always consult your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective for your specific health needs.

Hepatic Impairment

If you have liver problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or precautions related to your condition. This means that there are no tailored recommendations for how the medication may affect you differently due to your liver health.

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your specific situation. They can help determine the best approach based on your liver function and overall health.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you.

Always feel free to ask questions and share your complete list of medications and any lab tests you may be undergoing. This way, you can receive the best possible care tailored to your needs.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 20°-25°C (68°-77°F). It's important to keep it away from excessive heat and humidity, as these conditions can affect its effectiveness.

After using the product, please remember to discard the pad properly. Do not flush it down the toilet, as this can cause plumbing issues. Following these guidelines will help you use the product safely and effectively.

Additional Information

You should apply the medication evenly to the affected area no more than 3 to 4 times a day. If needed, you can apply it externally up to 6 times daily or after each bowel movement. Make sure to follow these guidelines for the best results.

FAQ

What is Hydrocortisone Cream 1% used for?

Hydrocortisone Cream 1% is an anti-itch cream used for temporary relief of minor skin irritations, itching, and rashes due to conditions like eczema, insect bites, and poison ivy.

How should I apply Hydrocortisone Cream?

For adults and children over 2 years, apply evenly to the affected area no more than 3 to 4 times daily. For adults, it can be applied up to 6 times daily or after each bowel movement.

Can I use Hydrocortisone Cream on children under 2 years?

No, do not use Hydrocortisone Cream on children under 2 years of age without consulting a doctor.

Are there any warnings for using Hydrocortisone Cream?

Yes, it is for external use only. Do not use in the eyes, for diaper rash, or if you have vaginal discharge. Stop use and consult a doctor if the condition worsens or persists for more than 7 days.

What should I do if I swallow Hydrocortisone Cream?

If swallowed, get medical help or contact a Poison Control Center right away.

Is it safe to use Hydrocortisone Cream during pregnancy or breastfeeding?

You should ask a doctor before using Hydrocortisone Cream if you are pregnant or breastfeeding.

What is the storage requirement for Hydrocortisone Cream?

Store Hydrocortisone Cream at 20°-25°C (68°-77°F) and avoid excessive heat and humidity.

Packaging Info

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

Packaging configurations for Elixircortirelief.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the temporary relief of minor skin irritations, itching, and rashes associated with various conditions, including eczema, insect bites, and contact with plants such as poison ivy, poison oak, and poison sumac. It is also effective for skin irritations caused by soaps, detergents, cosmetics, and jewellery. Additionally, this drug provides relief for external genital, feminine, and anal itching.

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

Dosage and Administration

For adults and children over 2 years of age, the product should be applied evenly to the affected area no more than 3 to 4 times daily. For optimal results, it is recommended that adults first clean the affected area with mild soap and warm water, rinsing thoroughly. The area should then be gently dried by patting or blotting with bathroom tissue or a soft cloth prior to application.

In adults, the product may be applied externally to the affected area up to 6 times daily or after each bowel movement. After each application, the pad should be discarded properly and not flushed down the toilet.

For children under 2 years of age, the use of this product is not recommended; consultation with a healthcare professional is advised.

Contraindications

Use of this product is contraindicated in the following situations:

Application in the eyes is prohibited due to the potential for irritation and damage to ocular tissues. The product should not be used for diaper rash, as it may not be suitable for the sensitive skin in that area. Additionally, it is contraindicated in patients with vaginal discharge, as this may indicate an underlying condition that requires different management. Finally, exceeding the recommended dosage is contraindicated to prevent adverse effects associated with overdose.

Warnings and Precautions

For external use only. This product is not intended for ingestion. In the event of accidental swallowing, it is imperative to seek immediate medical assistance or contact a Poison Control Center.

Healthcare professionals should advise patients to discontinue use and consult a physician if the condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. These precautions are essential to ensure patient safety and effective management of their condition.

Side Effects

For external use only. Patients are advised to stop use and consult a doctor if the condition worsens or if symptoms persist for more than 7 days, or if symptoms clear up and then occur again within a few days. Additionally, it is recommended that patients ask a doctor before use if they are pregnant or breastfeeding.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

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

Packaging configurations for Elixircortirelief.
Details

Pediatric Use

Pediatric patients over 2 years of age may apply the medication evenly to the affected area no more than 3 to 4 times daily. For children under 2 years of age, the use of this medication is not recommended, and consultation with a doctor is advised.

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 and those who are breastfeeding should consult a healthcare professional before using this medication. The safety of this drug during pregnancy has not been established, and potential risks to fetal outcomes are not fully understood. Therefore, it is essential for women of childbearing potential to discuss their individual circumstances with their healthcare provider to weigh the benefits and risks associated with the use of this medication during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a healthcare professional prior to using this medication if they are breastfeeding. There is no specific data available regarding the excretion of this medication in breast milk or its effects on breastfed infants. Therefore, caution is recommended when considering the use of this medication during lactation.

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 clinical trials for this medication. Consequently, there is no available information regarding 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 warranted based on clinical judgment.

Overdosage

In the absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant regarding the potential for overdose with this medication. In cases where an overdose is suspected, immediate medical attention should be sought.

Healthcare providers are advised to monitor patients closely for any signs or symptoms that may indicate an overdose. These may include, but are not limited to, increased severity of known side effects, unusual behavioral changes, or any other atypical clinical manifestations.

Management of an overdose should be guided by the clinical presentation of the patient. Supportive care is paramount, and symptomatic treatment should be initiated as necessary. It is recommended that healthcare professionals consult local poison control centers or relevant toxicology resources for specific guidance on the management of overdose cases.

In summary, while specific overdosage information is not available, healthcare professionals should exercise caution, remain observant for potential overdose symptoms, and implement appropriate management strategies as needed.

Nonclinical Toxicology

There is currently no available information regarding teratogenic or non-teratogenic effects associated with the compound. Additionally, no data has been provided concerning nonclinical toxicology, including animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are available in the provided text.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. In the event of swallowing the medication, patients should seek medical assistance or contact a Poison Control Center immediately.

Patients should be informed that the medication is not intended for use in the eyes and should not be applied for diaper rash. It is important to instruct patients not to use the medication if they have vaginal discharge or if they are considering exceeding the recommended dosage.

Healthcare providers should counsel patients to discontinue use and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms improve and then recur within a few days. Additionally, patients should be encouraged to consult with a healthcare professional before using the medication if they are pregnant or breastfeeding.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at a controlled temperature range of 20° to 25°C (68° to 77°F). Care should be taken to avoid exposure to excessive heat and humidity, as these conditions may compromise the integrity of the product.

After application, the used pad must be discarded appropriately. It is important to note that the pad should not be flushed down the toilet to prevent plumbing issues and environmental concerns.

Additional Clinical Information

Patients should apply the medication evenly to the affected area no more than 3 to 4 times daily. Additionally, it may be applied externally to the area up to 6 times daily or after each bowel movement, as needed. 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 Elixircortirelief, 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 Elixircortirelief, 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.