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Hydrocortisone Cream with Aloe

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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 2024
Label revision date
April 25, 2024
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 2024
Label revision date
April 25, 2024
Manufacturer
Cardinal Health 110 dba LEADER
Registration number
M017
NDC root
70000-0662
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

LEADER Hydrocortisone Cream with Aloe is a topical medication designed to provide temporary relief from itching caused by minor skin irritations, inflammation, and rashes. It is commonly used to treat conditions such as eczema, seborrheic dermatitis, psoriasis, insect bites, and reactions to plants like poison ivy, poison oak, and poison sumac. Additionally, it can help alleviate itching related to soaps, detergents, cosmetics, and even external feminine, genital, and anal areas.

This cream contains hydrocortisone, a type of corticosteroid that works by reducing inflammation and suppressing the immune response in the affected area, helping to soothe your skin and relieve discomfort. For any other uses, it is important to consult with a doctor for proper guidance.

Uses

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

If you have other uses in mind, it's important to consult with your doctor for advice and supervision.

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. For children under 2 years of age, it’s important to consult a doctor before use.

When dealing with external or anal itching, it’s best to start by gently cleaning the affected area. You can do this with mild soap and warm water, making sure to rinse thoroughly. Alternatively, you can pat or blot the area with toilet tissue or a soft cloth before applying the medication. This preparation helps ensure the product works effectively.

What to Avoid

You should avoid using this product for treating diaper rash or external genital itching if you have a vaginal discharge; in these cases, it's important to consult a doctor first. If your condition worsens, symptoms persist for more than 7 days, or if symptoms clear up and then return within a few days, stop using the product and do not start any other hydrocortisone (a type of steroid used to reduce inflammation) product without your doctor's guidance.

While using this product, be careful to avoid contact with your eyes. Do not exceed the recommended daily dosage unless directed by a doctor, and do not use any other hydrocortisone products without consulting a healthcare professional. If you experience any bleeding, stop using the product immediately and seek medical advice. Additionally, do not insert this product into the rectum using fingers or any devices.

Side Effects

This product is intended for external use only. If you notice that your condition worsens or if your symptoms last longer than 7 days, it's important to stop using the product and consult a doctor. Additionally, if your symptoms improve and then return within a few days, you should also discontinue use and seek medical advice before using any other hydrocortisone product.

Warnings and Precautions

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

You should stop using this product and consult your doctor if your condition worsens, if symptoms last longer than 7 days, or if your symptoms improve and then return within a few days. Do not start using any other hydrocortisone product unless your doctor advises you to do so.

Overdose

If you suspect an overdose, it's important to stay calm and take action. While there is no specific information available about the effects of an overdose for this medication, you should be aware of general signs that may indicate a problem. These can include unusual drowsiness, confusion, or difficulty breathing.

If you notice any of these symptoms or if you believe you have taken too much of the medication, seek immediate medical help. It's always better to be safe and get checked by a healthcare professional. Remember, your health and safety are the top priority.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that there are no specific guidelines or safety concerns mentioned regarding the use of Hydrocortisone Cream with Aloe during pregnancy. This means that the information available does not indicate any necessary dosage changes or special precautions for using this cream while pregnant.

As always, it's best to consult with your healthcare provider before using any medication, including over-the-counter products like Hydrocortisone Cream with Aloe, 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. Additionally, there is no information available about whether this product is excreted in breast milk or any potential risks to your infant.

As always, it's a good idea to consult with your healthcare provider if you have any concerns or questions about using any medication while breastfeeding.

Pediatric Use

If you have a child under 2 years old, it's important to consult with a doctor before using this medication. For children aged 2 years and older, you can apply the medication to the affected area, but be sure not to exceed 3 to 4 applications in a day. Always follow these guidelines to ensure the safety and effectiveness of the treatment for your child.

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 should be used if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your liver health. They can help determine the best course of action based on your individual situation.

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 may not have known conflicts with other drugs or tests. However, every individual is different, and your healthcare provider can help ensure that your treatment plan is safe and effective for you.

Always discuss any changes in your medication or health status with your healthcare provider to avoid potential issues and to get the best care tailored to your needs.

Storage and Handling

To ensure the safety and effectiveness of your product, store it at a controlled room temperature between 20°-25°C (68°-77°F). This temperature range helps maintain the product's integrity.

When handling the product, be sure to check the seal on the tube. If the seal is punctured or not visible, do not use the product, as this indicates it may have been tampered with. Following these guidelines will help you use the product safely and effectively.

Additional Information

You should apply this medication topically to the affected area, and it can be used by adults and children aged 2 years and older. It is recommended to apply it no more than 3 to 4 times a day. If you have any questions about how to use this medication or its effects, be sure to consult your healthcare provider for guidance.

FAQ

What is LEADER Hydrocortisone Cream with Aloe used for?

LEADER Hydrocortisone Cream with Aloe is used for temporary relief of itching associated with minor skin irritations, inflammation, and rashes, including conditions like eczema, psoriasis, and insect bites.

How should I use this cream?

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

Are there any warnings I should be aware of?

This product is for external use only. Avoid contact with the eyes and do not use if you have a vaginal discharge or for diaper rash without consulting a doctor.

What should I do if my symptoms persist?

Stop using the product and consult a doctor if conditions worsen or if symptoms persist for more than 7 days.

Can I use this cream during pregnancy or while nursing?

There is no specific information regarding the use of this product during pregnancy or lactation, so consult a doctor before use.

What should I do in case of an emergency?

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

How should I store this cream?

Store at controlled room temperature between 20°-25°C (68°-77°F) and do not use if the seal on the tube is punctured or not visible.

Packaging Info

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

Packaging configurations for Hydrocortisone Cream with Aloe.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

LEADER Hydrocortisone Cream with Aloe is a topical formulation containing hydrocortisone as the active ingredient. This cream is designed for dermatological use and is presented in a 1-ounce tube. The product is formulated to provide anti-inflammatory effects and is enhanced with aloe for additional skin soothing properties. The specific chemical composition and molecular weight of the active ingredient are not detailed in the provided information. The cream's appearance is consistent with typical hydrocortisone formulations, characterized by a smooth texture suitable for application on the skin.

Uses and Indications

This drug is indicated for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to various conditions, including eczema, seborrheic dermatitis, psoriasis, insect bites, and contact with plants such as poison ivy, poison oak, and poison sumac. It is also effective for itching caused by soaps, detergents, cosmetics, jewelry, and external feminine, genital, and anal areas.

Other uses of this product should only be undertaken under the advice and supervision of a healthcare professional. There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

For adults and children aged 2 years and older, the recommended application frequency is 3 to 4 times daily to the affected area. For children under 2 years of age, it is advised to consult a physician prior to use.

In cases of external and anal itching, it is recommended that adults, when practical, cleanse the affected area with mild soap and warm water, ensuring thorough rinsing. Alternatively, the area may be gently patted or blotted with toilet tissue or a soft cloth prior to the application of this product.

Contraindications

The product is contraindicated for the treatment of diaper rash and external genital itching in the presence of vaginal discharge; consultation with a doctor is advised in these cases.

Discontinue use and consult a doctor if conditions worsen, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days.

Avoid contact with the eyes during use. Do not initiate the use of any other hydrocortisone product without prior consultation with a doctor. Exceeding the recommended daily dosage is contraindicated unless directed by a healthcare professional. In the event of bleeding, stop use and seek medical advice. This product should not be administered rectally using fingers or any mechanical device or applicator.

Warnings and Precautions

For external use only. This product is not intended for internal use, and ingestion may lead to serious health consequences.

Healthcare professionals should advise patients to seek emergency medical assistance or contact a Poison Control Center immediately if the product is swallowed. Prompt action is essential to mitigate potential risks associated with ingestion.

Patients should be instructed to discontinue use and consult a healthcare provider if any of the following occur: worsening of conditions, persistence of symptoms beyond 7 days, or if symptoms resolve and then recur within a few days. In such cases, patients should refrain from using any other hydrocortisone products unless specifically directed by a healthcare professional.

Side Effects

Patients should be aware that this product is for external use only. In the event that conditions worsen or symptoms persist for more than 7 days, it is advised to discontinue use and consult a healthcare professional. Additionally, if symptoms clear up and then recur within a few days, patients should also stop using the product and refrain from starting any other hydrocortisone product unless directed by a doctor.

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions between the drug and laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the current information.

Packaging & NDC

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

Packaging configurations for Hydrocortisone Cream with Aloe.
Details

Pediatric Use

Pediatric patients under 2 years of age should consult a healthcare professional before use. For children aged 2 years and older, the recommended application is to the affected area no more than 3 to 4 times daily.

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

There are no specific statements regarding the use of Hydrocortisone Cream with Aloe during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients. It is advisable to weigh the potential benefits against any unknown risks to fetal outcomes. Women of childbearing potential should be counseled accordingly, and alternative treatments may be considered if necessary.

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 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 context of overdosage, there is currently no specific information available regarding the effects or management of an overdose for this medication. Healthcare professionals are advised to monitor patients closely for any unusual symptoms or adverse reactions that may arise.

In the absence of detailed overdosage data, it is recommended that standard supportive measures be employed. This may include symptomatic treatment and monitoring of vital signs. If an overdose is suspected, healthcare providers should consider contacting a poison control center or seeking guidance from a medical toxicologist for further management strategies.

As always, maintaining a comprehensive understanding of the patient's clinical status is essential in the event of an overdose scenario.

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 compound in these areas.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center if the product is swallowed. For patients using the product for the treatment of diaper rash, it is important to recommend consulting a doctor prior to use.

Patients experiencing external genital itching accompanied by vaginal discharge should also be instructed to consult a doctor. Healthcare providers should emphasize the importance of discontinuing use and seeking medical advice if the condition worsens or if symptoms persist for more than 7 days. Additionally, patients should be informed that if symptoms clear up and then recur within a few days, they should stop using the product and refrain from starting any other hydrocortisone product unless directed by a healthcare professional.

While using this product, patients must be cautioned to avoid contact with the eyes. It is essential to inform them not to exceed the recommended daily dosage unless specifically directed by a doctor. In the event of bleeding, patients should be advised to stop using the product and consult a doctor immediately. Furthermore, patients should be instructed not to insert the product into the rectum using fingers or any mechanical device or applicator.

Storage and Handling

The product is supplied in a tamper-evident tube. It is essential to inspect the seal before use; do not utilize the product if the seal is punctured or not visible.

For optimal storage, the product should be maintained at a controlled room temperature ranging from 20° to 25°C (68° to 77°F). Proper handling and storage conditions are crucial to ensure the integrity and efficacy of the product.

Additional Clinical Information

The medication is administered topically, with a recommended application frequency of no more than 3 to 4 times daily for adults and children aged 2 years and older. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Hydrocortisone Cream with Aloe, 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 Hydrocortisone Cream with Aloe, 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.

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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.