Symptom checker
Select audience type

Switch between content for healthcare professionals (PRO) and general audience (GEN).

ADD CONDITION

items per page

Leader Hydrocortisone with Aloe

Last content change checked dailysee data sync status

Active ingredient
Hydrocortisone 0.01 g/1 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 2020
Label revision date
September 29, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Hydrocortisone 0.01 g/1 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 2020
Label revision date
September 29, 2025
Manufacturer
LEADER
Registration number
M007
NDC root
70000-0543
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

Hydrocortisone Cream is a topical medication that provides maximum strength relief for itching and discomfort associated with minor skin irritations, inflammation, and rashes. This cream contains 1% hydrocortisone, which helps soothe conditions such as eczema, insect bites, poison ivy, poison oak, and other skin irritations caused by soaps, detergents, and cosmetics.

In addition to its general use for skin irritations, Hydrocortisone Cream can also offer relief for external anal and genital itching. With its soothing formula, it aims to provide fast itch relief, making it a helpful option for managing various skin-related issues.

Uses

You can use this medication for temporary relief from itching caused by minor skin irritations, inflammation, and rashes. This includes conditions related to eczema, insect bites, and contact with plants like poison ivy, poison oak, and poison sumac, as well as reactions to soaps, detergents, cosmetics, and jewelry.

Additionally, it is effective for alleviating itching in the external anal and genital areas. This medication is designed to help you feel more comfortable by addressing these specific types of itching.

Dosage and Administration

If you're dealing with itching from minor skin irritations, inflammation, or rashes, you can apply the medication to the affected area up to 3 to 4 times a day. This is suitable for adults and children who are 2 years old and older. However, if your child is under 2 years of age, it's best to consult a doctor before using the product.

For external itching in the anal and genital areas, adults and children aged 12 and older should first clean the area gently with mild soap or warm water, rinsing thoroughly. After cleaning, pat the area dry with toilet tissue or a soft cloth. You can then apply the medication to the affected area, also up to 3 to 4 times daily. If your child is younger than 12, please consult a doctor for guidance.

What to Avoid

You should avoid using this product if you have a vaginal discharge; it's important to consult a doctor in this case. Additionally, do not exceed the recommended daily dosage unless your doctor advises you to do so. It's also crucial not to insert the product into the rectum using fingers or any mechanical device or applicator.

If your condition worsens, symptoms last longer than 7 days, or if they clear up and then return within a few days, you should stop using the product and consult a doctor. Bleeding is another reason to seek medical advice. Always prioritize your health and safety by following these guidelines.

Side Effects

It's important to be aware of potential side effects when using this product. You should stop using it and consult a doctor if your condition worsens, if symptoms last more than 7 days, or if they clear up and then return within a few days. Additionally, if you experience any bleeding, seek medical advice immediately.

This product is for external use only, so avoid contact with your eyes. Do not use it if you have a vaginal discharge without consulting a doctor first. If you are pregnant or breastfeeding, it's best to talk to a healthcare professional before using this product. Always keep it out of reach of children, and if swallowed, contact a Poison Control Center or seek medical help right away.

Warnings and Precautions

This product is for external use only, so please avoid contact with your eyes. If you have a vaginal discharge, do not use this product and consult your doctor instead. When using it, make sure to follow the recommended daily dosage and never insert it into the rectum using fingers or any device.

You should stop using this product and call your doctor if your condition worsens, if symptoms last more than 7 days, or if they clear up and then return within a few days. Additionally, if you experience any bleeding, seek medical advice. If you are pregnant or breastfeeding, consult a healthcare professional before using this product. Always keep it out of reach of children, and if swallowed, seek medical help immediately or contact a Poison Control Center at 800-222-1222.

Overdose

It's important to keep this medication out of reach of children. If a child accidentally swallows it, you should seek medical help immediately or contact a Poison Control Center at 800-222-1222.

In case of an overdose, you may notice signs such as unusual drowsiness, confusion, or difficulty breathing. If you or someone else experiences these symptoms, it's crucial to get medical assistance right away. Always prioritize safety and act quickly in these situations.

Pregnancy Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using this medication. They can provide guidance on whether it’s safe for you and your baby. Always prioritize your health and the health of your child by seeking expert advice.

Lactation Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using any medication. This ensures that you understand any potential risks and can make informed decisions about your health and the health of your baby. Always prioritize open communication with your doctor regarding your breastfeeding journey.

Pediatric Use

If your child is experiencing itching from minor skin irritations, inflammation, or rashes, you can apply the treatment to the affected area up to 3 to 4 times a day for children aged 2 years and older. However, if your child is under 2 years old, it's important to consult a doctor before using the product.

For external itching in the anal and genital areas, the treatment is suitable for children aged 12 years and older, with the same application frequency of 3 to 4 times daily. If your child is younger than 12, please consult a doctor for guidance. Always prioritize your child's safety and seek professional advice when needed.

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. As you age, your body may process medications differently, which can affect how well they work and the potential for side effects.

If you or a loved one is considering this medication, it’s wise to discuss it with a healthcare provider. They can help determine if any special precautions or adjustments are needed based on individual health conditions and overall well-being. 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 any medication you take is safe and appropriate for your health situation. They can provide guidance based on your individual needs and kidney function.

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 differently due to your liver health.

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver condition and the use of this medication. They can help ensure that you receive the safest and most effective treatment.

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 share your complete list of medications and any health conditions you have to receive the best care possible.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 15 to 30°C (59 to 86°F). This temperature range helps maintain the product's effectiveness.

When handling the product, be sure to check the seal on the tube before use. If the seal is broken or missing, do not use the product, as this could compromise its safety and effectiveness. Always handle it with care to avoid any damage.

Additional Information

You can use this medication to relieve itching from minor skin irritations, inflammation, and rashes by applying it to the affected area up to 3 to 4 times a day. The same frequency applies for external anal and genital itching. If you are pregnant or breastfeeding, it's important to consult a healthcare professional before using this product.

Make sure to keep the medication out of reach of children. If a child accidentally swallows it, seek medical help immediately or contact a Poison Control Center at 800-222-1222.

FAQ

What is Hydrocortisone Cream used for?

Hydrocortisone Cream is used for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to conditions like eczema, insect bites, and poison ivy.

How should I apply Hydrocortisone Cream?

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

Are there any warnings for using this cream?

Yes, it is for external use only, avoid contact with eyes, and do not use if you have a vaginal discharge. Consult a doctor if symptoms worsen or persist.

Can I use Hydrocortisone Cream if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, you should ask a health professional before using Hydrocortisone Cream.

What should I do if I accidentally swallow Hydrocortisone Cream?

If swallowed, get medical help or contact a Poison Control Center immediately at 800-222-1222.

What should I do if my condition does not improve?

If your condition worsens, symptoms persist for more than 7 days, or bleeding occurs, stop use and consult a doctor.

What is the maximum strength of Hydrocortisone Cream?

Hydrocortisone Cream contains 1% hydrocortisone, which is considered maximum strength for over-the-counter topical corticosteroids.

Packaging Info

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

Packaging configurations for Leader Hydrocortisone with Aloe.
Details

Drug Information (PDF)

This file contains official product information for Leader Hydrocortisone with Aloe, 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 itching associated with minor skin irritations, inflammation, and rashes due to conditions such as eczema, insect bites, poison ivy, poison oak, poison sumac, as well as reactions to soaps, detergents, cosmetics, and jewelry. Additionally, it is indicated for the relief of external anal and genital itching.

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

Dosage and Administration

For the management of itching associated with minor skin irritations, inflammation, and rashes, the recommended dosage is as follows: Adults and children aged 2 years and older should apply the product to the affected area no more than 3 to 4 times daily. For children under 2 years of age, it is advised to consult a doctor prior to use.

In cases of external anal and genital itching, the following procedure should be followed: Adults and children aged 12 years and older should first cleanse the affected area with mild soap or warm water, ensuring thorough rinsing. Alternatively, the area may be cleansed by patting or blotting with an appropriate cleansing pad. After cleansing, the area should be gently dried by patting or blotting with toilet tissue or a soft cloth before applying the product. The application should not exceed 3 to 4 times daily. For children under 12 years of age, consultation with a doctor is recommended before use.

Contraindications

Use of this product is contraindicated in patients with a vaginal discharge. Consultation with a healthcare professional is advised in such cases.

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

Patients should discontinue use and seek medical advice if the condition worsens, if symptoms persist for more than 7 days, if symptoms resolve and then recur within a few days, or if any bleeding occurs.

Warnings and Precautions

This product is intended for external use only. It is imperative to avoid contact with the eyes to prevent irritation or injury. The use of this product is contraindicated in individuals experiencing vaginal discharge; such patients should consult a healthcare professional prior to use.

When utilizing this product, it is essential to adhere strictly to the recommended daily dosage. Exceeding this dosage should only occur under the guidance of a healthcare provider. Additionally, the product must not be administered rectally using fingers, mechanical devices, or applicators, as this may lead to complications.

Healthcare professionals should advise patients to discontinue use and seek medical advice if any of the following occur: worsening of the condition, persistence of symptoms beyond 7 days, recurrence of symptoms after resolution within a few days, or any occurrence of bleeding.

For individuals who are pregnant or breastfeeding, it is crucial to consult a healthcare professional before using this product to ensure safety for both the mother and child.

This product should be stored out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center should be contacted at 800-222-1222.

Side Effects

Patients should be aware that this product is for external use only and must be kept out of reach of children. In the event of accidental ingestion, medical assistance should be sought immediately, or the Poison Control Center should be contacted at 800-222-1222.

Patients are advised to avoid contact with the eyes while using this product. It is contraindicated for individuals with a vaginal discharge, and such patients should consult a healthcare professional prior to use.

When using this product, it is important not to exceed the recommended daily dosage unless directed by a healthcare provider. Additionally, patients should refrain from inserting the product into the rectum using fingers or any mechanical device or applicator.

Patients should discontinue use and consult a healthcare professional if their condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. The presence of any bleeding also necessitates immediate consultation with a healthcare provider.

For those who are pregnant or breastfeeding, it is recommended to seek advice from a health professional before using this product.

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 Leader Hydrocortisone with Aloe (hydrocortisone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Leader Hydrocortisone with Aloe.
Details

Pediatric Use

For the treatment of itching associated with minor skin irritations, inflammation, and rashes, the medication is indicated for use in adults and children aged 2 years and older, with a recommended application frequency of no more than 3 to 4 times daily. For children under 2 years of age, consultation with a doctor is advised prior to use.

In cases of external anal and genital itching, the medication is appropriate for adults and children aged 12 years and older, with the same application frequency of no more than 3 to 4 times daily. For children under 12 years of age, it is recommended to consult a doctor 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 they may have altered pharmacokinetics and pharmacodynamics. Close monitoring is recommended to ensure safety and efficacy in this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure the safety of both the mother and the developing fetus or nursing infant.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data regarding the excretion of this drug in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the insert. 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 to ensure safety and efficacy.

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 event of an overdosage, it is imperative to keep the product out of reach of children. Should ingestion occur, immediate medical assistance is required. Healthcare professionals are advised to contact a Poison Control Center without delay at 800-222-1222 for guidance on appropriate management.

Prompt action is crucial in mitigating 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 any clinical manifestations that arise.

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.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. In the event of swallowing the product, patients should seek medical assistance or contact a Poison Control Center immediately at 800-222-1222.

Patients should be informed not to use the product if they have a vaginal discharge and to consult a doctor in such cases. It is important to instruct patients to stop using the product and seek medical advice if their condition worsens or if symptoms persist for more than 7 days. Additionally, patients should be made aware that they should discontinue use and consult a doctor if any bleeding occurs.

When using this product, patients must not exceed the recommended daily dosage unless directed by a healthcare professional. Furthermore, patients should be cautioned against inserting the product into the rectum using fingers, mechanical devices, or applicators.

Storage and Handling

The product is supplied in a tube format. It is essential to store the product at a temperature range of 15 to 30°C (59 to 86°F) to maintain its efficacy. Healthcare professionals should ensure that the seal on the tube is intact; the product must not be used if the seal is broken or missing. Proper handling and storage conditions are crucial to ensure the product's quality and safety.

Additional Clinical Information

For the management of itching associated with minor skin irritations, inflammation, and rashes, as well as external anal and genital itching, the recommended administration is to apply the product to the affected area no more than 3 to 4 times daily. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. Additionally, it is crucial to keep the product out of reach of children; in the event of ingestion, immediate medical assistance should be sought or the Poison Control Center contacted at 800-222-1222.

No further information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Leader Hydrocortisone 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 Leader Hydrocortisone 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.

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.