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Hydrocortisone

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Active ingredient
Hydrocortisone 1.14 g/114 g
Other brand names
Drug class
Corticosteroid
Dosage form
Lotion
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2023
Label revision date
March 17, 2026
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Hydrocortisone 1.14 g/114 g
Other brand names
Drug class
Corticosteroid
Dosage form
Lotion
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 2023
Label revision date
March 17, 2026
Manufacturer
Mericon Industries
Registration number
M017
NDC root
0394-0859
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 1% is a lotion designed to provide temporary relief from minor skin irritations, inflammation, and rashes. It is commonly used to treat various skin conditions, including eczema, seborrheic dermatitis, psoriasis, insect bites, and reactions to poison ivy, oak, or sumac. Additionally, it can help alleviate itching caused by soaps, detergents, cosmetics, and jewelry.

This lotion works by reducing inflammation and soothing the affected area, making it a helpful option for managing discomfort associated with these skin issues. However, for other uses, it is important to consult with a doctor for proper guidance and supervision.

Uses

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

For any other uses, it's important to consult with your doctor to ensure safety and effectiveness.

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. Before applying, it's best to clean the area with mild soap and warm water, rinse it thoroughly, and then gently dry it by patting or blotting with toilet tissue or a soft cloth.

If your child is under 2 years old, do not use this product without consulting a doctor. Additionally, if your child is under 12 years of age, it's important to check with a doctor before use to ensure it's safe for them.

What to Avoid

It's important to be cautious when using this product. You should not use it if you have a vaginal discharge; in such cases, it's best to consult your doctor first. Additionally, avoid using this product for treating diaper rash or on children under 2 years of age without prior medical advice. Always prioritize safety and seek guidance if you're unsure about its use.

Side Effects

It's important to use this product only on the skin and avoid contact with your eyes. If your condition worsens, symptoms last more than 7 days, or if they clear up and return within a few days, stop using the product and consult a doctor. Additionally, do not use it if you have a vaginal discharge, are treating diaper rash, or if the user is a child under 2 years old.

For those using it for external anal itching, be sure not to exceed the recommended dosage unless directed by a doctor. If you experience any bleeding, seek medical advice immediately. Remember to keep this product and all medications out of the reach of children.

Warnings and Precautions

This product is for external use only, so be sure to avoid contact with your eyes. It's important to keep it out of reach of children to prevent accidental ingestion or misuse. If you experience any worsening of your condition, or if your symptoms last more than 7 days or return after clearing up, stop using the product and consult your doctor. Additionally, do not use this product if you have a vaginal discharge, are treating diaper rash, or if the user is a child under 2 years of age.

Make sure not to exceed the recommended daily dosage unless your doctor advises otherwise. If you notice any bleeding, seek medical attention right away. Remember, do not insert this product into the rectum using fingers or any devices. If you have any questions or concerns before starting this treatment, especially if you plan to use other hydrocortisone products, it's best to talk to your doctor first.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, it's always important to be aware of the potential risks associated with taking more than the recommended dose. If you suspect an overdose, look for signs such as unusual drowsiness, confusion, or difficulty breathing.

In the event of an overdose, you should seek immediate medical help. Contact your local emergency services or go to the nearest hospital. It's crucial to act quickly, as timely intervention can make a significant difference in your health outcomes. Always remember to keep medications out of reach of children and follow the prescribed dosage to avoid any risks.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the safety of hydrocortisone lotion during pregnancy has not been established. Before using this product, you should consult your doctor, as there may be potential risks to your fetus. The decision to use hydrocortisone should be made carefully, weighing the potential benefits against any risks.

Additionally, dosage adjustments may be necessary, so it's essential to seek guidance from your healthcare provider. Always prioritize your health and the health of your baby by discussing any concerns or questions with your doctor.

Lactation Use

If you are breastfeeding, you can use hydrocortisone lotion without specific warnings or recommendations against it. The information available does not indicate any concerns about the lotion being passed into breast milk or posing any risk to your nursing infant.

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

Pediatric Use

It's important to be cautious when using this product for children. You should not use it to treat diaper rash without first consulting a doctor. Additionally, this product is not recommended for children under 2 years of age; if your child is in this age group, please speak with a healthcare professional before use.

For children experiencing external anal itching, it's advised to consult a doctor if they are under 12 years old. If your child is 2 years or older, you can apply the product to the affected area, but limit use to no more than 3 to 4 times a day. Always prioritize your child's safety and well-being by following these guidelines.

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 there are no specific guidelines, dosage adjustments, or monitoring requirements mentioned for your condition in the provided information. This means that the standard recommendations for medication use may apply to you without any special considerations. However, always consult your healthcare provider for personalized advice and to ensure your treatment is safe and effective based on your kidney health.

Hepatic Impairment

If you have liver problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication may affect you if you have hepatic impairment (liver issues).

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

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. Currently, there are no specific drug interactions or laboratory test interactions noted for this medication. However, your healthcare provider can help ensure that your treatment plan is safe and effective, taking into account all the medications and tests you may be using. Always feel free to ask questions and share your complete health history to avoid any potential issues.

Storage and Handling

To ensure the best performance and safety of your product, store it in a cool, dry place at a temperature between 55°F and 76°F (13°C to 24°C). This temperature range helps maintain the integrity of the device and its components.

When handling the product, be sure to follow any specific instructions provided to avoid contamination or damage. Always keep the product in a clean environment to ensure it remains safe for use. If you have any questions about disposal or further handling instructions, please refer to the guidelines provided with your product.

Additional Information

You should apply this medication topically to the affected area, using it no more than 3 to 4 times a day if you are an adult or a child aged 2 years and older. If your child is under 2 years old, do not use this medication without consulting a doctor first. There are no additional details available regarding laboratory tests, abuse potential, or patient counseling.

FAQ

What is Hydrocortisone 1% used for?

Hydrocortisone 1% lotion is used for temporary relief from minor skin irritations, inflammation, and rashes associated with conditions like eczema, psoriasis, and insect bites.

How should I apply Hydrocortisone 1%?

For adults and children 2 years and older, apply to the affected area no more than 3 to 4 times daily. Cleanse the area with mild soap and warm water before application.

Can I use Hydrocortisone 1% on children under 2 years of age?

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

Are there any warnings associated with Hydrocortisone 1%?

Yes, it is for external use only, and you should avoid contact with the eyes. Consult a doctor if symptoms worsen or persist for more than 7 days.

Is it safe to use Hydrocortisone 1% during pregnancy?

The safety of Hydrocortisone lotion during pregnancy has not been established, and it should only be used if the potential benefit justifies the potential risk to the fetus.

What should I do if I have a vaginal discharge?

Do not use this product and consult a doctor if you have a vaginal discharge.

How should I store Hydrocortisone 1%?

Store Hydrocortisone 1% lotion at a temperature between 55 to 76°F.

What should I do if I experience bleeding while using this product?

If you experience bleeding, consult a doctor promptly.

Who manufactures Hydrocortisone 1%?

Hydrocortisone 1% is manufactured by Mericon Industries, Inc.

What are the indications for using Hydrocortisone 1%?

It is indicated for conditions such as eczema, seborrheic dermatitis, psoriasis, insect bites, and reactions to soaps, detergents, cosmetics, and jewelry.

Packaging Info

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

Packaging configurations for Hydrocortisone.
Details

Drug Information (PDF)

This file contains official product information for Hydrocortisone, 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, inflammation, and rashes associated with various conditions, including eczema, seborrheic dermatitis, psoriasis, insect bites, and reactions to poison ivy, oak, or sumac. It is also effective for irritations caused by soaps, detergents, cosmetics, jewelry, and external genital and anal itching.

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 product should be applied to the affected area no more than 3 to 4 times daily. Prior to application, it is recommended that adults cleanse the affected area with mild soap and warm water, rinsing thoroughly, and then gently drying the area by patting or blotting with toilet tissue or a soft cloth.

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

Contraindications

Use of this product is contraindicated in the following situations:

  • Patients presenting with vaginal discharge should not use this product without consulting a healthcare professional.

  • The product should not be applied prior to the treatment of diaper rash.

  • It is contraindicated for use in children under 2 years of age without prior medical advice.

Warnings and Precautions

For external use only, this product should be applied with caution to avoid contact with the eyes. Healthcare professionals are advised to instruct 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.

This product should not be used in the presence of vaginal discharge or for the treatment of diaper rash. Additionally, it is contraindicated for use in children under 2 years of age without prior consultation with a healthcare provider.

Patients must adhere to the recommended daily dosage and should not exceed this amount unless specifically directed by a physician. In the event of any bleeding, it is imperative to seek medical attention promptly. Furthermore, this product should not be administered rectally using fingers, mechanical devices, or applicators.

To ensure safety, this product must be kept out of reach of children, as with all medications.

Side Effects

Patients using this product should be aware that it is intended for external use only and must avoid contact with the eyes. In the event that the condition worsens, or if symptoms persist for more than 7 days or resolve and then recur within a few days, patients are advised to discontinue use and consult a doctor.

This product should not be used in the presence of vaginal discharge or for the treatment of diaper rash. Additionally, it is contraindicated for use in children under 2 years of age without prior consultation with a healthcare professional.

For patients experiencing external anal itching, it is crucial not to exceed the recommended daily dosage unless directed by a physician. Should any bleeding occur, patients must seek medical attention promptly. Furthermore, the product should not be inserted into the rectum using fingers or any mechanical device or applicator.

To ensure safety, this product should be kept out of reach of children, along with all other medications.

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 Hydrocortisone. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Hydrocortisone.
Details

Pediatric Use

Pediatric patients under 2 years of age should not use this product without consulting a doctor. For external anal itching, it is advised that children under 12 years of age also consult a doctor prior to use. For children aged 2 years and older, the product may be applied to the affected area no more than 3 to 4 times daily. Additionally, caregivers should seek medical advice before treating diaper rash in pediatric patients.

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

The safety of hydrocortisone lotion during pregnancy has not been established. Pregnant patients or those planning to become pregnant should consult a healthcare provider before using this product. There may be potential risks to the fetus; therefore, the use of hydrocortisone lotion should be carefully considered. Dosage adjustments may be necessary, and healthcare providers should be consulted for guidance on appropriate dosing. Use during pregnancy should only occur if the potential benefit justifies the potential risk to the fetus.

Lactation

There are no specific warnings or recommendations regarding the use of hydrocortisone lotion in lactating mothers. Additionally, there is no information available about the potential for excretion of hydrocortisone in breast milk or any associated risks to breastfed infants.

Renal Impairment

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

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

There is currently no specific information available regarding overdosage for this medication. Healthcare professionals are advised to monitor patients closely for any signs of adverse effects or symptoms that may arise from excessive dosing.

In the event of suspected overdosage, it is recommended that healthcare providers initiate supportive care and symptomatic treatment as necessary. Patients should be evaluated for potential complications, and appropriate interventions should be implemented based on the clinical presentation.

For further guidance, healthcare professionals may refer to established protocols for managing drug overdosage or consult a poison control center.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the use of the compound in these contexts.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions reported voluntarily or through surveillance programs: skin irritation, allergic reactions, and contact dermatitis. These events have been documented in the context of routine pharmacovigilance activities.

Patient Counseling

Healthcare providers should advise patients to keep this and all medications out of the reach of children to prevent accidental ingestion or misuse. Patients should be instructed not to use this product if they have a vaginal discharge and to consult a doctor in such cases.

Additionally, it is important to inform patients that they should not use this product for treating diaper rash without first consulting a healthcare professional. Providers should emphasize the necessity of seeking medical advice before using this product on children under 2 years of age.

Patients should be made aware that if their condition worsens, or if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days, they should stop using the product and consult a doctor. Furthermore, patients should be cautioned to stop using this product and seek medical advice before starting any other hydrocortisone product to avoid potential interactions or complications.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a temperature range of 55°F to 76°F to maintain its integrity and efficacy. Proper storage conditions must be adhered to, ensuring that the product is kept within this specified temperature range to prevent degradation.

Additional Clinical Information

The medication is administered topically, with a recommended application frequency of 3 to 4 times daily for adults and children aged 2 years and older. For children under 2 years of age, it is advised to consult a doctor before use. There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Hydrocortisone, 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, 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.