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Hydrocortisone

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Active ingredient
Hydrocortisone 1 g/100 g
Other brand names
Drug class
Corticosteroid
Dosage form
Ointment
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
December 12, 2023
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Hydrocortisone 1 g/100 g
Other brand names
Drug class
Corticosteroid
Dosage form
Ointment
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
December 12, 2023
Manufacturer
Weeks & Leo Co. , Inc.
Registration number
M017
NDC root
11383-268
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

This medication is designed to provide temporary relief from itching associated with minor skin irritations, inflammation, and rashes. It can help alleviate discomfort caused by conditions such as eczema, seborrheic dermatitis, poison ivy, poison oak, poison sumac, psoriasis, insect bites, and reactions to cosmetics, jewelry, detergents, and soaps.

In particular, it is effective for relieving external anal and genital itching. While it can be beneficial for various skin issues, it's important to use this product under the advice and supervision of a doctor for any other uses.

Uses

This product is designed to provide temporary relief from itching caused by various minor skin irritations, including conditions like eczema, seborrheic dermatitis, and psoriasis. It can also help soothe itching from rashes due to poison ivy, poison oak, and poison sumac, as well as from insect bites and reactions to cosmetics, jewelry, detergents, and soaps.

In addition to these uses, it can temporarily relieve itching in the external anal and genital areas. If you have other concerns or conditions, it's important to consult with your doctor before using this product.

Dosage and Administration

If you are an adult or a child aged 2 years and older, you can apply the medication to the affected area up to 3 to 4 times a day. For children under 2 years old, it’s important to consult a doctor before use.

If you are dealing with external anal itching, start by gently cleaning the area with mild soap and warm water, then rinse thoroughly. You can also use a suitable cleansing pad. After cleaning, make sure to dry the area gently by patting it with toilet tissue or a soft cloth before applying the medication. If the patient is a child under 12 years, please consult a doctor for guidance.

What to Avoid

It's important to use this medication safely. You should not use it for treating diaper rash; instead, consult your doctor for appropriate options. If you experience external genital itching accompanied by vaginal discharge, or if you have external anal itching with rectal bleeding, please seek medical advice before using this product. Your health and safety are paramount, so don't hesitate to ask a healthcare professional if you have any concerns.

Side Effects

When using this product, it's important to be aware of certain precautions and potential side effects. This medication is for external use only and should not be applied to diaper rash or used for external genital itching if you have a vaginal discharge. If you experience external anal itching and notice rectal bleeding, consult a doctor immediately. Avoid getting the product in your eyes, and do not use it more than directed for anal itching unless advised by a healthcare professional.

If your condition worsens, symptoms persist for more than 7 days, or if they clear up and return shortly after, stop using the product and consult a doctor. Keep this medication out of reach of children, and if swallowed, seek medical help or contact a Poison Control Center right away.

Warnings and Precautions

This product is for external use only, so please avoid using it on areas that are not specified. Do not use it for treating diaper rash, external genital itching with vaginal discharge, or external anal itching if there is rectal bleeding—consult a doctor in these cases.

If your condition worsens, lasts more than 7 days, or clears up only to return within a few days, stop using the product and contact your doctor. It's important not to start any other hydrocortisone product without guidance.

In case of accidental swallowing, seek emergency medical help or contact a Poison Control Center immediately. Always keep this product out of reach of children to ensure their safety.

Overdose

If you or someone else has swallowed too much of a medication, it’s important to seek medical help immediately. You can do this by contacting a Poison Control Center or going to the nearest emergency room. Acting quickly can make a significant difference in the outcome.

Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms, don’t hesitate to get help right away. Remember, it’s always better to be safe and get checked by a medical professional.

Pregnancy Use

While there are no specific guidelines or safety concerns mentioned regarding the use of hydrocortisone 1% ointment during pregnancy, it's always best to approach any medication with caution. If you are pregnant or planning to become pregnant, you should consult your healthcare provider before using this ointment. They can provide personalized advice and help ensure that any treatment you consider is safe for you and your baby.

Lactation Use

If you are breastfeeding and considering the use of hydrocortisone ointment, you can feel reassured that there are no specific warnings or recommendations against its use for nursing mothers. Additionally, the information available does not indicate any concerns about the ointment being passed into breast milk or posing any risk to your infant.

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

Pediatric Use

If your child is under 2 years old, it's important to consult a doctor before using this medication. For children aged 2 years and older, you can apply it to the affected area up to 3 to 4 times a day. However, if your child is under 12 years old and is experiencing external anal itching, you should also seek advice from a doctor. 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, it’s important to consult with a healthcare provider for personalized advice. 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 (issues with liver function).

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 you are taking, even if there are no specific drug interactions or laboratory test interactions noted for your treatment. This ensures that your healthcare team can monitor your health effectively and make informed decisions about your care.

Always feel free to ask questions and share all the medications and supplements you are using. This helps to avoid any potential issues and ensures that you receive the best possible treatment tailored to your needs.

Storage and Handling

To ensure the best performance and safety of your product, store it at a temperature between 20ºC to 25ºC (68ºF to 77ºF). This temperature range helps maintain the integrity of the device.

When handling the product, be sure to do so with clean hands and in a clean environment to avoid contamination. Always follow any specific disposal instructions provided to ensure safe and responsible disposal of any components.

Additional Information

No further information is available.

FAQ

What is the primary use of this drug?

This drug is used for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes.

What conditions can this drug help relieve itching from?

It can relieve itching due to eczema, seborrheic dermatitis, poison ivy, poison oak, poison sumac, psoriasis, insect bites, cosmetics, jewelry, detergents, and soaps.

How often can adults and children over 2 years use this drug?

Adults and children 2 years and over can apply it to the affected area not more than 3 to 4 times daily.

What should I do if I have external anal itching?

For external anal itching, cleanse the area with mild soap and warm water, dry gently, and then apply the drug.

Are there any contraindications for using this drug?

No specific contraindications are mentioned, but you should not use it for diaper rash or if you have a vaginal discharge.

What should I do if my condition worsens or does not improve?

Stop using the drug and ask a doctor if your condition gets worse, lasts more than 7 days, or clears up and occurs again within a few days.

Is this drug safe for children under 2 years?

You should ask a doctor before using this drug on children under 2 years.

What precautions should I take when using this drug?

Do not get it in your eyes, do not use more than directed, and do not put it into the rectum using fingers or any device.

What should I do if the drug is swallowed?

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

How should I store this drug?

Store it at 20ºC to 25ºC (68ºF to 77ºF).

Packaging Info

Below are the non-prescription pack sizes of Hydrocortisone (hydrocortisone 1%). 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

Hydrocortisone Ointment is a topical corticosteroid indicated for the treatment of various inflammatory skin conditions. The chemical name of the active ingredient is 11β,17,21-trihydroxypregn-4-ene-3,20-dione, with a molecular formula of C21H30O5 and a molecular weight of 362.46.

The formulation includes several inactive ingredients: white petrolatum, mineral oil, lanolin, propylene glycol, stearyl alcohol, glyceryl monostearate, sorbitan monostearate, and purified water. These components contribute to the ointment's consistency and stability, facilitating its application and effectiveness in dermatological use.

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, poison ivy, poison oak, poison sumac, psoriasis, insect bites, and reactions to cosmetics, jewelry, detergents, and soaps.

Additionally, this drug provides temporary relief for external anal and genital itching.

Other uses of this product should only be undertaken under the advice and supervision of a healthcare professional.

Dosage and Administration

Adults and children aged 2 years and older should apply the medication 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 physician prior to use.

In the case of external anal itching in adults, it is recommended to cleanse the affected area with mild soap and warm water when practical, 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 the application of the medication.

For external anal itching in children under 12 years, consultation with a physician is also recommended prior to use.

Contraindications

The product is contraindicated for the treatment of diaper rash. Consultation with a healthcare professional is advised prior to use in this context.

Additionally, the product should not be used for external genital itching in the presence of vaginal discharge; a healthcare professional should be consulted.

For external anal itching, the product is contraindicated if rectal bleeding occurs, and prompt consultation with a healthcare provider is recommended.

Warnings and Precautions

For external use only. This product is contraindicated for the treatment of diaper rash; healthcare professionals should advise patients to consult a doctor in such cases. Additionally, it should not be used for external genital itching if there is a vaginal discharge, nor for external anal itching if rectal bleeding occurs; in these situations, prompt medical consultation is necessary.

Patients should be instructed to discontinue use and seek medical advice if their condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. It is important to note that patients should not initiate the use of any other hydrocortisone product without consulting a healthcare professional.

In the event of accidental ingestion, immediate medical assistance should be sought, or the local Poison Control Center should be contacted without delay.

To ensure safety, this product must be kept out of reach of children.

Side Effects

Patients using this product should be aware that it is intended for external use only. It is contraindicated for the treatment of diaper rash, and individuals should consult a doctor if they have external genital itching accompanied by vaginal discharge or if they experience external anal itching with rectal bleeding.

While using this product, patients are advised to avoid contact with the eyes. For those experiencing external anal itching, it is important not to exceed the directed dosage unless instructed by a healthcare professional. Additionally, patients should refrain from inserting the product into the rectum using fingers or any mechanical device or applicator.

Patients should discontinue use and seek medical advice if their condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. It is also recommended that patients do not initiate the use of any other hydrocortisone product without consulting a healthcare provider.

This product should be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought or contact with a Poison Control Center should be made.

Drug Interactions

There are no specific drug interactions or laboratory test interactions identified in the available data. Therefore, no dosage adjustments or monitoring recommendations are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Hydrocortisone (hydrocortisone 1%). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Hydrocortisone.
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. In cases of external anal itching in children under 12 years, it is advised to seek guidance from a healthcare provider.

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

Hydrocortisone 1% ointment has not been specifically studied in pregnant patients, and there are no available data regarding its safety, dosage modifications, or special precautions for use during pregnancy. As such, the potential risks and benefits of using this medication in pregnant women should be carefully considered. Healthcare professionals are advised to weigh the necessity of treatment against any potential risks to fetal outcomes, particularly in the absence of established safety data. Women of childbearing potential should be counseled accordingly regarding the use of hydrocortisone 1% ointment during pregnancy.

Lactation

There are no specific warnings or recommendations regarding the use of hydrocortisone ointment in lactating mothers. Additionally, the insert does not provide any statements concerning the potential for excretion of hydrocortisone in breast milk or any associated risks to breastfed infants.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this medication. Consequently, there are no 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, immediate medical intervention is crucial. If the substance is ingested, it is imperative to seek medical assistance or contact a Poison Control Center without delay.

Healthcare professionals should be aware that prompt action can significantly influence the outcome of an overdosage situation. Symptoms of overdosage may vary depending on the specific substance involved; therefore, a thorough assessment of the patient's condition is essential.

Management procedures should include monitoring the patient for any adverse effects and providing supportive care as necessary. It is advisable to have the product label or any relevant information available when contacting medical professionals or poison control for guidance on further management.

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 keep this product out of reach of children. Instruct patients that if the product is swallowed, they should seek medical help or contact a Poison Control Center immediately.

Patients should be informed that this product is not intended for the treatment of diaper rash and that they should consult a doctor for appropriate alternatives. Additionally, they should be cautioned against using the product for external genital itching if they have a vaginal discharge, and to seek medical advice in such cases.

For patients experiencing external anal itching, it is important to advise them not to use the product if rectal bleeding occurs and to consult a doctor promptly. Patients should also be instructed to stop using the product and seek medical advice if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. They should be reminded not to begin the use of any other hydrocortisone product without consulting a healthcare professional.

While using this product, patients should be cautioned to avoid contact with the eyes. For those using the product for external anal itching, it is essential to emphasize that they should not exceed the directed dosage unless instructed otherwise by a doctor. Furthermore, patients should be advised against inserting the product into the rectum using fingers or any mechanical device or applicator.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It should be stored at a controlled room temperature of 20ºC to 25ºC (68ºF to 77ºF). Care should be taken to ensure that the storage environment maintains these temperature conditions to preserve product integrity.

Additional Clinical Information

No further data are available.

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

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Primary FDA sources:

Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.