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Hydrocortisone Anti-Itch

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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
October 30, 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
October 30, 2025
Manufacturer
Universal Distribution Center LLC
Registration number
M017
NDC root
52000-022
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 Anti-Itch Cream is a topical medication designed to provide temporary relief from itching caused by minor skin irritations and rashes. It is particularly effective for conditions such as eczema, seborrheic dermatitis, psoriasis, and itching resulting from insect bites or contact with plants like poison ivy, oak, and sumac. Additionally, it can help soothe irritation from soaps, detergents, cosmetics, and even jewelry.

This cream works by reducing inflammation and alleviating discomfort, making it a helpful option for various skin-related issues. However, if you find that you need to use it for more than seven days, it's important to consult with a doctor for guidance.

Uses

You can use this product for the temporary relief of itching caused by various minor skin irritations and rashes. This includes conditions like eczema, seborrheic dermatitis, and psoriasis, as well as itching from insect bites and contact with plants like poison ivy, oak, or sumac. It can also help with irritation from soaps, detergents, cosmetics, jewelry, and even external genital, feminine, and anal itching.

If you find that you need to use this product for more than seven days, it's important to consult with your doctor for guidance and supervision.

Dosage and Administration

If you're dealing with itching from skin irritation, inflammation, or rashes, you can apply the medication to the affected area up to 3 to 4 times a day if you are an adult or a child aged 2 years and older. However, if your child is under 2 years old, it's important to consult a doctor before use.

For external itching in the anal and genital areas, adults should first clean the area with mild soap and water, rinsing thoroughly. After gently drying the area by patting or blotting with toilet tissue or a soft cloth, you can apply the medication up to 3 to 4 times daily. If the person needing treatment is under 12 years old, please check with a doctor for guidance.

What to Avoid

It's important to follow specific guidelines when using this medication to ensure your safety. You should not use it in the genital area if you have a vaginal discharge. Additionally, avoid using more of the product than directed unless your doctor advises otherwise. Never insert the medication directly into the rectum using your fingers or any device, as this can lead to complications.

By adhering to these instructions, you can help prevent potential issues and ensure the medication works effectively for you. If you have any questions or concerns, please consult your healthcare provider for guidance.

Side Effects

This product is intended for external use only. It's important to monitor your condition while using it. If your symptoms worsen, persist for more than 7 days, or improve only to return within a few days, you should stop using the product and consult a doctor. Additionally, if you experience rectal bleeding, seek medical advice immediately.

Warnings and Precautions

This product is for external use only, so please avoid using it on any internal areas. Keep it out of reach of children, and if it is swallowed, seek medical help or contact a Poison Control Center immediately. If you have a vaginal discharge, do not use this product in the genital area, and consult your doctor for diaper rash treatment.

You should stop using this product and call your doctor if your condition worsens, if symptoms last longer than 7 days, if they improve and then come back within a few days, or if you experience rectal bleeding. Additionally, do not start using any other hydrocortisone product without first consulting your doctor.

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 signs of an overdose, which can include unusual drowsiness, confusion, or difficulty breathing. If you suspect that you or someone else may have taken too much of a medication, it’s crucial to seek immediate medical help.

In case of an overdose, contact your local emergency services or go to the nearest hospital. Having the medication packaging or information on hand can help medical professionals provide the best care. Always remember that when it comes to medications, it's better to be safe and get help if you have any concerns.

Pregnancy Use

You can use hydrocortisone cream during pregnancy without specific warnings or precautions mentioned in the information provided. There are no indications that it is contraindicated (not recommended) for pregnant individuals, nor are there any stated risks to the fetus associated with its use. Additionally, you do not need to make any dosage modifications or take special precautions while using this cream during your pregnancy.

As always, it's a good idea to consult with your healthcare provider before using any medication to ensure it’s appropriate for your individual situation.

Lactation Use

If you are breastfeeding, you can use hydrocortisone cream without specific warnings or recommendations against it. The information available does not indicate any concerns about the cream being passed into breast milk or posing risks to your nursing infant. However, as with any medication, it's always a good idea to consult with your healthcare provider if you have any questions or concerns.

Pediatric Use

If your child is experiencing itching from skin irritation, 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 anal and genital itching, adults should clean the area with mild soap and water, then gently dry it before applying the treatment up to 3 to 4 times daily. If your child is under 12 years old, please ask a doctor for guidance before use. Always prioritize your child's safety and consult a healthcare professional when in doubt.

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. Since older adults may have different health needs and responses to medications, you should always consult with a healthcare provider before starting any new medication. They can help determine the right dosage and monitor for any potential side effects, ensuring that the treatment is safe and effective for you or your loved one.

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 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 function and how it relates to your treatment. They can help ensure that your medication is safe and effective for you.

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 recent lab tests to avoid any potential issues. Your health and safety should always come first.

Storage and Handling

To ensure the best performance of your product, store it at a temperature between 20ºC to 25ºC (68ºF to 77ºF). This temperature range helps maintain the integrity and effectiveness of the device. Additionally, you can find important information such as the Lot Number and Expiration Date printed on the crimp of the tube, so be sure to check this before use.

When handling the product, always do so with care to maintain a sterile environment, which means keeping it free from germs and contaminants. Following these guidelines will help ensure your safety and the proper functioning of the device.

Additional Information

You can use this medication topically to relieve itching caused by skin irritation, inflammation, and rashes. For adults and children aged 2 years and older, apply it to the affected area no more than 3 to 4 times a day. If the patient is under 2 years old or if the treatment is for external anal and genital itching in children under 12, it's best to consult a doctor before use.

FAQ

What is Hydrocortisone Anti-Itch Cream used for?

Hydrocortisone Anti-Itch Cream provides temporary relief of itching associated with minor skin irritations and rashes, including conditions like eczema, psoriasis, and insect bites.

How should I use Hydrocortisone Anti-Itch 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 precautions I should take when using this cream?

Avoid contact with eyes, do not use more than directed unless advised by a doctor, and do not apply directly into the rectum.

Can I use this cream if I have a vaginal discharge?

No, do not use Hydrocortisone Anti-Itch Cream in the genital area if you have a vaginal discharge.

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

Stop using the cream and consult a doctor if your condition worsens, symptoms persist for more than 7 days, or if rectal bleeding occurs.

Is it safe to use Hydrocortisone Anti-Itch Cream during pregnancy?

The insert does not provide specific warnings or contraindications regarding the use of this cream during pregnancy.

What should I do if I accidentally swallow the cream?

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

How should I store Hydrocortisone Anti-Itch Cream?

Store the cream at a temperature between 20ºC to 25ºC (68ºF to 77ºF).

Packaging Info

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

Packaging configurations for Hydrocortisone Anti-Itch.
Details

Drug Information (PDF)

This file contains official product information for Hydrocortisone Anti-Itch, 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 drug.

Uses and Indications

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

Limitations of use include that the product should not be used for more than 7 days unless directed by a healthcare professional. Any other uses or prolonged use beyond this duration should be undertaken only under the advice and supervision of a doctor.

No teratogenic or nonteratogenic effects have been reported.

Dosage and Administration

For the treatment of itching associated with skin irritation, inflammation, and rashes, the recommended dosage for adults and children aged 2 years and older is to 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 cases of external anal and genital itching in adults, it is recommended that the affected area be cleaned with mild soap and water, followed by thorough rinsing. The area should then be gently dried by patting or blotting with toilet tissue or a soft cloth before application. The medication should be applied to the affected area no more than 3 to 4 times daily. For children under 12 years of age, consultation with a physician is also recommended prior to use.

Contraindications

Use is contraindicated in the genital area for patients with a vaginal discharge due to the potential for exacerbating the condition. Additionally, the product should not be used more than directed unless advised by a healthcare professional. Direct application into the rectum using fingers, mechanical devices, or applicators is also contraindicated to prevent injury or adverse effects.

Warnings and Precautions

For external use only. It is imperative that this product is kept out of reach of children to prevent accidental ingestion. In the event of swallowing, immediate medical assistance should be sought, or contact a Poison Control Center without delay.

General precautions should be observed when using this product. It is advised not to apply it to the genital area in the presence of vaginal discharge. For the treatment of diaper rash, consultation with a healthcare professional is recommended.

Healthcare professionals should instruct patients to discontinue use and seek medical advice if any of the following occur: the condition worsens, symptoms persist for more than 7 days, symptoms resolve and then recur within a few days, or if rectal bleeding is observed. Additionally, patients should be cautioned against the initiation of any other hydrocortisone product without prior consultation with a healthcare provider.

In cases of accidental ingestion, it is crucial to obtain emergency medical help or contact a Poison Control Center immediately.

Side Effects

For external use only. Patients should discontinue use and consult a healthcare professional if any of the following occur: the condition worsens, symptoms persist for more than 7 days, symptoms clear up and then recur within a few days, or if rectal bleeding occurs. These reactions warrant immediate medical attention to ensure appropriate management and care.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known 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 Anti-Itch (hydrocortisone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Hydrocortisone Anti-Itch.
Details

Pediatric Use

For the treatment of itching associated with skin irritation, inflammation, and rashes, the recommended application for pediatric patients aged 2 years and older is to 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 physician prior to use.

In cases of external anal and genital itching, adults are instructed to clean the affected area with mild soap and water, rinse thoroughly, and gently dry the area before application. Similar to the previous indication, children under 12 years of age should seek medical advice before using the product.

Geriatric Use

There is no specific information available 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 individual responses may vary. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

Hydrocortisone cream is not associated with specific warnings or precautions for use during pregnancy. The prescribing information does not indicate that the product is contraindicated in pregnant patients, nor does it provide any data regarding potential risks to the fetus associated with its use during this period. Additionally, there are no recommendations for dosage modifications or special precautions for women of childbearing potential. As with any medication, healthcare professionals should weigh the benefits against any potential risks when considering the use of hydrocortisone cream in pregnant patients.

Lactation

There are no specific warnings or recommendations regarding the use of hydrocortisone cream 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

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 established 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 available information.

Overdosage

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

Healthcare providers are advised to monitor patients closely for any signs or symptoms that may indicate an overdose. These may include, but are not limited to, altered mental status, cardiovascular instability, or gastrointestinal disturbances.

Management of an overdose should be guided by the clinical presentation of the patient. Supportive care is paramount, and symptomatic treatment should be initiated as necessary. Healthcare professionals should also consider contacting a poison control center for additional guidance on the management of overdose cases.

In summary, while specific overdosage information is not available, healthcare professionals should exercise caution, monitor for symptoms, and provide appropriate supportive care in the event of an overdose.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available in the provided text.

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 help or contact a Poison Control Center immediately.

Patients should be informed not to use the product in the genital area if they have a vaginal discharge. It is important for patients to consult a doctor regarding the treatment of diaper rash and to ask for guidance before using the product in such cases.

Patients should be instructed to stop using the product and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. Additionally, patients should not begin the use of any other hydrocortisone product without first consulting a doctor. They should also seek medical attention if rectal bleeding occurs.

When using this product, patients should be cautioned to avoid contact with the eyes. They should not use more than the directed amount unless specifically instructed to do so by a doctor. Furthermore, patients should be advised against inserting the product directly into the rectum using fingers or any mechanical device or applicator.

Storage and Handling

The product is supplied in a configuration that includes a tube, with the Lot Number and Expiration Date indicated on the crimp of the tube.

It is essential to store the product at a controlled temperature range of 20ºC to 25ºC (68ºF to 77ºF) to ensure its stability and efficacy. Proper handling and storage conditions must be maintained to preserve the integrity of the product.

Additional Clinical Information

The medication is administered topically for the relief of itching associated with skin irritation, inflammation, and rashes in patients aged 2 years and older. It is recommended that the affected area be treated no more than 3 to 4 times daily. For external anal and genital itching, adults may also apply the medication to the affected area up to 3 to 4 times daily, while children under 12 years should consult a doctor before use. For children under 2 years of age, it is advised to seek medical guidance prior to application.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Hydrocortisone Anti-Itch, 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 Anti-Itch, 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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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.