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Hydrocortisone

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This product has been discontinued

Active ingredient
Hydrocortisone 140 mg/14 g
Other brand names
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 2013
Label revision date
July 10, 2013
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Hydrocortisone 140 mg/14 g
Other brand names
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 2013
Label revision date
July 10, 2013
Manufacturer
Personal Care Products, Inc.
Registration number
part348
NDC root
29500-2439
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 an ultra-strength topical medication designed to provide fast relief from itching and rashes. It works by temporarily alleviating itching associated with minor skin irritations, inflammation, and various skin conditions. You can use it for issues such as eczema, insect bites, psoriasis, and reactions to cosmetics, soaps, or plants like poison ivy and sumac.

This cream is also effective for relieving external anal and genital itching. While it can be helpful for many common skin irritations, it's important to consult with a doctor for any other uses to ensure safety and effectiveness.

Uses

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

For any other uses, it's important to consult with your doctor for advice 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 best to consult a doctor before using it.

For external itching around the anal and genital areas, adults should first clean the area with mild soap and warm water, then rinse 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 a child under 12 years old, please consult a doctor for guidance.

What to Avoid

You can feel confident using this medication, as there are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with it. This means that, based on the available information, there are no known reasons that would prevent you from taking this medication safely. Always remember to follow your healthcare provider's guidance and reach out if you have any questions or concerns about your treatment.

Side Effects

When using this product, it's important to remember that it is for external use only. Avoid applying it in the genital area if you have a vaginal discharge or for treating diaper rash; in these cases, consult a doctor. Be careful to keep it away from your eyes and do not use more than the recommended amount unless directed by a healthcare professional.

If your condition worsens, if symptoms last longer than 7 days, or if they improve and then return within a few days, stop using the product and consult a doctor. Additionally, do not use any other hydrocortisone product without first speaking to a healthcare provider.

Warnings and Precautions

This product is for external use only, so please avoid using it on the genital area if you have a vaginal discharge or for treating diaper rash—consult your doctor in these cases. While using this product, be careful to keep it away from your eyes, and do not use more than the recommended amount unless your doctor advises otherwise. It’s also important not to apply it directly into the rectum.

If your condition worsens, if symptoms last longer than 7 days, or if they improve and then return within a few days, stop using the product and contact your doctor. Additionally, do not start using any other hydrocortisone product without consulting your doctor first. If you accidentally swallow the product, seek emergency medical help or contact a Poison Control Center immediately.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While there is no specific information available about the signs of overdose for this medication, general symptoms can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these signs, or if you are concerned about a possible overdose, seek medical help right away.

In case of an overdose, contacting your local poison control center or going to the nearest emergency room is crucial. They can provide the necessary guidance and treatment. Always remember that it's better to be safe and get checked if you have any doubts about your health.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that there are no specific guidelines or safety concerns mentioned about using hydrocortisone cream during pregnancy. This means that the information available does not indicate any need for dosage changes or special precautions when using this cream.

However, as with any medication, it's always best to consult with your healthcare provider before using hydrocortisone cream or any other treatment during pregnancy. They can provide personalized advice based on your individual health needs.

Lactation Use

If you are breastfeeding, it's important to consult your doctor before using this product. There is a possibility that it may be excreted in breast milk, which means it could potentially affect your nursing infant. Therefore, exercising caution while using this product during breastfeeding is highly recommended to ensure the safety and well-being of both you and your baby.

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 warm water, then gently dry it before applying the treatment. If your child is under 12 years old, please consult a doctor for guidance on how to proceed. Always prioritize your child's safety and well-being by seeking professional advice when needed.

Geriatric Use

While there is no specific information about the use of Hydrocortisone Ultra Strength cream in older adults, it's important to approach its use with caution. Since the drug insert does not mention any dosage adjustments or safety concerns for elderly patients, you should consult with a healthcare provider before using this cream. They can help determine if it's appropriate for your needs and ensure that it is used safely, considering any other medications or health conditions you may have. Always prioritize open communication with your healthcare team to address any concerns you might have.

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 usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment plan.

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 you are taking. In this case, there are no specific drug interactions or laboratory test interactions noted, which means that, based on the available information, this medication does not have known conflicts with other drugs or tests. However, every individual is different, and your healthcare provider can help ensure that your treatment is safe and effective for you.

Always discuss any new medications or tests with your healthcare provider to avoid potential issues and to get personalized advice tailored to your health needs.

Storage and Handling

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

When handling the product, be sure to check the tube's seal before use. If the seal is punctured or missing, do not use the product, as this could compromise its safety and effectiveness. Always prioritize these storage and handling guidelines to ensure optimal results.

Additional Information

No further information is available.

FAQ

What is Hydrocortisone Cream used for?

Hydrocortisone Cream is used to temporarily relieve 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 Hydrocortisone Cream?

Yes, it is for external use only. Do not use in the genital area if you have a vaginal discharge or for diaper rash without consulting a doctor.

What should I do if my condition worsens while using this cream?

Stop use and ask a doctor if your condition worsens, symptoms persist for more than 7 days, or if symptoms clear up and occur again within a few days.

Can I use Hydrocortisone Cream while breastfeeding?

Consult a doctor before using this product while breastfeeding, as there is a potential for excretion in breast milk.

What should I do if I accidentally swallow Hydrocortisone Cream?

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

Where should I store Hydrocortisone Cream?

Store the cream between 59° and 86° F (15° and 30° C) and do not use it if the seal on the tube is punctured or missing.

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

Hydrocortisone Cream is an ultra-strength topical formulation indicated for the fast relief of itching and rashes. The product is packaged in a net weight of 0.5 ounces (14 grams). It is distributed by Personal Care Products, LLC, located in Troy, Michigan, 48084, U.S.A. The cream is manufactured in India and is identified by the code number MH/DRUGS/KD-313.

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, insect bites, cosmetics, psoriasis, detergents, soaps, poison ivy, poison oak, poison sumac, jewelry, and seborrheic dermatitis. Additionally, it 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. There are no teratogenic or nonteratogenic effects associated with this drug.

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, adults should first clean the affected area with mild soap and warm water, ensuring 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 recommended before use.

Contraindications

There are no contraindications associated with the use of this product. It is not classified as a controlled substance, and there are no known risks of abuse, misuse, or dependence.

Warnings and Precautions

For external use only. This product is not intended for application in the genital area if there is a vaginal discharge; in such cases, consultation with a healthcare professional is advised. Additionally, it should not be used for the treatment of diaper rash without prior medical consultation.

When utilizing this product, it is imperative to avoid contact with the eyes. Users should adhere strictly to the recommended dosage and refrain from exceeding the directed amount unless specifically instructed by a healthcare provider. It is also important to note that the product should not be administered directly into the rectum.

Patients are advised to discontinue use and consult a physician if the condition worsens, if symptoms persist for more than seven days, or if symptoms resolve and then recur within a few days. Furthermore, users should not initiate the use of any other hydrocortisone product without first consulting a healthcare professional.

In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

Side Effects

Patients using this product should be aware that it is for external use only. It is contraindicated for use in the genital area if there is a vaginal discharge, and patients should consult a doctor in such cases. Additionally, the product should not be used for the treatment of diaper rash without prior consultation with a healthcare professional.

During the use of this product, patients are advised to avoid contact with the eyes and to adhere strictly to the recommended dosage. It is important not to exceed the directed use unless specifically instructed by a doctor. The product should not be administered directly into the rectum.

Patients should discontinue use 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. Furthermore, patients should refrain from using any other hydrocortisone products without consulting a doctor.

Drug Interactions

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

Packaging & NDC

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

Packaging configurations for Hydrocortisone.
Details

Pediatric Use

Pediatric patients aged 2 years and older may use the product for the relief of itching associated with skin irritation, inflammation, and rashes. The recommended application is to the affected area not 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, adults are instructed to clean the affected area with mild soap and warm water, rinse thoroughly, and gently dry before application. This product should also be applied to the affected area not more than 3 to 4 times daily. For children under 12 years of age, it is recommended to seek a doctor's advice before use.

Geriatric Use

Elderly patients may not have specific information regarding the use of Hydrocortisone Ultra Strength cream, including dosage adjustments, safety concerns, or special precautions. As such, healthcare providers should exercise caution when prescribing this medication to geriatric patients.

Due to the lack of data, it is advisable for clinicians to closely monitor elderly patients for any potential adverse effects or unusual responses to treatment. Individual patient factors, including comorbidities and concurrent medications, should be considered when determining the appropriateness of this therapy in the geriatric population.

Pregnancy

Hydrocortisone cream has not been specifically studied in pregnant patients, and there are no established safety concerns, dosage modifications, or special precautions regarding its use during pregnancy. As such, the potential risks and benefits should be carefully considered by healthcare professionals when prescribing this medication to women of childbearing potential. It is advisable for healthcare providers to discuss the lack of specific data and to evaluate the necessity of treatment in the context of the individual patient's condition and overall health.

Lactation

Lactating mothers should consult a doctor before using this product. There is a potential for excretion in breast milk, and caution is advised when using this product while breastfeeding.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of 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 information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, the following management procedures should be considered:

  1. Assessment: Conduct a thorough assessment of the patient's clinical status, including vital signs and level of consciousness.

  2. Supportive Care: Provide supportive care as needed, which may include airway management, oxygen supplementation, and intravenous fluids.

  3. Consultation: Engage with a poison control center or a medical toxicologist for guidance on specific interventions and antidotes, if applicable.

  4. Documentation: Document all findings, interventions, and the patient's response to treatment meticulously.

Healthcare professionals should remain vigilant and prepared to implement these general management strategies in the event of an overdose, even in the absence of specific overdosage information.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children. It is important to emphasize that if the medication is swallowed, patients should seek medical help or contact a Poison Control Center immediately. This precaution is crucial to ensure the safety and well-being of children who may inadvertently access the medication.

Storage and Handling

The product is supplied in a tube format. It is essential to store the product at temperatures ranging from 59° to 86° F (15° to 30° C) to maintain its efficacy. Healthcare professionals should ensure that the seal on the tube is intact; the product should not be used if the seal is punctured or missing. Proper handling and storage conditions are crucial for preserving the quality of the product.

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.