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Hydrocortisone

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This product has been discontinued

Active ingredient
Hydrocortisone 1 g/100 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 2012
Label revision date
September 28, 2012
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Hydrocortisone 1 g/100 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 2012
Label revision date
September 28, 2012
Manufacturer
Morales Distributors Inc
Registration number
part348
NDC root
53210-1002
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 percent Cream is an anti-itch cream designed to provide temporary relief from itching associated with minor skin irritations, inflammation, and rashes. It works quickly to alleviate discomfort caused by various conditions, including eczema, psoriasis, seborrheic dermatitis, poison ivy, insect bites, and reactions to soaps, detergents, cosmetics, and jewelry.

This cream is particularly useful for soothing redness and itching, making it a helpful option for external feminine and anal itching as well. If you have any specific concerns or conditions, it's always a good idea to consult with a doctor for further guidance on its use.

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, psoriasis, and seborrheic dermatitis. It’s also effective for itching related to poison ivy, oak, or sumac, as well as insect bites. Additionally, it can help soothe irritation from soaps, detergents, cosmetics, jewelry, and external feminine or anal itching.

If you have any other specific concerns or uses in mind, it's best to consult with a doctor for guidance.

Dosage and Administration

You should apply this medication to the affected area no more than 3 to 4 times a day. If you're using it for external anal itching, it's best to start by cleaning the area with mild soap and warm water. Make sure to rinse thoroughly and gently dry the area by patting or blotting it with toilet tissue or a soft cloth before applying the product.

If you have children, please note that this medication is not recommended for children under 2 years old, or for children under 12 years old who are experiencing external anal itching. In these cases, it's important to consult a doctor for advice.

What to Avoid

You should avoid using this product in or near your eyes, or inserting it directly into the rectum using fingers or any devices. It is also not recommended for treating external feminine itching if you have a vaginal discharge, or for diaper rash—please consult a doctor in those cases.

If your condition worsens or does not improve within 7 days, or if symptoms clear up and then return within a few days, stop using the product and seek medical advice. Additionally, if you experience rectal bleeding, you should also stop use and contact a doctor. When using this product for external anal itching, be sure not to exceed the recommended daily dosage unless directed by a healthcare professional.

Side Effects

It's important to be aware of potential side effects when using this medication. You should stop using it and consult a doctor if your condition worsens or does not improve within 7 days, if symptoms clear up and then return within a few days, or if you experience rectal bleeding.

Additionally, before using this product, it's a good idea to talk to your doctor or pharmacist if you are currently using any other hydrocortisone product, as this could affect your treatment. Remember, this medication is for external use only.

Warnings and Precautions

This product is for external use only, so please avoid swallowing it. If you accidentally ingest it, seek medical help immediately or contact Poison Control for assistance.

You should stop using this product and consult your doctor if your condition worsens or does not improve within 7 days, if your symptoms clear up and then return within a few days, or if you experience rectal bleeding. Your health and safety are important, so don’t hesitate to reach out for help if you have any concerns.

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 effects of an overdose for this medication, you should be aware of general signs that may indicate a problem. These can include unusual drowsiness, confusion, or difficulty breathing.

If you notice any of these symptoms or have concerns about a possible overdose, seek medical help right away. It's always better to err on the side of caution when it comes to your health. Remember, if you are ever in doubt, contacting a healthcare professional or poison control can provide you with the guidance you need.

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, it's always best to consult with your healthcare provider before using any medication, including over-the-counter products, to ensure they are safe for you and your baby.

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 you are considering using this medication for your child, it's important to know that it is not recommended for children under 2 years old. Additionally, if your child is under 12 years old and experiencing external anal itching, you should consult a doctor before use. Always prioritize your child's safety and seek professional advice when in doubt.

Geriatric Use

While there is no specific information about the use of hydrocortisone 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 medication. They can help determine if hydrocortisone cream is appropriate for you or your loved one, considering any individual health needs or conditions. Always prioritize safety and seek professional advice when it comes to medication use in older adults.

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 if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to discuss any concerns regarding your liver health and medication use. They can help ensure that your treatment is safe and effective based on your individual health needs.

Drug Interactions

It's important to talk to your doctor or pharmacist before using this medication, especially if you are already using any other hydrocortisone product. Combining different hydrocortisone treatments can lead to unexpected side effects or reduce the effectiveness of your treatment.

Always keep your healthcare provider informed about all the medications you are taking to ensure your safety and the best possible care.

Storage and Handling

To ensure the best performance of your product, store it at room temperature and make sure it is protected from freezing. This will help maintain its effectiveness and safety for use.

When handling the product, always do so with care to avoid any damage. Following these simple storage and handling guidelines will help you use the product safely and effectively.

Additional Information

You should apply this medication topically to the affected area, using it no more than 3 to 4 times a day. There are no additional details regarding laboratory tests, abuse potential, or patient counseling information available at this time.

FAQ

What is Hydrocortisone 1 percent Cream used for?

Hydrocortisone 1 percent Cream is an anti-itch cream that temporarily relieves itching associated with minor skin irritation, inflammation, and rashes due to conditions like eczema, psoriasis, and insect bites.

How should I apply Hydrocortisone Cream?

You should apply the cream to the affected area not more than 3 to 4 times daily.

Are there any precautions for using this cream?

Yes, do not use it in or near the eyes, or for diaper rash. If you have a vaginal discharge, do not use it for external feminine itching.

What should I do if my condition worsens?

Stop using the cream and ask a doctor if your condition worsens or does not improve within 7 days.

Can children use Hydrocortisone Cream?

Children under 2 years, or children under 12 years with external anal itching, should not use this product without consulting a doctor.

Is it safe to use this cream while breastfeeding?

Nursing mothers should consult a doctor before using this product, as there is a potential for excretion in breast milk.

Where is Hydrocortisone Cream manufactured?

This product is made in Korea and is exclusively distributed by Morales Distributors, Inc.

What should I do if I accidentally swallow the cream?

If swallowed, get medical help or contact a Poison Control center immediately.

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

This product is a maximum strength hydrocortisone 1 percent cream formulated for the relief of itching and redness associated with skin irritations. It is presented in a net weight of 1 oz (28.3 g). The cream is designed to provide fast relief from symptoms such as itching and redness. The product is exclusively distributed by Morales Distributors, Inc., located in Mayaguez, P.R. 00682. It is important to note that this product is not manufactured or distributed by Pharmacia Consumer Healthcare, the owner of the registered trademark Cortaid®. The cream is made in Korea. The National Drug Code (NDC) for this product is 53210-1002-0.

Uses and Indications

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

For any additional uses of this product, healthcare professionals are advised to consult a physician.

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

Dosage and Administration

The product should be applied to the affected area no more than 3 to 4 times daily. For the treatment of external anal itching, it is recommended that the area be cleaned with mild soap and warm water when practical. After cleaning, the area should be rinsed thoroughly and gently dried by patting or blotting with toilet tissue or a soft cloth prior to the application of the product.

This product is not indicated for use in children under 2 years of age, nor should it be used in children under 12 years of age with external anal itching without consulting a physician.

Contraindications

Use of this product is contraindicated in the following situations:

The product should not be applied in or near the eyes. It is also contraindicated for rectal administration using fingers, mechanical devices, or applicators. The product must not be used for external feminine itching in the presence of vaginal discharge or for diaper rash without consulting a healthcare professional.

If the condition worsens or does not improve within 7 days, if symptoms resolve and then recur within a few days, or if rectal bleeding occurs, discontinue use and seek medical advice.

When using this product for external anal itching, do not exceed the recommended daily dosage unless directed by a healthcare professional.

Warnings and Precautions

For external use only. This product is not intended for internal use, and ingestion may lead to serious health consequences. In the event of accidental ingestion, it is imperative to seek emergency medical assistance or contact a Poison Control Center immediately.

Healthcare professionals should advise patients to discontinue use and consult a physician under the following circumstances: if the condition worsens or fails to improve within 7 days; if symptoms resolve and then recur within a few days; or if rectal bleeding occurs. These actions are crucial to ensure patient safety and appropriate management of any potential adverse effects.

Side Effects

For external use only. Patients should discontinue use and consult a healthcare professional if the condition worsens or does not improve within 7 days, if symptoms clear up and then return within a few days, or if rectal bleeding occurs. Additionally, patients are advised to seek guidance from a doctor or pharmacist before using this product if they are currently using any other hydrocortisone product.

Drug Interactions

Concurrent use of hydrocortisone with other hydrocortisone-containing products should be approached with caution. It is advisable for patients to consult a healthcare professional, such as a doctor or pharmacist, prior to initiating treatment with additional hydrocortisone formulations. This precaution is essential to avoid potential cumulative effects and to ensure appropriate management of dosage and therapeutic outcomes. Monitoring for signs of excessive corticosteroid exposure may be warranted in such cases.

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, as well as those under 12 years experiencing external anal itching, should not use this medication without consulting a healthcare professional. It is important for healthcare providers to assess the appropriateness of treatment in these age groups to ensure safety and efficacy.

Geriatric Use

There is no specific information regarding the use of hydrocortisone cream 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 is advisable, given the lack of targeted data for this population.

Pregnancy

There are no specific statements regarding the use of hydrocortisone cream during pregnancy, including safety concerns, dosage modifications, or special precautions. As such, healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients. It is advisable to weigh the potential benefits against any unknown risks to fetal outcomes. Women of childbearing potential should be counseled on the importance of discussing any medications with their healthcare provider prior to use during pregnancy.

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 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 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 in the provided sections of the Summary of Product Characteristics (SPL), healthcare professionals are advised to exercise caution when administering the medication.

Should an overdosage occur, it is essential to monitor the patient closely for any potential symptoms that may arise, although these symptoms are not explicitly detailed in the available documentation.

Management of overdosage should be guided by standard medical practices, which may include supportive care and symptomatic treatment as necessary. Healthcare professionals are encouraged to consult local poison control centers or relevant medical authorities for further guidance on managing suspected overdosage cases.

In the event of an overdosage, it is critical to ensure that the patient receives appropriate medical attention promptly to mitigate any potential adverse effects.

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 specific postmarketing experience details are available in the extracted data. As such, there are no additional adverse events or rare case reports to summarize.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children. In the event of accidental ingestion, patients should seek medical help or contact Poison Control immediately.

Patients should be informed that this product is not intended for use in or near the eyes. Additionally, it should not be applied directly into the rectum using fingers, mechanical devices, or applicators. It is important to caution patients against using this product for external feminine itching if they have a vaginal discharge, and to refrain from using it for diaper rash unless directed by a doctor.

Patients should be instructed to stop using the product and consult a doctor if their condition worsens or does not improve within 7 days. They should also be advised to seek medical advice if symptoms resolve and then return within a few days, or if rectal bleeding occurs.

When using this product for external anal itching, patients should not exceed the recommended daily dosage unless directed by a healthcare professional. Furthermore, patients should be encouraged to consult with a doctor or pharmacist before using this product if they are currently using any other hydrocortisone product.

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 room temperature, ensuring that it is protected from freezing to maintain its integrity and efficacy. Proper handling should be observed to prevent exposure to extreme temperatures.

Additional Clinical Information

The medication is administered topically, with application to the affected area recommended no more than 3 to 4 times daily. There are no additional details available regarding laboratory tests, abuse information, 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.

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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.