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Hydrocortisone

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This product has been discontinued

Active ingredient
Hydrocortisone 10 mg/1 mL
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 2010
Label revision date
July 28, 2010
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Hydrocortisone 10 mg/1 mL
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 2010
Label revision date
July 28, 2010
Manufacturer
UniShield
Registration number
part348
NDC root
49314-5801
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 a topical medication that contains 1.0% hydrocortisone, which is a type of steroid. This cream is primarily used for the temporary relief of itching caused by minor skin irritations, inflammation, or rashes. It works by reducing inflammation and calming the skin, helping to alleviate discomfort.

While hydrocortisone cream can be effective for these common skin issues, it's important to use it as directed and consult a doctor for any other uses.

Uses

You can use this product for temporary relief from itching caused by minor skin irritations, inflammation, or rashes. It's important to remember that if you have other uses in mind, you should consult with your doctor for advice and supervision.

Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) associated with this product, making it a safer option for those concerned about such risks.

Dosage and Administration

You should apply the medication to the affected area no more than 3 to 4 times each day. This helps ensure that you get the best results while minimizing the risk of side effects.

If you are considering using this medication for a child under the age of 2, it’s important to consult with a doctor first. They can provide guidance on the appropriate use and any necessary precautions.

What to Avoid

It's important to use this product safely. You should avoid using it in your eyes, as this can cause irritation or harm. Additionally, do not use it for treating diaper rash, as it is not intended for that purpose. Following these guidelines will help ensure your safety and the effectiveness of the product.

Side Effects

You should only use this product on the skin and not for any other purpose. If your condition worsens, lasts more than 7 days, or improves and then comes back within a few days, it’s important to stop using the product. Additionally, avoid using it alongside other hydrocortisone products, as this could lead to unwanted effects. Always prioritize your health and consult a healthcare professional if you have any concerns.

Warnings and Precautions

This product is for external use only, so please avoid ingesting it. If you accidentally swallow it, contact a Poison Control Center immediately for assistance.

You should stop using this product and call your doctor if your condition worsens, lasts more than 7 days, or improves and then comes back within a few days. Additionally, be cautious if you are using other hydrocortisone products, as this may require you to consult your healthcare provider.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, it's always important to be aware of the potential risks associated with taking any medication. If you suspect that you or someone else may have taken too much of a medication, look out for unusual symptoms such as extreme drowsiness, confusion, or difficulty breathing.

In the event of an overdose, it is crucial to seek immediate medical help. You can do this by calling your local emergency number or going to the nearest hospital. Always keep the medication packaging on hand to provide healthcare professionals with important information. Remember, it's better to be safe and get checked out if you have any concerns about an overdose.

Pregnancy Use

When it comes to using this medication during pregnancy, there are no specific guidelines or safety concerns provided in the information available. This means that the effects of the medication on pregnant individuals and their developing babies are not clearly defined.

If you are pregnant or planning to become pregnant, it’s essential to consult with your healthcare provider before starting any new medication. They can help you understand any potential risks and make informed decisions about your health and the health of your baby. Always prioritize open communication with your doctor regarding any medications you may be considering.

Lactation Use

If you are breastfeeding, it's important to consult your doctor before using this product. There is a possibility that the ingredients may pass into your breast milk, which means your nursing infant could be exposed to it. Due to this potential risk, you should exercise caution when considering this product while breastfeeding. Always prioritize your health and your baby's safety by discussing any concerns with your healthcare provider.

Pediatric Use

If you are considering this medication for your child, it's important to note that you should consult a doctor if your child is under 2 years old. This is to ensure their safety and to receive appropriate guidance tailored to their specific needs. Always prioritize professional advice when it comes to the health of young children.

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 healthcare providers may not have tailored guidelines for elderly patients.

If you or a loved one is an older adult considering this medication, it’s important to discuss any potential risks or concerns with your healthcare provider. They can help determine the best approach based on individual health needs and circumstances. Always prioritize open communication about any changes in health or medication effects.

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 is safe and effective for your specific condition. They can help determine the best approach for managing your health, especially if you have concerns about your kidneys.

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 (liver issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your liver health. They can help determine the best course of action based on your individual situation.

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 feel free to ask questions and share your complete list of medications and any lab tests you may be undergoing. This way, you can receive the best possible care tailored to your needs.

Storage and Handling

You can store and handle the product or device without any specific instructions or warnings. There are no particular environmental conditions to be aware of, and no components related to storage or safe handling have been mentioned. Since there are no disposal instructions provided, you may want to follow local regulations for disposal when the time comes. Always ensure that you are using the product as intended for the best results.

Additional Information

No further information is available.

FAQ

What is Hydrocortisone Cream used for?

Hydrocortisone Cream is used for temporary relief of itching associated with minor skin irritations, inflammation, or rashes. Other uses should be under the advice and supervision of a doctor.

How often can I apply Hydrocortisone Cream?

You can apply Hydrocortisone Cream to the affected area not more than 3 to 4 times daily.

Is Hydrocortisone Cream safe for children?

For children under 2 years old, you should ask a doctor before use.

Are there any contraindications for using Hydrocortisone Cream?

There are no contraindications listed for Hydrocortisone Cream.

What should I do if my condition worsens while using Hydrocortisone Cream?

You should stop using the cream if your condition worsens or lasts more than 7 days, or if it clears up and occurs again within a few days.

Can I use Hydrocortisone Cream for diaper rash?

No, you should not use Hydrocortisone Cream for the treatment of diaper rash.

Is Hydrocortisone Cream safe to use during pregnancy?

The provided information does not explicitly mention safety during pregnancy; consult your doctor for advice.

Can nursing mothers use Hydrocortisone Cream?

Nursing mothers should consult a doctor before using this product due to the potential for excretion in breast milk.

What should I do if I accidentally ingest Hydrocortisone Cream?

If ingested, you should contact a Poison Control Center right away.

What are the storage instructions for Hydrocortisone Cream?

No specific storage instructions are provided for Hydrocortisone Cream.

Packaging Info

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

Packaging configurations for Hydrocortisone.
Details

Drug Information (PDF)

This file contains official product information for Hydrocortisone, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

No description information is available for the specified drug.

Uses and Indications

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

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

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

Dosage and Administration

The medication should be applied to the affected area no more than 3 to 4 times daily. For children under the age of 2, it is advised to consult a physician prior to use.

Contraindications

Use of this product is contraindicated in the following situations:

The product should not be applied to the eyes due to the potential for irritation or adverse effects. Additionally, it is contraindicated for the treatment of diaper rash, as it may not be effective or appropriate for this condition.

Warnings and Precautions

For external use only. It is imperative that healthcare professionals advise patients to avoid ingestion of the product. In the event of accidental ingestion, immediate contact with a Poison Control Center is recommended to ensure appropriate management.

Healthcare providers should monitor patients for any worsening of their condition. If symptoms persist beyond 7 days, or if there is a recurrence of symptoms after initial improvement, patients should be instructed to discontinue use and consult their physician. Additionally, caution is advised when using this product in conjunction with other hydrocortisone products, as this may increase the risk of adverse effects.

Side Effects

For external use only. Patients are advised to discontinue use if their condition worsens, persists for more than 7 days, or resolves and then recurs within a few days. Additionally, the use of this product should be stopped if other hydrocortisone products are being utilized concurrently.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

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

Packaging configurations for Hydrocortisone.
Details

Pediatric Use

Pediatric patients under the age of 2 years should consult a healthcare professional before use. It is important to assess the appropriateness of treatment in this age group, as specific dosing and safety considerations may apply.

Geriatric Use

There is no specific information 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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

Pregnancy

Pregnant patients should be aware that the safety of this medication during pregnancy has not been established. There are no specific data regarding the potential risks or fetal impacts associated with its use in pregnant individuals. Healthcare professionals are advised to consider the potential benefits and risks when prescribing this medication to women of childbearing potential. It is recommended that patients inform their healthcare provider if they are pregnant, plan to become pregnant, or are breastfeeding. Further studies may be necessary to fully understand the implications of this medication on pregnancy outcomes.

Lactation

Lactating mothers are advised to consult a doctor prior to using this product. There is a potential for excretion in breast milk, and caution is recommended due to the risk of infant exposure 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 clinical trials for this medication. Consequently, there is no available information regarding dosage adjustments, special monitoring requirements, or precautions 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 warranted based on clinical judgment.

Overdosage

In the absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant and prepared for potential scenarios involving overdose.

Healthcare providers should be aware that the clinical presentation of an overdose may vary depending on the substance involved and the individual patient’s characteristics. Symptoms of overdose can range from mild to severe and may include altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

In the event of suspected overdosage, immediate medical evaluation is recommended. Healthcare professionals should assess the patient's vital signs and conduct a thorough clinical examination. Supportive care should be initiated as necessary, which may include airway management, intravenous fluids, and monitoring of vital parameters.

If specific antidotes or treatments are available for the substance involved, they should be administered according to established protocols. Consultation with a poison control center or toxicology expert may also be beneficial in managing the case effectively.

It is crucial to document all findings and interventions in the patient's medical record to ensure continuity of care and facilitate further management.

Nonclinical Toxicology

There is currently no available data regarding teratogenic or non-teratogenic effects associated with the compound. Additionally, no information has been provided concerning nonclinical toxicology, animal pharmacology, or toxicology studies. As such, a comprehensive assessment of these aspects cannot be made at this time.

Postmarketing Experience

No postmarketing experience details are provided in the drug insert.

Patient Counseling

Healthcare providers should advise patients that in the event of ingestion, it is crucial to contact a Poison Control Center immediately. This action is essential for ensuring the safety and well-being of the patient. Providers should emphasize the importance of prompt communication with medical professionals in such situations to facilitate appropriate care and intervention.

Storage and Handling

The product is available in various package configurations, identified by the National Drug Code (NDC) numbers. Specific storage instructions, disposal guidelines, safe handling warnings, and environmental considerations have not been provided. Additionally, there are no components related to storage or safe handling mentioned. Therefore, it is recommended that healthcare professionals follow standard practices for the storage and handling of pharmaceutical products.

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

Last AI update:

Primary FDA sources:

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

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

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