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Hydrocortisone

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This product has been discontinued

Active ingredient
Hydrocortisone 10 mg/1 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 2015
Label revision date
March 9, 2016
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Hydrocortisone 10 mg/1 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 2015
Label revision date
March 9, 2016
Manufacturer
Acme United Corp
Registration number
part348
NDC root
0924-1132
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (3 NDCs)
Packaging & NDC Codes (3)

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 is an anti-itch cream that provides temporary relief from itching caused by minor skin irritations, inflammation, or rashes. It works by reducing inflammation and soothing the affected area, helping to alleviate discomfort and promote healing.

While hydrocortisone is effective for these common skin issues, it's important to consult with a doctor for any other uses to ensure safe and appropriate treatment.

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 guidance.

Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) associated with this product, and there are also no reported nonteratogenic effects. Always prioritize your health and safety by following professional advice when using any medication.

Dosage and Administration

You should apply the medication to the affected area no more than 3 to 5 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 dosage for young children.

What to Avoid

It's important to be aware of certain precautions when using this product. You should never use 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.

There are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with this product. Always follow these guidelines to ensure safe and effective use.

Side Effects

When using this product, it's important to remember that it is for external use only. Avoid applying it to your eyes or using it for treating diaper rash. If your condition worsens, lasts more than seven days, or clears up only to return shortly after, you should stop using the product and consult a doctor. Additionally, be cautious if you are using other hydrocortisone products, as this may not be advisable.

Keep this product out of reach of children. If a child accidentally ingests it, contact a Poison Control Center immediately for assistance.

Warnings and Precautions

This product is for external use only, so please avoid applying it to your eyes or using it for diaper rash. It's important to keep this medication out of reach of children. If a child accidentally ingests it, contact a Poison Control Center immediately.

You should stop using this product and consult your doctor if your condition worsens, lasts more than 7 days, or improves and then comes back within a few days. Additionally, avoid using it alongside other hydrocortisone products without your doctor's guidance.

Overdose

If you suspect an overdose has occurred, it’s important to act quickly. Contact a Poison Control Center immediately for guidance. They can provide you with the necessary steps to take based on the situation.

Signs of an overdose can vary, but they may include unusual symptoms that are not typical for you. If you notice any concerning changes in your health or behavior, don’t hesitate to seek immediate medical help. Your safety is the top priority, so getting professional assistance as soon as possible is crucial.

Pregnancy Use

You can use hydrocortisone cream during pregnancy without specific warnings or dosage changes mentioned in the product information. There are no indications that it is contraindicated (not recommended) for pregnant individuals, nor does it specify any risks to the fetus. However, as with any medication, it's always a good idea to consult with your healthcare provider before using it to ensure it's appropriate for your 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 particular concerns or precautions for nursing mothers regarding the use of this cream.

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

Pediatric Use

When it comes to using this medication for children, it's important to follow specific guidelines. For children under the age of 2, you should only use it if directed by a doctor. Always keep the medication out of reach of children to prevent accidental ingestion. If your child does ingest it, contact a Poison Control Center immediately for assistance.

By taking these precautions, you can help ensure the safe use of this medication in 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 if you or a loved one is an older adult considering this medication, it’s important to consult with a healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

Renal Impairment

If you have kidney problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to change based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective for your specific situation. They can help monitor your kidney health and make any necessary adjustments to your medications.

Hepatic Impairment

If you have liver problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or precautions related to your condition. This means that there are no tailored recommendations for how the medication may affect you differently due to your liver health.

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your specific situation. They can help determine the best approach based on your liver function and overall health.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking, even if there are no known drug interactions or laboratory test interactions associated with them. This ensures that your treatment plan is safe and effective for your individual health needs.

Always keep your healthcare team informed about all the medications and supplements you use, as well as any lab tests you may undergo. This way, they can provide the best care tailored to you.

Storage and Handling

To ensure the best performance of your product, store it at room temperature and keep it away from direct light. It's important not to freeze the product, as this can affect its effectiveness. After opening, remember to discard any unused portion to maintain safety and quality.

By following these simple storage and handling guidelines, you can help ensure that the product remains safe and effective for your use.

Additional Information

You should apply the medication to the affected area no more than 3 to 5 times a day. This helps ensure effective treatment while minimizing the risk of side effects. If you have any questions about how to use the medication or its effects, be sure to consult your healthcare provider for guidance.

FAQ

What is Hydrocortisone used for?

Hydrocortisone is an anti-itch cream used for temporary relief of itching associated with minor skin irritations, inflammation, or rashes.

How should I use Hydrocortisone?

Apply Hydrocortisone to the affected area not more than 3 to 5 times daily.

Can I use Hydrocortisone for diaper rash?

No, do not use Hydrocortisone for the treatment of diaper rash.

Is Hydrocortisone safe to use during pregnancy?

The insert does not provide specific information regarding the use of Hydrocortisone during pregnancy or any risks to the fetus.

What should I do if I accidentally ingest Hydrocortisone?

If ingested, contact a Poison Control Center right away.

Are there any contraindications for using Hydrocortisone?

There are no contraindications listed for Hydrocortisone.

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

Stop use and ask a doctor if your condition worsens or lasts more than 7 days, or if it clears up and occurs again within a few days.

Can children use Hydrocortisone?

Children under 2 should use Hydrocortisone only as directed by a doctor.

How should I store Hydrocortisone?

Store Hydrocortisone at room temperature, protect it from light, and do not freeze. Discard any unused portion after opening.

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 is an anti-itch cream formulated to provide relief from itching. It is available in individual packets, each containing 0.9 grams of the cream. The product is packaged in a total of 12 packets, designed for convenient application.

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 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

The medication should be applied to the affected area no more than 3 to 5 times daily. For pediatric patients under the age of 2 years, the use of this medication should be determined by a healthcare professional. It is essential to follow the prescribed frequency and ensure that the application is limited to the specified number of times to avoid potential adverse effects.

Contraindications

Use is contraindicated in the eyes. Additionally, the product should not be used for the treatment of diaper rash.

Warnings and Precautions

For external use only. This product is contraindicated for application in the eyes and should not be used for the treatment of diaper rash.

Healthcare professionals should advise patients to discontinue use and consult a physician if the condition worsens, persists for more than 7 days, or resolves and then recurs within a few days. Additionally, caution is warranted if the patient is concurrently using other hydrocortisone products, as this may lead to increased risk of adverse effects.

It is imperative to keep this product out of reach of children. In the event of ingestion, immediate contact with a Poison Control Center is recommended to ensure appropriate management.

Side Effects

Patients should be aware that the product is for external use only and should not be applied in or around the eyes. It is contraindicated for the treatment of diaper rash.

In clinical practice, patients are advised to discontinue use and consult a healthcare professional if their condition worsens, persists for more than 7 days, or if symptoms resolve and then recur within a few days. Additionally, caution is advised against concurrent use with other hydrocortisone products, as this may lead to increased risk of adverse effects.

It is essential to keep this product out of reach of children. In the event of ingestion, immediate contact with a Poison Control Center is recommended to ensure appropriate management.

Drug Interactions

No specific drug interactions have been identified for this medication. Additionally, there are no reported interactions with laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

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 should use this medication only as directed by a healthcare professional. It is essential to keep the product out of reach of children to prevent accidental ingestion. In the event of ingestion, immediate contact with a Poison Control Center is advised to ensure appropriate management and care.

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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

Hydrocortisone cream has not been associated with specific warnings, precautions, or dosage modifications for use during pregnancy. The prescribing information does not indicate whether the product is contraindicated in pregnant patients or if there are any known risks to the fetus. As such, healthcare professionals should consider the lack of specific data when advising women of childbearing potential regarding the use of hydrocortisone cream during pregnancy. It is advisable to weigh the potential benefits against any unknown risks when prescribing this medication to pregnant patients.

Lactation

There are no specific warnings or recommendations regarding the use of hydrocortisone cream in lactating mothers. Additionally, there are no specific considerations or precautions related to lactation or breastfeeding mentioned in the provided text. Therefore, healthcare professionals may consider the use of hydrocortisone cream in nursing mothers without specific concerns related to 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 event of an overdosage, immediate action is crucial. Healthcare professionals are advised to contact a Poison Control Center without delay if an overdose is suspected.

Symptoms of overdosage may vary depending on the substance involved and the amount ingested. It is essential to monitor the patient closely for any signs of adverse reactions or complications that may arise from the overdose.

Management of an overdosage should be guided by the specific circumstances of the case, including the substance involved and the patient's clinical status. Supportive care and symptomatic treatment may be necessary, and healthcare providers should follow established protocols for the management of overdose situations.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the use of the compound in these contexts.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

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 to ensure prompt and appropriate management of any potential toxicity. Providers should emphasize the importance of acting quickly and not waiting for symptoms to appear, as timely intervention can be critical in such situations.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at room temperature, ensuring that it is protected from light exposure. Freezing the product is strictly prohibited, as it may compromise its integrity. After opening, any unused portion must be discarded to maintain safety and efficacy.

Additional Clinical Information

Patients should apply the medication to the affected area no more than 3 to 5 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.

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.