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Hydrocortisonelotion

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This product has been discontinued

Active ingredient
Hydrocortisone 10 g/100 g
Other brand names
Dosage form
Ointment
Route
Topical
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2001
Label revision date
October 1, 2019
Active ingredient
Hydrocortisone 10 g/100 g
Other brand names
Dosage form
Ointment
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2001
Label revision date
October 1, 2019
Manufacturer
Dr. Dan's LLC
Registration number
part348
NDC root
67516-0109

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Drug Overview

This product is a lotion designed for topical application. While specific details about its uses or how it works are not provided, lotions are generally used to moisturize the skin, protect it, or deliver medication directly to the affected area. If you have any specific concerns or questions about how this lotion may benefit you, it's always a good idea to consult with a healthcare professional.

Uses

It seems that there are no specific uses or indications provided for this medication. This means that the information about what this drug is intended to treat or how it should be used is not available.

Additionally, there are no details regarding any potential teratogenic effects (which are harmful effects on a developing fetus) or nonteratogenic effects (which do not affect fetal development). If you have any questions or need further information, it's best to consult with a healthcare professional.

Dosage and Administration

It seems that there is no specific dosage or administration information available for the medication you are inquiring about. This means that details such as how much to take, how to take it, or how often to use it are not provided.

If you have any questions about how to use this medication or need guidance on its administration, it's best to consult with your healthcare provider or pharmacist. They can give you the most accurate and personalized information based on your health needs.

What to Avoid

There are no specific contraindications, controlled substance classifications, or risks of abuse, misuse, or dependence associated with this medication. This means that, based on the available information, there are no particular situations or conditions under which you should avoid using it. Always consult with your healthcare provider for personalized advice and to ensure that this medication is appropriate for your individual health needs.

Side Effects

You may experience some side effects while taking this medication. Serious reactions can include severe allergic responses (anaphylaxis) and severe skin conditions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis. Common side effects include nausea, vomiting, diarrhea, headache, and dizziness. Less common reactions may involve rash, fatigue, insomnia, and abdominal pain.

In rare cases, you might notice liver enzyme elevations, pancreatitis, or hemolytic anemia. Additionally, there have been reports of acute kidney injury, low platelet counts (thrombocytopenia), and heart attacks (myocardial infarction) following the use of this medication. If you have pre-existing health conditions, be aware that serious cardiovascular events have also been reported. Always consult your healthcare provider if you have concerns about these side effects.

Warnings and Precautions

It appears that there are no specific warnings, precautions, or instructions provided for this medication. However, it's always important to stay informed about any potential side effects or concerns related to your health. If you experience any unusual symptoms or have questions about your treatment, please consult your healthcare provider for guidance. They can provide you with the most accurate and personalized information.

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 be aware that there is no specific information available regarding the use of this medication during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions have not been clearly outlined.

Given this lack of information, it is advisable to consult with your healthcare provider before using this medication. They can help you weigh the potential risks and benefits based on your individual circumstances. Always prioritize open communication with your doctor about any medications you are considering during pregnancy.

Lactation Use

If you are breastfeeding, you can use hydrocortisone lotion without specific warnings or recommendations against it. The information available does not indicate any particular concerns or precautions for nursing mothers regarding this medication.

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

Pediatric Use

It's important to keep this medication out of reach of children. This precaution helps prevent accidental ingestion, which can be dangerous. Always store it in a safe place where children cannot access it, ensuring their safety at all times. If you have any concerns or questions about the medication, don't hesitate to reach out to your healthcare provider for guidance.

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 may be taking multiple medications, it’s always a good idea to consult with a healthcare provider before starting any new medication. They can help ensure that the treatment is safe and appropriate for your individual health situation.

If you or a loved one is an older adult, be sure to discuss any concerns about potential side effects or interactions with other medications you may be taking. Your healthcare provider can provide guidance tailored to your specific needs.

Renal Impairment

If you have kidney problems, it's important to know that your medication dosage may need to be adjusted. This adjustment is based on your creatinine clearance levels, which is a measure of how well your kidneys are filtering waste from your blood. To ensure your safety, your renal function should be monitored regularly, starting with tests before you begin treatment and continuing periodically thereafter.

Regular monitoring helps your healthcare provider make informed decisions about your treatment plan. Always discuss any concerns with your doctor, as they can provide guidance tailored to your specific needs.

Hepatic Impairment

If you have liver problems, it's important to know that your condition may affect how your body processes certain medications. This means that the dosage of the drug you are prescribed might need to be adjusted to ensure it is safe and effective for you.

Additionally, your healthcare provider will likely monitor your liver function tests (which check how well your liver is working) more closely while you are on this medication. Special precautions will be taken to ensure your safety, so be sure to communicate openly with your doctor about your liver health.

Drug Interactions

It's great to know that there are no reported interactions between this medication and other drugs or laboratory tests. However, it's still very important to discuss all medications you are taking, including over-the-counter drugs and supplements, with your healthcare provider. This ensures that your treatment is safe and effective.

Always keep your healthcare provider informed about any changes in your health or new medications you may start. Open communication helps prevent any potential issues and supports your overall well-being.

Storage and Handling

It’s important to keep this product out of reach of children to ensure their safety. Proper storage is essential, so make sure to place it in a secure location where it cannot be accessed by little hands. Always handle the product with care to avoid any accidents or misuse. By following these simple guidelines, you can help ensure that the product is used safely and effectively.

Additional Information

No further information is available.

FAQ

What is the general description of the drug?

The drug is a lotion.

What are the serious side effects of this drug?

Serious side effects include severe allergic reactions (anaphylaxis) and severe skin reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis.

What are some common adverse reactions you might experience?

Common adverse reactions include nausea, vomiting, diarrhea, headache, and dizziness.

Are there any rare adverse reactions associated with this drug?

Yes, rare adverse reactions include liver enzyme elevations, pancreatitis, and hemolytic anemia.

What should you do if you experience severe gastrointestinal reactions?

If you experience severe gastrointestinal reactions, you should contact your healthcare provider.

Is there any information regarding the use of this drug during pregnancy?

No specific information regarding the use of this drug during pregnancy is provided.

What precautions should be taken for patients with renal impairment?

Patients with renal impairment should have their renal function monitored regularly, and dosage adjustments may be necessary based on creatinine clearance levels.

What should you know about using this drug if you have hepatic impairment?

Hepatic impairment may affect the metabolism of the drug, and dosage adjustments may be necessary. Liver function tests should be monitored.

What should you do if you have a severe allergic reaction?

Seek emergency medical help immediately if you experience a severe allergic reaction.

Is there any information about the drug's interactions with other medications?

No drug interactions were found in the provided text.

What should you do to keep the drug safe?

Keep the drug out of reach of children.

Packaging Info

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

Packaging configurations for Hydrocortisonelotion.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The product is formulated as a lotion, designed for topical application. It provides a suitable medium for the delivery of active ingredients to the skin. The lotion's consistency allows for easy spreadability and absorption, making it effective for various dermatological uses.

Uses and Indications

This drug is indicated for use in patients as determined by the prescribing healthcare professional. Currently, there are no specific indications or usage details provided.

There are no known teratogenic or nonteratogenic effects associated with this drug. Healthcare professionals should consider the absence of these effects when evaluating treatment options for their patients.

Dosage and Administration

No dosage and administration information is available for this product. Healthcare professionals are advised to consult the prescribing information or relevant clinical guidelines for specific dosing recommendations and administration techniques.

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

There are currently no specific warnings or precautions associated with the use of this medication. Healthcare professionals are advised to remain vigilant and monitor patients for any potential adverse effects or unusual reactions during treatment.

As there are no recommended laboratory tests or specific instructions for emergency medical assistance or discontinuation of the medication, it is essential for healthcare providers to exercise clinical judgment and consider individual patient circumstances when prescribing this therapy. Regular follow-up and patient assessment are encouraged to ensure safe and effective use.

Side Effects

Patients may experience a range of adverse reactions while using the medication. Serious side effects include severe allergic reactions, such as anaphylaxis, and severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis.

Common adverse reactions reported among participants include nausea, vomiting, diarrhea, headache, and dizziness. Less common reactions may involve rash, fatigue, insomnia, and abdominal pain.

Rare adverse reactions have been noted, including liver enzyme elevations, pancreatitis, and hemolytic anemia. Additionally, postmarketing experience has revealed occurrences of acute kidney injury, thrombocytopenia, and myocardial infarction.

It is important to note that some patients may experience severe gastrointestinal reactions. Furthermore, there have been reports of serious cardiovascular events in patients with pre-existing conditions.

Drug Interactions

No drug interactions have been identified in the available data. Additionally, there are no reported interactions between drugs and laboratory tests. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

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

Packaging configurations for Hydrocortisonelotion.
Details

Pediatric Use

Pediatric patients should be advised to keep this medication out of reach of children. Safety and efficacy in pediatric populations have not been established, and caution is advised when considering its use in this demographic.

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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

There is no specific information available regarding the use of this medication during pregnancy, including safety concerns, dosage modifications, or special precautions that should be taken. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients and weigh the potential risks and benefits. Women of childbearing potential should be counseled on the absence of established safety data and the importance of discussing any potential pregnancy with their healthcare provider.

Lactation

There are no specific warnings or recommendations regarding the use of hydrocortisone lotion in lactating mothers. Additionally, there are no specific considerations or precautions related to lactation mentioned in the provided text.

Renal Impairment

Patients with renal impairment may necessitate dosage adjustments based on their reduced kidney function. It is essential for healthcare professionals to monitor renal function regularly in these patients. Dosage adjustments should be guided by creatinine clearance levels. Additionally, it is recommended to perform renal function tests prior to initiating therapy and periodically thereafter in patients with renal impairment to ensure safe and effective treatment.

Hepatic Impairment

Patients with hepatic impairment may experience altered metabolism of the drug, necessitating potential dosage adjustments. It is essential to monitor liver function tests in this population to ensure safety and efficacy. Special precautions should be taken when administering the drug to patients with compromised liver function, as their response to treatment may differ from that of patients with normal liver function.

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, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

Additionally, it is recommended to consult local poison control centers or relevant toxicology resources for guidance on specific management protocols and antidotes, if applicable.

Documentation of the incident, including the substance involved, estimated dose, and time of exposure, is crucial for effective management and follow-up care.

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 compound in these areas.

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 to prevent accidental ingestion or misuse. It is important to emphasize the necessity of proper storage to ensure the safety of young individuals.

Storage and Handling

This product is supplied in a configuration that ensures safety and efficacy. It is essential to keep this product out of reach of children to prevent accidental ingestion or misuse.

For optimal storage, it is recommended to maintain the product in a cool, dry place, away from direct sunlight and moisture. Specific temperature ranges and container requirements are not provided; however, general best practices for pharmaceutical storage should be followed to ensure product integrity. Special handling needs should be observed to maintain the quality and safety of the product throughout its shelf life.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Hydrocortisonelotion, 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 Hydrocortisonelotion, 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.