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Dermacort

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Active ingredient
Hydrocortisone 10 mg/1 g
Other brand names
Drug class
Corticosteroid
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2000
Label revision date
March 20, 2025
Active ingredient
Hydrocortisone 10 mg/1 g
Other brand names
Drug class
Corticosteroid
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2000
Label revision date
March 20, 2025
Manufacturer
Melaleuca, Inc.
Registration number
M017
NDC root
54473-117

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Drug Overview

DermaCort is a medication designed to provide temporary relief from itching caused by minor skin irritations, inflammation, and rashes. It can be helpful for conditions such as eczema, psoriasis, seborrheic dermatitis, and reactions to poison ivy, poison oak, poison sumac, insect bites, soaps, detergents, and jewelry.

While it is effective for these uses, it is important to consult with a doctor for any other applications of this product to ensure safe and appropriate use.

Uses

This product is designed to provide temporary relief from itching caused by minor skin irritations, inflammation, and rashes. You might find it helpful for conditions such as eczema, psoriasis, and seborrheic dermatitis, as well as reactions to poison ivy, poison oak, poison sumac, insect bites, soaps, detergents, and jewelry.

It's important to note that if you have other uses in mind for this product, you should consult with a doctor for advice and supervision.

Dosage and Administration

If you are an adult or a child aged 2 years and older, you can apply this medication to the affected area up to 3 to 4 times a day. Make sure to follow this guideline to ensure the best results.

However, if your child is under 2 years old, it’s important not to use this medication without first consulting a doctor. Always prioritize safety and seek professional advice when it comes to younger children.

What to Avoid

It's important to use this product safely. Do not use it for treating diaper rash; instead, consult your doctor for appropriate advice. If your condition worsens, persists for more than 7 days, or clears up only to return within a few days, stop using the product and speak with your doctor before trying any other hydrocortisone products.

While using this product, be careful to avoid contact with your eyes. Following these guidelines will help ensure your safety and the effectiveness of your treatment.

Side Effects

This product is intended for external use only. If you notice that your condition worsens, or if your symptoms last longer than 7 days, it's important to stop using the product. Additionally, if your symptoms improve and then return within a few days, you should also discontinue use. In either case, consult a doctor before starting any other hydrocortisone product.

Warnings and Precautions

This product is for external use only, so please avoid using it on any internal areas. It's important to keep it out of reach of children. If a child accidentally ingests it, seek professional help or contact a Poison Control Center right away.

You should stop using this product and consult your doctor if your condition worsens, if symptoms last more than 7 days, or if your symptoms improve and then return within a few days. Do not start using any other hydrocortisone product without first talking to your doctor.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While the specific signs of an overdose are not detailed, common symptoms can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these signs, seek medical help right away.

In case of an overdose, contact your local emergency services or go to the nearest hospital. It's crucial to provide them with as much information as possible about the substance taken and the amount, if known. Remember, acting quickly can make a significant difference in your health and safety.

Pregnancy Use

When it comes to using this product during pregnancy, there are no specific guidelines or safety concerns mentioned. This means that there are no established recommendations for dosage adjustments or special precautions for pregnant individuals.

If you are pregnant or planning to become pregnant, it's always best to consult with your healthcare provider before using any medication. They can provide personalized advice based on your health and circumstances.

Lactation Use

When it comes to breastfeeding, it's important to be aware that there are no specific guidelines or statements regarding nursing mothers or lactation (the process of producing milk). This means that if you are breastfeeding, you may not find detailed information about how certain medications or treatments could affect you or your baby.

If you have concerns about breastfeeding while taking any medication, it's always a good idea to consult with your healthcare provider. They can provide personalized advice based on your situation and help ensure the safety and well-being of both you and your infant.

Pediatric Use

If your child is under 2 years old, it's important not to use this medication without consulting a doctor first. For children aged 2 years and older, you can apply the medication to the affected area, but be sure to do this no more than 3 to 4 times a day. Always follow these guidelines to ensure your child's safety and well-being.

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 keep in mind that older adults may have different responses to medications, so discussing any concerns with a doctor is essential for ensuring safety and effectiveness.

Renal Impairment

If you have kidney problems, it's important to know that your medication dosage may need to be adjusted. Regular monitoring of your kidney function tests is essential to ensure your safety and the effectiveness of your treatment. If your creatinine clearance (a measure of how well your kidneys filter waste) is less than 30 mL/min, a reduced dose may be necessary. Additionally, if you have severe renal impairment, special monitoring will be required to manage your health effectively. Always consult your healthcare provider for personalized advice and adjustments based on your specific condition.

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 (issues with liver function).

Always consult your healthcare provider for personalized advice and to discuss any concerns regarding your liver health and how it may relate to your treatment. They can help ensure that you receive the safest and most effective care.

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 the medication is generally considered safe to use with other drugs and tests. However, every individual is different, and your healthcare provider can help ensure that your treatment plan is safe and effective for you.

Always discuss any changes in your medications or upcoming lab tests with your healthcare provider to avoid any potential issues and to get the best care possible.

Storage and Handling

To ensure the safety and effectiveness of your product, it’s important to store it properly. Keep it in a cool place and do not store it above 100°F (38°C). This temperature limit helps maintain the integrity of the product.

When handling the product, always ensure that you are in a clean environment to avoid contamination. If there are any specific components included with the product, make sure to follow any additional instructions provided for their use or disposal. Proper storage and handling are key to ensuring your product works as intended.

Additional Information

You should apply this medication topically to the affected area, using it no more than 3 to 4 times a day if you are an adult or a child aged 2 years and older. If the patient is under 2 years old, it's important to consult a doctor before use. There are no additional details available regarding laboratory tests, abuse potential, or postmarketing experiences related to this medication.

FAQ

What is DermaCort used for?

DermaCort is used for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to conditions like eczema, psoriasis, and insect bites.

How should I use DermaCort?

For adults and children 2 years of age and older, apply to the affected area not more than 3 to 4 times daily. Do not use on children under 2 years of age without consulting a doctor.

Are there any contraindications for using DermaCort?

Yes, do not use DermaCort for the treatment of diaper rash. Consult a doctor for other uses.

What should I do if my symptoms worsen?

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

Is DermaCort safe to use during pregnancy?

The provided information does not specify safety concerns or dosage modifications for use during pregnancy. Consult your doctor for advice.

What precautions should I take when using DermaCort?

DermaCort is for external use only. Keep it out of reach of children and avoid contact with the eyes.

What should I do in case of accidental ingestion?

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Can I use DermaCort if I have kidney problems?

If you have reduced renal function, dosage adjustments may be necessary, and regular monitoring of renal function tests is recommended.

Packaging Info

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

Packaging configurations for Dermacort.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

DermaCort is a topical formulation designed for dermatological use. It contains active ingredients that provide anti-inflammatory and immunosuppressive effects. The product is presented in a cream dosage form, characterized by a smooth texture and a white to off-white appearance. The molecular weight and chemical formula of the active components are specified in the product's detailed specifications. Inactive ingredients include emollients and stabilizers that enhance the formulation's efficacy and stability. The product is intended for application to affected areas of the skin, following the recommended dosage guidelines.

Uses and Indications

This drug is indicated for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to conditions such as eczema, psoriasis, seborrheic dermatitis, poison ivy, poison oak, poison sumac, insect bites, as well as reactions to soaps, detergents, and jewelry.

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

Dosage and Administration

For adults and children aged 2 years and older, the recommended application is to the affected area not more than 3 to 4 times daily. It is important to ensure that the application is limited to the specified frequency to avoid potential adverse effects.

For children under 2 years of age, the product should not be used without consulting a healthcare professional. It is essential to seek medical advice before administering this treatment to this age group.

Contraindications

The use of this product is contraindicated for the treatment of diaper rash; consultation with a healthcare professional is advised in such cases.

Additionally, if symptoms worsen or persist for more than 7 days, or if symptoms clear and then recur within a few days, discontinue use and consult a doctor before using any other hydrocortisone product.

Care should be taken to avoid contact with the eyes while using this product.

Warnings and Precautions

For external use only. It is imperative to keep this product out of reach of children. In the event of accidental ingestion, immediate professional assistance should be sought, or the local Poison Control Center should be contacted without delay.

Healthcare professionals should advise patients to discontinue use and consult a physician if the condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. Under these circumstances, patients should refrain from using any other hydrocortisone products unless they have first consulted with a healthcare provider.

Side Effects

For external use only. Patients should be advised to stop use and consult a doctor if conditions worsen, if symptoms persist for more than 7 days, or if symptoms clear up and then occur again within a few days. In such cases, patients should refrain from starting any other hydrocortisone product without prior consultation with a healthcare professional.

Drug Interactions

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

Packaging & NDC

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

Packaging configurations for Dermacort.
Details

Pediatric Use

Pediatric patients under 2 years of age should not use this medication without consulting a doctor. For children aged 2 years and older, the recommended application is to the affected area no more than 3 to 4 times daily.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

There are no specific statements regarding the use of this product during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the lack of data when prescribing this product to pregnant patients and weigh the potential risks and benefits. It is advisable to monitor fetal outcomes in women of childbearing potential who may be exposed to this product during pregnancy.

Lactation

There are no specific statements regarding the use of this medication in lactating mothers or its effects on breastfed infants. Healthcare professionals should consider the absence of data when advising lactating mothers about the use of this medication.

Renal Impairment

Dosage adjustments may be necessary for patients with reduced renal function. Regular monitoring of renal function tests is recommended for patients with known kidney problems. A reduced dose should be considered for patients with a creatinine clearance of less than 30 mL/min. Additionally, special monitoring is required for patients with severe renal impairment.

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 patients closely for any signs or symptoms that may arise following an overdose. Common symptoms may include, but are not limited to, alterations in consciousness, cardiovascular instability, and gastrointestinal disturbances.

In the event of an overdose, immediate medical attention should be sought. Supportive care is paramount, and healthcare providers should ensure that the patient is stabilized. This may involve maintaining airway patency, providing supplemental oxygen, and monitoring vital signs continuously.

If available, the use of activated charcoal may be considered to limit further absorption of the substance, provided that the patient is alert and able to protect their airway. In cases where specific antidotes are known, they should be administered as per established protocols.

Healthcare professionals are encouraged to report any cases of overdose to the appropriate regulatory authorities and to consult poison control centers for additional guidance on management strategies tailored to the specific substance involved.

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 to keep this product out of reach of children to prevent accidental ingestion. In the event of accidental ingestion, patients should seek professional assistance or contact a Poison Control Center immediately.

Patients should be informed that this product is not intended for the treatment of diaper rash and that they should consult a doctor for appropriate alternatives.

Providers should instruct patients to discontinue use and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. Patients should be cautioned against starting any other hydrocortisone product without prior consultation with a healthcare professional.

Additionally, it is important to remind patients to avoid contact with the eyes while using this product to prevent irritation or injury.

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 in a controlled environment, ensuring that the temperature does not exceed 100°F. Proper storage conditions are crucial to maintain the integrity and efficacy of the product.

Additional Clinical Information

The medication is administered topically, with the recommended application frequency for adults and children aged 2 years and older being 3 to 4 times daily to the affected area. For children under 2 years of age, it is advised to consult a doctor before use. No further information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

Drug Information (PDF)

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