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Dermacort

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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 2000
Label revision date
November 9, 2011
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 2000
Label revision date
November 9, 2011
Manufacturer
Melaleuca, Inc.
Registration number
part348
NDC root
54473-117
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

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

While Dermacort is effective for these specific skin issues, it's important to use it under the advice and supervision of a doctor for any other uses. This ensures that you receive the best care tailored to your individual needs.

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, seborrheic dermatitis, or reactions to poison ivy, poison oak, and poison sumac. It can also soothe itching from insect bites, soaps, detergents, and jewelry.

For any other uses, it's important to consult with your doctor to ensure it's appropriate for your situation.

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 safe and effective use.

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 medication safely. You should not use it for treating diaper rash; if you have questions about this condition, please consult your doctor. Additionally, be careful to avoid contact with your eyes, as this can lead to irritation or other issues. Always prioritize your health and seek professional advice when needed.

Side Effects

For external use only, it's important to monitor your condition while using this product. If your symptoms worsen, persist for more than 7 days, or improve only to return within a few days, you should stop using the product and consult a doctor. Additionally, do not start using any other hydrocortisone product without first speaking to your healthcare provider.

Warnings and Precautions

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

You should stop using this product and consult your doctor if your condition worsens, if symptoms last longer than 7 days, or if your symptoms improve and then return within a few days. Additionally, do not start using any other hydrocortisone product without first discussing it with your doctor.

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 reassuring to know that there are no specific warnings, precautions, or dosage changes related to the use of Dermacort Anti-Itch (hydrocortisone cream) mentioned in the drug insert. This means that, based on the available information, it is generally considered safe to use this cream during pregnancy.

However, as with any medication, it's always a good idea to consult with your healthcare provider before using it, just to ensure it’s appropriate for your individual situation. Your doctor can provide personalized advice and address any concerns you may have.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of this product while nursing. Additionally, there is no information available about whether this product is excreted in breast milk or any potential risks to your infant. Always consult with your healthcare provider if you have any concerns or questions about medications while breastfeeding.

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 make sure to do so no more than 3 to 4 times a day. Always follow these guidelines to ensure your child's safety and well-being.

Geriatric Use

While there is no specific information about the use of Dermacort Anti-Itch (hydrocortisone cream) in older adults, it's always important to approach any new medication with caution. If you or a loved one is considering using this cream, it's a good idea to consult with a healthcare provider, especially if there are existing health concerns or other medications being taken.

Since the drug insert does not mention any dosage adjustments or special precautions for elderly patients, your healthcare provider can help determine the best approach for your individual needs. Always prioritize safety and communicate any changes in health or reactions to the medication.

Renal Impairment

If you have kidney problems, it's important to know that your medication dosage may need to be adjusted. This is particularly true if your kidneys are not functioning as well as they should be. 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, you may require a lower dose of your medication. Always consult with your healthcare provider to determine the best approach for your specific situation.

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 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, even if there are no specific drug interactions or laboratory test interactions noted for your treatment. This ensures that your healthcare team can monitor your health effectively and make informed decisions about your care.

Always feel free to ask questions and share all the medications and supplements you are using. This helps to avoid any potential issues and ensures that you receive the best possible treatment tailored to your needs.

Storage and Handling

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

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 and safety. Proper storage and careful handling will help you use the product effectively and safely.

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 your child is under 2 years old, do not use this medication without consulting a doctor first. There are no additional details available regarding laboratory tests, abuse potential, or patient counseling.

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 it on children under 2 years of age without consulting a doctor.

Are there any contraindications for using Dermacort?

Do not use Dermacort for the treatment of diaper rash and avoid contact with the eyes.

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

Stop use and ask a doctor if your condition worsens, 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 or while nursing?

There are no specific pregnancy-related warnings or recommendations regarding the use of Dermacort during pregnancy or lactation.

What should I do if Dermacort is swallowed?

If Dermacort is swallowed, get medical help or contact a Poison Control Center right away.

How should Dermacort be stored?

Store Dermacort below 100°F (38°C).

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

The product is a topical corticosteroid containing hydrocortisone as the active ingredient. Its chemical name is 11β,17,21-trihydroxypregn-4-ene-3,20-dione, with a molecular formula of C21H30O5 and a molecular weight of 362.46. The formulation appears as a white to off-white cream. Inactive ingredients include cetyl alcohol, stearyl alcohol, polysorbate 60, propylene glycol, purified water, sodium phosphate dibasic, sodium phosphate monobasic, methylparaben, and propylparaben.

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.

No teratogenic or nonteratogenic effects have been reported.

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 unless directed by a healthcare professional. In such cases, consultation with a doctor is advised prior to use.

Contraindications

The product is contraindicated for the treatment of diaper rash; consultation with a healthcare professional is advised in such cases. Additionally, contact with the eyes should be avoided to prevent potential irritation or injury.

Warnings and Precautions

For external use only. It is imperative that healthcare professionals advise patients to seek emergency medical assistance immediately if the product is ingested. In such cases, contacting a Poison Control Center is strongly recommended.

Patients should be instructed to discontinue use and consult a healthcare provider if their condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. Additionally, patients should refrain from initiating the use of any other hydrocortisone products without prior consultation with a healthcare professional.

Side Effects

For external use only. Patients should be advised to stop use and consult a doctor if the condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then occur again within a few days. Additionally, patients should not begin use of any other hydrocortisone product without first consulting a doctor.

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions with laboratory tests. 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; consultation with a healthcare professional is advised. 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 use Dermacort Anti-Itch (hydrocortisone cream); however, the prescribing information does not provide specific guidance regarding geriatric use, dosage adjustments, safety concerns, or special precautions for this population.

Healthcare providers should exercise caution when prescribing this medication to geriatric patients, considering the potential for increased sensitivity to topical corticosteroids. Monitoring for adverse effects and therapeutic efficacy is recommended, as elderly patients may have altered pharmacokinetics and pharmacodynamics.

Due to the absence of specific data, clinicians are encouraged to evaluate the individual needs and health status of elderly patients when considering the use of Dermacort Anti-Itch.

Pregnancy

There are no specific pregnancy-related warnings, precautions, or dosage modifications associated with the use of Dermacort Anti-Itch (hydrocortisone cream) during pregnancy. Available data does not indicate any known risks or adverse fetal outcomes related to the use of this medication in pregnant patients. However, as with any medication, healthcare professionals should consider the potential benefits and risks when prescribing to women of childbearing potential. It is advisable to use this medication only if clearly needed and to discuss any concerns with patients regarding its use during pregnancy.

Lactation

There are no specific warnings or recommendations regarding the use of this product in nursing mothers. Additionally, there is no information available about the potential for excretion in breast milk or any associated risks to breastfed infants during the use of this product.

Renal Impairment

Dosage adjustments may be necessary for patients with reduced renal function. It is important to monitor renal function tests regularly in patients with known kidney problems. Additionally, a reduced dose should be considered for patients with a creatinine clearance of less than 30 mL/min.

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 context of overdosage, there is currently no specific information available regarding the effects or management of an overdose for this medication. Healthcare professionals are advised to monitor patients closely for any unusual symptoms or adverse reactions that may arise.

In the absence of detailed guidance, it is recommended that standard supportive measures be employed in the event of suspected overdosage. This may include symptomatic treatment and monitoring of vital signs. If necessary, healthcare providers should consider consulting a poison control center or a medical toxicologist for further assistance in managing the situation.

As always, maintaining open communication with patients and their families about the importance of adhering to prescribed dosages is essential in preventing potential overdosage scenarios.

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

Patients should be advised to keep this product out of reach of children. In the event of accidental ingestion, they should seek medical assistance or contact a Poison Control Center immediately.

It is important to inform patients that this product is not intended for the treatment of diaper rash. They should consult a healthcare provider if they have questions regarding its use for this condition.

Patients should be instructed to discontinue use and consult a healthcare provider if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. Additionally, they should not start using any other hydrocortisone product without first consulting a healthcare provider.

While using this product, patients must be cautioned to avoid contact with the eyes 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 (38°C). Proper storage conditions are crucial to maintain the integrity and efficacy of the product.

Additional Clinical Information

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

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.