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Dermarest

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Active ingredient
Hydrocortisone 10 mg/1 mL
Other brand names
Drug class
Corticosteroid
Dosage form
Lotion
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
October 25, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Hydrocortisone 10 mg/1 mL
Other brand names
Drug class
Corticosteroid
Dosage form
Lotion
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
October 25, 2024
Manufacturer
Insight Pharmaceuticals LLC
Registration number
M017
NDC root
63736-339
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

Dermarest® is a medicated lotion specifically designed to provide temporary relief from itching associated with minor skin irritations, inflammation, and rashes due to eczema (a condition that causes the skin to become inflamed and itchy). The active ingredient in Dermarest® is hydrocortisone 1%, which helps to reduce inflammation and soothe the skin.

This anti-itch lotion comes in a 4 FL OZ (118 mL) bottle and is intended for use when you experience discomfort from these skin conditions. It's important to use this product as directed, and for any other uses, you should consult with a doctor.

Uses

This product is designed to provide temporary relief from itching caused by minor skin irritations, inflammation, and rashes associated with eczema. If you're experiencing any of these issues, this treatment may help soothe your discomfort.

It's important to note that any other uses of this product should be discussed with your doctor to ensure safety and effectiveness. Always follow your healthcare provider's advice when using medications.

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 be aware of certain guidelines when using this medication. You should not use it for treating diaper rash, as it is not intended for that purpose. Additionally, if you are considering starting any other hydrocortisone product, make sure to consult your doctor first to ensure it's safe for you.

While there are no specific contraindications or concerns about abuse, misuse, or dependence associated with this medication, following these instructions will help you use it safely and effectively. Always prioritize your health by seeking professional advice when needed.

Side Effects

When using this product, it's important to remember that it is for external use only and should not be applied to diaper rash. Avoid getting the product in your eyes. If your condition worsens, persists for more than 7 days, or if symptoms clear up and then return within a few days, stop using the product and consult a doctor.

Keep this product out of reach of children. If swallowed, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

Warnings and Precautions

This product is for external use only, so please avoid applying it to your eyes or using it for diaper rash. While using this product, if your condition worsens, persists for more than 7 days, or clears up only to return within a few days, stop using it and consult your doctor. Additionally, do not start any other hydrocortisone product without first talking to your healthcare provider.

Keep this product out of reach of children. If a child accidentally swallows it, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

Overdose

If you or someone else has swallowed too much of a medication, it’s important to act quickly. You should seek medical help immediately or contact a Poison Control Center at 1-800-222-1222. They can provide guidance on what to do next.

Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms, don’t hesitate to get help right away. Remember, it’s always better to be safe and seek assistance if you suspect an overdose.

Pregnancy Use

If you are pregnant or planning to become pregnant, it is important to consult your doctor before using this product. You should not use it during pregnancy unless your doctor specifically directs you to do so. Always prioritize your health and the health of your baby by seeking professional medical advice.

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 2 years old or older, you can apply the medication to the affected area up to 3 to 4 times a day. However, if your child is under 2 years old, it’s important not to use this medication without first consulting a doctor. Always ensure you follow these guidelines to keep your child safe and healthy.

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 be adjusted 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 changes to your medications.

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 talk to your healthcare provider before starting any other hydrocortisone product. Mixing medications can lead to unexpected interactions that may affect how well they work or increase the risk of side effects. Your doctor can help ensure that any new treatments are safe and appropriate for your health needs. Always prioritize open communication about your medications to maintain your well-being.

Storage and Handling

To ensure the best performance of your product, make sure to shake it well before use. It's important to store it at room temperature, ideally between 15° and 25°C (59° and 77°F). Keeping it within this temperature range helps maintain its effectiveness and safety.

When handling the product, always do so with care to avoid contamination. Following these simple storage and handling guidelines will help you use the product safely and effectively.

Additional Information

No further information is available.

FAQ

What is Dermarest®?

Dermarest® is an eczema medicated lotion that contains hydrocortisone 1% as its active ingredient.

What is Dermarest® used for?

It provides temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to eczema.

How should I use Dermarest®?

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 in children under 2 years of age without consulting a doctor.

Are there any contraindications for using Dermarest®?

No specific contraindications are mentioned, but do not use it for the treatment of diaper rash.

What should I do if my condition worsens while using Dermarest®?

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

Can I use Dermarest® during pregnancy?

Do not use Dermarest® in pregnancy unless directed by a doctor. Consult your doctor if you are pregnant or planning to become pregnant before using this product.

Is Dermarest® safe for nursing mothers?

There are no specific warnings or recommendations regarding the use of Dermarest® by nursing mothers.

What should I do if Dermarest® is swallowed?

Keep Dermarest® out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

What are the storage instructions for Dermarest®?

Store Dermarest® at room temperature between 15° - 25°C (59°- 77°F) and shake well before use.

Packaging Info

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

Packaging configurations for Dermarest.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Dermarest® is a medicated lotion indicated for the treatment of eczema. The formulation contains hydrocortisone at a concentration of 1%, serving as an anti-itch agent. The product is available in a volume of 4 fluid ounces (118 mL).

Uses and Indications

This drug is indicated for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to eczema.

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

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 product is contraindicated for the treatment of diaper rash. Additionally, the initiation of any other hydrocortisone product should only occur after consultation with a healthcare professional.

Warnings and Precautions

For external use only. This product is not intended for the treatment of diaper rash.

When using this product, it is imperative to avoid contact with the eyes. In the event that the condition worsens, symptoms persist for more than 7 days, or symptoms resolve and then recur within a few days, the user should discontinue use and consult a healthcare professional. Additionally, it is advised not to initiate the use of any other hydrocortisone product without prior consultation with a doctor.

This product should be kept out of reach of children. In the case of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center (1-800-222-1222) should be contacted without delay.

Side Effects

Patients should be aware that this product is for external use only and is not intended for the treatment of diaper rash. Caution is advised to prevent contact with the eyes during application.

In the event that the condition worsens, symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days, patients are advised to stop use and consult a healthcare professional.

It is important to keep this product out of reach of children. If swallowed, immediate medical assistance should be sought, or the Poison Control Center (1-800-222-1222) should be contacted without delay.

Drug Interactions

The use of hydrocortisone in conjunction with other hydrocortisone products should be approached with caution. It is imperative that patients do not initiate the use of any additional hydrocortisone formulations without prior consultation with a healthcare professional. This precaution is necessary to avoid potential adverse effects associated with excessive corticosteroid exposure, which may lead to increased risk of systemic side effects or exacerbation of existing conditions.

Healthcare providers should evaluate the necessity of concurrent hydrocortisone therapy and consider appropriate monitoring for any signs of corticosteroid-related complications.

Packaging & NDC

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

Packaging configurations for Dermarest.
Details

Pediatric Use

Pediatric patients aged 2 years and older may apply the medication to the affected area no more than 3 to 4 times daily. For children under 2 years of age, the use of this medication is not recommended; consultation with a healthcare professional is advised.

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

Pregnant patients should not use this product unless directed by a healthcare professional. It is essential for women who are pregnant or planning to become pregnant to consult their doctor prior to using this product. The potential risks and benefits must be carefully evaluated in the context of individual circumstances.

Lactation

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

Renal Impairment

Patients with renal impairment may not have specific dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. Therefore, healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the lack of detailed guidance necessitates careful clinical judgment and individualized patient assessment. Regular monitoring of renal function is advisable to ensure patient safety and therapeutic efficacy.

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 medical assistance is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical help without delay. It is recommended to contact a Poison Control Center at 1-800-222-1222 for expert guidance on managing the situation.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Healthcare providers should be prepared to assess the patient's condition and implement appropriate management strategies based on the severity of symptoms and the specific substance involved.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

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. Instruct patients that if the product is swallowed, they should seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

It is important to inform patients that this product is not intended for the treatment of diaper rash. Patients should be counseled to stop using the product 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.

Additionally, healthcare providers should emphasize that patients should not begin the use of any other hydrocortisone product without first consulting a doctor. 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 a configuration that requires shaking well before use. It should be stored at room temperature, specifically within the range of 15° to 25°C (59° to 77°F). Proper handling and storage conditions are essential to maintain the product's integrity and efficacy.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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