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Dermfree Anti-Itch

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Active ingredient
Hydrocortisone 1 g/100 g
Other brand names
Drug class
Corticosteroid
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 2026
Label revision date
February 8, 2026
Active ingredient
Hydrocortisone 1 g/100 g
Other brand names
Drug class
Corticosteroid
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 2026
Label revision date
February 8, 2026
Manufacturer
Jiangxi Yudexi Pharmaceutical Co. , LTD
Registration number
M017
NDC root
85248-126
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

This medication is designed to temporarily relieve pain and itching caused by various skin irritations. You can use it for discomfort from insect bites, minor burns, sunburn, minor cuts, scrapes, and rashes due to poison ivy, poison oak, and poison sumac. Additionally, it helps to dry the oozing and weeping associated with these specific rashes.

By targeting these common skin issues, this medication aims to provide you with quick relief, allowing you to feel more comfortable while your skin heals.

Uses

You can use this medication to temporarily relieve pain and itching caused by various skin issues. It is effective for insect bites, minor burns, sunburn, and minor skin irritations. If you have minor cuts, scrapes, or rashes from poison ivy, poison oak, or poison sumac, this product can help soothe those symptoms as well. Additionally, it helps to dry up any oozing or weeping associated with these rashes, providing you with comfort and relief.

Dosage and Administration

When using this medication, it's important to follow the directions carefully. For adults and children aged 2 years and older, you should apply it to the affected area no more than 3 to 4 times a day. If your child is under 2 years old, make sure to consult a doctor before using the medication.

Always remember not to exceed the recommended amount. Applying it more frequently than directed can lead to unwanted side effects. By sticking to these guidelines, you can help ensure safe and effective use of the medication.

What to Avoid

It's important to use this medication safely. You should not apply it to large areas of your body, as this can increase the risk of side effects. Additionally, avoid using it alongside any other products that contain diphenhydramine, including those taken by mouth, to prevent potential complications.

By following these guidelines, you can help ensure that you use the medication effectively and safely. If you have any questions or concerns, please consult your healthcare provider for more information.

Side Effects

For your safety, this product is intended for external use only. If your condition worsens or does not improve within 15 days, or if symptoms persist for more than 15 days or return shortly after clearing up, you should stop using the product and consult your doctor.

It's also important to talk to your doctor if you have chicken pox or measles before using this product.

Warnings and Precautions

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

You should stop using this product and call your doctor if your condition worsens or does not improve within 15 days. Additionally, if your symptoms last for more than 15 days or improve only to return within a few days, it's important to reach out to your healthcare provider.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, it's always important to be aware of the potential risks associated with taking any medication. If you suspect that you or someone else may have taken too much of a medication, look out for unusual symptoms such as extreme drowsiness, confusion, or difficulty breathing.

In the event of an overdose, it is crucial to seek immediate medical help. You can do this by calling your local emergency number or going to the nearest hospital. Always keep the medication packaging on hand, as it can provide important information to healthcare professionals. Remember, when in doubt, it's better to err on the side of caution and get help.

Pregnancy Use

When it comes to using this medication during pregnancy, there is currently no specific information available about its safety, recommended dosage adjustments, or any special precautions you should take. This means that if you are pregnant or planning to become pregnant, it’s important to discuss your options with your healthcare provider. They can help you weigh the potential risks and benefits based on your individual situation. Always prioritize open communication with your doctor to ensure the best care for you and your baby.

Lactation Use

When it comes to breastfeeding, there is currently no specific information available regarding the use of this medication for nursing mothers. This means that if you are breastfeeding, it's important to consult with your healthcare provider to discuss any potential risks or effects on your milk production or your baby. Always prioritize open communication with your doctor to ensure the best outcomes for both you and your child.

Pediatric Use

If your child is under 2 years old, it's important to consult a doctor before using this medication. 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 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 or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you.

Always feel free to ask questions and share your complete list of medications and any tests you might be undergoing. This way, you can receive the best possible care tailored to your needs.

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, away from excessive heat—ideally, below 40°C (104°F). This will help maintain its quality and performance.

When handling the product, always do so with care to avoid any damage. If there are specific components included with the product, make sure to follow any additional instructions provided for their use and safety. Proper disposal methods should also be followed to ensure safety and compliance with local regulations.

Additional Information

You should apply the medication to the affected area no more than 3 to 4 times daily 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.

In case the medication is swallowed, seek medical help or contact a Poison Control Center immediately for assistance.

FAQ

What conditions does this drug temporarily relieve?

This drug temporarily relieves pain and itching associated with insect bites, minor burns, sunburn, minor skin irritations, minor cuts, scrapes, and rashes due to poison ivy, poison oak, and poison sumac.

How should I apply this drug?

For adults and children 2 years of age and older, apply to the affected area not more than 3 to 4 times daily. Children under 2 years of age should consult a doctor before use.

Are there any contraindications for using this drug?

Do not use this drug on large areas of the body or with any other product containing diphenhydramine, even if taken by mouth.

What should I do if my condition worsens?

Stop use if your condition worsens or does not improve within 15 days, or if symptoms persist for more than 15 days or clear up and occur again within a few days.

Is this drug safe for use during pregnancy?

There is no specific information regarding the safety of this drug during pregnancy.

What should I do if I accidentally swallow this drug?

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

Is this drug for external use only?

Yes, this drug is for external use only.

Packaging Info

Below are the non-prescription pack sizes of Dermfree Anti-Itch (hydrocortisone1% anti-itch). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Dermfree Anti-Itch.
Details

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the temporary relief of pain and itching associated with various dermatological conditions, including insect bites, minor burns, sunburn, minor skin irritations, minor cuts, scrapes, and rashes due to poison ivy, poison oak, and poison sumac. Additionally, it is effective in drying the oozing and weeping associated with rashes from poison ivy, poison oak, and poison sumac.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Healthcare professionals are advised to administer the medication as follows:

For adults and children aged 2 years and older, the medication should be applied to the affected area no more than 3 to 4 times daily. It is imperative to adhere to the recommended frequency and not exceed the directed dosage.

For children under 2 years of age, it is essential to consult a physician prior to use to ensure safety and appropriateness of treatment.

Contraindications

Use of this product is contraindicated in the following situations:

The product should not be applied to large areas of the body due to the potential for systemic absorption and associated adverse effects. Additionally, concurrent use with any other product containing diphenhydramine, including oral formulations, is contraindicated to avoid the risk of overdose and increased side effects.

Warnings and Precautions

For external use only. This product is not intended for ingestion. In the event of accidental swallowing, it is imperative to seek medical assistance immediately or contact a Poison Control Center.

Healthcare professionals should advise patients to discontinue use and consult a physician if the condition worsens or fails to improve within 15 days. Additionally, if symptoms persist for more than 15 days or if there is a recurrence of symptoms after they have resolved, patients should be instructed to seek medical advice promptly. Monitoring for these conditions is essential to ensure patient safety and effective treatment outcomes.

Side Effects

For external use only. Patients are advised to discontinue use if the condition worsens or does not improve within 15 days. Additionally, if symptoms persist for more than 15 days or clear up and then recur within a few days, patients should stop using the product.

Patients should consult a doctor if they have chicken pox or measles prior to using this product.

Drug Interactions

There are currently no documented drug interactions associated with the use of this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Dermfree Anti-Itch (hydrocortisone1% anti-itch). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Dermfree Anti-Itch.
Details

Pediatric Use

Pediatric patients under 2 years of age should consult a healthcare professional before use. 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

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

There is no specific information available regarding the use of this drug during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients. It is advisable to weigh the potential benefits against any unknown risks to fetal outcomes. Women of childbearing potential should be counseled on the importance of effective contraception during treatment and the need to inform their healthcare provider if they become pregnant or plan to become pregnant while using this medication.

Lactation

There is no specific information available regarding the use of this medication in nursing mothers or its effects during lactation. Healthcare professionals should consider the lack of data when advising lactating mothers about the use of this medication. It is recommended to weigh the potential benefits against any unknown risks to breastfed infants.

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 clinical trials for this medication. Consequently, there is no available information regarding dosage adjustments, special monitoring requirements, or precautions 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 warranted based on clinical judgment.

Overdosage

There is currently no specific information available regarding overdosage for this medication. In the absence of documented overdosage data, healthcare professionals are advised to exercise caution and monitor patients closely for any unusual symptoms or adverse effects that may arise following administration.

In the event of suspected overdosage, it is recommended that healthcare providers initiate supportive care and symptomatic treatment as necessary. Continuous monitoring of vital signs and clinical status is essential. If symptoms of overdosage are observed, appropriate interventions should be implemented based on the patient's condition.

Healthcare professionals should also consider contacting a poison control center or a medical toxicologist for guidance on management strategies tailored to the specific situation.

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 question. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Patients should be advised to seek immediate medical assistance or contact a Poison Control Center if the product is swallowed. It is important to inform patients that the product should not be applied to large areas of the body. They should also be cautioned against using this product in conjunction with any other medications containing diphenhydramine, including those taken orally.

Patients must be instructed to discontinue use if their condition worsens or does not show improvement within 15 days. Additionally, they should stop using the product if symptoms persist for more than 15 days or if symptoms resolve and then recur within a few days.

While using the product, patients should be reminded to avoid contact with their eyes. Furthermore, it is essential to encourage patients to consult a healthcare provider if they have chicken pox or measles before using the product.

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 manner that protects it from excessive heat, ensuring that the temperature does not exceed 40°C (104°F). Proper storage conditions are crucial to maintain the integrity and efficacy of the product.

Additional Clinical Information

Patients aged 2 years and older are advised to apply the medication to the affected area no more than 3 to 4 times daily. For children under 2 years of age, it is recommended to consult a doctor prior to use. Clinicians should inform patients that if the medication is swallowed, they should seek medical assistance or contact a Poison Control Center immediately.

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 Dermfree Anti-Itch, 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.