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Barmicil Plus

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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 2020
Label revision date
December 3, 2024
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 2020
Label revision date
December 3, 2024
Manufacturer
OPMX LLC
Registration number
M017
NDC root
69729-103
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

Barmicil plus is a topical cream that contains 1% hydrocortisone, which is a type of medication used to relieve itching and discomfort associated with minor skin irritations, inflammation, and rashes. This cream is particularly helpful for conditions such as eczema, seborrheic dermatitis, psoriasis, insect bites, and reactions to plants like poison ivy, poison oak, and poison sumac.

In addition to these uses, Barmicil plus can provide temporary relief for external anal and genital itching. It's important to use this product as directed, and for any other uses, you should consult with a doctor for guidance.

Uses

This product is designed to provide temporary relief from itching caused by various minor skin irritations, including conditions like eczema, seborrheic dermatitis, and psoriasis. It can also help soothe itching from insect bites and reactions to plants such as poison ivy, poison oak, and poison sumac. Additionally, if you experience irritation from cosmetics, jewelry, detergents, or soaps, this product may offer relief.

You can also use it to temporarily relieve itching in external anal and genital areas. However, for any other uses, it's important to consult with your doctor for guidance and supervision.

Dosage and Administration

If you are an adult or a child aged 2 years and older, you can apply the medication to the affected area up to 3 to 4 times a day. For children under 2 years old, it’s important to consult a doctor before use.

If you are dealing with external anal itching, start by gently cleaning the area with mild soap and warm water, then rinse thoroughly. Alternatively, you can use a suitable cleansing pad to clean the area. After cleaning, make sure to dry the area gently by patting or blotting it with toilet tissue or a soft cloth before applying the medication. If the patient is a child under 12 years, please consult a doctor for guidance.

What to Avoid

It's important to be aware of specific instructions regarding the use of this medication. If you accidentally swallow it, seek medical help immediately or contact the Poison Control Center. This is crucial for your safety.

Currently, there are no listed contraindications, controlled substance classifications, or concerns about abuse, misuse, or dependence associated with this medication. However, always follow the guidance provided by your healthcare professional to ensure safe use.

Side Effects

When using this product, it's important to remember that it is for external use only. You should not use it for treating diaper rash, external genital itching if you have vaginal discharge, or external anal itching if you experience rectal bleeding—consult a doctor in these cases. Avoid getting the product in your eyes, and do not exceed the recommended amount for external anal itching unless directed by a doctor.

If your condition worsens, or if symptoms persist for more than 7 days or improve and then return within a few days, stop using the product and consult a doctor. Additionally, do not use any other hydroquinone products without medical advice.

Warnings and Precautions

This product is for external use only, so please avoid using it on areas like diaper rashes or for external genital itching if you have vaginal discharge. If you experience rectal bleeding while using it for anal itching, seek medical attention immediately. Be careful not to get the product in your eyes, and do not use it more than directed unless your doctor advises otherwise. Also, avoid inserting it into the rectum with fingers or any devices.

If your condition worsens, or if symptoms persist for more than 7 days or return shortly after improvement, stop using the product and consult your doctor. It's important not to start any other hydroquinone products without guidance. In case of accidental swallowing, seek emergency medical help or contact Poison Control Center right away.

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 signs of overdose for this medication, general symptoms can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these signs, or if you are unsure, seek medical help right away.

In case of an overdose, contact your local emergency services or go to the nearest hospital. It's always better to be safe and get checked by a healthcare professional if you have any concerns about your health.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that there are no specific statements about the use of BARMICIL PLUS (hydrocortisone cream) during pregnancy. The information available does not mention any safety concerns, contraindications (situations where the product should not be used), or special precautions for pregnant individuals. Additionally, there are no recommended dosage modifications for those who are pregnant.

As always, it's best to consult with your healthcare provider before using any medication during pregnancy to ensure it is safe for you and your baby.

Lactation Use

If you are breastfeeding, you can use BARMICIL PLUS hydrocortisone cream without specific warnings or recommendations against it. The information available does not indicate any particular precautions or considerations for nursing mothers.

However, as with any medication, it's always a good idea to consult with your healthcare provider if you have any concerns about its use while breastfeeding. They can provide personalized advice based on your situation.

Pediatric Use

When using this medication for children aged 2 years and older, you can apply it to the affected area no more than 3 to 4 times a day. However, if your child is under 2 years old, it's important to consult a doctor before use. Additionally, if your child is under 12 years old and experiencing external anal itching, you should also seek advice from a doctor. Always prioritize your child's safety and well-being by following these guidelines.

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, it’s important to consult with a healthcare provider for personalized advice. They can help determine the best approach to using this medication safely and effectively, taking into account any unique health needs or conditions that may be present. Always prioritize open communication with your healthcare team to ensure the best outcomes.

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 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. In this case, there are no specific drug interactions or laboratory test interactions noted, which means that this medication is generally considered safe to use alongside other treatments and tests. However, every individual is different, and your healthcare provider can help ensure that your overall treatment plan is safe and effective for you. Always feel free to ask questions or express any concerns you may have regarding your medications or tests.

Storage and Handling

To ensure the best performance of your product, store it at a temperature between 20°C to 25°C (68°F to 77°F). This temperature range helps maintain the integrity and effectiveness of the device.

When handling the product, be sure to do so with clean hands and in a sterile field (a clean area free from germs) to prevent contamination. Always follow any specific disposal instructions provided to ensure safe and responsible disposal of any components.

Additional Information

For adults and children aged 2 years and older, you can apply the medication to the affected area up to 3 to 4 times a day. If you are treating external anal itching, it's best to first cleanse the area with mild soap and warm water, rinse thoroughly, and then gently dry it before applying the medication. If your child is under 2 years old or if you have any questions about treating children under 12, consult a doctor for guidance.

FAQ

What is Barmicil Plus?

Barmicil Plus is a 1% hydrocortisone anti-itch cream that contains aloe vera.

What conditions does Barmicil Plus treat?

It is indicated for the temporary relief of itching associated with eczema, seborrheic dermatitis, psoriasis, insect bites, poison ivy, poison oak, poison sumac, and reactions to cosmetics, jewelry, detergents, and soaps.

How should I use Barmicil Plus?

Adults and children 2 years and over should apply it to the affected area not more than 3 to 4 times daily. For children under 2 years, consult a doctor.

Are there any warnings for using Barmicil Plus?

Yes, it is for external use only. Do not use for diaper rash, external genital itching with vaginal discharge, or if rectal bleeding occurs. Avoid contact with eyes.

What should I do if I swallow Barmicil Plus?

If swallowed, get medical help or contact Poison Control Center immediately.

Can I use Barmicil Plus during pregnancy?

The insert does not provide specific information regarding the use of Barmicil Plus during pregnancy.

Is Barmicil Plus safe for nursing mothers?

There are no specific warnings or recommendations regarding the use of Barmicil Plus in nursing mothers mentioned in the insert.

What should I do if my condition worsens while using Barmicil Plus?

Stop use and consult a doctor if your condition worsens, if symptoms last more than 7 days, or if they clear up and occur again within a few days.

How should I store Barmicil Plus?

Store Barmicil Plus at a temperature between 20°C to 25°C (68°F to 77°F).

Packaging Info

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

Packaging configurations for Barmicil Plus.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Barmicil Plus is a topical formulation containing 1% hydrocortisone, designed for anti-itch relief. The cream is enhanced with Aloe Vera, known for its soothing properties. Each container has a net weight of 1 oz (28 g).

Uses and Indications

This drug is indicated for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to various conditions, including eczema, seborrheic dermatitis, psoriasis, insect bites, and contact with poison ivy, poison oak, or poison sumac. It is also effective for itching caused by cosmetics, jewelry, detergents, and soaps.

Additionally, this drug provides temporary relief of external anal and genital itching. 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. For children under 2 years of age, it is advised to consult a physician prior to use.

In cases of external anal itching in adults, it is recommended that, when practical, the affected area be cleansed with mild soap and warm water, followed by thorough rinsing. Alternatively, the area may be cleansed by patting or blotting with an appropriate cleansing pad. After cleansing, the area should be gently dried by patting or blotting with toilet tissue or a soft cloth before the application of the product.

For external anal itching in children under 12 years, consultation with a physician is also recommended prior to use.

Contraindications

There are no specific contraindications listed for this product. However, it is advised that if the product is swallowed, medical assistance should be sought immediately or the Poison Control Center should be contacted.

Warnings and Precautions

For external use only. This product is contraindicated for the treatment of diaper rash; patients should consult a doctor before use. It is also not recommended for external genital itching in the presence of vaginal discharge or for external anal itching if rectal bleeding occurs; in these cases, prompt medical consultation is advised.

When using this product, it is imperative to avoid contact with the eyes. For external anal itching, the product should not be used in excess of the directed dosage unless specifically instructed by a healthcare professional. Additionally, the product must not be inserted into the rectum using fingers, mechanical devices, or applicators.

Patients should discontinue use and contact their healthcare provider if the condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. It is advised not to initiate the use of any other hydroquinone product during this time.

In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

Side Effects

Patients using this product should be aware that it is intended for external use only. It is contraindicated for the treatment of diaper rash; patients are advised to consult a doctor if such a condition is present. Additionally, the product should not be used for external genital itching if there is a vaginal discharge, or for external anal itching if rectal bleeding occurs; in these cases, prompt consultation with a healthcare professional is recommended.

While using this product, patients must take care to avoid contact with the eyes. For those experiencing external anal itching, it is crucial not to exceed the directed dosage unless specifically instructed by a doctor. Furthermore, patients should not insert the product into the rectum using fingers or any mechanical device or applicator.

Patients are advised to discontinue use and seek medical advice if their condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. It is also important to refrain from using any other hydroquinone products during this time.

Drug Interactions

No specific drug interactions have been identified for this medication. Additionally, there are no reported interactions with laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

Packaging & NDC

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

Packaging configurations for Barmicil Plus.
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, it is advised to consult a doctor prior to use. Additionally, for external anal itching in children under 12 years, a doctor's consultation is recommended.

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 are no specific statements regarding the use of BARMICIL PLUS (hydrocortisone cream) during pregnancy. The prescribing information does not mention any safety concerns, contraindications, or special precautions related to the use of this product in pregnant patients. Additionally, no dosage modifications for pregnant individuals are provided. Healthcare professionals should consider the absence of data when advising women of childbearing potential regarding the use of this product during pregnancy.

Lactation

There are no specific warnings or recommendations regarding the use of BARMICIL PLUS hydrocortisone cream in lactating mothers. Additionally, the insert does not provide any specific considerations or precautions related to lactation. Therefore, healthcare professionals may consider the use of this medication in nursing mothers without specific concerns related to breastfeeding.

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 absence 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 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 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 monitoring vital signs, providing symptomatic treatment, and ensuring the patient's safety.

If available, consultation with a poison control center or a medical toxicologist is recommended to guide the management of the overdose effectively.

Documentation of the incident, including the substance involved, the amount taken, and the time of ingestion, is crucial for appropriate treatment 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 for SPL code 90375-7.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. In the event that the medication is swallowed, patients should be instructed to seek medical help immediately or contact the Poison Control Center for guidance. It is essential for patients to understand the importance of these precautions to ensure their safety and the safety of others.

Storage and Handling

The product is supplied in accordance with the following specifications. It should be stored at a controlled room temperature of 20°C to 25°C (68°F to 77°F). Proper storage conditions are essential to maintain the integrity and efficacy of the product.

Additional Clinical Information

For adults and children aged 2 years and older, the product should be applied to the affected area no more than 3 to 4 times daily. For children under 2 years, it is advised to consult a doctor prior to use. In cases of external anal itching in adults, it is recommended to cleanse the affected area with mild soap and warm water, rinsing thoroughly, or by using an appropriate cleansing pad. The area should be gently dried by patting or blotting with toilet tissue or a soft cloth before application. For external anal itching in children under 12 years, consultation with a doctor is also recommended.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Barmicil Plus, 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 Barmicil Plus, 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.