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Hemorrodil Unguento Plus

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This product has been discontinued

Active ingredient
Hydrocortisone 10 mg/1 g
Other brand names
Dosage form
Ointment
Route
Rectal
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 1964
Label revision date
March 11, 2014
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Hydrocortisone 10 mg/1 g
Other brand names
Dosage form
Ointment
Route
Rectal
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 1964
Label revision date
March 11, 2014
Manufacturer
ZURICH MEDICAL LABS, LLC
NDC root
61357-132
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

HEMORRODIL Plus is a topical ointment designed to provide temporary relief from pain and itching associated with external anal itch and minor skin irritations and rashes. It contains hydrocortisone (a type of medication that helps reduce inflammation), which helps soothe discomfort in the affected area. This ointment is typically used for managing symptoms related to hemorrhoids and other minor skin issues.

Uses

You can use this medication for the temporary relief of external anal itching and to soothe minor skin irritations and rashes. It’s designed to help alleviate discomfort in these areas, providing you with some much-needed relief.

Rest assured, there are no known teratogenic effects (which means it doesn’t cause birth defects) associated with this medication, making it a safer option for those concerned about such risks.

Dosage and Administration

If you are 12 years old or 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.

If you are caring for a child under 12, 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 patients.

What to Avoid

It's important to use this medication safely. You should not use it for treating diaper rash; always consult a doctor for appropriate advice. If you experience any bleeding, if your condition worsens, or if symptoms persist for more than 7 days or return after clearing up, stop using the product and consult your doctor.

Additionally, avoid contact with your eyes, do not exceed the recommended daily dosage unless directed by a doctor, and never insert the medication into the rectum using fingers or any device. Always seek medical guidance before starting any other hydrocortisone product.

Side Effects

When using this product, it's important to be aware of some potential side effects. You should stop using it and consult a doctor if you experience any bleeding, if your condition worsens, or if your symptoms last more than 7 days or return after clearing up. Additionally, avoid contact with your eyes and do not exceed the recommended dosage unless directed by a healthcare professional.

This product is for external use only and should not be used for treating diaper rash. Keep it out of reach of children, and if swallowed, seek medical help immediately. Always 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 diaper rashes without consulting a doctor first. When applying, be careful not to get it in your eyes, and do not exceed the recommended daily dosage unless your doctor advises you to. It's important not to insert the product into the rectum using fingers or any devices.

If you notice any bleeding, if your condition worsens, or if your symptoms last more than 7 days or return after clearing up, stop using the product and contact your doctor. Additionally, keep this product out of reach of children. If it is swallowed, seek medical help or contact a Poison Control Center immediately.

Overdose

If you or someone else has swallowed too much of a medication, it’s important to seek medical help immediately. You can do this by contacting a Poison Control Center or going to the nearest emergency room. Acting quickly can make a significant difference in the outcome.

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 get checked by a professional if you suspect an overdose has occurred.

Pregnancy Use

When considering the use of Hemorrodil Unguento Plus (hydrocortisone ointment) during pregnancy, it's important to note that the drug insert does not provide specific information about its safety, dosage adjustments, or any special precautions for pregnant individuals. This means that there are no established guidelines or known risks associated with its use in pregnancy.

If you are pregnant or planning to become pregnant, it is always best to consult with your healthcare provider before using any medication, including over-the-counter products like this ointment. They can help you weigh the potential benefits and risks based on your individual health needs.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to consult your doctor before using this product. There is a possibility that it may be excreted in breast milk, which means it could potentially affect your nursing infant. Additionally, the safety of this product during lactation has not been established, so discussing your options with a healthcare professional is crucial to ensure the well-being of both you and your baby.

Pediatric Use

If you are considering this medication for your child, it's important to know that it is not recommended for children under 12 years of age. If your child is younger than this, please consult a doctor for advice on appropriate treatment options. Always prioritize your child's safety and well-being by seeking professional guidance when it comes to their health.

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 is safe and effective, especially if you have any concerns about your kidney health. They can provide the necessary guidance based on your individual 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 talk to your healthcare provider before starting any new hydrocortisone product. Using another hydrocortisone product without consulting a doctor can lead to complications or reduce the effectiveness of your treatment.

While there are no specific interactions with other drugs or lab tests mentioned, keeping your healthcare provider informed about all medications and tests you are undergoing is essential for your safety and well-being. Always prioritize open communication with your healthcare team to ensure the best care possible.

Storage and Handling

To ensure the best performance of your product, store it at room temperature or in a cool place, making sure it does not exceed 80°F (about 27°C). This helps maintain its effectiveness and safety.

When handling the product, always do so with clean hands and in a clean environment to avoid contamination. If you have any specific disposal instructions, be sure to follow them carefully to ensure safety and compliance.

Additional Information

You should apply the medication rectally to the affected area, and it can be used up to 3 to 4 times a day for both adults and children aged 12 years and older. There are no additional details available regarding laboratory tests, abuse potential, or patient counseling.

FAQ

What is HEMORRODIL Plus used for?

HEMORRODIL Plus is used for the temporary relief of external anal itch and minor skin irritations and rashes.

How should I use HEMORRODIL Plus?

For adults and children 12 years and older, apply to the affected area not more than 3 to 4 times daily. Children under 12 years should not use it without consulting a doctor.

Are there any contraindications for using HEMORRODIL Plus?

Do not use HEMORRODIL Plus for the treatment of diaper rash. Consult a doctor if you have any concerns.

What should I do if I experience side effects?

Stop use and ask a doctor if bleeding occurs, the condition worsens, or symptoms persist for more than 7 days or return after clearing up.

Can I use HEMORRODIL Plus while pregnant or breastfeeding?

Consult a doctor before using HEMORRODIL Plus if you are pregnant or nursing, as the safety during these periods has not been established.

What precautions should I take when using HEMORRODIL Plus?

Avoid contact with eyes, do not exceed the recommended dosage, and do not insert it into the rectum using fingers or any device.

How should I store HEMORRODIL Plus?

Store HEMORRODIL Plus at room temperature or in a cool place, but not over 80°F.

Packaging Info

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

Packaging configurations for Hemorrodil Unguento Plus.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

HEMORRODIL Plus is a hemorrhoidal ointment formulated with hydrocortisone at a concentration of 1%. This product is indicated for the relief of pain and itch associated with hemorrhoidal conditions. The net weight of the ointment is 15 grams.

Uses and Indications

This drug is indicated for the temporary relief of external anal itch, as well as minor skin irritations and rashes.

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

Dosage and Administration

For adults and children aged 12 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 performed with clean hands and that the affected area is clean and dry prior to application.

For children under 12 years of age, the use of this medication is not recommended without consulting a healthcare professional.

Contraindications

The product is contraindicated for the treatment of diaper rash; consultation with a doctor is advised in such cases.

Additionally, the following precautions should be observed:

  • Discontinue use and consult a doctor if bleeding occurs, if the condition worsens, or if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days.

  • Avoid contact with eyes.

  • Do not exceed the recommended daily dosage unless directed by a doctor.

  • The product should not be administered rectally using fingers or any mechanical device or applicator.

Warnings and Precautions

This product is intended for external use only and is not suitable for the treatment of diaper rash. Healthcare professionals should advise patients to consult a doctor for appropriate alternatives in such cases.

When utilizing this product, it is imperative to avoid contact with the eyes. Patients should be instructed not to exceed the recommended daily dosage unless specifically directed by a healthcare provider. Additionally, the product should not be administered rectally using fingers, mechanical devices, or applicators.

Patients must be advised to discontinue use and seek medical advice if any of the following occur: bleeding, worsening of the condition, or if symptoms persist for more than 7 days. If symptoms resolve and then recur within a few days, consultation with a healthcare professional is also recommended. It is crucial that patients do not initiate the use of any other hydrocortisone products without prior consultation with a doctor.

To ensure safety, this product should be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center should be made without delay.

Side Effects

Patients using this product should be aware of several important warnings and precautions. This product is intended for external use only and should not be used for the treatment of diaper rash without consulting a doctor.

While using this product, patients are advised to avoid contact with the eyes and to adhere strictly to the recommended daily dosage unless directed otherwise by a healthcare professional. It is also important to refrain from inserting the product into the rectum using fingers or any mechanical device or applicator.

Patients should discontinue use and seek medical advice if any of the following occur: bleeding, worsening of the condition, or if symptoms persist for more than 7 days or resolve only to recur within a few days. Additionally, patients should not initiate the use of any other hydrocortisone product without prior consultation with a healthcare provider.

To ensure safety, this product should be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought or contact with a Poison Control Center should be made.

Drug Interactions

The initiation of any additional hydrocortisone product should only occur after consultation with a healthcare professional. This precaution is essential to avoid potential adverse effects or interactions that may arise from concurrent use.

No specific drug or laboratory test interactions have been identified in the available data. Therefore, routine monitoring or dosage adjustments related to drug interactions are not indicated at this time.

Packaging & NDC

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

Packaging configurations for Hemorrodil Unguento Plus.
Details

Pediatric Use

Pediatric patients under 12 years of age should not use this medication without consulting a healthcare professional. The safety and efficacy of this treatment have not been established in this age group, and appropriate dosing guidelines are not available. It is essential for healthcare providers to evaluate the risks and benefits before prescribing this medication to pediatric patients.

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.

Pregnancy

There are no specific statements regarding the use of Hemorrodil Unguento Plus (hydrocortisone ointment) 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. As with any medication, the potential benefits must be weighed against any unknown risks to fetal outcomes. Women of childbearing potential should be counseled on the importance of discussing any medications with their healthcare provider prior to use during pregnancy.

Lactation

Lactating mothers are advised to consult a healthcare professional prior to using this product. There is a potential for excretion of the product in breast milk, and the safety of its use during lactation has not been established. Therefore, careful consideration and professional guidance are recommended for nursing mothers.

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 relation to this medication. Consequently, there are no established 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 prudent in these cases, although specific parameters are not defined in the prescribing 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 or contact a Poison Control Center without delay.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved; therefore, a thorough assessment by a medical professional is recommended to determine the appropriate course of action.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and evaluation are advised to ensure patient safety and effective resolution of any complications arising from the overdosage.

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 product out of reach of children. In the event of accidental ingestion, patients should seek medical 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.

It is important for healthcare providers to instruct patients to discontinue use and consult a doctor if any of the following occur: bleeding, worsening of the condition, or if symptoms persist for more than 7 days. Patients should also be cautioned against starting any other hydrocortisone product without prior consultation with a healthcare professional.

While using this product, patients should be advised to avoid contact with the eyes. They should not exceed the recommended daily dosage unless directed by a doctor, and they should refrain from inserting the product into the rectum using fingers or any mechanical device or applicator.

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 at room temperature or in a cool place, ensuring that the temperature does not exceed 80°F. Proper storage conditions are crucial to maintain the integrity and efficacy of the product.

Additional Clinical Information

The route of administration for the medication is rectal. It is indicated for use in adults and children aged 12 years and older, with a recommended application frequency of 3 to 4 times daily to the affected area.

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 Hemorrodil Unguento 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 Hemorrodil Unguento 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.

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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.