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Avedana Hydrocortisone

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This product has been discontinued

Active ingredient
Hydrocortisone 0.0102 g/1 g
Other brand names
Dosage form
Ointment
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2018
Label revision date
January 4, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Hydrocortisone 0.0102 g/1 g
Other brand names
Dosage form
Ointment
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 2018
Label revision date
January 4, 2024
Manufacturer
Unipack LLC
Registration number
M017
NDC root
43749-250
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

Avedana® Maximum Strength Hydrocortisone Ointment is a topical medication designed to provide temporary relief from itching caused by minor skin irritations, inflammation, and rashes. It is particularly effective for conditions such as eczema, insect bites, and reactions to plants like poison ivy, poison oak, and poison sumac, as well as irritations from soaps, jewelry, detergents, cosmetics, psoriasis, and seborrheic dermatitis.

This ointment can also be used for itching in sensitive areas, including the external genital region and anal area. However, it's important to use this product under the advice and supervision of a doctor for any other uses.

Uses

This product is designed to provide temporary relief from itching caused by various minor skin irritations, inflammation, and rashes. You can use it for conditions such as eczema, insect bites, and reactions to plants like poison ivy, poison oak, and poison sumac. It can also help with irritation from soaps, jewelry, detergents, cosmetics, psoriasis, and seborrheic dermatitis. Additionally, it is effective for external genital, feminine, and anal itching.

If you have other uses in mind, it's important to consult with your doctor for advice and supervision.

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. For children under 2 years old, it’s important not to use this product without first consulting a doctor.

If you are dealing with external anal itching, start by cleaning the affected area with mild soap and warm water. Make sure to rinse thoroughly and gently dry the area by patting or blotting it with toilet tissue or a soft cloth before applying the medication. If the person needing treatment is a child under 12 years old, please consult a doctor for guidance.

What to Avoid

It's important to be cautious when using this medication. You should not use it for external feminine itching if you have a vaginal discharge; in this case, it's best to consult a doctor. Additionally, do not use this medication for treating diaper rash without first speaking to a healthcare professional.

Always prioritize your health and safety by following these guidelines. If you have any questions or concerns about your symptoms or the appropriate treatment, don't hesitate to reach out to your doctor for advice.

Side Effects

It's important to use this product only on the outside of your body. If you notice that your symptoms last longer than 7 days, worsen, or improve only to return a few days later, you should stop using the product and consult your doctor. Additionally, if you experience any rectal bleeding, seek medical attention right away.

Warnings and Precautions

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

You should stop using this product and consult your doctor if your symptoms persist for more than 7 days, worsen, improve and then return within a few days, or if you experience rectal bleeding. It's important to take these precautions seriously to ensure your safety and well-being.

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 if you believe you have taken too much of the medication, seek medical help right away. Contact your healthcare provider or go to the nearest emergency room. It's always better to be safe and get checked out if you have concerns about an overdose.

Pregnancy Use

When considering the use of Avedana Maximum Strength 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 is no clear guidance on how this ointment may affect you or your developing baby.

If you are pregnant or planning to become pregnant, it's 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, you can use Avedana Maximum Strength Hydrocortisone Ointment without specific warnings or recommendations against it. The information available does not indicate any concerns regarding its use while nursing or any potential effects on breast milk.

As always, if you have any questions or concerns about using this ointment while breastfeeding, it's a good idea to consult with your healthcare provider for personalized advice.

Pediatric Use

If your child is under 2 years old, it's important not to use this medication without first consulting a doctor. For children aged 2 years and older, you can apply the medication to the affected area, but make sure to do this no more than 3 to 4 times a day. If your child is under 12 years old, it's best to check with a doctor before using the medication to ensure it's safe and appropriate for them. Always prioritize your child's health and seek professional advice when needed.

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 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 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 should consider using 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 talk to your healthcare provider before starting any new medications, especially if you're considering using another hydrocortisone product. Your doctor can guide you on the safe use of these medications to avoid any potential issues.

Currently, there are no specific interactions with laboratory tests mentioned, but keeping your healthcare provider informed about all the medications you are taking is always a good practice. This ensures that your treatment is safe and effective.

Storage and Handling

To ensure the safety and effectiveness of your product, store it in a cool, dry place where the temperature does not exceed 30°C (86°F). This helps maintain its quality and performance. Before using any medication, be sure to read all label directions carefully. It's also a good idea to keep the carton, as it contains important information that you may need later.

Handling your product safely is crucial. Always follow the instructions provided to avoid any mishaps. If you have any questions about the product or its use, don’t hesitate to reach out for guidance.

Additional Information

You should apply this medication topically to the affected area, no more than 3 to 4 times a day if you are an adult or a child aged 2 years and older. If you are treating external anal itching, it's best to clean the area with mild soap and warm water, rinse thoroughly, and gently dry it before applying the product. If you are under 2 years old, do not use this medication without consulting a doctor, and if you are under 12 years old, it's advisable to consult a doctor as well.

Before using this medication, make sure to read all the label directions carefully. Keep the carton, as it contains important information you may need.

FAQ

What is Avedana® Maximum Strength Hydrocortisone Ointment used for?

Avedana® Maximum Strength Hydrocortisone Ointment is used for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes.

Who can use Avedana® Maximum Strength Hydrocortisone Ointment?

Adults and children 2 years of age and older can use it, but children under 2 years should consult a doctor.

How often can I apply this ointment?

You can apply it to the affected area not more than 3 to 4 times daily.

Are there any contraindications for using this ointment?

Yes, do not use it for external feminine itching if you have a vaginal discharge or for the treatment of diaper rash without consulting a doctor.

What should I do if my symptoms last more than 7 days?

You should stop using the ointment and consult a doctor if symptoms last for more than 7 days, worsen, or recur after clearing.

Can I use this ointment if I am pregnant or nursing?

There are no specific warnings or recommendations regarding the use of this ointment during pregnancy or lactation.

What precautions should I take when using this ointment?

Avoid contact with the eyes, and do not use any other hydrocortisone product unless directed by a doctor.

What should I do if I accidentally swallow the ointment?

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

What is the storage requirement for this ointment?

Store the ointment at a temperature not to exceed 30°C (86°F).

Packaging Info

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

Packaging configurations for Avedana Hydrocortisone.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Avedana® Maximum Strength Hydrocortisone Ointment is formulated as an ointment and is packaged in a 1 oz carton. This product is designed for topical application and contains hydrocortisone as its active ingredient, providing anti-inflammatory properties. The ointment's formulation allows for effective delivery of the active ingredient to the affected area.

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 but not limited to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, jewelry, detergents, cosmetics, psoriasis, and seborrheic dermatitis. Additionally, it is indicated for external genital, feminine, and anal itching.

Other uses of this product should only be undertaken 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 product should be applied to the affected area no more than 3 to 4 times daily. For children under 2 years of age, the product is not recommended; consultation with a healthcare professional is advised.

In cases of external anal itching, it is recommended that adults first clean the affected area with mild soap and warm water. The area should be rinsed thoroughly and gently dried by patting or blotting with toilet tissue or a soft cloth prior to the application of the product. For children under 12 years of age, consultation with a healthcare professional is also recommended before use.

Contraindications

Use is contraindicated in the following situations:

External feminine itching should not be treated with this product in the presence of vaginal discharge; consultation with a healthcare professional is advised. Additionally, this product is contraindicated for the treatment of diaper rash, and a healthcare professional should be consulted in such cases.

Warnings and Precautions

For external use only. It is imperative that healthcare professionals advise patients to adhere strictly to this guideline to prevent any adverse effects associated with inappropriate use.

In the event of accidental ingestion, immediate medical assistance should be sought. Patients or caregivers are encouraged to contact a Poison Control Center without delay to ensure appropriate management of the situation.

Healthcare providers should instruct patients to discontinue use and seek medical advice under the following circumstances: if symptoms persist for more than 7 days, if the condition worsens, if symptoms resolve and then recur within a few days, or if rectal bleeding occurs. Prompt consultation with a healthcare professional is essential in these cases to evaluate the need for further intervention or alternative treatment options.

Side Effects

For external use only. Patients should discontinue use and consult a healthcare professional if symptoms persist for more than 7 days, if the condition worsens, if symptoms resolve and then recur within a few days, or if rectal bleeding occurs.

Drug Interactions

The initiation of any additional hydrocortisone product should only occur under the guidance of 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 Avedana Hydrocortisone (hydrocortisone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Avedana Hydrocortisone.
Details

Pediatric Use

Pediatric patients under 2 years of age should not use this medication without consulting a doctor. For children aged 2 years and older, the recommended application is to the affected area no more than 3 to 4 times daily. Additionally, for children under 12 years of age, it is advised to consult a doctor prior to use.

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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

There are no specific statements regarding the use of Avedana Maximum Strength 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. The potential risks and benefits should be carefully evaluated, and alternative treatments may be considered if necessary. Women of childbearing potential should be counseled on the absence of established safety data in pregnancy.

Lactation

There are no specific warnings or recommendations regarding the use of Avedana Maximum Strength Hydrocortisone Ointment in lactating mothers. Additionally, there are no considerations or precautions related to lactation or the potential for excretion in breast milk mentioned in the prescribing information. Therefore, healthcare professionals may consider the use of this ointment in nursing mothers without specific concerns related to breastfeeding.

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, it is important to note that there is currently no specific information available regarding the effects or management of an overdose for this medication. Healthcare professionals are advised to exercise caution and consider the individual patient's circumstances when faced with a potential overdosage scenario.

In the absence of detailed guidance, it is recommended that healthcare providers monitor the patient closely for any unusual symptoms or adverse reactions that may arise. Supportive care should be initiated as necessary, and symptomatic treatment should be provided based on the clinical presentation of the patient.

In cases of suspected overdosage, it is prudent to consult local poison control centers or relevant medical authorities for further assistance and guidance on management strategies.

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 these contexts.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center if the product is swallowed.

Patients experiencing external feminine itching accompanied by vaginal discharge should be instructed to consult a doctor for further evaluation and management.

For those considering the product for the treatment of diaper rash, it is essential to recommend consulting a healthcare professional prior to use to ensure appropriate care.

Additionally, patients should be informed that if their symptoms persist for more than 7 days, worsen, resolve and then recur within a few days, or if they experience rectal bleeding, they must consult a doctor promptly for further assessment and guidance.

Storage and Handling

The product is supplied in packaging that includes important information, which should be retained for reference. It is essential to read all label directions prior to use.

For optimal storage, the product must be kept at a temperature not exceeding 30°C (86°F). Proper handling and adherence to these storage conditions are crucial to maintain the integrity and efficacy of the medication.

Additional Clinical Information

The product is administered topically, with a recommended application frequency of 3 to 4 times daily for adults and children aged 2 years and older. For external anal itching, adults should clean the affected area with mild soap and warm water, rinse thoroughly, and gently dry before applying the product. It is advised that the product not be used in children under 2 years of age without consulting a doctor, and children under 12 years of age should also seek medical advice prior to use.

Clinicians should counsel patients to read all label directions carefully and retain the carton, as it contains important information regarding the medication. No additional information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Avedana Hydrocortisone, 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 Avedana Hydrocortisone, 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.