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Avedana Hydrocortisone Cream with Aloe

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Active ingredient
Hydrocortisone 10.2 mg/1 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 2016
Label revision date
July 13, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Hydrocortisone 10.2 mg/1 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 2016
Label revision date
July 13, 2025
Manufacturer
Unipack LLC
Registration number
M017
NDC root
43749-620
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 Hydrocortisone Cream with Aloe 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 poison ivy, poison oak, and poison sumac, as well as irritations from soaps, jewelry, detergents, cosmetics, psoriasis, and seborrheic dermatitis.

This cream can also be used for itching in sensitive areas, including the external genital region and anal area. While it can be helpful for these issues, it's important to consult with a doctor for any other uses to ensure safe and appropriate treatment.

Uses

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

For any other uses, 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 under 12 years old, please consult a doctor for guidance.

What to Avoid

You should avoid using this product if you have a vaginal discharge or if you are treating diaper rash; in these cases, it's important to consult a doctor first. Additionally, do not use this product for external feminine itching if you have a vaginal discharge.

While using this product, be careful to avoid contact with your eyes. Do not start using any other hydrocortisone product unless your doctor advises you to do so, and make sure not to exceed the recommended dosage unless directed by a healthcare professional. Lastly, do not insert this product into the rectum using your fingers or any device.

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. If you are experiencing feminine itching along with a vaginal discharge or if you need treatment for diaper rash, it’s important to consult your doctor before using this product.

You should stop using this product and call your doctor if your symptoms last more than 7 days, if your condition worsens, if symptoms clear up and then return within a few days, or if you experience rectal bleeding.

If the product is swallowed, seek emergency medical help or contact a Poison Control Center immediately.

Overdose

If you suspect an overdose of this medication, it's important to know that there is no specific information available about what to do in such cases. However, you should always take any signs of overdose seriously. Common signs may include unusual drowsiness, confusion, or difficulty breathing.

If you notice any of these symptoms or have concerns about a possible overdose, seek immediate medical help. It's always better to be cautious and get professional advice if you think something might be wrong.

Pregnancy Use

You can use Avedana Hydrocortisone Cream with Aloe during pregnancy without specific warnings or precautions mentioned in the information provided. There are no indications that this product is contraindicated for pregnant individuals, nor are there any safety concerns noted regarding its use. Additionally, you do not need to make any dosage modifications or take special precautions while using this cream during your pregnancy.

As always, it's a good idea to consult with your healthcare provider before using any medication or product during pregnancy to ensure it’s appropriate for your individual situation.

Lactation Use

If you are breastfeeding, you can use Avedana Hydrocortisone Cream with Aloe without specific warnings or recommendations against it. Currently, there is no information available about whether this cream is passed into breast milk or if it poses any risk to your nursing infant.

As always, it's a good idea to consult with your healthcare provider if you have any concerns about using medications while breastfeeding. They can provide personalized advice based on your situation.

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 between 2 and 12 years of age, you should also check with a healthcare professional before use.

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. 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, 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 you may need a lower dose of the medication. Before starting treatment, your healthcare provider will assess your creatinine clearance (a test that measures how well your kidneys are filtering waste). Regular tests to monitor your kidney function are also recommended to ensure your safety while on this medication. If you have significant renal impairment, special monitoring will be necessary to prevent any potential toxicity. Always discuss your kidney health with your doctor to ensure the best care.

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 best course of action to ensure your safety and the effectiveness of your treatment.

Currently, there are no specific interactions noted with laboratory tests, but maintaining open communication with your healthcare provider about all medications and tests is essential for your overall health. Always keep them informed about any changes in your medication regimen.

Storage and Handling

To ensure the best performance and safety of your product, store it in a cool, dry place where the temperature does not exceed 30 °C (86 °F). It's important to protect it from freezing, as extreme temperatures can affect its effectiveness. Before using the product, make sure to read all label directions carefully. Keeping the carton is also a good idea, as it contains important information that you may need later.

Handling the product safely is crucial. Always follow the instructions provided to avoid any mishaps. By taking these precautions, you can help ensure that the product remains effective and safe for use.

Additional Information

No further information is available.

FAQ

What is Avedana Hydrocortisone Cream with Aloe used for?

Avedana Hydrocortisone Cream with Aloe is used for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes.

What conditions can this cream help relieve itching from?

It can relieve itching due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, jewelry, detergents, cosmetics, psoriasis, and seborrheic dermatitis.

How should I apply this cream?

Adults and children 2 years of age and older should apply it to the affected area not more than 3 to 4 times daily.

Can children under 2 years use this cream?

No, children under 2 years of age should not use this cream and should consult a doctor.

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

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

Are there any contraindications for using this cream?

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 precautions should I take when using this cream?

Avoid contact with the eyes, do not use more than directed, and do not apply it into the rectum using fingers or any device.

Is this cream safe to use during pregnancy?

There are no specific warnings or contraindications regarding the use of this cream during pregnancy mentioned in the provided information.

Can nursing mothers use this cream?

There are no specific warnings or recommendations regarding the use of this cream in nursing mothers.

What should I do if I accidentally swallow this cream?

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

Packaging Info

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

Packaging configurations for Avedana Hydrocortisone Cream with Aloe.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Avedana Hydrocortisone Cream with Aloe is formulated as a cream and is contained in a 1 oz tube. This product combines hydrocortisone with aloe to provide a topical treatment option.

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

Adults and children aged 2 years and older are instructed to apply the product to the affected area no more than 3 to 4 times daily. For external anal itching, it is recommended that adults first clean the affected area with mild soap and warm water, ensuring thorough rinsing. The area should then be gently dried by patting or blotting with toilet tissue or a soft cloth prior to the application of the product.

For children under 2 years of age, the product should not be used without consulting a doctor. Additionally, for children under 12 years of age, it is advised to consult a doctor before use.

Contraindications

Use of this product is contraindicated in the following situations:

  • External feminine itching associated with vaginal discharge. Consultation with a healthcare professional is advised.

  • Treatment of diaper rash. Consultation with a healthcare professional is advised.

Additionally, the following precautions should be observed during use:

  • Avoid contact with the eyes.

  • Do not initiate the use of any other hydrocortisone product unless directed by a healthcare professional.

  • Do not exceed the recommended dosage unless directed by a healthcare professional.

  • Do not administer this product rectally using fingers or any mechanical device or applicator.

Warnings and Precautions

For external use only. This product is intended solely for topical application and should not be ingested.

In cases of external feminine itching accompanied by vaginal discharge, it is imperative to consult a healthcare professional prior to use. Similarly, for the treatment of diaper rash, a consultation with a doctor is recommended to ensure appropriate management.

Patients should discontinue use and contact their healthcare provider if any of the following occur: symptoms persist for more than 7 days, the condition worsens, symptoms resolve only to reappear within a few days, or if rectal bleeding is observed. Prompt medical attention is essential in these situations to prevent complications.

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

Side Effects

Patients should be aware that the product is intended for external use only.

In clinical practice, it is advised that patients discontinue use and consult a healthcare professional if symptoms persist for more than 7 days, if the condition worsens, or if symptoms resolve and then recur within a few days. Additionally, patients should seek prompt medical attention if rectal bleeding occurs. These recommendations are based on clinical observations and are crucial for ensuring patient safety and effective management of their condition.

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 Cream with Aloe (hydrocortisone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Avedana Hydrocortisone Cream with Aloe.
Details

Pediatric Use

Pediatric patients under 2 years of age should not use this medication and must consult a doctor prior to use. For children under 12 years of age, it is advised to consult a doctor before administration.

For pediatric patients aged 2 years and older, the medication may be applied to the affected area no more than 3 to 4 times daily.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any potential adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

There are no specific warnings or precautions regarding the use of Avedana Hydrocortisone Cream with Aloe during pregnancy. The prescribing information does not indicate whether the product is contraindicated in pregnant patients or if there are any safety concerns associated with its use during this period. Additionally, no dosage modifications or special precautions are recommended for women of childbearing potential. As with any medication, healthcare professionals should weigh the potential benefits against any unknown risks when considering the use of this product in pregnant patients.

Lactation

There are no specific warnings or recommendations regarding the use of Avedana Hydrocortisone Cream with Aloe in lactating mothers. Additionally, there is no information available concerning the potential for excretion of the product in breast milk or any associated risks to breastfed infants.

Renal Impairment

Patients with renal impairment may necessitate a reduced dose of the medication. It is essential for healthcare professionals to assess creatinine clearance prior to initiating therapy in these patients. Regular renal function tests are recommended for individuals with existing kidney problems to monitor their condition effectively. Additionally, special monitoring is required for patients with significant renal impairment to avoid potential toxicity associated with the medication.

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 no specific information regarding overdosage provided in the available sections of the drug insert.

Healthcare professionals are advised to exercise caution and consider the potential implications of an overdose, even in the absence of detailed guidance. In the event of suspected overdosage, it is recommended that healthcare providers monitor the patient closely for any adverse effects and manage symptoms as they arise.

Supportive care should be initiated as necessary, and consultation with a poison control center or a medical toxicologist may be beneficial for further 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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

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. It is important to inform patients that this product should not be used for external feminine itching if they have a vaginal discharge, and they should consult a doctor in such cases. Additionally, patients should be cautioned against using this product for the treatment of diaper rash without first consulting a healthcare professional.

Patients should be instructed to stop using the product and consult a doctor if their symptoms persist for more than 7 days, if the condition worsens, or if symptoms resolve only to reoccur within a few days. They should also be made aware that rectal bleeding is a serious concern, and they should seek prompt medical attention if this occurs.

While using the product, patients should be advised to avoid contact with the eyes. They should not initiate the use of any other hydrocortisone product unless directed by a healthcare provider. Furthermore, patients should be cautioned not to exceed the directed dosage unless specifically instructed by a doctor. It is also critical to inform patients that the product should not be inserted into the rectum using fingers or any mechanical device or applicator.

Storage and Handling

The product is supplied in packaging that includes important information, which should be retained for reference. It is essential to store the product at a temperature not exceeding 30 °C (86 °F) and to protect it from freezing. Prior to use, healthcare professionals are advised to thoroughly read all label directions to ensure proper handling and administration of the medication.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Avedana Hydrocortisone Cream with Aloe, 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 Cream with Aloe, 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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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.