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Hydrocortisone Cream with Aloe

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Active ingredient
Hydrocortisone 1 g/100 g
Other brand names
Drug class
Corticosteroid
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2024
Label revision date
December 20, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Hydrocortisone 1 g/100 g
Other brand names
Drug class
Corticosteroid
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2024
Label revision date
December 20, 2024
Manufacturer
Rugby Laboratories
Registration number
M017
NDC root
0536-1407
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

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 commonly used for conditions such as eczema, seborrheic dermatitis, psoriasis, insect bites, and reactions to poison ivy, oak, or sumac, as well as irritations from soaps, detergents, cosmetics, jewelry, and external feminine, genital, and anal areas.

The cream works by reducing inflammation and soothing the skin, helping to alleviate discomfort. While it can be effective for these common skin issues, it's important to use it under the guidance of a doctor for any other conditions.

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 like eczema, seborrheic dermatitis, and psoriasis. It’s also effective for soothing itching from insect bites and reactions to plants such as poison ivy, oak, and sumac. Additionally, it can help relieve discomfort caused by soaps, detergents, cosmetics, jewelry, and external feminine, genital, and anal itching.

For any other uses, it's important to consult with your doctor to ensure safety and effectiveness.

Dosage and Administration

If you or your child are experiencing external or anal itching, you can apply the medication to the affected area. For adults and children aged 2 years and older, it’s recommended to apply the product no more than 3 to 4 times a day. Before applying, it’s best to gently clean the area with mild soap and warm water, then rinse thoroughly by patting or blotting with toilet tissue or a soft cloth.

If your child is under 2 years old, do not use this product without consulting a doctor. Additionally, if your child is under 12 years old and has external anal itching, it’s important to speak with a doctor before use. Always follow these guidelines to ensure safe and effective use of the medication.

What to Avoid

It's important to be cautious when using this product. If you're treating diaper rash or experiencing external genital itching with vaginal discharge, please consult your doctor first. Avoid contact with your eyes, and do not start using any other hydrocortisone product without your doctor's guidance.

For external genital, feminine, and anal itching, make sure not to exceed the recommended daily dosage unless directed by a doctor. If you notice any bleeding, stop using the product and consult your doctor immediately. Additionally, do not insert this product into the rectum using fingers or any device. Your health and safety are paramount, so always seek professional advice when in doubt.

Side Effects

You should be aware that this product is for external use only and must not come into contact with your eyes. It's important to avoid inserting it into the rectum using fingers or any devices. If you are using this product for external anal itching, do not exceed the recommended daily dosage unless your doctor advises otherwise. If you experience any bleeding, consult your doctor immediately. Additionally, if you are considering this product for a child under 12 years old, please speak with a doctor first.

You should stop using this product and consult a doctor if your condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then return within a few days. In such cases, do not start using any other hydrocortisone product unless directed by a healthcare professional.

Warnings and Precautions

This product is for external use only, so please avoid contact with your eyes and do not insert it into the rectum using fingers or any devices. It's important not to exceed the recommended daily dosage unless your doctor advises you to do so. If you experience any bleeding, consult your doctor right away. Additionally, if you are considering using this product for a child under 12 years old, please consult a doctor first.

If you accidentally swallow this product, seek emergency medical help or contact a Poison Control Center at 1-800-222-1222 immediately. You should also stop using the product and call your doctor if your condition worsens, if symptoms last more than 7 days, or if symptoms improve and then return within a few days. Do not start using any other hydrocortisone product without your doctor's guidance.

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, seek medical help right away.

In case of an overdose, contact your local emergency services or go to the nearest hospital. It's crucial to provide healthcare professionals with as much information as possible about the medication taken and the amount. Remember, when in doubt, it's always better to err on the side of caution and seek help.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that there are no specific guidelines or safety concerns mentioned regarding the use of Hydrocortisone Cream with Aloe during pregnancy. This means that the information available does not indicate any required dosage changes or special precautions for using this cream while you are expecting.

As always, it's best to consult with your healthcare provider before using any medication, including over-the-counter products like Hydrocortisone Cream with Aloe, to ensure it is safe for you and your baby.

Lactation Use

You can use hydrocortisone cream with aloe while breastfeeding, as there are no specific warnings or recommendations against it for nursing mothers. Additionally, there is no information indicating that this product is passed into breast milk or poses any risk to your infant. Always feel free to consult with your healthcare provider if you have any concerns about using medications while nursing.

Pediatric Use

If your child is under 12 years old, it's important to consult a doctor before using this medication. For children under 2 years of age, you should not use it at all without a doctor's guidance. If your child is 2 years or 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. Additionally, if your child under 12 is experiencing external anal itching, please consult a doctor for advice.

Geriatric Use

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. Since older adults may have different health needs and responses to medications, you should always consult with a healthcare provider before starting any new medication. They can help determine the right dosage and monitor for any potential side effects, ensuring that the treatment is safe and effective for you or your loved one.

Renal Impairment

If you have kidney problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment plan.

Hepatic Impairment

If you have liver problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations for the medication do not change based on liver impairment. However, it’s always best to discuss your individual health situation with your healthcare provider, as they can offer personalized advice and monitor your liver function as needed.

Make sure to keep your doctor informed about your liver health, as they may want to conduct regular liver function tests (which check how well your liver is working) to ensure your safety while using this medication.

Drug Interactions

It's important to talk to your healthcare provider before starting any new hydrocortisone product. This ensures that you avoid any potential complications or interactions with your current medications. Your doctor can help you understand the best options for your health needs.

While there are no specific interactions with laboratory tests mentioned, maintaining open communication with your healthcare team about all medications and tests is crucial for your safety and well-being. Always consult your doctor to make informed decisions about your treatment.

Storage and Handling

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

When handling the product, make sure to do so in a clean environment to avoid contamination. Always follow any specific instructions provided for safe use and disposal to ensure your safety and the safety of others.

Additional Information

For adults and children aged 2 years and older, apply the product to the affected area no more than 3 to 4 times daily. If you're treating external or anal itching, it's best to clean the area with mild soap and warm water, then gently pat it dry before applying the product. Children under 2 years should not use this product, and those under 12 years with external anal itching should consult a doctor.

Always keep this product out of reach of children. If swallowed, seek medical help or contact a Poison Control Center immediately. Before using, read all label directions carefully and keep the carton for important information. If your symptoms worsen, persist for more than 7 days, or return after clearing up, stop using the product and consult a doctor. Avoid contact with your eyes, and do not insert the product into the rectum using fingers or any device.

FAQ

What is Hydrocortisone Cream with Aloe used for?

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

What conditions can this cream treat?

It is indicated for conditions such as eczema, seborrheic dermatitis, psoriasis, insect bites, and itching from poison ivy, oak, sumac, soaps, detergents, cosmetics, jewelry, and external feminine, genital, and anal itching.

How should I apply this cream?

For adults and children 2 years and older, apply to the affected area not more than 3 to 4 times daily.

Can children under 2 years use this cream?

No, do not use this cream on children under 2 years of age without consulting a doctor.

What should I do before applying the cream for external anal itching?

When practical, cleanse the affected area with mild soap and warm water, then rinse thoroughly before applying the cream.

Are there any warnings I should be aware of?

Yes, avoid contact with the eyes, do not use in the rectum, and do not exceed the recommended dosage unless directed by a doctor.

What should I do if my symptoms persist?

If conditions worsen or symptoms persist for more than 7 days, stop using the product and consult a doctor.

Is this cream safe to use during pregnancy or while nursing?

There is no specific information provided regarding the use of this cream during pregnancy or lactation, so consult a doctor before use.

What should I do if I accidentally swallow the cream?

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

Can I use other hydrocortisone products while using this cream?

Do not begin the use of any other hydrocortisone product unless you have consulted a doctor.

Packaging Info

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

Packaging configurations for Hydrocortisone Cream with Aloe.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

371172 Rugby Hydrocortisone Cream with Aloe is a topical formulation containing hydrocortisone as the active ingredient. This cream is designed for dermatological use and incorporates aloe for its soothing properties. The product is identified by the CDER number 112823, indicating its regulatory status. The formulation is intended for the relief of inflammation and itching associated with various skin conditions.

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, oak, or sumac. It is also effective for itching resulting from exposure to soaps, detergents, cosmetics, jewelry, and external feminine, genital, and anal areas.

Other uses of this product should only be undertaken under the advice and supervision of a healthcare professional.

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 optimal results, it is recommended to cleanse the affected area with mild soap and warm water, followed by thorough rinsing. This can be achieved by patting or blotting the area with toilet tissue or a soft cloth prior to application.

Children under 2 years of age should not use this product and are advised to consult a doctor. Additionally, for children under 12 years of age experiencing external anal itching, it is essential to seek medical advice before use.

Contraindications

The use of this product is contraindicated in the following situations:

  • Consultation with a doctor is required for the treatment of diaper rash.

  • Consultation with a doctor is necessary for external genital itching accompanied by vaginal discharge.

  • Contact with the eyes must be avoided.

  • The initiation of any other hydrocortisone product should only occur after consulting a doctor.

  • For external genital, feminine, and anal itching, do not exceed the recommended daily dosage unless directed by a doctor. In the event of bleeding, discontinue use and consult a doctor.

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

Warnings and Precautions

For external use only. It is imperative to avoid contact with the eyes. The product should not be introduced into the rectum using fingers, mechanical devices, or applicators. Users are advised not to exceed the recommended daily dosage unless specifically directed by a healthcare professional, particularly for those experiencing external anal itching. In the event of bleeding, it is crucial to consult a doctor promptly.

For pediatric patients, those under 12 years of age should seek medical advice before use in the context of external anal itching.

In cases of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center (1-800-222-1222) is recommended.

Patients should discontinue use and contact their healthcare provider if conditions worsen, 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 hydrocortisone product without a doctor's guidance.

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 come into contact with the eyes. Additionally, it is crucial that patients do not insert this product into the rectum using fingers, mechanical devices, or applicators.

For patients using this product for external anal itching, it is advised not to exceed the recommended daily dosage unless directed by a healthcare professional. In the event of bleeding, patients should consult a doctor promptly. Furthermore, children under 12 years of age should seek medical advice before use.

Patients are instructed to discontinue use and consult a doctor if conditions worsen or if symptoms persist for more than 7 days. If symptoms clear up and then recur within a few days, patients should also stop using the product and refrain from starting any other hydrocortisone product unless directed by a healthcare provider.

Drug Interactions

The initiation of any hydrocortisone product should be preceded by consultation with a healthcare professional to ensure safety and appropriateness of therapy. This precaution is essential to avoid potential adverse effects or interactions with other medications.

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

Packaging configurations for Hydrocortisone Cream with Aloe.
Details

Pediatric Use

Pediatric patients under 2 years of age should not use this product and must consult a doctor prior to use. For children aged 2 years and older, the recommended application is to the affected area no more than 3 to 4 times daily.

In children under 12 years of age experiencing external anal itching, it is advised to consult a doctor before use.

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 efficacy, given the lack of targeted data for this population.

Pregnancy

There are no specific statements regarding the use of Hydrocortisone Cream with Aloe during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients. It is advisable to weigh the potential benefits against any unknown risks to fetal outcomes. Women of childbearing potential should be counseled accordingly, and alternative treatments may be considered if necessary.

Lactation

There are no specific warnings or recommendations regarding the use of hydrocortisone cream with aloe in lactating mothers. Additionally, there is no information available about the potential for excretion of this product in breast milk or any associated risks to breastfed infants.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of 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 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 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 at 1-800-222-1222 if the product is swallowed. Patients should be informed that for the treatment of diaper rash, it is essential to consult a doctor before use.

In cases of external genital itching accompanied by vaginal discharge, patients should also be directed to consult a healthcare professional. Providers should emphasize the importance of monitoring symptoms; if conditions worsen or if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days, patients should discontinue use of the product. They should not begin using any other hydrocortisone product unless specifically directed by a doctor.

Patients should be cautioned to avoid contact with the eyes and to refrain from using any other hydrocortisone product without prior consultation with a healthcare provider. For those experiencing external genital, feminine, or anal itching, it is crucial to adhere to the recommended daily dosage and not exceed it unless directed by a doctor. In the event of bleeding, patients should stop use immediately and consult a healthcare professional.

Additionally, patients should be instructed not to insert this 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 a controlled room temperature, maintaining a range of 20° to 25°C (68° to 77°F). Proper storage conditions are crucial to ensure the integrity and efficacy of the product.

Additional Clinical Information

Patients aged 2 years and older are advised to apply the product to the affected area no more than 3 to 4 times daily. For external and anal itching, it is recommended to cleanse the area with mild soap and warm water, followed by thorough rinsing before application. Children under 2 years of age should not use this product without consulting a doctor, and those under 12 years with external anal itching should also seek medical advice.

Clinicians should counsel patients to keep the product out of reach of children and to seek immediate medical assistance or contact a Poison Control Center if swallowed. Patients are encouraged to read all label directions carefully and retain the carton for important information. They should discontinue use and consult a doctor if symptoms worsen, persist beyond 7 days, or recur shortly after resolution. Additionally, patients should avoid contact with the eyes and refrain from inserting the product into the rectum using fingers or any mechanical device.

Drug Information (PDF)

This file contains official product information for 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 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.