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Hydrocortisone 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 2025
Label revision date
February 26, 2025
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 2025
Label revision date
February 26, 2025
Manufacturer
Encube Ethicals, Inc.
Registration number
M017
NDC root
21922-097
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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Drug Overview

Hydrocortisone Cream USP, 1% with Aloe is an anti-itch cream designed to provide temporary relief from itching caused by minor skin irritations, inflammation, and rashes. This cream can help soothe discomfort associated with conditions such as eczema, psoriasis, insect bites, and reactions to poison ivy, oak, or sumac, as well as irritations from detergents, jewelry, cosmetics, soaps, and seborrheic dermatitis. Additionally, it can relieve external anal and genital itching.

This cream works by reducing inflammation and calming the skin, making it a helpful option for various skin irritations. However, it's important to use it under the advice and supervision of a doctor for any other uses.

Uses

This product is designed to help you temporarily relieve itching caused by various minor skin irritations, inflammation, and rashes. You can use it for conditions like eczema, psoriasis, insect bites, and reactions to poison ivy, oak, or sumac. It can also soothe irritation from detergents, jewelry, cosmetics, soaps, and seborrheic dermatitis.

Additionally, this product provides temporary relief for external anal and genital itching. If you have other uses in mind, it's best to consult with your doctor for advice and supervision.

Dosage and Administration

If you're dealing with itching from skin irritation, inflammation, or rashes, you can apply the medication to the affected area up to 3 to 4 times a day if you are an adult or a child aged 2 years and older. However, if your child is under 2 years old, it's important to consult a doctor before using this product.

For external itching around the anal and genital areas, adults should first clean the area gently with mild soap and warm water, making sure to rinse thoroughly. After cleaning, pat or blot the area dry with toilet tissue or a soft cloth before applying the medication. Again, you can apply it up to 3 to 4 times daily. 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 use this medication safely. You should not apply it in the genital area if you have a vaginal discharge or use it for diaper rash without consulting a doctor. Additionally, avoid starting any ether hydrocortisone product unless your doctor has instructed you to do so.

Make sure to keep the medication away from your eyes and do not exceed the recommended dosage unless advised by your doctor. Lastly, do not insert the medication directly into the rectum using your fingers or any device. Always prioritize your health and consult a healthcare professional if you have any questions or concerns.

Side Effects

It's important to use this product only on the skin and not for any other purpose. If your condition worsens, if symptoms last longer than 7 days, or if they improve and then return within a few days, you should stop using the product and consult your doctor. Additionally, if you experience rectal bleeding, seek medical advice immediately. Always consult with a healthcare professional before starting any new treatment.

Warnings and Precautions

This product is for external use only. If you accidentally swallow it, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

You should stop using this product and call your doctor if your condition worsens, if symptoms last more than 7 days, or if they improve and then return within a few days. Additionally, do not start using any ether hydrocortisone product unless your doctor has instructed you to do so. If you experience rectal bleeding, seek medical attention right away.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, it's important to be aware of the general signs of an overdose, which can include symptoms like extreme drowsiness, confusion, or difficulty breathing. If you suspect an overdose, it is crucial to seek immediate medical help.

In case of an emergency, call your local emergency number or go to the nearest hospital. Always keep medications out of reach of children and follow the prescribed dosage to prevent any potential risks. If you have any concerns or questions about your medication, don’t hesitate to reach out to your healthcare provider for guidance.

Pregnancy Use

You can use hydrocortisone cream during pregnancy without specific warnings or precautions. The information available does not indicate that this product is contraindicated (not recommended) for pregnant individuals. Additionally, there are no dosage modifications or special precautions you need to follow while using this cream during your pregnancy. However, it's always a good idea to consult with your healthcare provider before starting any new medication.

Lactation Use

If you are breastfeeding, you can use hydrocortisone cream without specific warnings or recommendations against it. The information available does not indicate any concerns about the cream being passed into breast milk or posing risks to your infant. However, as with any medication, it's always a good idea to consult with your healthcare provider if you have any questions or concerns about its use while nursing.

Pediatric Use

If your child is under 2 years old, it's important to consult a doctor before using this medication. For children aged 2 years and older, you can apply the medication to the affected area up to 3 to 4 times a day. However, if your child is under 12 years old and is experiencing external anal or genital itching, you should also consult a doctor before using the product. Always prioritize your child's safety and well-being by seeking 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 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 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 the information provided does not include specific guidelines for dosage adjustments, special monitoring, or precautions related to your condition. This means that there are no tailored recommendations for how the medication may affect you differently due to your liver health.

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your specific situation. They can help determine the best approach based on your liver function and overall health.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that your overall treatment plan is safe and effective.

Always discuss any other medications, supplements, or health conditions you have, as this information is crucial for your safety and well-being. Your provider can guide you on how to manage your health effectively.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 15°C and 30°C (59°F to 86°F). It's important to protect it from freezing, as extreme cold can damage the product. Before using any medication, make sure to read all the label directions carefully. Don't forget 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, refer back to the carton or consult a healthcare professional for guidance.

Additional Information

You should apply the medication to the affected area no more than 3 to 4 times daily if you are an adult or a child aged 2 years and older. For children under 2 years, it's important to consult a doctor before use. If you're treating external anal or genital itching, first clean the area with mild soap and warm water, rinse thoroughly, and gently dry it by patting with toilet tissue or a soft cloth before applying the medication.

Always read the label directions carefully before using any medication, and keep the carton as it contains important information. If you have any questions or if the patient is under 12 years of age, consult a doctor for guidance.

FAQ

What is Hydrocortisone Cream USP, 1% with Aloe used for?

Hydrocortisone Cream is an anti-itch cream that temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to conditions like eczema, psoriasis, insect bites, and poison ivy.

How should I use Hydrocortisone Cream?

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

Are there any precautions I should take when using this cream?

Avoid contact with the eyes, do not use more than directed unless advised by a doctor, and do not apply directly into the rectum.

Can I use this cream for diaper rash?

No, do not use Hydrocortisone Cream for the treatment of diaper rash; consult a doctor instead.

What should I do if my condition worsens?

If your condition worsens, symptoms persist for more than 7 days, or if rectal bleeding occurs, stop using the cream and consult a doctor.

Is it safe to use Hydrocortisone Cream during pregnancy?

The insert does not mention any contraindications for use during pregnancy, but consult your 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.

What are the storage instructions for this cream?

Store Hydrocortisone Cream at 15°C to 30°C (59°F to 86°F) and protect it from freezing.

Packaging Info

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

Packaging configurations for Hydrocortisone with Aloe.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

No description information is available for the specified drug.

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, psoriasis, insect bites, and contact with poison ivy, oak, or sumac. It is also effective for itching resulting from exposure to detergents, jewelry, cosmetics, soaps, and seborrheic dermatitis.

Additionally, this drug provides temporary relief for external anal and genital itching.

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

Dosage and Administration

For the treatment of itching associated with skin irritation, inflammation, and rashes, the recommended dosage for adults and children aged 2 years and older is to apply the product to the affected area no more than 3 to 4 times daily. For children under 2 years of age, it is advised to consult a physician prior to use.

In cases of external anal and genital itching, adults should first clean the affected area with mild soap and warm water, ensuring thorough rinsing. After cleansing, the area should be gently dried by patting or blotting with toilet tissue or a soft cloth. The product should then be applied to the affected area no more than 3 to 4 times daily. For children under 12 years of age, consultation with a healthcare professional is recommended before application.

Contraindications

Use of this product is contraindicated in the following situations:

The product should not be applied to the genital area in the presence of vaginal discharge; medical consultation is advised. Additionally, it is contraindicated for the treatment of diaper rash, and a healthcare professional should be consulted in such cases.

The initiation of any ether hydrocortisone product should only occur under the guidance of a physician. Contact with the eyes must be avoided. The product should not be used in excess of the directed dosage unless specifically instructed by a healthcare provider. Furthermore, direct application into the rectum using fingers or any mechanical device or applicator is contraindicated.

Warnings and Precautions

For external use only. It is imperative that healthcare professionals advise patients to adhere strictly to this guideline to prevent unintended ingestion or misuse.

In the event of accidental ingestion, immediate medical assistance should be sought. Patients should be instructed to contact a Poison Control Center at 1-800-222-1222 without delay.

Patients should be advised to discontinue use and consult a healthcare provider under the following circumstances: if the condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. Additionally, the initiation of any ether hydrocortisone product should only occur under the guidance of a physician.

Healthcare professionals must also be vigilant for signs of rectal bleeding in patients, as this warrants immediate medical evaluation.

Side Effects

For external use only. Patients are advised to stop use and consult a doctor if the condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then occur again within a few days. Additionally, patients should not begin the use of any ether hydrocortisone product unless directed by a healthcare professional. Rectal bleeding is also a serious concern that necessitates immediate medical consultation.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

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

Packaging configurations for Hydrocortisone with Aloe.
Details

Pediatric Use

Pediatric patients under 2 years of age should consult a doctor prior to use. For children aged 2 years and older, the medication may be applied 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 before using the product for external anal and genital itching.

Geriatric Use

There is no specific information available regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

Hydrocortisone cream is not contraindicated in pregnancy, and there are no specific warnings or precautions regarding its use during this period. The prescribing information does not indicate that dosage modifications or special precautions are necessary for pregnant patients. However, as with any medication, healthcare professionals should consider the potential benefits and risks when prescribing hydrocortisone cream to women of childbearing potential. It is advisable to use the lowest effective dose for the shortest duration necessary to manage the condition being treated.

Lactation

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

Renal Impairment

Patients with renal impairment may not have specific dosage adjustments, special monitoring, or safety considerations outlined in the available data. Therefore, healthcare professionals should exercise caution when prescribing to this population, as the lack of information necessitates careful clinical judgment regarding the use of the medication in individuals with reduced kidney function. Regular monitoring of renal function is advisable to ensure patient safety and therapeutic efficacy.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

In the absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant regarding the potential risks associated with excessive administration of the medication.

Healthcare providers are advised to monitor patients closely for any signs of adverse effects that may arise from overdosage. Symptoms may vary depending on the medication's pharmacological profile and the individual patient's response.

In the event of suspected overdosage, immediate medical intervention is recommended. Healthcare professionals should initiate supportive care and consider symptomatic treatment as necessary. It is also advisable to consult local poison control centers or relevant toxicology resources for guidance on management protocols specific to the medication in question.

Documentation of the incident, including the amount ingested and the time of exposure, is crucial for effective management and follow-up care. Continuous assessment of the patient's clinical status is necessary to ensure appropriate interventions are implemented.

In summary, while specific overdosage information is not provided, healthcare professionals should exercise caution, remain alert to potential symptoms, and be prepared to take appropriate action in the event of an overdose.

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 ability to draw conclusions regarding the potential toxicological profile of the substance 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 at 1-800-222-1222 if the product is swallowed. Patients should be informed to consult a doctor if they experience vaginal discharge in the genital area or if they are considering the product for the treatment of diaper rash.

It is important for healthcare providers to instruct patients to monitor their condition closely. If symptoms worsen, persist for more than 7 days, or if symptoms clear up and then recur within a few days, patients should be advised to consult their healthcare provider.

Patients should be cautioned against initiating the use of any ether hydrocortisone product unless specifically directed by a doctor. They should also be informed to report any occurrence of rectal bleeding to their healthcare provider.

Healthcare providers should emphasize the importance of avoiding contact with the eyes and instruct patients not to exceed the recommended dosage unless directed by a doctor. Additionally, patients should be advised against inserting the product directly 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 should be stored at a temperature range of 15°C to 30°C (59°F to 86°F) and must be protected from freezing to maintain its efficacy.

Healthcare professionals are advised to read all label directions prior to use. It is important to retain the carton, as it contains essential information regarding the product.

Additional Clinical Information

Patients aged 2 years and older are advised to apply the medication to the affected area no more than 3 to 4 times daily. For children under 2 years of age, consultation with a doctor is recommended. In adults experiencing external anal and genital itching, it is suggested to first clean the affected area with mild soap and warm water, rinse thoroughly, and gently dry by patting or blotting with toilet tissue or a soft cloth before application. For children under 12 years, a doctor's consultation is also advised.

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

Drug Information (PDF)

This file contains official product information for Hydrocortisone 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 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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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.