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Hydrocortisone Cream

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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 2017
Label revision date
May 8, 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 2017
Label revision date
May 8, 2025
Manufacturer
Trifecta Pharmaceuticals USA
Registration number
M017
NDC root
69396-028
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (4 NDCs)
Packaging & NDC Codes (4)

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

4040 GLOBE HYDROCORTISONE CREAM WITH ALOE is a topical cream designed to temporarily relieve itching caused by minor skin irritations, inflammation, and rashes. It can be particularly helpful for conditions such as eczema (a skin condition that causes inflammation and irritation), seborrheic dermatitis (a type of skin rash), psoriasis (a chronic skin condition), insect bites, and reactions to plants like poison ivy, oak, and sumac, as well as irritations from soaps, detergents, cosmetics, and jewelry.

This cream works by reducing inflammation and soothing the affected area, providing relief from discomfort. While it is effective for these common skin issues, it's important to use it under the guidance of a healthcare professional 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 may find it helpful for conditions such as eczema, seborrheic dermatitis, and psoriasis. It can also soothe itching from insect bites and reactions to plants like poison ivy, oak, and sumac. Additionally, it may alleviate discomfort caused by soaps, detergents, cosmetics, jewelry, and even external genital and anal itching.

For any other uses, it's important to consult with your doctor to ensure safe and appropriate application.

Dosage and Administration

To use this medication effectively, start by cleaning the affected area with mild soap and warm water. Make sure to rinse it thoroughly to remove any soap residue. After cleansing, gently dry the area by patting or blotting it with toilet tissue or a soft cloth.

For adults and children aged 12 years and older, you can apply the medication to the affected area up to 3 to 4 times a day. However, if the person is under 12 years old, it’s important not to use this medication without first consulting a doctor. This ensures safety and proper care for younger individuals.

What to Avoid

You should avoid using this product if you have a vaginal discharge, are treating diaper rash, or if the user is a child under 2 years of age. It's important to stop using the product and consult a doctor if you experience any bleeding, if your condition worsens, or if symptoms persist for more than 7 days. Additionally, if your symptoms clear up and then return within a few days, or if you plan to use any other hydrocortisone product, you should also seek medical advice.

Always prioritize your health and safety by following these guidelines closely.

Side Effects

You should be aware that this product is for external use only and should not come into contact with your eyes. It's important not to insert it into the rectum using fingers or any devices. If you are using it 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 you notice any bleeding, if your condition worsens, or if your symptoms persist for more than 7 days. If your symptoms improve and then return within a few days, it's also important to seek medical advice. Lastly, consult your doctor before starting any other hydrocortisone product.

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. If you are considering using this product for a child under 12 years old, please speak with a doctor first.

Before using this medication, make sure to read all the label directions carefully and keep the carton, as it contains important information. If you accidentally swallow the product, seek medical help or contact a Poison Control Center immediately. You should stop using the product and call your doctor if you notice any bleeding, if your condition worsens, or if symptoms persist for more than 7 days or return shortly after clearing up. Additionally, consult your doctor before starting any other hydrocortisone product.

Overdose

Taking more than the recommended daily dosage of medication can lead to serious health risks. It's important to follow your doctor's instructions carefully and not exceed the dosage unless specifically directed by them.

If you suspect an overdose, look out for signs such as unusual drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms, seek immediate medical help. Always prioritize your safety and consult a healthcare professional if you have any concerns about your medication.

Pregnancy Use

When it comes to using this medication during pregnancy, there are no specific guidelines or safety concerns mentioned. This means that there are no established recommendations for dosage adjustments or special precautions for pregnant individuals. However, it's always important to consult with your healthcare provider before starting or continuing any medication while you are pregnant or planning to become pregnant. They can provide personalized advice based on your health and circumstances.

Lactation Use

If you are breastfeeding and considering the use of hydrocortisone cream, you can feel reassured that there are no specific warnings or recommendations against its use for nursing mothers. Additionally, there is no information indicating that hydrocortisone cream is passed into breast milk or poses any risk to your infant.

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

Pediatric Use

If your child is under 12 years old, it's important to consult a doctor before using this medication. For children aged 12 and older, you can apply it to the affected area up to 3 to 4 times a day. However, if your child is under 2 years old, you should also speak with a doctor before using it.

Always prioritize your child's safety by following these guidelines and seeking professional advice when necessary.

Geriatric Use

When it comes to using this medication, there are no specific guidelines or dosage adjustments mentioned for older adults. This means that the information provided does not highlight any unique safety concerns or precautions that you or your caregivers need to be aware of.

However, it's always important to consult with your healthcare provider about your individual health needs, especially if you are an older adult. They can help ensure that any medication you take is safe and appropriate for your situation.

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.

It's always best to discuss your individual situation with your healthcare provider, who can offer personalized advice and ensure that any medications you take are safe and appropriate for your kidney health.

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 apply, but you should always consult your healthcare provider for personalized advice. They can help determine the best approach for your treatment 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 tests to ensure your safety while using any medication. Your well-being is a priority, so don't hesitate to ask questions or express any concerns you may have.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. In this case, there are no known drug interactions or laboratory test interactions associated with the medication. However, always ensure that your healthcare provider is aware of all the medications you are using, as this helps them provide the best care tailored to your needs.

By discussing your full medical history and any other treatments, you can help prevent potential issues and ensure your safety.

Storage and Handling

To ensure the best performance and safety of your product, store it at a controlled room temperature between 15° and 30°C (59° and 86°F). This temperature range helps maintain the product's effectiveness.

If you notice that the seal has been broken, it’s important not to use the product. Instead, please return it to the store where you purchased it for a refund or exchange. Following these guidelines will help you use the product safely and effectively.

Additional Information

You should apply this medication topically to the affected area, using it no more than 3 to 4 times a day. This guidance applies to both adults and children aged 12 years and older. If you have any questions about how to use this medication or its effects, be sure to consult your healthcare provider for more information.

FAQ

What is 4040 GLOBE HYDROCORTISONE CREAM WITH ALOE used for?

It temporarily relieves 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, seborrheic dermatitis, psoriasis, insect bites, poison ivy, soaps, detergents, cosmetics, jewelry, and external genital and anal itching.

How should I apply this cream?

Cleanse the affected area with mild soap and warm water, gently dry it, and then apply the cream not more than 3 to 4 times daily for adults and children 12 years and older.

Can children use this cream?

Children under 12 years of age should not use this product without consulting a doctor.

What should I do if I experience bleeding while using this cream?

Stop using the cream and consult a doctor promptly.

Are there any warnings I should be aware of?

This product is for external use only, avoid contact with eyes, and do not use it in the rectum.

What should I do if I swallow this cream?

Get medical help or contact a Poison Control Center immediately.

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

There is no specific information provided regarding the use of this cream during pregnancy or lactation.

How should I store this cream?

Store it at controlled room temperature between 15°-30°C (59°-86°F) and do not use it if the seal has been broken.

Packaging Info

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

Packaging configurations for Hydrocortisone Cream.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

4040 Globe Hydrocortisone Cream with Aloe is a topical formulation containing hydrocortisone as the active ingredient. This cream is designed for dermatological use and is presented in a 1-ounce tube. The product is formulated to provide anti-inflammatory effects and is indicated for the relief of various skin conditions. The inclusion of aloe is intended to enhance skin soothing properties. The cream's composition and formulation adhere to regulatory standards set forth by the Center for Drug Evaluation and Research (CDER).

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, and jewelry, as well as external genital and anal itching.

Limitations of use: Other applications of this product should only be undertaken under the advice and supervision of a healthcare professional.

Dosage and Administration

When practical, the affected area should be cleansed with mild soap and warm water, followed by thorough rinsing. After cleansing, the area must be gently dried by patting or blotting with toilet tissue or a soft cloth prior to application.

For adults and children aged 12 years and older, the product should be applied to the affected area no more than 3 to 4 times daily. The use of this product is not recommended for children under 12 years of age; consultation with a healthcare professional is advised in such cases.

Contraindications

Use of this product is contraindicated in the following situations:

Patients with a vaginal discharge should not use this product without consulting a healthcare professional. Additionally, it is contraindicated for the treatment of diaper rash and in children under 2 years of age.

If bleeding occurs, or if the condition worsens or symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days, the use of this product should be discontinued and a healthcare professional consulted. Furthermore, this product should not be used concurrently with any other hydrocortisone product without prior medical advice.

Warnings and Precautions

For external use only. It is imperative to avoid contact with the eyes. The product should not be administered rectally using fingers, mechanical devices, or applicators. Healthcare professionals should advise patients not to exceed the recommended daily dosage unless specifically directed by a physician. In the event of bleeding, patients must consult a doctor promptly. Special caution is warranted for children under 12 years of age; a consultation with a healthcare provider is recommended prior to use.

Prior to the administration of this medication, patients should thoroughly read all label directions. It is advisable to retain the carton, as it contains essential information regarding the product.

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

Patients are instructed to discontinue use and contact their healthcare provider if bleeding occurs, if the condition worsens, or if symptoms persist for more than 7 days. Additionally, if symptoms resolve and then recur within a few days, medical advice should be sought. Patients should also consult their doctor before initiating the use of any other hydrocortisone product.

Side Effects

Patients using this product should be aware that it is intended for external use only and must avoid contact with the eyes. It is crucial not to insert this product into the rectum using fingers or any mechanical device or applicator.

For patients experiencing external anal itching, it is important to adhere to the recommended daily dosage and not exceed it unless directed by a healthcare professional. In the event of bleeding, patients are advised to consult a doctor promptly. Additionally, children under 12 years of age should seek medical advice before use.

Patients should discontinue use and consult a doctor if bleeding occurs, if the condition worsens, or if symptoms persist for more than 7 days. They should also seek medical advice if symptoms clear up and then recur within a few days, or before starting any other hydrocortisone product.

Drug Interactions

No drug interactions or drug and laboratory test interactions have been identified in the available data. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

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

Packaging configurations for Hydrocortisone Cream.
Details

Pediatric Use

Pediatric patients under 12 years of age should not use this medication without consulting a doctor. For children under 2 years of age, it is essential to seek medical advice prior to use.

For adolescents and children aged 12 years and older, the recommended application is to the affected area no more than 3 to 4 times daily.

Geriatric Use

Geriatric patients may not have specific considerations outlined in the prescribing information. The absence of recommended age cutoffs, dosage adjustments, or safety concerns suggests that the available data does not indicate a need for special precautions or monitoring in this population.

Healthcare providers should remain vigilant when prescribing this medication to elderly patients, as individual responses may vary. It is advisable to consider the overall health status and comorbidities of geriatric patients when determining treatment plans, even in the absence of explicit guidelines. Regular monitoring and assessment of therapeutic outcomes are recommended to ensure the safety and efficacy of the treatment in this demographic.

Pregnancy

There are no specific statements regarding the use of this medication 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 and weigh the potential benefits against any unknown risks to fetal outcomes. Women of childbearing potential should be counseled on the importance of effective contraception during treatment.

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 have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

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

Overdosage of the medication can lead to serious health consequences. It is imperative that healthcare professionals adhere to the recommended daily dosage guidelines to mitigate the risk of adverse effects.

In the event of suspected overdosage, immediate medical attention should be sought. Symptoms of overdosage may vary depending on the specific medication involved, but healthcare providers should be vigilant for signs of toxicity.

Management of overdosage typically involves supportive care and symptomatic treatment. Healthcare professionals are advised to monitor the patient closely and provide appropriate interventions based on the clinical presentation.

It is crucial to emphasize that patients should not exceed the recommended daily dosage unless explicitly directed by a healthcare provider. This precaution is essential to ensure patient safety and to prevent potential complications associated with overdosage.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data 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 they should not use this product if they have a vaginal discharge and should consult a doctor before treating diaper rash.

Patients should be cautioned against using this product on children under 2 years of age without prior consultation with a healthcare professional. Providers should emphasize the need to stop using the product and consult a doctor if any bleeding occurs.

Additionally, patients should be instructed to discontinue use and seek medical advice if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up only to recur within a few days. Healthcare providers should also remind patients to consult a doctor before starting any other hydrocortisone product.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It should be stored at a controlled room temperature between 15° and 30°C (59° and 86°F).

In the event that the seal has been broken, the product should not be used and must be returned to the store where it was purchased. Proper handling and adherence to these storage conditions are essential to maintain the product's integrity and efficacy.

Additional Clinical Information

The medication is administered topically, with a recommended application frequency of 3 to 4 times daily for adults and children aged 12 years and older, specifically to the affected area. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

Drug Information (PDF)

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