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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 2022
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 2022
Label revision date
May 8, 2025
Manufacturer
Trifecta Pharmaceuticals USA
Registration number
M017
NDC root
69396-096
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

4075 Globe Hydrocortisone Cream with Aloe is a topical cream designed to provide temporary relief from itching caused by minor skin irritations, inflammation, and rashes. It is particularly effective for conditions such as eczema, seborrheic dermatitis, psoriasis, and itching from insect bites or contact with plants like poison ivy, poison oak, and poison sumac. Additionally, it can help alleviate itching related to soaps, detergents, cosmetics, and jewelry, as well as external anal and genital itching.

This cream contains hydrocortisone, which is a type of medication that helps reduce inflammation and soothe irritated skin. While it can be beneficial for various skin issues, it's important to use it under the advice and supervision of a doctor for any other uses.

Uses

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

Additionally, this product offers temporary relief for external anal and genital itching. However, for any other uses, it's important 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. This is suitable for adults and children aged 2 years and older.

For external itching around the anal and genital areas in adults, it's best to start by gently cleaning the area with mild soap and warm water, then rinse thoroughly. After that, pat or blot the area dry with toilet tissue or a soft cloth before applying the medication. Again, you can use it up to 3 to 4 times daily.

If your child is under 2 years old, or if they are under 12 years old, it's important to consult a doctor before using this medication.

What to Avoid

You should avoid using this product in the genital area if you have a vaginal discharge or for treating diaper rash without first consulting a doctor. If your condition worsens, symptoms last longer than 7 days, or if you experience rectal bleeding, stop using the product and seek medical advice. It's important not to use any other hydrocortisone product unless directed by a healthcare professional.

While using this product, be careful to avoid contact with your eyes, and do not exceed the recommended dosage unless instructed by your doctor. Additionally, do not insert the product directly into the rectum using your fingers or any device. Always prioritize your health and consult a doctor if you have any concerns.

Side Effects

This product is intended for external use only. If you notice that your condition worsens, symptoms last longer than 7 days, or if they improve and then return within a few days, it’s important to stop using the product and consult a doctor. Additionally, if you experience rectal bleeding, you should also seek medical advice before using any other hydrocortisone product.

Warnings and Precautions

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

You should stop using this product and call your doctor if your condition worsens, if your symptoms last more than 7 days, or if they improve and then return within a few days. Additionally, if you experience rectal bleeding, it’s important to stop use and consult your doctor. Before starting any other hydrocortisone product, make sure to ask your doctor for 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 effects of an overdose for this medication, you should be aware of general signs that may indicate a problem. These can include unusual drowsiness, confusion, or difficulty breathing.

If you notice any of these symptoms or if you believe you have taken too much of the medication, seek medical help right away. Contact your healthcare provider or go to the nearest emergency room. It's always better to be safe and get checked out if you're unsure.

Pregnancy Use

It's important to be cautious when considering treatments during pregnancy. If you are dealing with diaper rash, it's best to consult your doctor instead of using over-the-counter treatments. Similarly, if you experience external genital itching accompanied by vaginal discharge, seek medical advice before using any products.

For parents, please note that treatments should not be used for children under 2 years of age without consulting a doctor. Additionally, if a child under 12 years is experiencing external or anal itching, it's advisable to talk to a healthcare professional before proceeding with any treatment. Always prioritize safety and professional guidance when it comes to health concerns during pregnancy and for young children.

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 medications while breastfeeding, it's a good idea to consult with your healthcare provider for personalized advice.

Pediatric Use

When using this medication for children, it's important to follow specific guidelines. For children aged 2 years 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 not use this medication without first consulting a doctor. Additionally, if your child is under 12 years old and is experiencing external or anal itching, it's best to consult a doctor before use. Always prioritize your child's safety and seek professional advice when needed.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that if you or a loved one is an older adult 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 the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to change based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment is safe and effective for your specific condition. They can help you understand any necessary precautions or adjustments based on your kidney health.

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 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 how different treatments may affect each other and your overall health.

While there are no specific interactions with laboratory tests mentioned, discussing all medications and tests with your healthcare provider is always a good practice. This way, you can ensure that your treatment plan is safe and effective.

Storage and Handling

To ensure the best performance and safety 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 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 use and disposal to ensure safety and effectiveness.

Additional Information

You should apply this medication topically to the affected area, using it no more than 3 to 4 times a day if you are an adult or a child aged 2 years and older. If your child is under 2 years old, do not use this medication without consulting a doctor first. There are no additional details available regarding laboratory tests, abuse potential, or patient counseling.

FAQ

What is 4075 GLOBE HYDROCORTISONE CREAM WITH ALOE used for?

It 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 from eczema, seborrheic dermatitis, psoriasis, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, and external anal and genital itching.

How should adults and children 2 years and older use this cream?

Apply to the affected area not more than 3 to 4 times daily.

What should I do if I have external anal or genital itching?

Clean 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.

Can children under 2 years use this cream?

No, you should consult a doctor before using it on children under 2 years of age.

What should I do if my symptoms worsen or persist?

Stop using the product and consult a doctor if conditions worsen, symptoms persist for more than 7 days, or if rectal bleeding occurs.

Are there any contraindications for using this cream?

Do not use it in the genital area 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 directly into the rectum.

What should I do if I accidentally swallow this cream?

Get medical help or contact a Poison Control Center immediately.

How should I store this cream?

Store it at a controlled room temperature of 20°- 25°C (68°-77°F).

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

4075 Globe Hydrocortisone Cream with Aloe is a topical formulation designed for dermatological use. This cream contains hydrocortisone as the active ingredient, which is a corticosteroid known for its anti-inflammatory properties. The product is presented in a 16-ounce container, suitable for various applications. The inclusion of aloe is intended to provide additional soothing effects on the skin. The formulation is designed to deliver effective relief from skin irritation and inflammation.

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 plants such as poison ivy, poison oak, and poison sumac. It is also effective in alleviating itching caused by soaps, detergents, cosmetics, and jewelry. Additionally, this drug provides temporary relief of 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 medication to the affected area no more than 3 to 4 times daily.

In cases of external anal and genital itching in adults, it is advised to 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 prior to application. The medication should then be applied to the affected area no more than 3 to 4 times daily.

For children under 2 years of age, consultation with a physician is recommended before use. Additionally, for children under 12 years of age, it is also advised to seek a doctor's guidance prior to administration.

Contraindications

Use of this product is contraindicated in the following situations:

  • Application in the genital area is contraindicated in patients with vaginal discharge; medical consultation is advised.

  • The product should not be used for the treatment of diaper rash without prior consultation with a healthcare professional.

Additionally, patients should discontinue use and seek medical advice if any of the following occur:

  • Symptoms worsen or persist for more than 7 days, or if symptoms resolve and then recur within a few days.

  • Rectal bleeding is observed.

It is also advised to avoid contact with the eyes and not to exceed the recommended dosage unless directed by a healthcare provider. Direct application into the rectum using fingers or any mechanical device or applicator is not recommended.

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 of the product.

In the event of accidental ingestion, immediate medical assistance should be sought. Patients should be instructed to contact a Poison Control Center or seek emergency medical help without delay.

Healthcare providers should counsel patients to discontinue use and consult their physician if any of the following occur: worsening of conditions, persistence of symptoms beyond 7 days, or if symptoms resolve only to recur within a few days. Additionally, patients should be advised against initiating the use of any other hydrocortisone products without prior consultation with a healthcare professional.

Patients must also be informed to seek medical attention if rectal bleeding occurs, as this may indicate a serious underlying condition that requires further evaluation and management.

Side Effects

For external use only. Patients should discontinue use and consult a doctor if conditions worsen, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. Additionally, patients should seek medical advice if rectal bleeding occurs. It is advised not to initiate the use of any other hydrocortisone product without prior consultation with a healthcare professional.

Drug Interactions

The use of hydrocortisone products should be approached with caution. It is advised that patients do not initiate the use of any other hydrocortisone product without prior consultation with a healthcare professional. This precaution is essential to avoid potential adverse effects or interactions that may arise from concurrent use.

Currently, there are no specific drug or laboratory test interactions identified in the available data. However, healthcare providers should remain vigilant and monitor for any unforeseen interactions when hydrocortisone is administered alongside other medications or during laboratory testing.

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 aged 2 years and older may apply the medication to the affected area no more than 3 to 4 times daily. For children under 2 years of age, the use of this medication is not recommended; consultation with a doctor is advised. Additionally, pediatric patients under 12 years of age experiencing external and anal itching should also consult a doctor prior to use.

Geriatric Use

There is no specific information available regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. 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

Pregnant patients should be advised against using this medication for the treatment of diaper rash and external genital itching, particularly if they have a vaginal discharge. Consultation with a healthcare provider is recommended in these cases to ensure safety and appropriateness of treatment.

Additionally, this medication is not indicated for use in children under 2 years of age, and healthcare providers should be consulted for any use in children under 12 years of age experiencing external and anal itching. The safety and efficacy of this medication in pregnant patients and young children have not been established, and caution is warranted.

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 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 clinical trials for this medication. Consequently, there is no available information regarding 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 warranted in these patients to ensure safety and therapeutic effectiveness.

Overdosage

In the context of overdosage, there is currently no specific information available regarding the effects or management of an overdose for this medication. Healthcare professionals are advised to monitor patients closely for any unusual symptoms or adverse reactions that may arise.

In the absence of detailed overdosage data, it is recommended that standard supportive measures be employed. This includes ensuring the patient's safety, providing symptomatic treatment, and considering the use of activated charcoal if the ingestion occurred recently and the patient is alert.

Healthcare providers should remain vigilant and report any observed adverse effects to the appropriate regulatory authorities to enhance the understanding of the medication's safety profile.

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

Patients should be advised to seek immediate medical assistance or contact a Poison Control Center if the product is swallowed. It is important to inform patients that the product should not be used in the genital area if they have a vaginal discharge and that they should consult a doctor in such cases. Additionally, patients should be cautioned against using the product for the treatment of diaper rash and should seek medical advice if they are considering its use for this purpose.

Patients must be instructed to discontinue use and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. They should also be advised not to start using any other hydrocortisone product without first consulting a doctor. Furthermore, patients should be informed to stop using the product and seek medical attention if rectal bleeding occurs.

While using the product, patients should be reminded to avoid contact with the eyes. It is essential to communicate that the product should not be used in greater amounts than directed unless specifically instructed to do so by a doctor. Lastly, patients should be cautioned 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 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

The medication is administered topically, with a recommended application frequency of 3 to 4 times daily for adults and children aged 2 years and older. For children under 2 years of age, it is advised to consult a doctor before use. There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

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.

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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.