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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 2024
Label revision date
March 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
March 20, 2024
Manufacturer
Trifecta Pharmaceuticals USA
Registration number
M017
NDC root
69396-147
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

AWGAS Hydrocortisone Cream 1 percent is a topical medication designed to temporarily relieve itching caused by minor skin irritations, inflammation, and rashes. It can be particularly effective for conditions such as eczema, seborrheic dermatitis, psoriasis, and reactions to insect bites or plants like poison ivy, poison oak, and poison sumac. Additionally, it may help alleviate itching related to soaps, detergents, cosmetics, jewelry, and external feminine, genital, and anal areas.

This cream works by reducing inflammation and soothing the skin, providing you with relief from discomfort. However, it's important to use this product under the advice and supervision of a doctor for any other uses beyond its primary purpose.

Uses

This product is designed to temporarily relieve 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 with itching caused by soaps, detergents, cosmetics, jewelry, and external feminine, genital, and anal areas.

For any other uses, it's important to consult with your doctor to ensure it's appropriate for your situation.

Dosage and Administration

If you are an adult or a child aged 2 years and older, you can apply this medication to the affected area up to 3 to 4 times a day. Before applying, it’s best to clean the area gently with mild soap and warm water, then rinse thoroughly. Alternatively, you can pat or blot the area dry with toilet tissue or a soft cloth.

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

What to Avoid

It's important to be cautious when using this product. You should consult a doctor if you are treating diaper rash or experiencing external genital itching with vaginal discharge. Additionally, avoid using this product if you have these conditions.

While using this product, make sure to keep it away from your eyes and do not start any other hydrocortisone product without consulting your doctor first. If you're using it for external genital, feminine, or anal itching, do not exceed the recommended dosage unless directed by a doctor. If you notice any bleeding, stop using the product and seek medical advice. Lastly, do not insert this product into the rectum using fingers or any device.

Side Effects

This product is intended for external use only. You should stop using it and consult a doctor if your condition worsens or if your symptoms last longer than 7 days. If your symptoms improve and then return within a few days, discontinue use and do not start any other hydrocortisone product unless your doctor advises you to do so.

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 symptoms last longer than 7 days, or if your symptoms improve and then return within a few days. Do not start using any other hydrocortisone product unless your doctor advises you to do so.

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 have concerns about an overdose.

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 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.

However, as with any medication, it's always best to consult with your healthcare provider before using Hydrocortisone Cream to ensure it is appropriate for your individual situation. Your doctor can provide personalized advice based on your health and pregnancy.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to consult your doctor before using this product. There is a possibility that it may be excreted in breast milk, which means it could potentially affect your baby. Since the effects on nursing infants have not been thoroughly studied, exercising caution is advised. Always prioritize your health and your baby's well-being by discussing any concerns with your healthcare provider.

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 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

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 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 plan is safe and effective for your specific condition. They can help monitor your kidney health and make any necessary adjustments to your medications.

Hepatic Impairment

If you have liver problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication may affect you if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your liver health. They can help monitor your condition and make any necessary adjustments to your treatment plan.

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 keep your provider informed about any changes in your treatment plan.

Storage and Handling

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

When handling the product, make sure to do so in a clean environment to avoid contamination. Always follow any specific instructions provided for use to ensure safety and effectiveness. If you have any questions about storage or handling, don’t hesitate to reach out for guidance.

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. There are no additional details available regarding laboratory tests, abuse potential, or patient counseling.

FAQ

What is AWGAS Hydrocortisone Cream used for?

AWGAS Hydrocortisone Cream 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, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, and external feminine, genital, and anal itching.

How should I use this cream?

For adults and children 2 years and older, apply to the affected area not more than 3 to 4 times daily. Children under 2 years of age should not use it without consulting a doctor.

Are there any warnings I should be aware of?

Yes, avoid contact with the eyes, and do not use any other hydrocortisone product unless directed by a doctor. If conditions worsen or symptoms persist for more than 7 days, stop use and consult a doctor.

Can I use this cream if I am pregnant or nursing?

Consult a doctor before using this product if you are nursing, as there is a potential for excretion in breast milk and effects on a nursing infant are not well studied.

What should I do if I accidentally swallow this cream?

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

Is this cream safe for children?

Children under 2 years of age should not use this cream without consulting a doctor. For children under 12 years with external anal itching, consult a doctor.

What should I do if my symptoms do not improve?

If symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use and consult a doctor.

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

AWGAS Hydrocortisone Cream contains 1 percent hydrocortisone as the active ingredient. It is presented in a dosage form of a cream, with a total volume of 1 ounce (approximately 28.35 grams). The product is intended for topical application and is formulated to provide anti-inflammatory effects. The cream is manufactured in compliance with 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 resulting from 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 for itching caused by 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. Prior to application for external and anal itching, it is recommended that adults cleanse the affected area with mild soap and warm water, rinsing thoroughly, or patting or blotting with toilet tissue or a soft cloth.

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

Contraindications

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

Patients should consult a doctor prior to using this product for the treatment of diaper rash. Additionally, it is contraindicated for external genital itching in the presence of vaginal discharge; medical consultation is advised in such cases.

Contact with the eyes must be avoided. The initiation of any other hydrocortisone product should only occur after consulting a healthcare professional. For external genital, feminine, and anal itching, the recommended daily dosage should not be exceeded unless directed by a doctor. In the event of bleeding, discontinue use and seek medical advice. This product should not be administered rectally using fingers or any mechanical device or applicator.

Warnings and Precautions

For external use only. Healthcare professionals should advise patients to seek emergency medical assistance if the product is ingested. In such cases, contacting a Poison Control Center immediately is essential.

Patients are instructed to discontinue use and consult a healthcare provider if any of the following occur: worsening of conditions, persistence of symptoms beyond 7 days, or if symptoms resolve and then recur within a few days. Under these circumstances, patients should refrain from using any other hydrocortisone products unless specifically directed by a healthcare professional.

Side Effects

For external use only. Patients are advised to stop using this product and consult a doctor if conditions worsen or if symptoms persist for more than 7 days. Additionally, if symptoms clear up and then occur again within a few days, patients should discontinue use of this product and refrain from starting any other hydrocortisone product unless directed by 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, and a consultation with a doctor is advised. Additionally, pediatric patients under 12 years of age experiencing external anal itching should also consult a doctor prior to use.

Geriatric Use

There is no specific information 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 they may have altered pharmacokinetics and pharmacodynamics. Close monitoring is recommended to ensure safety and efficacy in this population.

Pregnancy

Hydrocortisone Cream has not been specifically studied in pregnant patients, and there are no available data regarding its safety, dosage modifications, or special precautions for use during pregnancy. As such, the potential risks and benefits of using Hydrocortisone Cream in pregnant women should be carefully considered. Healthcare professionals are advised to weigh the necessity of treatment against any potential risks to fetal outcomes, particularly in the absence of established safety data. Women of childbearing potential should be counseled on the lack of specific information regarding the use of this medication during pregnancy.

Lactation

Nursing mothers are advised to consult a doctor before using this product. There is a potential for excretion in breast milk, and the effects on a nursing infant are not well studied; therefore, caution is advised when considering the use of this product during lactation.

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 outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

In the context of overdosage, 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 within a timeframe that warrants its use.

Healthcare providers should remain vigilant and report any observed adverse effects to the appropriate regulatory authorities to contribute to the ongoing assessment 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 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 if the product is swallowed. For patients using the product for the treatment of diaper rash, it is important to recommend consulting a doctor prior to use.

Patients experiencing external genital itching accompanied by vaginal discharge should also be instructed to consult a doctor. Healthcare providers should emphasize that 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 directed by a doctor.

It is crucial to inform patients to avoid contact with the eyes while using this product. Additionally, patients should be cautioned against exceeding the recommended daily dosage for external genital, feminine, and anal itching unless directed by a doctor. In the event of bleeding, patients should stop use and consult a doctor.

Finally, healthcare providers should instruct patients not to insert the 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 should be stored at a controlled room temperature ranging from 20°C to 25°C (68°F to 77°F) to ensure optimal stability and efficacy. Proper storage conditions are essential to maintain the integrity of the product.

Additional Clinical Information

The medication is administered topically, with a recommended application frequency of no more than 3 to 4 times daily for adults and children aged 2 years and older. 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.

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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.