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Hydrocortisone

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Active ingredient
Hydrocortisone 1 g/100 g
Other brand names
Drug class
Corticosteroid
Dosage form
Ointment
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 11, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Hydrocortisone 1 g/100 g
Other brand names
Drug class
Corticosteroid
Dosage form
Ointment
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 11, 2024
Manufacturer
TRIFECTA PHARMACEUTICALS USA LLC
Registration number
M017
NDC root
69396-149
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 Ointment 1 percent is a topical medication 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, insect bites, and reactions to poison ivy, oak, or sumac. Additionally, it can help alleviate itching related to soaps, detergents, cosmetics, jewelry, and external feminine genital and anal areas.

This ointment works by reducing inflammation and soothing the skin, making it a helpful option for managing discomfort associated with various skin issues. However, it's important to use this product under the advice and supervision of a doctor for any other uses beyond its primary indications.

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

For any other uses, it's important to consult with your doctor to ensure 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 with mild soap and warm water, rinsing thoroughly. Alternatively, you can gently pat or blot the area with toilet tissue or a soft cloth.

If you have a child under 2 years old, do not use this product without 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 this medication. Always follow these guidelines to ensure safe and effective use.

What to Avoid

You should avoid using this product for treating diaper rash or external genital itching if you have a vaginal discharge; in these cases, it's important to consult a doctor first. If your condition worsens, symptoms last more than 7 days, or if they clear up and then return within a few days, stop using the product and seek medical advice before using any other hydrocortisone product.

While using this product, be careful to avoid contact with your eyes. Do not exceed the recommended daily dosage for external genital, feminine, and anal itching unless directed by a doctor. If you experience any bleeding, stop using the product immediately and consult a doctor. Additionally, 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 using it on internal areas. If you are treating diaper rash or experiencing external genital itching with a vaginal discharge, it’s important to consult your doctor before use.

You should stop using this product and contact your doctor if your condition worsens, if symptoms last longer than 7 days, or if symptoms improve and then return within a few days. Do not start using any other hydrocortisone product without your doctor's guidance.

If you accidentally swallow this product, seek emergency medical help or contact a Poison Control Center right away.

Overdose

If you suspect an overdose, it's important to stay calm and take 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 immediate medical help. It's always better to be safe and get checked by a healthcare professional. Remember, your health and safety are the top priority.

Pregnancy Use

If you are pregnant or planning to become pregnant, it is important to avoid using this product. The potential risks associated with its use during pregnancy are significant, and it is best to consult your doctor for guidance. They can provide you with the necessary information and support to ensure your health and the health of your baby. Always prioritize open communication with your healthcare provider regarding any medications or treatments you may be considering during this time.

Lactation Use

If you are breastfeeding, you can use hydrocortisone ointment without specific warnings or recommendations against it. The information available does not indicate any particular precautions or considerations for nursing mothers regarding this medication.

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

Pediatric Use

If your child is under 2 years old, it's important not to use this medication without first consulting a doctor. For children between 2 and 12 years old who are experiencing external anal itching, you should also reach out to a healthcare professional for guidance.

For children aged 2 years and older, you can apply the medication to the affected area, but be sure to limit the application to no more than 3 to 4 times a day. Always follow your healthcare provider's recommendations to ensure your child's safety and well-being.

Geriatric Use

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

Renal Impairment

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

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

Hepatic Impairment

If you have liver problems, it's important to know that 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 differently due to your liver health.

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver function and how it relates to your treatment. They can help ensure that your medication is safe and effective for you.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking. In this case, there are no specific drug interactions or laboratory test interactions noted, which means that this medication is generally considered safe to use alongside other treatments and tests. However, every individual is different, and your healthcare provider can help ensure that your overall treatment plan is safe and effective for you. Always feel free to ask questions or express any concerns you may have regarding your medications or tests.

Storage and Handling

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

When handling the product, be sure to do so with clean hands and in a clean environment to avoid contamination. Always follow any specific disposal instructions provided to ensure safe and responsible disposal of any components.

Additional Information

You should apply this topical 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. It's important to keep this product out of the reach of children. If swallowed, seek medical help or contact a Poison Control Center immediately.

If your symptoms worsen, persist for more than 7 days, or clear up and then return within a few days, stop using the product and consult a doctor. Avoid contact with your eyes, and do not use any other hydrocortisone product unless directed by a doctor. For external genital, feminine, and anal itching, do not exceed the recommended dosage unless advised by a healthcare professional. If you experience any bleeding, stop using the product and consult a doctor. Additionally, do not insert this product into the rectum using fingers or any device.

FAQ

What is AWGAS Hydrocortisone Ointment used for?

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

What conditions can this ointment help with?

It can help with itching due to eczema, seborrheic dermatitis, psoriasis, insect bites, poison ivy, soaps, detergents, cosmetics, jewelry, and external feminine genital and anal itching.

How should I apply this ointment?

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

Can I use this ointment on children under 2 years old?

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

What should I do if my symptoms persist?

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

Are there any warnings for using this ointment?

Yes, it is for external use only, and you should avoid contact with eyes. Consult a doctor for specific conditions like diaper rash or external genital itching with vaginal discharge.

Is this ointment safe to use during pregnancy?

You should not use this product during pregnancy without consulting a doctor.

What should I do if I accidentally swallow this ointment?

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

How should I store this ointment?

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

Packaging Info

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

Packaging configurations for Hydrocortisone.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

AWGAS Hydrocortisone Ointment contains 1 percent hydrocortisone as the active ingredient. It is presented in a dosage form of an ointment, with a total volume of 1 ounce. The product is manufactured under the regulatory oversight of 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 caused by 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.

No teratogenic or nonteratogenic effects have been reported.

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 the affected area be cleansed with mild soap and warm water, followed by thorough rinsing or gentle patting with toilet tissue or a soft cloth.

For children under 2 years of age, the product is not recommended, and consultation with a healthcare professional is advised. Additionally, for children under 12 years of age experiencing external anal itching, it is essential to consult a doctor before use.

Contraindications

The product is contraindicated for the treatment of diaper rash and external genital itching in the presence of vaginal discharge; consultation with a doctor is advised in these cases.

Discontinue use and consult a healthcare professional if conditions worsen, symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. The use of any other hydrocortisone product should not be initiated without medical guidance.

While using this product, avoid contact with the eyes. For external genital, feminine, and anal itching, do not exceed the recommended daily dosage unless directed by a doctor. In the event of bleeding, discontinue use and seek medical advice. This product should not be administered rectally using fingers or any mechanical device or applicator.

Warnings and Precautions

This product is intended for external use only. It is imperative that healthcare professionals advise patients against using this product for the treatment of diaper rash; consultation with a physician is recommended in such cases. Additionally, patients should not use this product for external genital itching if they are experiencing vaginal discharge, and they should seek medical advice.

Patients should be instructed to discontinue use and contact their healthcare provider if any of the following occur: the condition worsens, symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. In such instances, patients should refrain from using any other hydrocortisone products unless specifically directed by a healthcare professional.

In the event of accidental ingestion, it is crucial to seek emergency medical assistance or contact a Poison Control Center immediately.

Side Effects

Patients should be aware that this product is intended for external use only.

In the event that conditions worsen or symptoms persist for more than 7 days, it is advised to discontinue use of this product. Should symptoms clear up and then reoccur within a few days, patients should also stop using the product. Furthermore, it is important not to initiate the use of any other hydrocortisone product unless directed by a healthcare professional.

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions with laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

Packaging & NDC

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

Packaging configurations for Hydrocortisone.
Details

Pediatric Use

Pediatric patients under 2 years of age should not use this medication and must consult a doctor for guidance. For children under 12 years of age experiencing external anal itching, it is advised to consult a doctor prior to use.

For pediatric patients aged 2 years and older, the medication may be applied to the affected area no more than 3 to 4 times daily.

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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

The use of this product is contraindicated in pregnant patients. Women who are pregnant or planning to become pregnant should consult a healthcare professional prior to using this product. It is essential to evaluate the potential risks and benefits in such cases to ensure the safety of both the patient and the developing fetus.

Lactation

There are no specific warnings or recommendations regarding the use of hydrocortisone ointment in lactating mothers. Additionally, the insert does not provide any specific considerations or precautions related to lactation or breastfeeding. Therefore, healthcare professionals may consider the use of hydrocortisone ointment in nursing mothers without specific concerns related to excretion in breast milk or effects on 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 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 based on clinical judgment.

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 may include symptomatic treatment and monitoring of vital signs. If an overdose is suspected, healthcare providers should consider contacting a poison control center for further guidance on management strategies tailored to the specific situation.

As always, maintaining open communication with patients and their families about the importance of adhering to prescribed dosages is essential in preventing potential overdosage scenarios.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

Postmarketing experience has not been explicitly detailed in the provided text. As such, there are no additional adverse events or rare case reports to summarize at this time.

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 the importance of discontinuing use and seeking medical advice if the condition worsens or if symptoms persist for more than 7 days. Additionally, patients should be informed that if symptoms clear up and then recur within a few days, they should stop using the product and refrain from starting any other hydrocortisone product unless directed by a healthcare professional.

It is crucial to advise patients to avoid contact with the eyes while using this product. They should not exceed the recommended daily dosage for external genital, feminine, and anal itching unless specifically directed by a doctor. In the event of bleeding, patients must be instructed to stop use immediately and consult a healthcare provider.

Finally, healthcare providers should caution patients against inserting 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 is essential to store the product at a controlled room temperature, maintaining a range of 20° to 25°C (68° to 77°F). Proper storage conditions are crucial to ensure the integrity and efficacy of the product.

Additional Clinical Information

Patients aged 2 years and older are advised to apply the topical product to the affected area no more than 3 to 4 times daily. Clinicians should counsel patients to keep the product out of the reach of children and to seek medical assistance or contact a Poison Control Center immediately if swallowed. 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 recur within a few days.

Additionally, patients should avoid contact with the eyes and refrain from using any other hydrocortisone products without prior consultation with a healthcare provider. For external genital, feminine, and anal itching, it is important not to exceed the recommended daily dosage unless directed by a doctor. In cases of bleeding, patients should stop use and consult a physician. The product should not be inserted into the rectum using fingers or any mechanical device or applicator.

Drug Information (PDF)

This file contains official product information for Hydrocortisone, 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, 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.