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Hydrocortisone 1%

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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 2019
Label revision date
December 18, 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 2019
Label revision date
December 18, 2024
Manufacturer
Trifecta Pharmaceuticals Usa Llc
Registration number
M017
NDC root
69396-055
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

This medication 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 (a chronic skin condition that causes inflammation and irritation), seborrheic dermatitis (a skin disorder that causes scaly patches and red skin), psoriasis (a condition that leads to the rapid growth of skin cells), insect bites, and reactions to plants like poison ivy, oak, or sumac. It can also relieve itching caused by soaps, detergents, cosmetics, jewelry, and external feminine genital and anal areas.

While this product is effective for these specific uses, it's important to consult with a doctor for any other applications to ensure safe and appropriate use.

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 safety and effectiveness.

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. For best results, especially for external and anal itching, it’s a good idea to first clean the area with mild soap and warm water, then rinse thoroughly. You can also gently pat or blot the area with toilet tissue or a soft cloth before applying the product.

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

What to Avoid

It's important to use this product safely and as directed. You should not start using any other hydrocortisone product unless your doctor tells you to do so. Additionally, make sure not to exceed the recommended daily dosage for treating itching in the external genital area, feminine area, or anal area unless advised by your doctor.

Also, please avoid inserting this product into the rectum using your fingers or any medicated device or applicator, as this can lead to complications. Always follow your healthcare provider's instructions to ensure your safety and the effectiveness of the treatment.

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. Additionally, 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 for diaper rash or for external genital itching if you have a vaginal discharge; in these cases, consult your doctor. Always keep this product out of the reach of children. If it is swallowed, seek 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 symptoms improve and then return within a few days. Do not start using any other hydrocortisone product without your doctor's 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 signs of overdose for this medication, general symptoms can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these signs, seek medical help right away.

In case of an overdose, contact your local emergency services or go to the nearest hospital. It's always better to err on the side of caution when it comes to your health. Remember, if you have any concerns or questions about your medication, don’t hesitate to reach out to your healthcare provider for guidance.

Pregnancy Use

This product is intended for external use only, so it's important to avoid applying it to sensitive areas like diaper rashes. If you experience external genital itching and have a vaginal discharge, please consult your doctor before using this product. For children under 2 years old, it's crucial to seek medical advice before use.

If your symptoms worsen or do not improve after 7 days, stop using the product and talk to your doctor. Additionally, if your symptoms clear up but then return within a few days, do not use any other hydrocortisone product unless directed by your doctor. Always prioritize your health and safety during pregnancy by consulting with a healthcare professional when in doubt.

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, the information available does not indicate any risk of the cream being passed into breast milk or affecting your infant.

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

Pediatric Use

It's important to keep this medication out of the reach of children. If a child accidentally swallows it, seek medical help or contact a Poison Control Center right away. For children aged 2 years and older, you can apply the medication to the affected area up to 3 to 4 times a day. However, if your child is under 2 years old, do not use it without 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.

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. If you or a loved one is an older adult, it’s always a good idea to discuss any medications with a healthcare provider. They can help ensure that the treatment is safe and appropriate, considering any unique health needs or conditions that may be present.

Since there are no dosage adjustments or special precautions mentioned for elderly patients, your healthcare provider will be the best resource for personalized advice. Always keep them informed about any other medications or health issues to ensure safe and effective care.

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 situation. 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 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, and your healthcare team is there to support you.

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, maintaining open communication with your healthcare team about all medications and tests is crucial for safe and effective care. Always feel free to ask questions or express concerns regarding your treatment plan.

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, make 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 medication topically to the affected area, and it can be used by adults and children aged 2 years and older. Make sure to apply it no more than 3 to 4 times a day for best results. There is no additional information available regarding laboratory tests, abuse potential, or patient counseling.

FAQ

What is this product used for?

This product is used for temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to conditions like eczema, psoriasis, and insect bites.

Who can use this product?

Adults and children 2 years of age and older can use this product. Children under 2 years of age should not use it without consulting a doctor.

How often can I apply this product?

You can apply this product to the affected area not more than 3 to 4 times daily.

Are there any warnings I should be aware of?

Yes, this product is for external use only. Do not use it for diaper rash or if you have a vaginal discharge; consult a doctor in these cases.

What should I do if my symptoms persist?

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

What should I do if I accidentally swallow this product?

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

Can I use this product for external genital itching?

You should consult a doctor before using this product for external genital itching, especially if you have a vaginal discharge.

Is there any specific information for nursing mothers?

There are no specific warnings or recommendations regarding the use of this product in nursing mothers mentioned.

What should I do if I want to use another hydrocortisone product?

Do not begin the use of any other hydrocortisone product unless directed by a doctor.

How should I store this product?

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

Packaging Info

Below are the non-prescription pack sizes of Hydrocortisone 1% (hydrocortisone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Hydrocortisone 1%.
Details

Drug Information (PDF)

This file contains official product information for Hydrocortisone 1%, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

Hydrocortisone is a corticosteroid with a molecular weight of 362.46 g/mol. The chemical formula is C21H30O5. Specific physical characteristics and inactive ingredients are not provided in the available data.

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, 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 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:

  • Initiation of any other hydrocortisone product should only occur under the guidance of a healthcare professional.

  • Exceeding the recommended daily dosage for external genital, feminine, and anal itching is contraindicated unless specifically directed by a healthcare provider.

  • Administration of this product into the rectum using fingers or any medicated device or applicator is contraindicated.

Warnings and Precautions

For external use only. This product is not intended for the treatment of diaper rash; healthcare professionals should advise patients to consult a doctor for appropriate management. Additionally, it is contraindicated for use in cases of external genital itching accompanied by vaginal discharge; a consultation with a healthcare provider is recommended in such instances.

General precautions must be observed to ensure safety. This product should be kept out of the reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

Patients should be instructed to discontinue use and consult a doctor 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. Under these circumstances, patients should refrain from using any other hydrocortisone products unless specifically directed by a healthcare professional.

In cases of ingestion, it is imperative to seek emergency medical help or contact a Poison Control Center immediately.

Side Effects

For external use only. Patients are advised to discontinue use and consult a healthcare professional if conditions worsen or if symptoms persist for more than 7 days. Additionally, if symptoms clear up and then recur within a few days, patients should stop using this product and refrain from starting any other hydrocortisone product unless directed by a doctor.

Drug Interactions

The initiation of any additional hydrocortisone product should only occur after consultation with a healthcare professional. This precaution is essential to avoid potential adverse effects or interactions that may arise from concurrent use.

No specific drug or laboratory test interactions have been identified in the available data. Therefore, routine monitoring or dosage adjustments related to drug interactions are not indicated at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Hydrocortisone 1% (hydrocortisone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Hydrocortisone 1%.
Details

Pediatric Use

Pediatric patients should be kept out of the reach of children. In the event of accidental ingestion, medical assistance or contact with a Poison Control Center is advised immediately.

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. However, for children under 2 years of age, the use of this medication is not recommended without consulting a doctor. Additionally, children under 12 years of age experiencing external anal itching should also consult a doctor prior to use.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

This product is indicated for external use only and is not recommended for the treatment of diaper rash. Pregnant patients should consult with a healthcare professional prior to use, especially if experiencing external genital itching or vaginal discharge. The safety of this product during pregnancy has not been established, and potential risks to fetal outcomes are not well characterized.

For children under 2 years of age, the use of this product is contraindicated, and a doctor should be consulted. Pregnant patients should be advised to discontinue use and seek medical advice if symptoms worsen or persist for more than 7 days. Additionally, if symptoms resolve and then recur within a few days, pregnant patients should refrain from using this product or any other hydrocortisone product unless directed by a healthcare provider.

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 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 absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise, as the clinical presentation can vary depending on the substance involved and the individual patient's response. Common symptoms of overdose may include, but are not limited to, altered mental status, cardiovascular instability, and respiratory distress.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs. The use of activated charcoal may be considered if the patient presents within a suitable timeframe and is deemed appropriate based on clinical judgment.

Furthermore, it is recommended to consult local poison control centers or toxicology experts for guidance on specific management protocols and antidotes, if applicable. Continuous assessment and supportive measures are critical in managing the patient effectively until they stabilize.

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 keep this product out of the reach of children. Instruct patients that if the product is swallowed, they should seek medical help or contact a Poison Control Center immediately.

Patients should be informed to stop using the product and consult a doctor if their condition worsens. Additionally, they should discontinue use and seek medical advice if symptoms persist for more than 7 days or if symptoms clear up and then recur within a few days. It is important to emphasize that patients should not begin using any other hydrocortisone product unless directed by a healthcare professional.

When using this product, patients must be cautioned to avoid contact with the eyes. For those using the product for external genital, feminine, and anal itching, it is crucial to adhere to the recommended daily dosage and not exceed it 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 this product into the rectum using fingers or any medicated 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, 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 1%, 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 1%, 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.