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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 2021
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 2021
Label revision date
December 18, 2024
Manufacturer
Trifecta Pharmaceuticals Usa Llc
Registration number
M017
NDC root
69396-081
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

Hydrocortisone is a medication that provides temporary relief from external anal itching. It is commonly used to alleviate itching associated with minor skin irritations and rashes. By reducing inflammation and irritation in the affected area, hydrocortisone helps to soothe discomfort and promote healing.

While it is effective for these purposes, it's important to use hydrocortisone as directed and consult with a doctor for any other uses to ensure safety and effectiveness.

Uses

If you're experiencing external anal itching, this product can provide temporary relief. It’s also effective for soothing itching caused by minor skin irritations and rashes. However, for any other uses, it's important to consult with your doctor for guidance and supervision.

Dosage and Administration

Before using this product, it's important to prepare the affected area properly. For adults, start by gently cleansing the area with a suitable wipe, then pat it dry with a tissue or a soft cloth. This helps ensure that the product can work effectively.

If you are 12 years old or older, you can apply the product to the affected area up to three to four times a day. However, if you are under 12 years old, you should not use this product without first consulting a doctor. Following these steps will help you use the product safely and effectively.

What to Avoid

It's important to be aware of certain situations where you should not use this medication. Specifically, do not use it for treating diaper rash; always consult your doctor for appropriate alternatives. If you experience any bleeding, if your condition worsens, or if your symptoms last more than 7 days or return shortly after improvement, stop using the product and seek medical advice.

While using this medication, avoid contact with your eyes, and do not exceed the recommended dosage unless your doctor advises otherwise. Additionally, do not insert the medication into the rectum using fingers or any devices. Following these guidelines will help ensure your safety and the effectiveness of your treatment.

Side Effects

You should use this product only on the skin and not for any other purpose. If you experience any bleeding, notice that your condition is getting worse, or if your symptoms last more than 7 days or improve and then return shortly after, it’s important to stop using the product and consult a doctor. Additionally, do not start using any other hydrocortisone product without first speaking to your healthcare provider.

Warnings and Precautions

This product is for external use only, so please avoid swallowing it. If you accidentally swallow it, seek emergency medical help immediately or contact the Poison Control Center at 1-800-222-1222.

You should stop using this product and call your doctor if you experience any bleeding, if your condition worsens, or if your symptoms last more than 7 days. Additionally, if your symptoms improve and then return within a few days, do not start using any other hydrocortisone product without consulting your doctor first.

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 have concerns about a possible overdose, seek medical help right away. It's always better to err on the side of caution when it comes to your health. Remember, if you are ever in doubt, contacting a healthcare professional or poison control can provide you with the guidance you need.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that this medication should not be used for treating diaper rash. Always consult your doctor for guidance on safe treatment options during pregnancy. Your healthcare provider can help you find the best solutions for your needs while ensuring the safety of you and your baby.

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, it's best to exercise caution. Always prioritize your health and your baby's well-being by discussing any concerns with your healthcare provider.

Pediatric Use

If your child is under 12 years old, it's important not to use this medication without first consulting a doctor. For those aged 12 and older, you can apply the medication to the affected area, but be sure to do so no more than 3 to 4 times a day. Always follow these guidelines to ensure your child's safety and well-being.

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 there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations for the medication do not include special monitoring or safety considerations tailored for patients with renal impairment (kidney issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your kidney health. They can provide guidance based on your individual situation.

Hepatic Impairment

If you have liver problems, it's important to know that the information provided does not include specific guidelines about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no detailed recommendations available for how your liver health might affect the use of this medication.

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and appropriate for your liver health. They can help you understand how to manage your condition while considering any medications you may need.

Drug Interactions

It's important to talk to your healthcare provider before starting any other hydrocortisone product. Mixing medications can lead to unexpected interactions that may affect how well they work or increase the risk of side effects. Your doctor can help ensure that any new treatments are safe and appropriate for your health needs. Always prioritize open communication about your medications to maintain your well-being.

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 product's effectiveness and safety.

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

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 12 years and older. It's important to avoid contact with your eyes and not to exceed the recommended dosage unless your doctor advises otherwise.

If you experience any bleeding, if your condition worsens, or if your symptoms persist for more than 7 days or return shortly after improvement, stop using the product and consult your doctor. Additionally, do not use any other hydrocortisone product without first discussing it with your healthcare provider.

FAQ

What is Hydrocortisone used for?

Hydrocortisone temporarily relieves external anal itching and provides relief from minor skin irritations and rashes.

How should I apply Hydrocortisone?

Cleanse the affected area by patting or blotting, then gently dry before applying Hydrocortisone to the affected area no more than 3 to 4 times daily for adults and children 12 years and older.

Are there any age restrictions for using Hydrocortisone?

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

What should I avoid while using Hydrocortisone?

Avoid contact with eyes, do not exceed the recommended dosage, and do not insert it into the rectum using fingers or any device.

When should I stop using Hydrocortisone?

Stop use and consult a doctor if bleeding occurs, if the condition worsens, or if symptoms persist for more than 7 days.

Can I use Hydrocortisone for diaper rash?

No, do not use Hydrocortisone for the treatment of diaper rash; consult a doctor instead.

What should nursing mothers know before using Hydrocortisone?

Nursing mothers should consult a doctor before using Hydrocortisone, as there is potential for excretion in breast milk and effects on a nursing infant are not well studied.

What should I do if I accidentally swallow Hydrocortisone?

If swallowed, get medical help or contact Poison Control Center immediately at 1-800-222-1222.

How should I store Hydrocortisone?

Store Hydrocortisone at a controlled room temperature of 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

CDER 397141 CVS Hydrocortisone is a pharmaceutical formulation containing hydrocortisone as the active ingredient. Hydrocortisone is a corticosteroid with anti-inflammatory and immunosuppressive properties. The molecular weight of hydrocortisone is 362.46 g/mol, and its chemical formula is C21H30O5. This product is available in a dosage form suitable for topical application. The formulation is designed to provide effective relief from inflammatory skin conditions.

Uses and Indications

This drug is indicated for the temporary relief of external anal itching. It also provides temporary relief of itching associated with minor skin irritations and rashes.

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

Dosage and Administration

For adults, it is recommended to cleanse the affected area by patting or blotting with an appropriate cleansing wipe prior to application. The area should then be gently dried by patting or blotting with a tissue or soft cloth.

For adults and children aged 12 years and older, the product should be applied to the affected area no more than 3 to 4 times daily.

Use of this product is not recommended for children under 12 years of age without consulting a doctor.

Contraindications

The product is contraindicated for the treatment of diaper rash; consultation with a healthcare professional is advised prior to use in this context.

Additionally, the following conditions warrant discontinuation of use and consultation with a doctor:

  • Bleeding occurs.

  • The condition worsens.

  • Symptoms persist for more than 7 days or resolve and recur within a few days.

It is also advised not to initiate the use of any other hydrocortisone product without prior consultation with a healthcare professional.

While using the product, avoid contact with the eyes, do not exceed the recommended daily dosage unless directed by a doctor, and refrain from inserting the product into the rectum using fingers or any mechanical device or applicator.

Warnings and Precautions

For external use only. It is imperative that healthcare professionals advise patients to avoid ingestion of the product. In the event of accidental swallowing, immediate medical assistance should be sought by contacting the Poison Control Center at 1-800-222-1222.

Patients should be instructed to discontinue use and consult their healthcare provider if any of the following occur: bleeding, worsening of the condition, or if symptoms persist for more than 7 days. Additionally, if symptoms resolve and then recur within a few days, patients must refrain from using any other hydrocortisone products without prior consultation with a healthcare professional. This precaution is essential to ensure patient safety and effective management of their condition.

Side Effects

For external use only. Patients should discontinue use and consult a doctor if bleeding occurs, if the condition worsens, or if symptoms persist for more than 7 days or resolve and then recur within a few days. 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 in conjunction with other hydrocortisone products should be approached with caution. It is advised that patients do not initiate the use of any additional hydrocortisone formulations without prior consultation with a healthcare professional. This precaution is essential to avoid potential adverse effects and to ensure appropriate management of therapy. Monitoring for signs of excessive corticosteroid exposure may be warranted if multiple hydrocortisone products are used concurrently.

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 under 12 years of age should not use this medication without consulting a doctor. For adolescents and adults aged 12 years and older, the recommended application is to the affected area not more than 3 to 4 times daily.

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

Pregnant patients should be advised that this medication is not indicated for the treatment of diaper rash. It is important for healthcare professionals to consult with a physician before prescribing this medication to pregnant patients. The potential risks and benefits should be carefully considered, and alternative treatments may be more appropriate for managing conditions during pregnancy.

Lactation

Lactating mothers should 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.

Renal Impairment

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of specific guidance necessitates careful clinical judgment.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in clinical trials for this medication. Consequently, there is no information available 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, 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 from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

Additionally, it is recommended to consult local poison control centers or relevant toxicology resources for guidance on specific management protocols and antidotes, if applicable.

Documentation of the incident, including the substance involved, estimated dose, and time of exposure, is crucial for effective management and follow-up care.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact the Poison Control Center at 1-800-222-1222 if the product is swallowed. It is important to inform patients that this product is not intended for the treatment of diaper rash and that they should consult a doctor for appropriate alternatives.

Patients should be instructed to discontinue use and consult a doctor if any bleeding occurs, if their condition worsens, or if symptoms persist for more than 7 days. Additionally, patients should be made aware that if their symptoms clear up and then recur within a few days, they should also seek medical advice before using any other hydrocortisone product.

While using this product, patients must be cautioned to avoid contact with the eyes. They should not exceed the recommended daily dosage unless specifically directed by a healthcare professional. Furthermore, patients should be advised 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

The medication is administered topically, with a recommended application frequency of 3 to 4 times daily for adults and children aged 12 years and older. Clinicians should advise patients to avoid contact with the eyes and to adhere strictly to the recommended dosage, unless otherwise directed by a healthcare professional.

Patients are cautioned against using fingers or any mechanical devices to apply the medication rectally. They should discontinue use and consult a doctor if bleeding occurs, if the condition worsens, or if symptoms persist for more than 7 days or recur shortly after resolution. Additionally, patients should not initiate the use of any other hydrocortisone products without prior consultation with a healthcare provider.

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.