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Preparation H Hydrocortisone

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Active ingredient
Hydrocortisone 10 mg/1 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 2004
Label revision date
February 29, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Hydrocortisone 10 mg/1 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 2004
Label revision date
February 29, 2024
Manufacturer
Haleon US Holdings LLC
Registration number
M015
NDC root
0573-2830
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

Preparation H is an anti-itch cream that contains hydrocortisone (a type of medication that helps reduce inflammation and itching) at a strength of 1%. It is designed to provide relief from external anal itching and can also help with itching associated with minor skin irritations and rashes.

This product is available in a 0.9 oz (26 g) tube and is the maximum strength formulation that you can obtain without a prescription. While it is effective for relieving anal itch, any other uses should be discussed with a doctor to ensure safety and appropriateness.

Uses

You can use this product for temporary relief of external anal itching, which can be uncomfortable and bothersome. It also helps soothe itching caused by minor skin irritations and rashes, providing you with quick comfort when you need it.

For any other uses, it's important to consult with your doctor to ensure it's appropriate for your situation. Always follow their advice and supervision when considering additional applications of this product.

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 soft cloth. This helps ensure the product works effectively.

When you first open the tube, make sure to puncture the foil seal using the top end of the cap. For adults and children aged 12 and older, you can apply the product to the affected area up to 3 to 4 times a day. However, if the person is under 12 years old, it's best to consult a doctor before use.

What to Avoid

It's important to use this medication safely. You should not use it for treating diaper rash; if you have questions about your condition, please consult a doctor. Additionally, avoid contact with your eyes, and do not exceed the recommended daily dosage unless your doctor advises you to do so. Lastly, never insert the medication into the rectum using your fingers or any device, as this can lead to complications. Always prioritize your health and safety by following these guidelines.

Side Effects

When using this product, it's important to remember that it is for external use only. Avoid contact with your eyes, and do not exceed the recommended daily dosage unless your doctor advises you to do so. Additionally, do not use it for diaper rash or insert it into the rectum with fingers or any device.

You should stop using the product and consult a doctor if you experience any bleeding, if your condition worsens, or if your symptoms last more than 7 days or return shortly after improvement. Always keep this product out of reach of children, and if swallowed, seek medical help or contact a Poison Control Center immediately.

Warnings and Precautions

This product is for external use only and should not be used to treat diaper rash. If you have any questions, it's best to consult your doctor. While using this product, be careful to avoid contact with your eyes, and do not exceed the recommended daily dosage unless your doctor advises you to do so. Additionally, do not insert the product into the rectum using fingers or any devices.

You should stop using the product and contact your doctor if you experience any bleeding, if your condition worsens, or if your symptoms last more than 7 days. If your symptoms improve and then return within a few days, do not start using any other hydrocortisone product without consulting your doctor first. Always keep this product out of reach of children, and if it is swallowed, seek medical help or contact a Poison Control Center immediately.

Overdose

If you or someone else has swallowed too much of a medication, it’s important to seek medical help immediately. You can do this by contacting a Poison Control Center or going to the nearest emergency room. Acting quickly can make a significant difference in the outcome.

Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms, don’t hesitate to get help right away. Remember, it’s always better to be safe and get checked by a medical professional.

Pregnancy Use

You can use hydrocortisone cream during pregnancy without specific warnings or dosage changes mentioned in the information provided. There are no indications that it is contraindicated (not recommended) for pregnant individuals, nor does it state any risks to the fetus associated with its use.

However, it's always a good idea to consult with your healthcare provider before using any medication during pregnancy to ensure it’s safe for you and your baby.

Lactation Use

If you are breastfeeding or planning to breastfeed, it’s important to talk to your doctor before using this product. Currently, there is no specific information available about whether this product can pass into breast milk or what risks it may pose to your baby. Consulting with a healthcare professional can help ensure the safety of both you and your infant while making informed choices about your health.

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 this no more than 3 to 4 times a day. Always follow these guidelines to ensure your child's safety and well-being.

Geriatric Use

While there is no specific information about the use of Preparation H Hydrocortisone cream in older adults, it's important to approach any new medication with caution. Since the drug insert does not mention dosage adjustments or safety concerns for elderly patients, you should consult with a healthcare provider before using this cream. They can help determine if it's appropriate for your needs and ensure that it fits safely into your overall health plan. Always prioritize open communication with your doctor, especially when considering treatments for sensitive conditions.

Renal Impairment

If you have kidney problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or safety considerations for your condition. This means that there are no tailored guidelines for how this medication may affect you if your kidneys are not functioning properly.

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 help monitor your condition and make any necessary adjustments to 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 detailed guidelines available for how the medication may affect you or how your liver health might influence the treatment.

It's always best to discuss your liver condition with your healthcare provider before starting any new medication. They can help determine the safest approach for you and monitor your health as needed.

Drug Interactions

It's important to talk to your healthcare provider before starting any new hydrocortisone product. This ensures that you avoid any potential interactions with your current medications. Your doctor can help you understand how different treatments may affect each other and your overall health.

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

Storage and Handling

To ensure the best performance and safety of your product, store it at a temperature between 20-25°C (68-77°F). This temperature range helps maintain the integrity 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 medication topically to the affected area, and it can be used by adults and children aged 12 years and older. Make sure to apply it no more than 3 to 4 times a day for best results. There are no additional details available regarding laboratory tests, abuse potential, or patient counseling.

FAQ

What is Preparation H?

Preparation H is an anti-itch cream that contains hydrocortisone 1% and is used for temporary relief of external anal itching and minor skin irritations.

How should I use Preparation H?

For adults and children 12 years and older, apply to the affected area not more than 3 to 4 times daily. Cleanse the area gently before application.

Are there any contraindications for using Preparation H?

Do not use Preparation H for the treatment of diaper rash or if you are under 12 years of age without consulting a doctor.

What should I do if I experience side effects?

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

Can I use Preparation H during pregnancy?

There is no specific information regarding the use of Preparation H during pregnancy, so consult your doctor before use.

What should I avoid while using Preparation H?

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

How should I store Preparation H?

Store Preparation H at a temperature between 20-25°C (68-77°F).

What should I do if Preparation H is swallowed?

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

Packaging Info

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

Packaging configurations for Preparation H Hydrocortisone.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Hydrocortisone 1% is an anti-itch cream formulated for topical application. Each tube contains a net weight of 0.9 ounces (26 grams). The product is identified by the National Drug Code (NDC) 0573-2830-11.

Uses and Indications

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

Other uses of this product should be undertaken only under the advice and supervision of a healthcare professional. There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

For adults, it is recommended to cleanse the affected area by patting or blotting with an appropriate cleansing wipe, followed by gentle drying using a tissue or soft cloth prior to the application of this product. When first opening the tube, the foil seal should be punctured using the top end of the cap.

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. It is important to note that the product is not intended for use in children under 12 years of age; consultation with a doctor is advised in such cases.

Contraindications

The product is contraindicated for the treatment of diaper rash; consultation with a healthcare professional is advised in such cases.

Contact with the eyes should be avoided to prevent irritation or injury. Exceeding the recommended daily dosage is contraindicated unless directed by a physician. Additionally, the product should not be administered rectally using fingers, mechanical devices, or applicators due to the risk of adverse effects.

Warnings and Precautions

This product is intended for external use only and is not suitable for the treatment of diaper rash. Healthcare professionals should advise patients to consult a doctor for appropriate alternatives in such cases.

When utilizing this product, it is imperative to avoid contact with the eyes. Patients must adhere strictly to the recommended daily dosage; exceeding this dosage should only occur under the guidance of a healthcare provider. Additionally, patients should be cautioned against inserting the product into the rectum using fingers, mechanical devices, or applicators.

Patients are advised to discontinue use and seek medical consultation if any of the following occur: bleeding, worsening of the condition, or if symptoms persist beyond 7 days. Should symptoms resolve and then reappear within a few days, patients should refrain from using any other hydrocortisone products without prior consultation with a healthcare professional.

It is essential to keep this product out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

Side Effects

Patients using this product should be aware that it is intended for external use only. It is contraindicated for the treatment of diaper rash, and consultation with a healthcare professional is advised in such cases.

While using this product, patients should avoid contact with the eyes and adhere strictly to the recommended daily dosage. Exceeding the recommended dosage should only occur under the guidance of a healthcare provider. Additionally, patients are cautioned against inserting the product into the rectum using fingers or any mechanical device or applicator.

Patients are advised to discontinue use and seek medical attention if any of the following occur: bleeding, worsening of the condition, or if symptoms persist for more than 7 days. If symptoms resolve and then recur within a few days, patients should not resume use of any other hydrocortisone product without consulting a doctor.

It is essential to keep this product out of the reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

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 Preparation H Hydrocortisone (hydrocortisone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Preparation H Hydrocortisone.
Details

Pediatric Use

Pediatric patients under 12 years of age should not use this medication without consulting a healthcare professional. For adolescents and adults aged 12 years and older, the recommended application is to the affected area no more than 3 to 4 times daily.

Geriatric Use

Elderly patients may not have specific information regarding the use of Preparation H Hydrocortisone cream, including dosage adjustments, safety concerns, or special precautions. As such, healthcare providers should exercise caution when prescribing this medication to geriatric patients.

Due to the lack of data, it is advisable for clinicians to closely monitor elderly patients for any potential adverse effects or unusual responses to treatment. Individual patient factors, including comorbidities and concurrent medications, should be considered when determining the appropriateness of this therapy in the geriatric population.

Pregnancy

Hydrocortisone cream is not associated with specific warnings, precautions, or dosage modifications for use during pregnancy. The prescribing information does not indicate whether the product is contraindicated in pregnant patients or if there are any known risks to the fetus associated with its use. As with any medication, healthcare professionals should weigh the potential benefits against any unknown risks when considering the use of hydrocortisone cream in pregnant patients. Women of childbearing potential should be counseled accordingly.

Lactation

Lactating mothers are advised to consult a doctor prior to using this product. Currently, there is no specific information available regarding the potential for excretion of this product in breast milk or any associated risks to breastfed infants.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data may impact the drug's efficacy and safety profile in this population. Regular monitoring of renal function is advisable to ensure patient safety.

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 event of an overdosage, immediate medical intervention is crucial. If the substance is ingested, it is imperative to seek medical assistance or contact a Poison Control Center without delay.

Healthcare professionals should be aware that prompt action can significantly influence the outcome of an overdosage situation. Symptoms of overdosage may vary depending on the specific substance involved; therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous evaluation and appropriate interventions should be implemented based on the clinical presentation and severity of symptoms.

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.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. In the event of swallowing the product, patients should seek medical assistance or contact a Poison Control Center immediately.

Patients should be informed that this product is not intended for the treatment of diaper rash and that they should consult a doctor for appropriate alternatives.

Healthcare providers should instruct patients to discontinue use and consult a doctor if any of the following occur: bleeding, worsening of the condition, or if symptoms persist for more than 7 days or resolve and then recur within a few days. Patients should also be cautioned against starting any other hydrocortisone product without prior consultation with a healthcare professional.

While using this product, patients should be advised to avoid contact with the eyes and to adhere strictly to the recommended daily dosage unless otherwise directed by a doctor. Additionally, patients should be warned 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 is essential to store the product at a controlled temperature range of 20-25°C (68-77°F) to maintain its integrity and efficacy. Proper storage conditions should be ensured to prevent any degradation 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, 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 Preparation H 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 Preparation H 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.

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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.