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Preparation H Soothing Relief Anti-Itch

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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 2020
Label revision date
July 7, 2025
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 2020
Label revision date
July 7, 2025
Manufacturer
Haleon US Holdings LLC
Registration number
M015
NDC root
0573-0552
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 a soothing 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 temporary relief from external anal itching and itching associated with minor skin irritations and rashes.

This cream is available without a prescription and is formulated to be effective for itch relief, making it a convenient option for those seeking comfort from these common skin issues. It is important to use this product as directed and consult a doctor for any other uses.

Uses

If you're experiencing external anal itching or itching from minor skin irritations and rashes, this product can provide temporary relief. It's designed to help soothe discomfort in these areas, making your day-to-day activities more comfortable.

For any other uses, it's important to consult with your doctor first to ensure it's appropriate for your situation. Always prioritize your health and seek professional advice when needed.

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 user 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; instead, consult your doctor for appropriate options. Always keep the medication out of reach of children to prevent accidental ingestion. Avoid contact with your eyes, and do not exceed the recommended daily dosage unless your doctor advises you to do so. Additionally, never insert the medication into the rectum using your fingers or any device, as this can lead to complications.

Side Effects

When using this product, it's important to remember that it is for external use only. Avoid getting it in your eyes, and do not exceed the recommended 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. 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, so please avoid using it on diaper rash and consult your doctor if you have any questions. When applying, be careful not to get it in your eyes, and stick to the recommended dosage unless your doctor advises otherwise. It's important not to insert the product into the rectum using fingers or any devices.

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 or return shortly after improvement. Additionally, if you accidentally swallow the product, seek emergency medical help or contact a Poison Control Center immediately.

Overdose

If you or someone else has swallowed too much of this 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.

Signs of an overdose may include unusual symptoms, but specific details on these symptoms are not provided. Therefore, if you suspect an overdose, don’t hesitate to get help. Acting quickly can make a significant difference in ensuring safety and health.

Pregnancy Use

Currently, there is no specific information available about the use of this product during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions for pregnant individuals have not been addressed. If you are pregnant or planning to become pregnant, it is essential to consult your healthcare provider for personalized advice and to discuss any potential risks associated with this product. Your health and the health of your baby are the top priority, so always seek professional guidance when considering any medication during pregnancy.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of this product while nursing. Additionally, there is no information available about whether this product is excreted in breast milk or any potential risks to your infant. Always consult with your healthcare provider if you have any concerns or questions about medications while breastfeeding.

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 limit this to 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 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 wise to discuss any medications with a healthcare provider, especially since older adults may have different health needs and may be taking other medications.

Since there are no dosage adjustments or special precautions mentioned for elderly patients, your healthcare provider can help determine the best approach based on individual health conditions and overall treatment goals. Always prioritize open communication with your healthcare team to ensure safe and effective use of any medication.

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 should be used if you have 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 help you understand how to manage your treatment effectively.

Hepatic Impairment

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

Before starting any new medication, including this one, you should discuss your liver health with your healthcare provider. They can help determine the best approach for your treatment and ensure your safety.

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, using it no more than 3 to 4 times a day if you are an adult or a child aged 12 years and older. If the patient is under 12 years old, it's important to consult a doctor before use. There are no additional details available regarding laboratory tests, abuse potential, or postmarketing experiences related to this medication.

FAQ

What is PREPARATION H used for?

PREPARATION H is used for the temporary relief of external anal itching and itching associated with minor skin irritations and rashes.

How should I apply PREPARATION H?

Adults and children 12 years of age and older should apply it to the affected area not more than 3 to 4 times daily. Cleanse and gently dry the area before application.

Can children use PREPARATION H?

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

Are there any warnings associated with PREPARATION H?

Yes, it is for external use only, and you should avoid contact with the eyes. Do not use for diaper rash or exceed the recommended dosage unless directed by a doctor.

What should I do if symptoms persist?

If symptoms persist for more than 7 days or worsen, stop use and consult a doctor. Do not begin use of any other hydrocortisone product without consulting a doctor.

What should I do if I accidentally swallow PREPARATION H?

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

Is there any specific information regarding use during pregnancy or nursing?

There is no specific information provided regarding the use of PREPARATION H during pregnancy or nursing.

What is the active ingredient in PREPARATION H?

The active ingredient in PREPARATION H is hydrocortisone 1%, which provides soothing relief for itching.

Packaging Info

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

Packaging configurations for Preparation H Soothing Relief Anti-Itch.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

PREPARATION H® is a soothing relief anti-itch cream formulated with hydrocortisone 1%. This product provides maximum strength itch relief without the need for a prescription. It is designed to effectively alleviate itching and discomfort. The cream is free from added fragrance, ensuring a neutral application experience. Each tube contains a net weight of 0.9 ounces (26 grams).

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 with 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. The use of this product is not advised for children under 12 years of age; consultation with a doctor is recommended in such cases.

Contraindications

The product is contraindicated in the following situations:

Use is not recommended for the treatment of diaper rash; consultation with a healthcare professional is advised in such cases.

The product should be kept out of reach of children to prevent accidental ingestion.

Contact with the eyes must be avoided to prevent irritation or injury.

Exceeding the recommended daily dosage is contraindicated unless directed by a healthcare professional.

Inserting the product into the rectum using fingers or any mechanical device or applicator is not advised.

Warnings and Precautions

For external use only. This product is not intended for the treatment of diaper rash; consultation with a healthcare professional is advised prior to use in such cases.

When utilizing this product, it is imperative to avoid contact with the eyes. Users should adhere strictly to the recommended daily dosage and should not exceed this amount unless specifically directed by a healthcare provider. Additionally, the product should not be administered rectally using fingers, mechanical devices, or applicators.

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, the use of any other hydrocortisone product should not commence without prior consultation with a healthcare professional.

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.

During the use of this product, patients are cautioned to avoid contact with the eyes and to adhere strictly to the recommended daily dosage. Exceeding this dosage should only occur under the guidance of a healthcare provider. Additionally, patients should not insert the product into the rectum using fingers or any mechanical device or applicator.

Patients are advised to discontinue use and seek medical advice 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 also consult a doctor before resuming use of any other hydrocortisone product.

It is important 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.

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 Soothing Relief Anti-Itch (hydrocortisone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Preparation H Soothing Relief Anti-Itch.
Details

Pediatric Use

Pediatric patients under 12 years of age should not use this medication without consulting a healthcare professional. For adolescents and children 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 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 potential adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

There is no specific information available regarding the use of this product during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the lack of data when prescribing this product to pregnant patients and weigh the potential risks and benefits. Women of childbearing potential should be counseled on the absence of established safety data and the importance of discussing any potential pregnancy with their healthcare provider.

Lactation

There are no specific warnings or recommendations regarding the use of this product in nursing mothers. Additionally, there is no information available concerning the potential for excretion 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 necessitates careful clinical judgment.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to 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 prescribing 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 question.

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 reach of children to prevent accidental ingestion. Instruct patients that if the product is swallowed, they should seek medical help 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. Additionally, they should be cautioned to stop using the product and consult a doctor if any bleeding occurs, if their condition worsens, or if symptoms persist for more than 7 days. Patients should also be advised to seek medical advice if their symptoms clear up and then recur within a few days. It is important to inform patients not to begin using any other hydrocortisone product without first consulting a doctor.

While using this product, patients should be instructed to avoid contact with the eyes. They should also be reminded not to exceed the recommended daily dosage unless directed by a healthcare professional. Furthermore, patients should be cautioned 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 temperature range of 20–25°C (68–77°F) to maintain its integrity and efficacy. Proper storage conditions should be ensured to prevent exposure to extreme temperatures, which may compromise the product's quality.

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. For children under 12 years of age, it is advised to consult a doctor before use. There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Preparation H Soothing Relief Anti-Itch, 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 Soothing Relief Anti-Itch, 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.