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Xpect Hydrocortisone

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Active ingredient
Hydrocortisone 0.01 g/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 2023
Label revision date
September 26, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Hydrocortisone 0.01 g/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 2023
Label revision date
September 26, 2025
Manufacturer
Cintas Corporation
Registration number
M017
NDC root
42961-237
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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 an anti-itch cream that contains 1% hydrocortisone, a medication designed to provide temporary relief from itching caused by minor skin irritations, inflammation, or rashes. You can use it for conditions such as eczema, insect bites, and reactions to plants like poison ivy, poison oak, and poison sumac, as well as irritations from soaps, detergents, and cosmetics.

This cream works by reducing inflammation and soothing the affected area, helping to alleviate discomfort. While it is effective for these common skin issues, it's important to consult a doctor for any other uses or if symptoms persist.

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, insect bites, and reactions to plants like poison ivy, poison oak, and poison sumac. It can also help soothe irritation from soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis, and scrapes.

For any other uses, it's important to consult with your doctor for advice and supervision.

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 3 to 4 times a day. Before applying, it's important to clean the area gently. You can do this by using mild soap and warm water, rinsing thoroughly, or by patting the area with a suitable cleansing pad. After cleaning, make sure to dry the area gently by patting it with toilet tissue or a soft cloth.

If you are caring for a child under 12 years old who is experiencing external anal itching, it's best to consult a doctor before using this product. For children under 2 years of age, do not use this medication without first speaking to a doctor.

What to Avoid

It's important to be aware of certain situations where you should not use this product. Specifically, you should avoid using it for the treatment of diaper rash, in your eyes, or for feminine itching. These guidelines help ensure your safety and the effectiveness of the product. If you have any questions or concerns about its use, please consult a healthcare professional for guidance.

Side Effects

This product is intended for external use only. You should not use it for treating diaper rash, in your eyes, or for feminine itching. If your condition worsens, lasts more than 7 days, or clears up and then comes back within a few days, stop using the product and consult a doctor. Additionally, if you experience any bleeding, seek medical advice.

Keep this product out of reach of children. If swallowed, it’s important to get medical help or contact a Poison Control Center immediately. Always consult a doctor before using any other Hydrocortisone product while using this one.

Warnings and Precautions

This product is for external use only, so please avoid using it on your face or in your eyes. It is not intended for treating diaper rash or feminine itching.

If your condition worsens, lasts more than 7 days, or clears up only to return within a few days, stop using the product and consult your doctor. Additionally, do not start using any other Hydrocortisone product without first talking to your doctor. If you notice any bleeding, stop use immediately and seek medical advice.

Keep this product out of reach of children. If swallowed, seek medical help or contact a Poison Control Center right away.

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 seek assistance if you suspect an overdose.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to be cautious with hydrocortisone cream, as its safety during pregnancy has not been established. You should consult your doctor before using this medication, as there may be potential risks to your fetus that are not clearly defined.

If your healthcare provider determines that you need to use hydrocortisone cream, it should only be used when absolutely necessary, and the benefits must outweigh any potential risks. There are no specific dosage modifications provided for pregnant individuals, so always seek guidance from your healthcare professional regarding the appropriate use.

Lactation Use

When it comes to breastfeeding, it's important to be aware that there are no specific guidelines or statements regarding nursing mothers or lactation (the process of producing milk). This means that if you are breastfeeding, you may not find detailed information about how certain medications or treatments could affect you or your baby.

If you have concerns about breastfeeding while taking any medication, it's always best to consult with your healthcare provider for personalized advice and to ensure the safety of both you and your infant.

Pediatric Use

If your child is 2 years old or older, you can apply the medication to the affected area 3 to 4 times a day. However, if your child is under 12 years old and experiencing external anal itching, it's important to consult a doctor before using the product. For children under 2 years of age, you should not use this medication without first speaking to a doctor. Always prioritize your child's safety and seek professional advice when needed.

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, it’s important to consult with a healthcare provider before starting the medication. 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 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 health situation. They can help determine the best course of action based on your kidney function and overall health.

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 should be used 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 have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you.

Always feel free to ask questions and share your complete list of medications and any lab tests you may be undergoing. This way, you can receive the best possible care tailored to your needs.

Storage and Handling

To ensure the best performance of your product, store it at room temperature and avoid freezing it. It's important to keep the product in its original packaging and never use any opened or torn packets, as this can compromise safety and effectiveness. By following these simple guidelines, you can help maintain the quality and reliability of the product.

Additional Information

No further information is available.

FAQ

What is Hydrocortisone used for?

Hydrocortisone is an anti-itch cream used for temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to conditions like eczema, insect bites, and poison ivy.

How should I use Hydrocortisone?

For adults and children 2 years and older, apply to the affected area 3 to 4 times daily. For children under 2, consult a doctor before use.

Are there any contraindications for using Hydrocortisone?

Do not use Hydrocortisone for the treatment of diaper rash, in the eyes, or for feminine itching. Consult a doctor if you are pregnant or planning to become pregnant.

What should I do if my condition worsens?

Stop use and ask a doctor if your condition worsens, lasts more than 7 days, or if bleeding occurs.

Is Hydrocortisone safe to use during pregnancy?

The safety of Hydrocortisone during pregnancy has not been established. Use only if clearly needed and the benefits outweigh the risks.

What should I do if Hydrocortisone is swallowed?

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

How should I store Hydrocortisone?

Store Hydrocortisone at room temperature and do not freeze. Do not use any opened or torn packets.

Packaging Info

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

Packaging configurations for Xpect Hydrocortisone.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

No description information is available for the drug.

Uses and Indications

This drug is indicated for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes resulting from various conditions, including but not limited to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis, and scrapes.

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

Dosage and Administration

For adults and children aged 2 years and older, the recommended application frequency is 3 to 4 times daily to the affected area. Prior to application, adults experiencing external anal itching should cleanse the affected area with mild soap and warm water, ensuring thorough rinsing. Alternatively, the area may be cleansed by patting or blotting with an appropriate cleansing pad. After cleansing, the area should be gently dried by patting or blotting with toilet tissue or a soft cloth before applying the product.

For children under 12 years of age experiencing external anal itching, it is advised to consult a healthcare professional prior to use. The product is not recommended for children under 2 years of age; consultation with a doctor is necessary in such cases.

Contraindications

The product is contraindicated for the treatment of diaper rash. It should not be applied to the eyes. Additionally, the product is not intended for use in cases of feminine itching.

Warnings and Precautions

For external use only. This product is contraindicated for the treatment of diaper rash, application in the eyes, and for feminine itching.

Healthcare professionals should advise patients to discontinue use and seek medical advice if the condition worsens, persists for more than 7 days, or resolves only to recur within a few days. Additionally, patients should be cautioned against the concurrent use of any other Hydrocortisone products without prior consultation with a healthcare provider. Immediate medical attention is warranted if any bleeding occurs during treatment.

It is imperative to keep this product out of reach of children. In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center without delay.

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, application in the eyes, and for feminine itching.

In clinical practice, patients are advised to discontinue use and consult a healthcare professional if their condition worsens, persists for more than 7 days, or if symptoms resolve and then recur within a few days. Additionally, patients should seek medical advice before using any other Hydrocortisone product concurrently.

Serious adverse reactions may include bleeding at the application site, which necessitates immediate medical consultation.

It is crucial to keep this product out of reach of children. In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center without delay.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

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

Packaging configurations for Xpect Hydrocortisone.
Details

Pediatric Use

Pediatric patients aged 2 years and older may apply the medication to the affected area 3 to 4 times daily. For children under 12 years of age experiencing external anal itching, it is advised to consult a doctor prior to use. The medication is not recommended for children under 2 years of age; consultation with a doctor is necessary for this age group.

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

The safety of hydrocortisone cream during pregnancy has not been established. Pregnant patients or those planning to become pregnant should consult a healthcare professional before use. While potential risks to the fetus are not clearly defined, caution is advised when considering the use of this medication. There are no specific dosage modifications for pregnant individuals; therefore, it is essential to seek guidance from a healthcare professional regarding appropriate use. Hydrocortisone cream should only be used if clearly needed, and the benefits must outweigh the risks.

Lactation

There are no specific statements regarding the use of this medication in nursing mothers or its effects during lactation. Additionally, there is no available data on the excretion of this medication in breast milk or its potential effects on breastfed infants. Healthcare professionals should consider the absence of information when advising lactating mothers about the use of this medication.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

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 assistance is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical help or contact a Poison Control Center without delay.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved; therefore, a thorough assessment by a medical professional is recommended to determine the appropriate course of action.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. It is imperative that healthcare providers remain vigilant and prepared to address any complications that may arise from an overdosage scenario.

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

Postmarketing experience has revealed the following adverse reactions reported voluntarily or through surveillance programs: skin irritation, allergic reactions, and contact dermatitis.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children. It is important to emphasize that if the medication is swallowed, patients should seek medical help or contact a Poison Control Center immediately. This precaution is vital to ensure the safety and well-being of children who may inadvertently access the medication.

Storage and Handling

The product is supplied in packets that must be stored at room temperature. It is essential to ensure that the product is not frozen, as freezing may compromise its integrity. Healthcare professionals should also be aware that any opened or torn packets should not be used, as this may affect the product's safety and efficacy.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Xpect 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 Xpect 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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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.