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Hydrocortisone

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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 2020
Label revision date
December 20, 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 2020
Label revision date
December 20, 2024
Manufacturer
Pharmacy Value Alliance LLC
Registration number
M017
NDC root
68016-149
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

If you are a consumer or patient please visit this version.

Drug Overview

This medication is designed to provide temporary relief from itching caused by minor skin irritations, inflammation, and rashes. You may find it helpful for various conditions, including eczema, insect bites, and reactions to plants like poison ivy, poison oak, and poison sumac. It can also be effective for irritations caused by soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis, and external feminine, genital, and anal itching.

While this product can be beneficial for these issues, it's important to use it under the advice and supervision of a doctor for any other uses.

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, and even jewelry. Additionally, it may be effective for seborrheic dermatitis, psoriasis, and external itching in sensitive areas.

For any other uses, it's important to consult with your doctor to ensure it's appropriate for your situation.

Dosage and Administration

If you are an adult or a child aged 2 years and older, you can apply this medication to the affected area up to 3 to 4 times a day. Before applying, it's best to clean the area gently with mild soap and warm water, then rinse thoroughly or pat it dry with toilet tissue or a soft cloth.

If you have a child under 2 years old, do not use this product without first consulting a doctor. For children under 12 years who are experiencing external anal itching, it's also important to speak with a doctor before use. Always follow these guidelines to ensure safe and effective treatment.

What to Avoid

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

Also, please avoid inserting this product into the rectum using your fingers or any mechanical device or applicator. Following these guidelines will help ensure your safety and the effectiveness of the treatment.

Side Effects

When using this product, it's important to be aware of potential side effects. If you notice that your condition worsens or if your symptoms last longer than 7 days, you should stop using the product and consult a doctor. Additionally, if your symptoms improve and then return within a few days, discontinue use and seek medical advice before trying any other hydrocortisone products.

Remember, this product is for external use only. Always prioritize your health and safety by following these guidelines.

Warnings and Precautions

This product is intended for external use only. You should not use it for treating diaper rash or external genital itching, especially if you have a vaginal discharge; in these cases, please consult your doctor first.

If you accidentally swallow this product, seek emergency medical help or contact a Poison Control Center immediately. Additionally, stop using the product and consult your doctor if your condition worsens, if symptoms last longer than 7 days, or if symptoms improve and then return within a few days. Do not start using any other hydrocortisone product without your doctor's guidance.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While the specific signs of an overdose are not detailed, common symptoms can include extreme drowsiness, confusion, or difficulty breathing. If you notice any of these signs, seek medical help right away.

In case of an overdose, contact your local emergency services or go to the nearest hospital. It's crucial to provide them with as much information as possible about the substance taken and the amount, if known. Remember, acting quickly can make a significant difference in your health and safety.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the safety of hydrocortisone 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.

It's advisable to use hydrocortisone only under the supervision of a healthcare professional, who can provide guidance on whether dosage adjustments are necessary for your situation. Always prioritize open communication with your healthcare provider to ensure the best care 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. There is a possibility that it may pass into your breast milk, and the effects on your nursing infant have not been thoroughly studied. Because of this uncertainty, it's best to exercise caution and seek professional advice to ensure the safety of both you and your baby.

Pediatric Use

When using this medication for children, it's important to follow specific guidelines. For adults and children aged 2 years and older, you can apply it to the affected area up to 3 to 4 times a day. However, if your child is under 2 years old, you should not use this medication and should consult a doctor instead. Additionally, if your child is under 12 years old and is experiencing external anal itching, it's best to consult a doctor before use. Always prioritize your child's safety and seek professional advice when needed.

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. Since older adults may have different health needs and may be taking multiple medications, it’s always a good idea to consult with a healthcare provider before starting any new medication. They can help ensure that the treatment is safe and appropriate for your individual health situation.

If you or a loved one is an older adult, be sure to discuss any concerns about potential side effects or interactions with other medications you may be taking. Your healthcare provider can provide guidance tailored to your specific needs.

Renal Impairment

If you have kidney issues, it's important to know that there are no specific guidelines provided for dosage adjustments, special monitoring, or safety considerations related to your condition. This means that the information available does not outline any particular changes you may need to make regarding your treatment.

Always consult with your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective for your kidney health. They can help you understand how your condition may affect your medication and what steps to take for your well-being.

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).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your liver health. They can help you understand how to manage your treatment effectively.

Drug Interactions

It's important to be cautious when using hydrocortisone. You should not use any other hydrocortisone product without first consulting your doctor. This is crucial because combining different hydrocortisone products can lead to unexpected side effects or complications.

Always discuss any medications or treatments you are considering with your healthcare provider. They can help ensure that your treatment plan is safe and effective for your specific health needs.

Storage and Handling

To ensure the best performance of your product, store it at a controlled room temperature between 20° and 25°C (68° and 77°F). This temperature range helps maintain the integrity and effectiveness of the device.

When handling the product, 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 2 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 this product used for?

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

Who can use this product?

Adults and children 2 years and older can use this product. Children under 2 years of age should not use it and should consult a doctor.

How often can I apply this product?

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

What should I do if my symptoms persist?

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

Can I use this product if I am pregnant?

The safety of this product during pregnancy has not been established, so consult a doctor before use.

What precautions should I take when using this product?

Avoid contact with the eyes, do not exceed the recommended dosage, and do not use any other hydrocortisone product unless directed by a doctor.

What should I do if I accidentally swallow this product?

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

Is this product safe for nursing mothers?

Nursing mothers should consult a doctor before using this product, as there is potential for excretion in breast milk.

What conditions should I consult a doctor about before using this product?

Consult a doctor if you have external genital itching with vaginal discharge, or if you are pregnant or planning to become pregnant.

Packaging Info

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

Packaging configurations for Hydrocortisone.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

pv hydrocortisone cream is a topical formulation containing hydrocortisone as the active ingredient. The product is available in a 1 oz dosage form. It is identified by the SPL Code 34089-3. The cream is designed for local application to provide anti-inflammatory effects.

Uses and Indications

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

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

No teratogenic or nonteratogenic effects have been reported.

Dosage and Administration

Adults and children aged 2 years and older are instructed to apply the product to the affected area no more than 3 to 4 times daily. For optimal results in managing external and anal itching, it is recommended that adults cleanse the affected area with mild soap and warm water, rinsing thoroughly, or patting or blotting with toilet tissue or a soft cloth prior to application.

For children under 2 years of age, the product should not be used, and consultation with a healthcare professional is advised. Additionally, for children under 12 years of age experiencing external anal itching, it is essential to consult a doctor before use.

Contraindications

The use of this product is contraindicated in the following situations:

Patients should not initiate the use of any other hydrocortisone product unless directed by a healthcare professional. Additionally, exceeding the recommended daily dosage for external genital, feminine, and anal itching is contraindicated unless specifically instructed by a physician. The product should not be administered rectally using fingers, mechanical devices, or applicators.

Warnings and Precautions

This product is intended for external use only. It is imperative that healthcare professionals advise patients against using this product for the treatment of diaper rash without consulting a physician. Additionally, patients should be cautioned not to use this product for external genital itching if they are experiencing vaginal discharge; in such cases, a consultation with a healthcare provider is necessary.

In the event of accidental ingestion, immediate medical assistance should be sought, or the local Poison Control Center should be contacted without delay.

Patients should be instructed to discontinue use of this product and seek medical advice if any of the following occur: the condition worsens, symptoms persist for more than seven days, or if symptoms resolve and then recur within a few days. Under these circumstances, patients should refrain from using any other hydrocortisone products unless specifically directed by a healthcare professional.

Side Effects

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

Drug Interactions

The use of hydrocortisone in conjunction with other hydrocortisone products is not recommended without prior consultation with a healthcare professional. This precaution is essential to avoid potential additive effects and complications associated with corticosteroid therapy. It is advisable for patients to discuss their current medication regimen with their healthcare provider to ensure safe and effective use of hydrocortisone.

Packaging & NDC

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

Packaging configurations for Hydrocortisone.
Details

Pediatric Use

Pediatric patients aged 2 years and older may apply the medication to the affected area no more than 3 to 4 times daily. For children under 2 years of age, the medication is not recommended, and a consultation with a doctor is advised. Additionally, children under 12 years of age experiencing external anal itching should also consult a doctor before use.

Geriatric Use

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

Pregnancy

The safety of hydrocortisone during pregnancy has not been established. Pregnant patients or those planning to become pregnant should consult a healthcare provider before use, as potential risks to the fetus are not clearly defined. Caution is advised when considering the use of this medication during pregnancy.

Dosage adjustments may be necessary, and it is important for healthcare professionals to provide guidance tailored to the individual patient's needs. Use of hydrocortisone during pregnancy should be under the supervision of a healthcare professional to ensure the safety of both the mother and the developing fetus.

Lactation

Nursing 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

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in clinical trials for this medication. Consequently, there is no available information 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 based on clinical judgment.

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 initiate supportive care, which may include maintaining airway patency, ensuring adequate ventilation, and monitoring vital signs.

If available, the use of antidotes or specific treatments should be considered based on the substance involved and the clinical presentation. Consultation with a poison control center or a medical toxicologist may provide additional guidance on the management of overdose cases.

Documentation of the incident, including the substance, amount ingested, and time of ingestion, is crucial for effective management and treatment planning.

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 understanding of potential risks associated with the compound 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 a Poison Control Center if the product is swallowed. Patients should be instructed to discontinue use and consult a doctor if their condition worsens or if symptoms persist for more than 7 days. Additionally, if symptoms clear up and then recur within a few days, patients should stop using the product and refrain from starting any other hydrocortisone product unless directed by a healthcare professional.

It is important to inform patients to avoid contact with the eyes while using this product. They should also be cautioned against initiating the use of any other hydrocortisone product without prior consultation with a doctor.

For patients using the product for external genital, feminine, and anal itching, healthcare providers should emphasize the importance of not exceeding the recommended daily dosage unless specifically directed by a doctor. In the event of any bleeding, patients should be advised to stop use immediately and seek medical advice.

Lastly, patients must be informed that the product should not be inserted 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 2 years and older, specifically to the affected area. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Hydrocortisone, 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, 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.

Learn more in our Editorial Policy

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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.