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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
68016-529
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

PV hydrocortisone cream plus aloe is a topical medication 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 used for irritation from soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis, and external feminine, genital, and anal itching.

This cream combines hydrocortisone, a type of steroid that helps reduce inflammation, with aloe, known for its soothing properties. While it can be effective for these common skin issues, it's important to use it under the guidance of a healthcare professional 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 jewelry, as well as conditions like seborrheic dermatitis and psoriasis. Additionally, it may be used for external itching in the genital and anal 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 with mild soap and warm water, rinsing thoroughly. You can also gently pat or blot the area with toilet tissue or a soft cloth to prepare it for the medication.

If you are caring for a child under 2 years old, do not use this product without first consulting a doctor. Additionally, if a child under 12 is experiencing external anal itching, it’s important to speak with a doctor for guidance. Always follow these instructions to ensure safe and effective use of the medication.

What to Avoid

It's important to use this product safely and effectively. You should not start using any other hydrocortisone product without first consulting your doctor. Additionally, make sure not to exceed the recommended daily dosage for treating external genital, feminine, and anal itching unless your doctor advises you to do so.

For your safety, avoid inserting this product into the rectum using your fingers or any mechanical device or applicator. Following these guidelines will help ensure that you use the product correctly and minimize any potential risks.

Side Effects

This product is intended for external use only. You should stop using it and consult a doctor if your condition worsens or if your symptoms last longer than 7 days. If your symptoms improve and then return within a few days, discontinue use and do not start any other hydrocortisone product unless your doctor advises you to do so.

Warnings and Precautions

This product is 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.

If you accidentally swallow this product, seek emergency medical help or contact a Poison Control Center right away. Additionally, if your condition worsens, or if your symptoms last more than 7 days or improve and then return within a few days, stop using the product and consult your doctor before using any other hydrocortisone product.

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

While the information regarding the use of hydrocortisone 1% cream during pregnancy is limited, the insert does not indicate any specific safety concerns or contraindications for pregnant individuals. There are also no recommended dosage modifications or special precautions mentioned for its use during this time.

If you are pregnant and considering using this cream, it is always a good idea to consult with your healthcare provider to ensure it is appropriate for your situation.

Lactation Use

If you are breastfeeding and considering the use of hydrocortisone cream, you can feel reassured that there are no specific warnings or recommendations against its use for nursing mothers. Additionally, there is no information indicating that hydrocortisone cream is passed into breast milk or poses any risk to your infant.

As always, if you have any concerns or questions about using this cream while breastfeeding, it's a good idea to consult with your healthcare provider for personalized advice.

Pediatric Use

If your child is under 2 years old, it's important not to use this medication without first consulting a doctor. For children aged 2 years and older, you can apply the medication to the affected area up to 3 to 4 times a day. However, if your child is under 12 years old and is experiencing external anal itching, please consult a doctor before use to ensure their safety and proper care.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that if you or a loved one is an older adult considering this medication, it’s important to consult with a healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken.

Always keep in mind that older adults may have different responses to medications, so discussing any concerns with a doctor is essential for ensuring safety and effectiveness.

Renal Impairment

If you have kidney problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to change based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment is safe and effective for your specific condition. They can help you understand any necessary precautions or adjustments based on your kidney 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 may affect you 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 monitor your condition and make any necessary adjustments to your treatment plan.

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 product's effectiveness and safety.

When handling the product, be sure to do so with clean hands and in a clean environment to avoid contamination. Always follow any specific instructions provided with the product for safe use and disposal. Keeping these guidelines in mind will help you use the product safely and effectively.

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 PV hydrocortisone cream plus aloe used for?

It is used for temporary relief of itching associated with minor skin irritations, inflammation, and rashes.

What conditions can PV hydrocortisone cream help with?

It is indicated for itching associated with eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis, and external feminine, genital, and anal itching.

How often can adults and children over 2 years use this cream?

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

Is this cream safe for children under 2 years?

No, do not use this product on children under 2 years of age without consulting a doctor.

What should I do if my symptoms persist?

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

Can I use this cream for diaper rash?

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

What precautions should I take when using this cream?

Avoid contact with the eyes, do not use any other hydrocortisone product unless directed by a doctor, and do not apply it into the rectum.

Is there any information about using this cream during pregnancy?

The insert does not provide specific information regarding the use of hydrocortisone cream during pregnancy.

What should I do if I accidentally swallow this cream?

Get medical help or contact a Poison Control Center immediately if swallowed.

How should I store PV hydrocortisone cream?

Store it at controlled room temperature between 20°-25°C (68°-77°F).

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 plus aloe is a topical formulation that combines hydrocortisone, a corticosteroid, with aloe vera. This cream is designed for the relief of inflammation and itching associated with various skin conditions. The presence of aloe vera is intended to provide additional soothing properties. The formulation is typically presented in a cream dosage form, suitable for application to affected areas of the skin.

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. These conditions include eczema, insect bites, poison ivy, poison oak, poison sumac, reactions to soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis, and external feminine, genital, and anal itching.

Other uses of this product should only be undertaken 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 and children aged 2 years and older, the product should be applied to the affected area no more than 3 to 4 times daily. Prior to application for external and anal itching in adults, it is recommended to cleanse the affected area with mild soap and warm water, followed by thorough rinsing or gentle patting with toilet tissue or a soft cloth.

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

Contraindications

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

Patients should not initiate treatment with any other hydrocortisone product without prior consultation with a healthcare professional. Additionally, exceeding the recommended daily dosage for external genital, feminine, and anal itching is contraindicated unless directed by a physician. The product should not be administered rectally using fingers, mechanical devices, or applicators.

Warnings and Precautions

For external use only. This product is not intended for the treatment of diaper rash; patients should consult a healthcare professional for appropriate management. Additionally, it should not be used for external genital itching in the presence of vaginal discharge; medical advice is recommended in such cases.

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

Patients are advised to discontinue use and consult a healthcare provider if any of the following occur: worsening of conditions, persistence of symptoms beyond 7 days, or if symptoms resolve and then recur within a few days. Under these circumstances, the use of this product should be halted, and no other hydrocortisone products should be initiated unless specifically directed by a healthcare professional.

Side Effects

For external use only. Patients are advised to stop using this product 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 discontinue use of 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 seek medical advice before combining hydrocortisone with any other corticosteroid formulations to ensure safe and effective treatment management.

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 under 2 years of age should not use this medication and must consult a doctor for guidance. For children aged 2 years and older, the recommended application is to the affected area no more than 3 to 4 times daily. Additionally, children under 12 years of age experiencing external anal itching should seek medical advice 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 adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

The available prescribing information does not provide specific data regarding the use of hydrocortisone 1% cream during pregnancy. There are no stated safety concerns or contraindications related to pregnancy, and no dosage modifications for pregnant individuals are mentioned. Additionally, the insert does not include any special precautions regarding the use of this product during pregnancy. Healthcare professionals should consider the lack of specific data when advising pregnant patients and weigh the potential benefits against any unknown risks.

Lactation

There are no specific warnings or recommendations regarding the use of hydrocortisone cream in lactating mothers. Additionally, there is no information available about the potential for excretion of hydrocortisone in breast milk or any associated risks to breastfed infants. Therefore, healthcare professionals may consider the use of hydrocortisone cream in nursing mothers on a case-by-case basis, taking into account the clinical situation and the absence of documented risks.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

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 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 activated charcoal may be considered to limit further absorption of the substance, provided that the patient is alert and able to protect their airway.

In cases where specific antidotes are known, they should be administered as per established protocols. Continuous assessment and supportive measures are critical until the patient stabilizes or further medical intervention is deemed necessary.

Healthcare professionals are encouraged to report any cases of overdose to the appropriate regulatory authorities to contribute to the ongoing evaluation of the safety profile of the medication.

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 compound in these areas.

Postmarketing Experience

No postmarketing experience details are available in the insert.

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, they should not exceed the recommended daily dosage unless specifically directed by a healthcare provider. In the event of any bleeding, patients must stop use immediately and seek medical advice. Furthermore, patients should be clearly instructed not to insert this product into the rectum using fingers or any mechanical device or applicator.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a controlled room temperature, maintaining a range of 20° to 25°C (68° to 77°F). Proper storage conditions are crucial to ensure the integrity and efficacy of the product.

Additional Clinical Information

The medication is administered topically, with a recommended application frequency of no more than 3 to 4 times daily for adults and children aged 2 years and older. 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.

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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.