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Hydrocortisone

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This product has been discontinued

Active ingredient
Hydrocortisone 10 mg/1 g
Other brand names
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 2012
Label revision date
January 27, 2023
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Hydrocortisone 10 mg/1 g
Other brand names
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 2012
Label revision date
January 27, 2023
Manufacturer
Valu Merchandisers, Co.
Registration number
part348
NDC root
63941-312
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

Best Choice Hydrocortisone Anti-Itch Cream is a topical medication designed to temporarily relieve itching caused by various minor skin irritations, inflammation, and rashes. You can use it for conditions such as eczema, psoriasis, and seborrheic dermatitis, as well as for itching resulting from poison ivy, oak, sumac, insect bites, soaps, detergents, cosmetics, and even jewelry. It can also help with external feminine and anal itching.

This cream works by reducing inflammation and soothing the skin, providing you with relief from discomfort. If you have any specific concerns or questions about its use, it's always a good idea to consult with a healthcare professional.

Uses

This product is designed to temporarily relieve itching caused by various minor skin irritations, inflammation, and rashes. You can use it for conditions like eczema, psoriasis, and seborrheic dermatitis. It’s also effective for itching related to poison ivy, oak, or sumac, as well as insect bites. Additionally, it can help with irritation from soaps, detergents, cosmetics, and even jewelry. If you experience external feminine or anal itching, this product may also provide relief.

If you have any other specific uses in mind, it's best to consult with a doctor for guidance.

Dosage and Administration

You should apply this medication to the affected area no more than 3 to 4 times a day. If you are using it for external anal itching, it's important to first clean the area with mild soap and warm water. Make sure to rinse thoroughly and gently dry the area by patting or blotting it with toilet tissue or a soft cloth before applying the product.

If you have a child under 2 years old, or a child under 12 years old who is experiencing external anal itching, do not use this product without consulting a doctor first. Always follow these guidelines to ensure safe and effective use of the medication.

What to Avoid

It's important to use this product safely. You should avoid using it in or near your eyes, and do not apply it directly into the rectum using your fingers or any device. If you have a vaginal discharge, refrain from using it for external feminine itching. Additionally, do not use it for diaper rash without consulting a doctor first. Following these guidelines will help ensure your safety and well-being.

Side Effects

You should be aware that this product is for external use only and should not be applied in or near the eyes, or inserted into the rectum using fingers or any devices. If you have vaginal discharge, do not use it for external feminine itching, and for diaper rash, consult a doctor first.

While using this product for external anal itching, make sure to follow the recommended dosage. If your condition worsens or does not improve within 7 days, or if symptoms clear up and then return shortly after, you should stop using it and consult a doctor. Additionally, if you experience rectal bleeding or accidentally swallow the product, seek medical help or contact a Poison Control Center immediately.

Warnings and Precautions

This product is intended for external use only, so please avoid applying it near your eyes or inserting it into the rectum using fingers or any devices. If you have a vaginal discharge, do not use it for external feminine itching, and for diaper rash, consult your doctor first.

While using this product for external anal itching, make sure not to exceed the recommended daily dosage unless your doctor advises otherwise. If your condition worsens or does not improve within 7 days, if symptoms clear up and then return shortly after, or if you experience rectal bleeding, stop using the product and contact your doctor.

In case of accidental swallowing, seek emergency medical help or contact a Poison Control Center immediately.

Overdose

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

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

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to be cautious with any medications, including hydrocortisone cream. The available information does not specify whether it is safe to use this cream during pregnancy, nor does it provide guidance on dosage adjustments or any special precautions you should take.

Before using hydrocortisone cream, you should consult your healthcare provider to discuss any potential risks and to ensure that it is appropriate for your situation. Your health and the health of your baby are the top priority, so getting professional advice is essential.

Lactation Use

If you are breastfeeding, it's important to consult your doctor before using this product. There is a possibility that it may be excreted in breast milk, which means it could pass to your baby. Therefore, exercising caution while using this product during breastfeeding is advised to ensure the safety of both you and your infant.

Pediatric Use

If you have a child under 2 years old, or a child under 12 years old who is experiencing external anal itching, it’s important to consult a doctor before using this medication. This is to ensure their safety and to find the most appropriate treatment for their condition. Always prioritize professional guidance when it comes to the health of your children.

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 wise to discuss any potential risks or benefits 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 regular check-ins with your healthcare team are essential to ensure safety and effectiveness.

Renal Impairment

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

Hepatic Impairment

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

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 determine the best course of action based on your individual situation.

Drug Interactions

It's important to talk to your doctor or pharmacist before using this medication, especially if you are already using any other hydrocortisone products. Combining different hydrocortisone treatments can lead to unexpected side effects or reduce the effectiveness of your treatment.

Always keep your healthcare provider informed about all the medications you are taking to ensure your safety and the best possible care.

Storage and Handling

To ensure the best performance of your product, store it at room temperature and make sure it is protected from freezing. This will help maintain its effectiveness and safety.

When handling the product, always do so with care to avoid any damage. Following these simple storage and handling guidelines will help you use the product safely and effectively.

Additional Information

You should apply this medication topically to the affected area no more than 3 to 4 times a day. Before using it, consult with your doctor or pharmacist if you are already using any other hydrocortisone products. If your condition worsens or does not improve within 7 days, or if symptoms clear up and then return after a few days, stop using the medication and seek medical advice. Additionally, if you experience rectal bleeding, stop use and consult a doctor immediately. This medication is not recommended for children under 2 years old, or for children under 12 years old with external anal itching—please ask a doctor in these cases.

FAQ

What is Best Choice Hydrocortisone Anti-Itch Cream used for?

It temporarily relieves itching associated with minor skin irritation, inflammation, and rashes due to conditions like eczema, psoriasis, and insect bites.

How often can I apply this cream?

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

Are there any contraindications for using this cream?

There are no specific contraindications mentioned, but do not use it in or near the eyes or for diaper rash without consulting a doctor.

What should I do if my condition worsens?

Stop using the cream and ask a doctor if your condition worsens or does not improve within 7 days.

Can I use this cream if I am pregnant or breastfeeding?

Consult a doctor before using this product if you are pregnant or nursing, as there is a potential for excretion in breast milk.

What should I do if I accidentally swallow the cream?

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

Is this cream safe for children?

Do not use it on children under 2 years or on children under 12 years for external anal itching without consulting a doctor.

What are the side effects of this cream?

For external use only; stop use and ask a doctor if you experience rectal bleeding or if symptoms return after clearing up.

Packaging Info

Below are the non-prescription pack sizes of Hydrocortisone. 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

Best Choice Hydrocortisone Anti-Itch Cream is a topical formulation designed to alleviate itching and inflammation associated with various skin conditions. The active ingredient, hydrocortisone, is a corticosteroid that exerts anti-inflammatory effects. The cream is presented in a convenient dosage form suitable for application to affected areas of the skin. Its formulation is designed to provide relief from discomfort while minimizing potential side effects associated with topical corticosteroids.

Uses and Indications

This drug is indicated for the temporary relief of itching associated with minor skin irritation, inflammation, and rashes resulting from various conditions, including eczema, psoriasis, seborrheic dermatitis, and contact with irritants such as poison ivy, oak, and sumac. It is also effective for alleviating itching caused by insect bites, soaps, detergents, cosmetics, jewelry, and external feminine and anal itching.

For any additional uses of this product, healthcare professionals are advised to consult a physician.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

The product should be applied to the affected area no more than 3 to 4 times daily. For the treatment of external anal itching, it is recommended that the area be cleaned with mild soap and warm water when practical. After cleaning, the area should be rinsed thoroughly and gently dried by patting or blotting with toilet tissue or a soft cloth prior to the application of the product.

It is important to note that this product is not indicated for use in children under 2 years of age, or in children under 12 years of age with external anal itching. In such cases, consultation with a healthcare professional is advised before use.

Contraindications

Use is contraindicated in the following situations:

  • Application in or near the eyes is prohibited due to the potential for irritation or injury.

  • Direct insertion into the rectum using fingers or any mechanical device or applicator is not recommended, as this may lead to adverse effects.

  • The product should not be used for external feminine itching in the presence of vaginal discharge, as this may indicate an underlying condition requiring medical evaluation.

  • For diaper rash, consultation with a healthcare professional is advised prior to use.

Warnings and Precautions

For external use only. This product is contraindicated for use in or near the eyes and should not be administered directly into the rectum using fingers, mechanical devices, or applicators. It is also not recommended for external feminine itching in the presence of vaginal discharge or for diaper rash; in such cases, consultation with a healthcare professional is advised.

When utilizing this product for external anal itching, it is imperative not to exceed the recommended daily dosage unless specifically directed by a healthcare provider.

Healthcare professionals should instruct patients to discontinue use and seek medical advice if any of the following occur: the condition worsens or fails to improve within 7 days; symptoms resolve and then recur within a few days; or if rectal bleeding is observed.

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 should not be applied in or near the eyes, nor should it be administered directly into the rectum using fingers or any mechanical device or applicator. Additionally, it is contraindicated for external feminine itching in the presence of vaginal discharge and should not be used for diaper rash without consulting a doctor.

While using this product for external anal itching, patients are advised not to exceed the recommended daily dosage unless directed by a healthcare professional. If the condition worsens or does not improve within 7 days, or if symptoms resolve and then return within a few days, patients should discontinue use and consult a doctor. Rectal bleeding is another serious condition that warrants immediate cessation of use and medical consultation.

In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center without delay.

Drug Interactions

Patients should consult a healthcare professional prior to using any hydrocortisone product concurrently with this medication. The co-administration of multiple hydrocortisone formulations may lead to an increased risk of systemic side effects due to cumulative corticosteroid exposure. Monitoring for signs of adrenal suppression or other corticosteroid-related adverse effects is advisable in such cases.

Packaging & NDC

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

Packaging configurations for Hydrocortisone.
Details

Pediatric Use

Pediatric patients under 2 years of age, as well as those under 12 years experiencing external anal itching, should not use this medication without consulting a healthcare professional. It is important for healthcare providers to assess the appropriateness of treatment in these age groups to ensure safety and efficacy.

Geriatric Use

There is no specific information available regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

The safety of hydrocortisone cream during pregnancy has not been established, as the prescribing information does not provide specific data regarding its use in this population. Consequently, healthcare professionals should exercise caution when recommending this medication to pregnant patients. There are no documented safety concerns, dosage modifications, or special precautions outlined for the use of hydrocortisone cream in pregnant women. Given the lack of information, it is advisable for women of childbearing potential to discuss the potential risks and benefits with their healthcare provider before using this medication during pregnancy.

Lactation

Lactating mothers should consult a doctor before using this product. There is a potential for excretion in breast milk, and caution is advised when using this product while breastfeeding.

Renal Impairment

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

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to 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 compound in these areas.

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. It is important to instruct patients not to use the product in or near the eyes, and to avoid inserting it directly into the rectum using fingers or any mechanical device or applicator.

Patients should be informed that the product is not intended for use in cases of external feminine itching if they have a vaginal discharge. Additionally, they should be cautioned against using it for diaper rash without consulting a doctor.

Healthcare providers should emphasize the importance of discontinuing use and consulting a doctor if the condition worsens or does not improve within 7 days. Patients should also be advised to stop using the product and seek medical advice if symptoms resolve and then return within a few days, or if rectal bleeding occurs.

When using this product for external anal itching, patients must be reminded not to exceed the recommended daily dosage unless directed by a healthcare professional. Lastly, it is advisable for patients to consult a doctor or pharmacist before using this product if they are currently using any other hydrocortisone product.

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 room temperature, ensuring that it is protected from freezing to maintain its integrity and efficacy. Proper handling should be observed to prevent exposure to extreme temperatures.

Additional Clinical Information

The medication is administered topically, with a recommended application frequency of no more than 3 to 4 times daily to the affected area. Clinicians should advise patients to consult a doctor or pharmacist prior to use if they are currently using any other hydrocortisone products. Patients are instructed to discontinue use and seek medical advice if their condition worsens or fails to improve within 7 days, if symptoms resolve and then return within a few days, or if rectal bleeding occurs. Additionally, the product is not recommended for use in children under 2 years of age, or in children under 12 years experiencing external anal itching, without prior consultation with a healthcare professional.

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.