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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
February 10, 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
February 10, 2023
Manufacturer
Valu Merchandisers, Co.
Registration number
part348
NDC root
63941-229
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 with Aloe is a topical medication designed to temporarily relieve itching associated with various minor skin irritations, inflammation, and rashes. It can help soothe itching caused by conditions such as eczema, psoriasis, and reactions to poison ivy, oak, or sumac. Additionally, it provides relief from itching due to insect bites, detergents, jewelry, cosmetics, soaps, and seborrheic dermatitis, as well as external anal and genital itching.

This product works by reducing inflammation and calming the skin, making it a helpful option for managing discomfort from these common skin issues. However, 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, including conditions like eczema and psoriasis. It can also help soothe rashes resulting from contact with poison ivy, oak, or sumac, as well as from insect bites, detergents, jewelry, cosmetics, soaps, and seborrheic dermatitis.

In addition to these uses, it can relieve itching in external anal and genital areas. If you have other concerns or conditions, it's best to consult with your doctor before using this product.

Dosage and Administration

If you're dealing with itching from skin irritation, inflammation, or rashes, you can apply the medication to the affected area up to 3 to 4 times a day if you are an adult or a child aged 2 years and older. However, if your child is under 2 years old, it's best to consult a doctor before use.

For external itching in the anal and genital areas, adults should first clean the area with mild soap and warm water, making sure to rinse thoroughly. After cleaning, gently dry the area by patting it with toilet tissue or a soft cloth. You can then apply the medication to the affected area, again up to 3 to 4 times daily. If the person needing treatment is under 12 years old, please consult a doctor for guidance.

What to Avoid

It's important to use this product safely to avoid potential issues. You should not use it in the genital area if you have a vaginal discharge or for treating diaper rash—please consult your doctor in these cases. Additionally, do not exceed the recommended dosage unless directed by your healthcare provider, and avoid inserting the product directly into the rectum using fingers or any devices.

While using this product, be careful to keep it away from your eyes to prevent irritation. Always prioritize your health and consult a healthcare professional if you have any concerns or questions.

Side Effects

You should be aware that this product is for external use only and should not be applied in the genital area if you have a vaginal discharge or used for diaper rash without consulting a doctor. While using this product, avoid contact with your eyes and do not exceed the recommended dosage unless directed by a healthcare professional. It’s important not to insert the product directly into the rectum using fingers or any devices.

If your condition worsens, symptoms last more than 7 days, or if they clear up and then return within a few days, stop using the product and consult a doctor. Additionally, seek medical help immediately if you experience rectal bleeding or if the product is swallowed, as you should contact a Poison Control Center right away. Always keep this product out of reach of children.

Warnings and Precautions

This product is intended for external use only, so please avoid applying it to the genital area if you have a vaginal discharge or for treating diaper rash—consult your doctor in these cases. Be careful to keep it away from your eyes, and do not use more than the recommended amount unless your doctor advises otherwise. It's important not to insert the product directly into the rectum using fingers or any devices.

If your condition worsens, if symptoms last longer than 7 days, or if they improve and then return within a few days, stop using the product and consult your doctor. Additionally, if you experience rectal bleeding, you should also stop use and seek medical advice. In the event that the product is swallowed, please get 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 seek assistance if you suspect an overdose.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that there are no specific guidelines or safety concerns mentioned regarding the use of hydrocortisone cream during pregnancy. This means that the information available does not indicate any special precautions or dosage adjustments that you need to consider while using this medication.

However, as with any medication, it's always best to consult with your healthcare provider before using hydrocortisone cream. They can provide personalized advice based on your individual health needs and circumstances.

Lactation Use

You can use hydrocortisone cream while breastfeeding without specific warnings or recommendations against it. The information available does not indicate any concerns about the cream affecting your milk production or being passed into breast milk. However, it's always a good idea to consult with your healthcare provider if you have any questions or concerns about using any medication while nursing.

Pediatric Use

If your child is experiencing itching from skin irritation, inflammation, or rashes, you can apply the treatment to the affected area up to 3 to 4 times a day for children aged 2 years and older. However, if your child is under 2 years old, it's important to consult a doctor before using the product.

For external anal and genital itching, adults should first clean the area with mild soap and warm water, then gently dry it before applying the treatment. For children under 12 years old, you should also seek advice from a doctor before use. Always prioritize your child's safety and well-being by following these guidelines.

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 for personalized advice. 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 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 plan is safe and effective for your specific situation. They can help monitor your kidney health and make any necessary adjustments to your medications.

Hepatic Impairment

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

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

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking, even if there are no specific drug interactions or laboratory test interactions noted for your treatment. This ensures that your healthcare team can monitor your health effectively and make informed decisions about your care.

Always feel free to ask questions and share all the medications and supplements you are using. This way, you can work together to ensure your treatment is safe and effective.

Storage and Handling

To ensure the best performance of your product, store it at room temperature. This helps maintain its effectiveness and safety. When handling the product, be sure to follow any specific instructions provided to avoid contamination or damage. Always keep the product in a clean environment to ensure it remains safe for use. If you have any questions about proper handling or storage, don’t hesitate to reach out for guidance.

Additional Information

You should apply this medication topically to the affected area, using it no more than 3 to 4 times daily. This guidance applies to both adults and children aged 2 years and older. If you are treating external anal and genital itching, adults should also follow the same application frequency. Always ensure you are using the medication as directed for the best results.

FAQ

What is Best Choice Hydrocortisone with Aloe used for?

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

How should I apply this product?

For adults and children 2 years and older, apply to the affected area not more than 3 to 4 times daily. For children under 2 years, consult a doctor.

Can I use this product for diaper rash?

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

What should I do if my condition worsens?

Stop use and ask a doctor if your condition worsens, symptoms persist for more than 7 days, or if rectal bleeding occurs.

Are there any contraindications for using this product?

Yes, do not use in the genital area if you have a vaginal discharge or for diaper rash without consulting a doctor.

Is it safe to use this product during pregnancy?

The provided information does not mention specific safety concerns or recommendations for use during pregnancy.

What should I avoid while using this product?

Avoid contact with eyes and do not use more than directed unless advised by a doctor.

What if I swallow this product?

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

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 with Aloe is a topical formulation that combines hydrocortisone, a corticosteroid, with aloe vera for its soothing properties. This product is designed for the relief of minor skin irritations, itching, and inflammation. The formulation is presented in a cream dosage form, providing ease of application to affected areas. The inclusion of aloe vera enhances the moisturizing and calming effects on the skin, making it suitable for various dermatological conditions.

Uses and Indications

This drug is indicated for the temporary relief of itching associated with minor skin irritation, inflammation, and rashes due to various conditions, including eczema, psoriasis, poison ivy, oak, sumac, insect bites, detergents, jewelry, cosmetics, soaps, and seborrheic dermatitis. Additionally, it provides temporary relief for external anal and genital 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 the treatment of itching associated with skin irritation, inflammation, and rashes, the recommended dosage for adults and children aged 2 years and older is to apply the medication to the affected area no more than 3 to 4 times daily. For children under 2 years of age, it is advised to consult a physician prior to use.

In cases of external anal and genital itching in adults, it is recommended to first clean the affected area with mild soap and warm water, ensuring thorough rinsing. After cleansing, the area should be gently dried by patting or blotting with toilet tissue or a soft cloth. The medication should then be applied to the affected area no more than 3 to 4 times daily. For children under 12 years of age, consultation with a physician is also recommended before use.

Contraindications

Use of this product is contraindicated in the following situations:

The product should not be applied to the genital area in the presence of vaginal discharge; medical consultation is advised. Additionally, it is contraindicated for the treatment of diaper rash, and a healthcare professional should be consulted in such cases.

The product should not be used in excess of the directed dosage unless specifically instructed by a physician. Furthermore, direct application into the rectum using fingers, mechanical devices, or applicators is prohibited.

Care should be taken to avoid contact with the eyes during use.

Warnings and Precautions

For external use only. This product is contraindicated for application in the genital area in the presence of vaginal discharge; healthcare professionals should advise patients to consult a doctor in such cases. Additionally, it is not indicated for the treatment of diaper rash, and patients should be directed to seek medical advice before use in this context.

Healthcare professionals should instruct patients to avoid contact with the eyes while using this product. It is imperative that patients adhere to the recommended dosage and not exceed the directed amount unless specifically instructed by a physician.

Direct application into the rectum using fingers, mechanical devices, or applicators is contraindicated. Patients should be advised to discontinue use and consult a doctor if the condition worsens, if symptoms persist beyond 7 days, or if symptoms resolve and then recur within a few days. Furthermore, patients should not initiate the use of any other hydrocortisone product without prior consultation with a healthcare provider.

In the event of rectal bleeding, patients must stop using the product and seek medical advice immediately. If ingested, it is crucial to obtain 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 use in the genital area if there is a vaginal discharge, and patients are advised to consult a doctor in such cases. Additionally, the product should not be used for the treatment of diaper rash without prior consultation with a healthcare professional.

While using this product, patients should avoid contact with the eyes and adhere strictly to the recommended dosage. It is important not to exceed the directed use unless specifically instructed by a doctor. The product should not be administered directly into the rectum using fingers or any mechanical device or applicator.

Patients are advised to discontinue use and seek medical advice if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. Furthermore, if rectal bleeding occurs, patients should stop using the product and consult a healthcare provider.

This product should be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions with laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the current information.

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

For the treatment of itching associated with skin irritation, inflammation, and rashes, the recommended application for pediatric patients aged 2 years and older is to apply the medication to the affected area no more than 3 to 4 times daily. For children under 2 years of age, consultation with a healthcare provider is advised prior to use.

In cases of external anal and genital itching, adults are instructed to clean the affected area with mild soap and warm water, rinse thoroughly, and gently dry the area before application. Similar to the previous indication, children under 12 years of age should seek medical advice before using the product.

Geriatric Use

There is no specific information 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.

Pregnancy

Hydrocortisone cream has not been specifically studied in pregnant patients, and there are no established safety concerns, dosage modifications, or special precautions regarding its use during pregnancy. As such, the potential risks and benefits should be carefully considered by healthcare professionals when prescribing this medication to women of childbearing potential. Given the lack of data, it is advisable to use hydrocortisone cream during pregnancy only if clearly needed and after a thorough evaluation of the individual patient's circumstances.

Lactation

There are no specific warnings or recommendations regarding the use of hydrocortisone cream in lactating mothers. Additionally, there is no information available concerning the potential for excretion of hydrocortisone in breast milk or its effects on breastfed infants.

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 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 in these areas limits the understanding of the compound's potential effects 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. It is important to inform patients that the product should not be used in the genital area if they have a vaginal discharge and that they should consult a doctor in such cases. Additionally, patients should be cautioned against using the product for the treatment of diaper rash without prior consultation with a healthcare professional.

Patients should be instructed to discontinue use and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. They should also be advised not to begin the use of any other hydrocortisone product without first consulting a doctor. Furthermore, patients should be made aware that they need to stop using the product and seek medical advice if rectal bleeding occurs.

While using this product, patients should be reminded to avoid contact with their eyes. It is essential to emphasize that they should not exceed the recommended dosage unless directed by a healthcare provider. Lastly, patients should be cautioned against inserting the product directly 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 room temperature to maintain its integrity and efficacy. Proper handling should be observed to ensure optimal conditions are met throughout the storage period.

Additional Clinical Information

The medication is administered topically, with the recommended application frequency for adults and children aged 2 years and older being no more than 3 to 4 times daily to the affected area. For external anal and genital itching, adults should also apply to the affected area no more than 3 to 4 times daily.

No additional information is available regarding laboratory tests, abuse potential, 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.