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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
Ointment
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 8, 2023
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Hydrocortisone 10 mg/1 g
Other brand names
Dosage form
Ointment
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 8, 2023
Manufacturer
Valu Merchandisers, Co.
Registration number
part348
NDC root
63941-313
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 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 is effective for alleviating discomfort from insect bites, detergents, jewelry, cosmetics, soaps, and seborrheic dermatitis. This product can also provide temporary relief for external anal and genital itching.

While Best Choice Hydrocortisone is effective for these uses, it's important to consult with a doctor for any other applications to ensure safe and appropriate use.

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 like eczema, psoriasis, and reactions to plants such as poison ivy, oak, or sumac. It’s also effective for soothing itching from insect bites, as well as irritation caused by detergents, jewelry, cosmetics, soaps, and seborrheic dermatitis.

Additionally, this product can help relieve external itching in the anal and genital areas. If you have other uses in mind, it's best to consult with your doctor for advice and supervision.

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 important 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, rinsing 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 check with 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 without consulting a doctor first. Additionally, be careful to avoid contact with your eyes while using this product.

When using it, make sure to follow the directions closely. Do not exceed the recommended amount unless your doctor advises you to do so. Also, avoid inserting the product directly into the rectum using your fingers or any devices, as this can lead to complications. Always prioritize your health and consult a healthcare professional if you have any concerns.

Side Effects

You should be aware that this product is for external use only. Avoid using it in the genital area if you have a vaginal discharge or for treating diaper rash; consult a doctor in these cases. While using the product, take care to avoid contact with your eyes and do not exceed the recommended dosage unless directed by a doctor.

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, if you experience rectal bleeding, seek medical advice. Keep this product out of reach of children, and if swallowed, contact a medical professional or Poison Control Center immediately.

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 clear up and then return within a few days, stop using the product and consult your doctor. Additionally, if you experience rectal bleeding, seek medical advice. In case of accidental ingestion, 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 ointment during pregnancy. This means that the information available does not indicate any necessary dosage changes or special precautions for using this medication while pregnant.

As always, it's best to consult with your healthcare provider before using any medication during pregnancy to ensure it is safe for you and your baby. They can provide personalized advice based on your individual health needs.

Lactation Use

If you are breastfeeding, you can use hydrocortisone ointment without specific warnings or recommendations against it. The information available does not indicate any particular precautions or considerations for nursing mothers regarding this ointment.

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

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 clean the area with mild soap and warm water, then gently dry it before applying the treatment. If your child is under 12 years old, please consult a doctor for guidance on how to proceed. Always prioritize your child's safety and well-being by seeking 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 responses to medications, you should always consult with a healthcare provider before starting any new medication. They can help determine the right dosage and monitor for any potential side effects, ensuring that the treatment is safe and effective for you or your loved one.

Renal Impairment

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

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your health situation. They can help determine the best course of action based on your kidney function and overall health.

Hepatic Impairment

If you have liver problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication 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 or tests you may be taking. In this case, there are no known drug interactions or laboratory test interactions associated with the medication. However, discussing your full list of medications and any tests you undergo ensures that your healthcare provider can help you avoid potential issues and provide the best care tailored to your needs. Always feel free to ask questions and share your concerns during your appointments.

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 components that come with the product, make sure to handle them carefully and store them as directed to ensure they function properly. Proper storage and handling are key to your safety and the product's reliability.

Additional Information

This medication is for external use only and should be applied topically. It's important to avoid using it in the genital area if you have a vaginal discharge, and you should consult a doctor for treatment of diaper rash. When using this product, keep it away from your eyes and do not exceed the recommended dosage unless directed by a doctor.

If your condition worsens, persists for more than 7 days, or clears up only to return within a few days, stop using the product and consult a doctor. Additionally, do not use it if you experience rectal bleeding, and always keep it out of reach of children. If swallowed, seek medical help or contact a Poison Control Center immediately.

FAQ

What is Best Choice Hydrocortisone used for?

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

How should I apply Best Choice Hydrocortisone?

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 Best Choice Hydrocortisone 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 precautions I should take when using this product?

Yes, avoid contact with eyes, do not use more than directed unless told by a doctor, and do not apply directly into the rectum.

Is it safe to use Best Choice Hydrocortisone during pregnancy?

There are no specific warnings or recommendations regarding the use of hydrocortisone ointment during pregnancy mentioned in the provided information.

What should I do if I swallow this product?

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

Can I use this product on my genital area?

Do not use Best Choice Hydrocortisone in the genital area if you have a vaginal discharge. Consult a doctor.

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 is a pharmaceutical preparation containing hydrocortisone as the active ingredient. Hydrocortisone is a corticosteroid with anti-inflammatory and immunosuppressive properties. The molecular weight of hydrocortisone is 362.46 g/mol, and its chemical formula is C21H30O5. This product is available in a topical dosage form, designed for application to the skin. The formulation is characterized by its white to off-white appearance, ensuring ease of identification and use in clinical settings.

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, and sumac exposure, insect bites, and reactions to detergents, jewelry, cosmetics, soaps, and seborrheic dermatitis.

Additionally, this drug 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, not exceeding 3 to 4 applications per day. 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:

  • Application in the genital area is not recommended for individuals with vaginal discharge; consultation with a healthcare professional is advised.

  • The product should not be used for the treatment of diaper rash; consultation with a healthcare professional is advised.

Additionally, the following precautions should be observed during use:

  • Avoid contact with eyes.

  • Do not exceed the recommended dosage unless directed by a healthcare professional.

  • The product should not be administered directly into the rectum 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 in the genital area if they are experiencing vaginal discharge; consultation with a physician is recommended in such cases. Additionally, this product should not be utilized for the treatment of diaper rash without prior medical consultation.

Healthcare providers should instruct patients to avoid contact with the eyes while using this product. It is crucial that patients adhere strictly to the recommended dosage and refrain from exceeding the directed amount unless specifically instructed to do so by a healthcare professional. Furthermore, patients should be cautioned against inserting the product directly into the rectum using fingers, mechanical devices, or applicators.

Patients must be advised to discontinue use and seek medical advice if their condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve only to recur within a few days. It is also important to inform patients not to initiate the use of any other hydrocortisone products without consulting a healthcare provider.

In the event of rectal bleeding, patients should stop using the product and consult a physician immediately. If the product is ingested, it is critical to seek medical assistance or contact a Poison Control Center without delay.

Side Effects

Patients using this product should be aware that it is intended for external use only. It is contraindicated for 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 medical consultation.

While using this product, patients should avoid contact with the eyes and should not exceed the recommended dosage unless directed by a healthcare professional. It is important to refrain from inserting the product directly into the rectum using fingers or any mechanical device or applicator.

Patients are advised 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. Furthermore, if rectal bleeding occurs, patients should stop using the product and seek medical advice.

This product should be kept out of reach of children. In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center immediately.

Drug Interactions

There are no reported drug interactions associated with the use of this medication. Additionally, no interactions with laboratory tests have been identified. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug interactions.

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 aged 2 years and older may use the medication for the relief of itching associated with skin irritation, inflammation, and rashes. The recommended application is to the affected area not more than 3 to 4 times daily. For children under 2 years of age, consultation with a doctor 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 before application. Similar to the previous indication, children under 12 years of age should seek medical advice before using the product.

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

There are no specific statements regarding the use of hydrocortisone ointment during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients. It is advisable to weigh the potential benefits against any unknown risks to fetal outcomes. Women of childbearing potential should be counseled accordingly, and alternative treatments may be considered if necessary.

Lactation

There are no specific warnings or recommendations regarding the use of hydrocortisone ointment in lactating mothers. Additionally, the insert does not provide any specific considerations or precautions related to lactation or breastfeeding. Therefore, healthcare professionals may consider the use of hydrocortisone ointment in nursing mothers without specific concerns related to excretion in breast milk or effects on breastfed infants.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients, although specific recommendations are not provided.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this drug. Consequently, there are no 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.

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, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and evaluation are recommended to ensure patient safety and effective resolution of any complications arising from the overdosage.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

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 and should seek medical advice if they are considering its use for this purpose.

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 healthcare professional. Furthermore, patients should be made aware that they need to stop using the product and seek medical attention if rectal bleeding occurs.

While using the 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. No special handling requirements are noted; however, standard precautions should be observed to ensure optimal storage conditions.

Additional Clinical Information

The product is administered topically and is intended for external use only. Patients should be advised not to apply it in the genital area if experiencing vaginal discharge and to consult a doctor for treatment of diaper rash. Clinicians should instruct patients to avoid contact with the eyes and to adhere strictly to the recommended dosage, avoiding any direct application into the rectum using fingers or devices.

Patients are cautioned to discontinue use and seek medical advice if their condition worsens, if symptoms persist beyond 7 days, or if symptoms resolve and then recur shortly thereafter. Additionally, they should stop use if rectal bleeding occurs. It is important to keep the product out of reach of children, and in the event of ingestion, medical assistance or contact with a Poison Control Center is necessary.

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.