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Quality Choice

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Active ingredient
Hydrocortisone 10 mg/1 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 2025
Label revision date
October 16, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Hydrocortisone 10 mg/1 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 2025
Label revision date
October 16, 2025
Manufacturer
Chain Drug Marketing Association, Inc.
Registration number
M017
NDC root
83324-297
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

You may be looking for a medication that helps relieve itching caused by skin irritation, inflammation, and rashes. This treatment is suitable for adults and children aged 2 years and older, and it can be applied to the affected area up to 3 to 4 times daily. For children under 2 years of age, it's best to consult a doctor before use.

If you're dealing with itching in the external anal and genital areas, it's recommended to clean the area with mild soap and warm water, then gently dry it before applying the medication. Again, for children under 12, consulting a doctor is advised. This medication aims to provide relief from discomfort and improve your skin's condition.

Uses

You can use this medication to relieve itching caused by skin irritation, inflammation, and rashes. If you are an adult or a child aged 2 years and older, you can apply it to the affected area up to 3 to 4 times a day. For children under 2 years old, it's best to consult a doctor before use.

If you're dealing with itching in the external anal or genital area, adults can also apply the medication to the affected area up to 3 to 4 times daily. Before applying, it's a good idea to clean the area gently with mild soap and warm water, then rinse thoroughly. Make sure to dry the area by patting it with toilet tissue or a soft cloth before applying the medication. If the person is under 12 years old, consult a doctor for guidance.

Dosage and Administration

It seems that there are no specific dosage or administration details available for this medication. This means that you should consult your healthcare provider for personalized instructions on how to take or use it. They will provide you with the necessary information regarding the correct dosage, how to administer it, and how often you should do so. Always follow their guidance to ensure safe and effective use of the medication.

What to Avoid

It's important to use this medication safely. You should not apply it to the genital area if you have a vaginal discharge or use it for diaper rash without consulting a doctor first. Always follow the directions provided and do not exceed the recommended dosage unless your doctor advises otherwise.

Additionally, avoid contact with your eyes, and never insert the medication directly into the rectum using your fingers or any device. If you have any questions or concerns, please reach out to your healthcare provider for guidance.

Side Effects

You should only use this product on the outside of your body. If your condition worsens, if symptoms last longer than 7 days, or if they improve and then come back within a few days, stop using it and consult your doctor. Additionally, if you experience rectal bleeding, seek medical advice immediately. It's important not to start any other hydrocortisone products without first discussing it with your healthcare provider.

Warnings and Precautions

This product is for external use only, so please avoid applying it to any internal areas. Keep it out of reach of children, and if it is swallowed, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

You should stop using this product and consult your doctor if your condition worsens, if symptoms last longer than 7 days, or if they improve and then return within a few days. Additionally, if you experience any rectal bleeding, it’s important to call your doctor right away.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, it’s always important to be aware of the signs of an overdose, which can include unusual drowsiness, confusion, or difficulty breathing. If you suspect an overdose, it’s crucial to seek immediate medical help.

In case of an emergency, contact your local poison control center or go to the nearest hospital. Always keep medications out of reach of children and follow the prescribed dosage to prevent any potential risks. If you have any concerns or questions about your medication, don’t hesitate to reach out to your healthcare provider for guidance.

Pregnancy Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using this medication. They can provide guidance on whether it’s safe for you and your baby. Always prioritize your health and the health of your child by seeking expert advice.

Lactation Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using any medication. This ensures that you understand any potential risks and can make informed decisions about your health and the health of your baby. Always prioritize open communication with your doctor regarding your breastfeeding journey.

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. This can also be done up to 3 to 4 times daily. If your child is under 12 years old, please consult a doctor for guidance. Always prioritize your child's safety and seek professional advice when needed.

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 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 differently due to your liver health.

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver function and how it relates to your treatment. They can help ensure that your medication is safe and effective for you.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you. Always share your complete list of medications and any health conditions you have to receive the best care possible.

Storage and Handling

To ensure the best performance of your product, store it at room temperature, ideally between 20-25°C (68-77°F). This temperature range helps maintain its effectiveness and safety.

When handling the product, make sure to do so 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

No further information is available.

FAQ

How should I use this medication for itching of skin irritation, inflammation, and rashes?

For adults and children 2 years and older, apply to the affected area no more than 3 to 4 times daily. For children under 2 years, consult a doctor.

What should I do before applying the medication for external anal and genital itching?

When practical, clean the affected area with mild soap and warm water, rinse thoroughly, and gently dry by patting or blotting before applying.

Are there any contraindications for using this medication?

Do not use in the genital area if you have a vaginal discharge or for the treatment of diaper rash without consulting a doctor.

What should I do if my condition worsens or symptoms persist?

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

What precautions should I take when using this medication?

This medication is for external use only. Keep it out of reach of children, and if swallowed, seek medical help immediately.

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

If you are pregnant or breastfeeding, consult a health professional before use.

What should I avoid while using this medication?

Do not use more than directed, avoid contact with eyes, and do not insert it directly into the rectum using fingers or any device.

Packaging Info

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

Packaging configurations for Quality Choice.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the relief of itching associated with skin irritation, inflammation, and rashes in adults and children aged 2 years and older. It should be applied to the affected area no more than 3 to 4 times daily. For children under 2 years of age, consultation with a healthcare professional is advised prior to use.

Additionally, this drug is indicated for the treatment of external anal and genital itching in adults, with the same application frequency of no more than 3 to 4 times daily. It is recommended that, when practical, the affected area be cleaned with mild soap and warm water, followed by thorough rinsing. The area should be gently dried by patting or blotting with toilet tissue or a soft cloth before application.

For children under 12 years of age, it is advised to consult a healthcare professional before use.

No teratogenic or nonteratogenic effects have been reported.

Dosage and Administration

There is currently no specific dosage or administration information available for this medication. Healthcare professionals are advised to refer to the prescribing information or clinical guidelines for detailed instructions regarding the appropriate dosage, route, method, and frequency of administration. It is essential to consider individual patient factors and clinical judgment when determining the appropriate treatment regimen.

Contraindications

Use 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.

Furthermore, the product should not be used in excess of the directed dosage unless specifically instructed by a physician. Contact with the eyes must be avoided, and the product should not be administered directly into the rectum using fingers or any mechanical device or applicator.

Warnings and Precautions

For external use only. It is imperative that this product is kept out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought by contacting a Poison Control Center at 1-800-222-1222.

Healthcare professionals should advise patients to discontinue use and consult a physician if any of the following occur: the condition worsens, symptoms persist for more than 7 days, or symptoms resolve and then recur within a few days. Patients should refrain from using any other hydrocortisone products unless directed by a healthcare provider. Additionally, if rectal bleeding is observed, patients must stop using the product and seek medical advice promptly.

In cases of ingestion, it is crucial to obtain emergency medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Side Effects

For external use only. Patients should discontinue use and consult a doctor if the condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. Additionally, patients should not begin the use of any other hydrocortisone product without first consulting a healthcare professional. Rectal bleeding is another serious condition that warrants immediate medical attention.

Drug Interactions

There are currently no documented drug interactions or interactions with laboratory tests associated with this medication. As such, no specific recommendations for dosage adjustments or monitoring are necessary at this time. Healthcare professionals should continue to assess individual patient circumstances and consider any potential interactions based on the patient's overall medication regimen.

Packaging & NDC

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

Packaging configurations for Quality Choice.
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. The same frequency of application, not more than 3 to 4 times daily, applies. For children under 12 years of age, it is recommended to seek a doctor's 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

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data on the excretion of this drug in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

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

There is currently no specific information available regarding overdosage for this medication. Healthcare professionals are advised to monitor patients closely for any signs of adverse effects or symptoms that may arise from excessive dosing.

In the event of suspected overdosage, it is recommended that healthcare providers initiate supportive care and symptomatic treatment as necessary. The management of overdosage should be tailored to the individual patient, taking into account their clinical presentation and any underlying health conditions.

Healthcare professionals should also consider contacting a poison control center or a medical toxicologist for guidance on the appropriate management of overdosage cases.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. No non-teratogenic effects have been specified in the available data. Additionally, there are no details provided regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children. In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center immediately at 1-800-222-1222.

Patients should be informed not to use this product in the genital area if they have a vaginal discharge and to consult a doctor in such cases. Additionally, it should not be used for the treatment of diaper rash without prior consultation with a healthcare professional.

It is important to instruct patients not to exceed the recommended dosage unless directed by a doctor. They should be made aware that 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 stop using the product and consult a doctor. Patients should also be cautioned against using any other hydrocortisone product without first consulting a healthcare provider.

Patients should be advised to stop using the product and seek medical advice if they experience rectal bleeding. Furthermore, while using this product, patients should avoid contact with their eyes and should not insert 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, maintaining a range of 20-25°C (68-77°F). Proper storage conditions are crucial to ensure the integrity and efficacy of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Quality Choice, 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 Quality Choice, 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

Last AI update:

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.