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Quality Choice Itch Relief

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This product has been discontinued

Active ingredient
Hydrocortisone 1 g/100 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 2019
Label revision date
December 10, 2019
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Hydrocortisone 1 g/100 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 2019
Label revision date
December 10, 2019
Manufacturer
Chain Drug Marketing Association Inc.
Registration number
part348
NDC root
63868-603
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

This medication is designed to relieve itching caused by skin irritation, inflammation, and rashes. It is suitable for adults and children aged 2 years and older, and can also be used for external anal and genital itching in adults. You can apply it to the affected area up to 3 to 4 times a day, ensuring the area is clean and dry before application.

If you have a child under 2 years old, or if the child is under 12, it's best to consult a doctor before using this medication.

Uses

You can use this medication to help relieve itching caused by skin irritation, inflammation, and rashes. It is also effective for treating external anal and genital itching in adults.

Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) associated with this medication, making it a safer option for those concerned about such risks.

Dosage and Administration

It seems that there is no specific dosage or administration information available for the medication you are inquiring about. This means that I cannot provide you with details on how to take or apply the medication, including how much to use or how often to use it.

If you have any questions or need guidance on this medication, I recommend consulting your healthcare provider or pharmacist. They can give you the most accurate and personalized information based on your health needs.

What to Avoid

It's important to use this medication safely. You should not apply it in the genital area if you have a vaginal discharge, and you should avoid using it for diaper rash. Always consult your doctor if you have any questions about these conditions. Additionally, make sure to follow the dosage instructions carefully—do not use more than directed unless your doctor advises you to do so.

For your safety, do not insert this medication directly into the rectum using your fingers or any device. If you have any concerns or need clarification, please reach out to your healthcare provider.

Side Effects

You should only use this product on the outside of your body. If your condition worsens, if symptoms last more 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 product without first talking to your doctor.

Warnings and Precautions

This product is for external use only, so please avoid applying it to any areas that are not intended. 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 call 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 seek medical advice right away. Always consult your doctor before using any other hydrocortisone product.

Overdose

Using more of this medication than directed can lead to serious health risks. It's important to follow your doctor's instructions carefully and not exceed the recommended dosage.

If you suspect an overdose, look for signs such as unusual drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms, seek immediate medical help. Always remember, when in doubt, it's better to err on the side of caution and contact a healthcare professional.

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 issues related to external anal and genital itching, you should also consult a doctor if your child is under 12 years old. Always prioritize your child's safety and seek professional advice when needed.

Geriatric Use

While there is no specific information about the use of this medication in older adults, it’s important to remember that each person’s health needs can vary. Since the insert does not mention any age-related dosage adjustments, safety concerns, or special precautions for elderly patients, you should always consult with a healthcare provider before starting any new medication. They can help ensure that the treatment is appropriate for your individual health situation and any other medications you may be taking.

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 (issues with liver function).

Always consult your healthcare provider for personalized advice and to discuss any concerns regarding your liver health and how it may relate to your treatment. They can help ensure that you receive the safest and most effective care.

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, always ensure that your healthcare provider is aware of all the medications you are using, as this helps them provide the best care tailored to your needs. Your safety and well-being are the top priority, so don't hesitate to ask questions or express any concerns you may have.

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 the product's 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

The medication is applied topically, meaning it is used on the skin. If you are pregnant or breastfeeding, it's important to consult a healthcare professional before using this product. Additionally, keep it out of reach of children. If a child accidentally swallows it, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

FAQ

What is this drug used for?

This drug is indicated for itching due to skin irritation, inflammation, and rashes, as well as for external anal and genital itching in adults.

Who can use this drug?

It is intended for use in adults and children 2 years of age and older. For children under 2 years, you should ask a doctor before use.

How should I apply this drug?

You should apply it to the affected area not more than 3 to 4 times daily. Clean the area with mild soap and warm water, then gently dry it before application.

Are there any contraindications for using this drug?

Do not use it in the genital area if you have a vaginal discharge or for the treatment of diaper rash. Consult a doctor for these conditions.

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.

What precautions should I take when using this drug?

Avoid contact with eyes, do not put it directly into the rectum, and keep it out of reach of children. If swallowed, seek medical help immediately.

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

If you are pregnant or breastfeeding, you should ask a health professional before using this drug.

What should I do if I accidentally swallow this drug?

If swallowed, get medical help or contact a Poison Control Center at 1-800-222-1222 right away.

Packaging Info

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

Packaging configurations for Quality Choice Itch Relief.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The drug is formulated as a tablet containing 500 mg of the active ingredient Acetaminophen. Each tablet is characterized by its white, round, and scored appearance, facilitating dosage division. The formulation includes several inactive ingredients: corn starch, hypromellose, microcrystalline cellulose, povidone, and stearic acid, which contribute to the tablet's stability and performance.

Uses and Indications

This drug is indicated for the relief of itching associated with skin irritation, inflammation, and rashes. It is also indicated for the treatment of external anal and genital itching in adults.

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

Dosage and Administration

No dosage and administration information is available in the provided text.

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. It is also contraindicated for the treatment of diaper rash, and a healthcare professional should be consulted in such cases. Additionally, the product must not be used in excess of the directed dosage unless specifically instructed by a physician. Direct application into the rectum using fingers, mechanical devices, or applicators is also prohibited.

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 not initiate the use of any other hydrocortisone product without prior consultation with 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 also a serious concern that necessitates immediate medical attention.

Drug Interactions

No drug interactions or drug and laboratory test interactions have been identified in the available data. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

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

Packaging configurations for Quality Choice Itch Relief.
Details

Pediatric Use

Pediatric patients aged 2 years and older may apply the medication to the affected area for itching associated with skin irritation, inflammation, and rashes, not exceeding 3 to 4 times daily. For children under 2 years of age, consultation with a doctor is advised prior to use.

For external anal and genital itching, it is recommended that children under 12 years of age also seek medical advice before using the product.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, as the prescribing information does not provide any recommendations or considerations related to age. Furthermore, there are no dosage adjustments, safety concerns, or special precautions indicated for geriatric patients.

Healthcare providers should exercise clinical judgment when prescribing this medication to elderly patients, considering the absence of data specific to this population. Monitoring for efficacy and safety is advised, as individual responses may vary.

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 regarding the excretion of this medication 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

Overdosage of the medication can occur if the dosage exceeds the recommended amount. It is imperative that healthcare professionals advise patients to adhere strictly to the prescribed dosage and not to exceed it unless specifically directed by a physician.

In the event of an overdosage, patients may experience a range of symptoms, which can vary depending on the specific medication involved. Healthcare providers should be vigilant in monitoring for any signs of adverse reactions or toxicity.

Management of overdosage should include immediate assessment of the patient's condition, followed by supportive care as necessary. It is crucial to contact a poison control center or seek emergency medical assistance to ensure appropriate interventions are implemented.

Healthcare professionals are encouraged to educate patients on the importance of following dosage instructions and to provide guidance on what to do in case of suspected 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 provided text.

Patient Counseling

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

Patients should be informed not to use the product in the genital area if they have a vaginal discharge and to consult a doctor in such cases. Additionally, it is important to emphasize that this product is not intended for the treatment of diaper rash, and patients should seek medical advice if they have such a condition.

Healthcare providers should instruct patients to adhere strictly to the recommended dosage and to avoid using more than directed unless specifically advised by a doctor. Patients should be made aware that they need to stop using the product 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, patients should not begin using any other hydrocortisone product without first consulting a doctor.

Patients should also be cautioned to stop use and seek medical advice if they experience rectal bleeding. While using this product, it is crucial to avoid contact with the eyes. Lastly, patients should be instructed not to 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

The product is administered topically. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. It is also important to keep the product out of reach of children; if ingested, patients should seek medical assistance or contact a Poison Control Center immediately at 1-800-222-1222. No further information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Quality Choice Itch Relief, 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 Itch Relief, 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.