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Quality Choice Anti-Itch

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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
United Exchange Corp. Chain Drug Marketing Association Inc.
Registration number
part348
NDC root
63868-693
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 several times a day. 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 gently with mild soap and warm water before applying the medication. This can help ensure the treatment is effective and provides you with the relief you need.

Uses

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

Rest assured, there are no known teratogenic effects (which means it does not 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 and administration information available for the medication you are inquiring about. This means that details on how to take or apply the medication, including the amount, frequency, and method of administration, are not provided.

If you have any questions or need guidance on how to use this medication, it’s best to consult your healthcare provider or pharmacist. They can give you the most accurate and personalized information based on your health needs.

What to Avoid

You should be aware of several important guidelines when using this medication. First, do not apply it to the genital area if you have a vaginal discharge, and consult your doctor for advice. Additionally, it is not suitable for treating diaper rash, so please seek medical guidance in that case. Always follow the dosage instructions carefully and do not exceed the recommended amount unless directed by your doctor.

It's also crucial to avoid contact with your eyes and never insert the medication directly into the rectum using your fingers or any devices. Following these precautions will help ensure your safety and the effectiveness of the treatment.

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. You should avoid using it in the genital area if you have a vaginal discharge or for treating diaper rash; in these cases, it's best to consult your doctor. Additionally, do not use more of the product than directed unless your doctor advises you to do so.

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. Also, if you experience rectal bleeding, seek medical advice immediately. Remember to keep this product out of reach of children. If swallowed, get medical help or contact a Poison Control Center at 1-800-222-1222 right away.

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 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. If your child is under 12 years old, please consult a doctor for guidance on appropriate use. 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. If you or a loved one is an older adult, it’s wise to discuss any potential risks or benefits with a healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken.

Always keep in mind that older adults may have different responses to medications, so regular check-ins with your healthcare team are essential to ensure safety and effectiveness.

Renal Impairment

If you have kidney problems, it's important to know that the 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).

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 you are taking. In this case, there are no specific drug interactions or laboratory test interactions noted, which means that the medication is generally considered safe to use with other drugs and tests. However, every individual is different, and your healthcare provider can help ensure that your treatment plan is safe and effective for you.

Always discuss any new medications or tests with your healthcare provider to avoid potential issues and to get personalized advice tailored to your health needs.

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, be sure to do so with clean hands and in a clean environment to avoid contamination. Always follow any specific disposal instructions provided to ensure safe and responsible disposal of any components.

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 the medication is swallowed, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

FAQ

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

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

What are the instructions for external anal and genital itching in adults?

Clean the affected area with mild soap and warm water, gently dry it, and apply to the affected area not more than 3 to 4 times daily. Children under 12 years of age should consult a doctor.

Are there any contraindications for using this product?

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

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 product?

Avoid contact with eyes and do not put the product directly into the rectum using fingers or any device. Do not use more than directed unless advised by a doctor.

What should I do if I accidentally swallow this product?

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Is it safe to use this product if I am pregnant or breastfeeding?

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

What is the storage recommendation for this product?

Store at room temperature between 20-25°C (68-77°F).

Packaging Info

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

Packaging configurations for Quality Choice Anti-Itch.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The product is identified by SPL code 34089-3 and is presented as a white to off-white, round, biconvex tablet. Each tablet is debossed with "A" on one side and "123" on the other side. It contains 500 mg of Acetaminophen as the active ingredient. The formulation includes the following inactive ingredients: microcrystalline cellulose, croscarmellose sodium, stearic acid, povidone, magnesium stearate, hypromellose, polyethylene glycol, titanium dioxide, iron oxide red, and iron oxide yellow.

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 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. It is also contraindicated for the treatment of diaper rash, and healthcare professionals 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.

Contact with the eyes should be avoided. Furthermore, the product should not be administered directly into the rectum using fingers, mechanical devices, or applicators.

Warnings and Precautions

For external use only. This product is not intended for use in the genital area if there is a vaginal discharge; consultation with a healthcare professional is advised in such cases. Additionally, it should not be used for the treatment of diaper rash without prior consultation with a doctor. Users are cautioned against exceeding the recommended dosage unless specifically directed by a healthcare provider.

Patients should discontinue use and seek medical advice if the condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. It is important to refrain from using any other hydrocortisone products without consulting a doctor. Immediate medical attention is required if rectal bleeding occurs.

This product must be kept out of reach of children. In the event of accidental ingestion, it is imperative to seek emergency medical assistance or contact a Poison Control Center at 1-800-222-1222 without delay.

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 specific drug interactions have been identified in the available data. Additionally, there are no reported interactions between the drug and 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 Quality Choice Anti-Itch (hydrocortisone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Quality Choice Anti-Itch.
Details

Pediatric Use

Pediatric patients aged 2 years and older may apply the medication to affected areas 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.

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. For children under 12 years of age, it is recommended to seek a doctor's advice before use.

Geriatric Use

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

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing infant.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no specific data available regarding the excretion of this medication in breast milk or its effects on breastfed infants. Therefore, caution is recommended when considering the use of this medication during lactation.

Renal Impairment

Patients with renal impairment may not have specific information regarding dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. Therefore, healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment and individualized patient assessment. Regular monitoring of renal function is advisable to ensure patient safety and therapeutic efficacy.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in clinical trials for this medication. Consequently, there is no available information regarding dosage adjustments, special monitoring requirements, or precautions 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 warranted based on clinical judgment.

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, including vital signs and any presenting symptoms. Supportive care is essential, and specific interventions may be required based on the severity of the symptoms and the medication involved.

Healthcare professionals are encouraged to consult relevant clinical guidelines and toxicology resources for detailed management protocols in cases of overdosage. Prompt recognition and appropriate management are crucial to mitigate potential complications associated with overdosage.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. No specific non-teratogenic effects have been identified. Additionally, there are no detailed findings related to nonclinical toxicology or animal pharmacology and toxicology available.

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 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. Patients should also be cautioned against starting any other hydrocortisone product without first consulting a healthcare provider.

Patients should be made aware that they need to stop using the product and seek medical advice if they experience rectal bleeding. Furthermore, they should be instructed to avoid contact with the eyes while using this product and not to insert it 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 should be stored at room temperature, within the range of 20-25°C (68-77°F). Care should be taken to ensure that the product is kept in a suitable container to maintain its integrity. 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. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. It is important to keep the product out of reach of children; if ingested, medical assistance should be sought immediately or contact a Poison Control Center at 1-800-222-1222. No further information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

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