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Quality Choice

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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 1995
Label revision date
March 8, 2013
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 1995
Label revision date
March 8, 2013
Manufacturer
Chain Drug Marketing Association
Registration number
part348
NDC root
63868-099
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

Hydrocortisone Cream 1% is a topical medication designed to provide maximum strength relief from itching associated with minor skin irritations and rashes. It contains antioxidants and chamomile, which can help soothe the skin. This cream is commonly used for conditions such as eczema, insect bites, poison ivy, poison oak, and other irritations caused by soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis, and external genital and anal itching.

When applied, hydrocortisone works by temporarily alleviating discomfort and reducing inflammation in the affected areas. It's important to use this product as directed, and for any other uses, you should consult with a doctor for guidance.

Uses

This product is designed to provide temporary relief from itching caused by various minor skin irritations and rashes. You can use it for conditions such as eczema, insect bites, and reactions to plants like poison ivy, poison oak, or poison sumac. It can also help soothe itching from soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis, and even external genital and anal itching.

For any other uses, it's important to consult with your doctor to ensure it's appropriate for your situation.

Dosage and Administration

When using this medication, you should apply it to the affected area no more than 3 to 4 times a day if you are an adult or a child aged 2 years and older. Before applying the product, it's best to clean the area gently with mild soap and warm water, then rinse it thoroughly. After cleaning, make sure to dry the area by patting or blotting it with toilet tissue or a soft cloth.

If you have a child under 2 years of age, do not use this product without consulting a doctor. Additionally, if the user is a child under 12 years old, it's important to check with a doctor before use to ensure safety and proper guidance.

What to Avoid

You should avoid using this product in your eyes or inserting it into the rectum using fingers or any mechanical device. If your condition worsens, lasts longer than 7 days, or clears up only to return within a few days, stop using the product and consult a doctor. It's important not to start any other hydrocortisone product without first speaking to a healthcare professional.

While using this product, make sure to follow the recommended dosage closely. If you feel the need to exceed the recommended amount, consult your doctor beforehand to ensure your safety.

Side Effects

You should be aware that this product is for external use only and should not be applied to the eyes or inserted into the rectum using fingers or any devices. Before using it, consult a doctor if you have a vaginal discharge, rectal bleeding, or diaper rash.

If your condition worsens, lasts more than 7 days, or clears up only to return within a few days, stop using the product and seek medical advice. Additionally, keep this product out of reach of children; if swallowed, seek medical help or contact a Poison Control Center immediately.

Warnings and Precautions

This product is for external use only, so please avoid using it in your eyes or inserting it into the rectum with fingers or any devices. If you have a vaginal discharge, rectal bleeding, or diaper rash, it's important to consult your doctor before using this product.

While using this product, make sure not to exceed the recommended dosage without consulting your doctor. If your condition worsens, does not improve after 7 days, or clears up only to return within a few days, stop using the product and talk to your doctor. Avoid starting any other hydrocortisone product without medical advice.

Keep this product out of reach of children. If swallowed, seek 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

You can use hydrocortisone cream during pregnancy, as there are no specific warnings or precautions mentioned regarding its use. The information available does not indicate any risks to the fetus or state that the product is contraindicated (not recommended) during pregnancy. Additionally, there are no dosage modifications or special precautions required for pregnant individuals.

As always, it's a good idea to consult with your healthcare provider before using any medication while pregnant to ensure it’s safe for you and your baby.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of this product while nursing. Additionally, there is no information available about whether this product is excreted in breast milk or any potential risks to your infant. This means that, based on current knowledge, you can use this product without concern for its effects on your milk production or your baby’s health.

Pediatric Use

If your child is under 2 years old, it's important not to use this medication without first consulting a doctor. For children aged 2 years and older, you can apply the medication to the affected area, but make sure to do this no more than 3 to 4 times a day. If your child is under 12 years old, it's best to check with a doctor before using the medication to ensure it's safe and appropriate for them. Always prioritize your child's health and seek professional advice when needed.

Geriatric Use

When it comes to using Quality Choice Hydrocortisone cream, there is no specific information available about how it should be used by older adults. This means that there are no special dosage adjustments, safety concerns, or precautions outlined for elderly patients.

If you are caring for an older adult, it’s always a good idea to consult with a healthcare professional before starting any new medication, including topical treatments like hydrocortisone cream. They can provide personalized advice based on individual health needs and conditions.

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 should be used if you have hepatic impairment (liver issues).

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

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking, even if there are no specific drug interactions or laboratory test interactions noted for your treatment. This ensures that your healthcare team can provide the best care tailored to your needs.

Always feel free to ask questions and share all the medications and supplements you are using. This helps your provider monitor your health effectively and make informed decisions about your treatment.

Storage and Handling

To ensure the best quality and safety of your product, store it at room temperature. It's important to check the carton or tube crimp for the lot number and expiration date, as this information helps you confirm the product's validity and safety for use.

Always handle the product with care, and make sure to follow any additional instructions provided to maintain its integrity. Proper storage and attention to these details will help you use the product effectively and safely.

Additional Information

You should apply this medication topically to the affected area, using it no more than 3 to 4 times a day if you are an adult or a child aged 2 years and older. If you are treating external anal itching, it's best to first cleanse the area with mild soap and warm water, rinse thoroughly, and gently dry it by patting or blotting with toilet tissue or a soft cloth before applying the product.

FAQ

What is Hydrocortisone Cream 1% used for?

Hydrocortisone Cream 1% provides temporary relief of itching associated with minor skin irritations and rashes, including conditions like eczema, insect bites, and poison ivy.

How should I apply Hydrocortisone Cream?

For adults and children 2 years and older, apply to the affected area not more than 3 to 4 times daily. Cleanse the area with mild soap and warm water before application.

Can I use Hydrocortisone Cream on children under 2 years old?

No, do not use Hydrocortisone Cream on children under 2 years of age without consulting a doctor.

What should I do if my condition worsens or persists?

Stop using the cream and consult a doctor if your condition gets worse, persists for more than 7 days, or clears up and occurs again within a few days.

Are there any warnings for using Hydrocortisone Cream?

Yes, it is for external use only. Do not use it in the eyes or insert it into the rectum.

Is it safe to use Hydrocortisone Cream during pregnancy?

The insert does not provide specific warnings or contraindications regarding the use of Hydrocortisone Cream during pregnancy.

What should I do if I accidentally swallow Hydrocortisone Cream?

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

What are the side effects of Hydrocortisone Cream?

The insert does not list specific side effects, but you should stop use and consult a doctor if your condition worsens or persists.

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

Hydrocortisone Cream 1% is formulated as a maximum strength topical preparation designed for intensive healing. This cream exhibits antipruritic properties, effectively alleviating itching. The formulation is enhanced with antioxidants and chamomile, contributing to its soothing effects. Each tube contains 1 ounce (28.4 grams) of the cream, ensuring a sufficient quantity for therapeutic use.

Uses and Indications

This drug is indicated for the temporary relief of itching associated with minor skin irritations and rashes due to various conditions, including eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, seborrheic dermatitis, psoriasis, and external genital and anal itching.

Other uses of this product should only be undertaken under the advice and supervision of a healthcare professional.

Dosage and Administration

For adults and children aged 2 years and older, the product should be applied to the affected area no more than 3 to 4 times daily. Prior to application, it is recommended that the affected area be cleansed with mild soap and warm water, followed by thorough rinsing. The area should then be gently dried by patting or blotting with toilet tissue or a soft cloth before applying the product.

For children under 2 years of age, the product should not be used without consulting a doctor. Additionally, for children under 12 years of age, it is advised to consult a doctor prior to use.

Contraindications

Use of this product is contraindicated in the following situations:

  • Application in the eyes is prohibited due to potential for serious ocular complications.

  • Administration via the rectum using fingers, mechanical devices, or applicators is not recommended, as it may lead to adverse effects.

If the condition worsens, persists for more than 7 days, or resolves and recurs within a few days, discontinue use and consult a healthcare professional. The use of any other hydrocortisone product should not be initiated without medical advice. Additionally, consultation with a healthcare provider is advised before exceeding the recommended dosage.

Warnings and Precautions

For external use only. This product is contraindicated for application in the eyes and should not be administered rectally using fingers, mechanical devices, or applicators.

Healthcare professionals should advise patients to consult a physician prior to use if they present with any of the following conditions: vaginal discharge, rectal bleeding, or diaper rash.

During the use of this product, it is imperative to adhere to the recommended dosage. Patients should be cautioned against exceeding this dosage without prior consultation with a healthcare provider.

Patients must be instructed to discontinue use and seek medical advice if any of the following occur: the condition worsens, persists for more than 7 days, or resolves and then recurs within a few days. It is essential that patients do not initiate the use of any other hydrocortisone product without first consulting a healthcare professional.

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

Side Effects

Patients using this product should be aware that it is intended for external use only. It is contraindicated for use in the eyes and should not be administered rectally, either by fingers or any mechanical device or applicator.

Before using this product, patients are advised to consult a healthcare professional if they have a vaginal discharge, rectal bleeding, or diaper rash.

Patients should discontinue use and seek medical advice if their condition worsens, persists for more than 7 days, or if the condition resolves and then recurs within a few days. It is important not to initiate the use of any other hydrocortisone product without prior consultation with a healthcare provider.

Additionally, 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 specific drug interactions identified for this medication. Additionally, no laboratory test interactions have been noted in the available data. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

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 under 2 years of age should not use this medication and must consult a doctor for guidance. For children aged 2 years and older, the recommended application is to the affected area no more than 3 to 4 times daily. Additionally, for children under 12 years of age, it is advised to consult a doctor prior to use.

Geriatric Use

Elderly patients may not have specific information regarding the use of Quality Choice Hydrocortisone cream, including dosage adjustments, safety concerns, or special precautions. As such, healthcare providers should exercise caution when prescribing this medication to geriatric patients.

Due to the lack of available data, it is advisable for clinicians to closely monitor elderly patients for any potential adverse effects or changes in response to treatment. Individual patient factors, including comorbidities and concurrent medications, should be considered when determining the appropriateness of this therapy in the geriatric population.

Pregnancy

The use of hydrocortisone cream during pregnancy does not have specific warnings or precautions outlined in the prescribing information. There is no indication that the product is contraindicated in pregnant patients, nor are there any documented risks to the fetus associated with its use. Additionally, the prescribing information does not recommend any dosage modifications or special precautions for women of childbearing potential. As with any medication, healthcare professionals should weigh the benefits against potential risks when considering treatment options for pregnant patients.

Lactation

There are no specific warnings or recommendations regarding the use of this product by nursing mothers. Additionally, there is no information provided about the potential for excretion in breast milk or any associated risks to breastfed infants during lactation.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this 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. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the prescribing information.

Overdosage

In the event of an overdosage, immediate medical intervention is crucial. If the substance is ingested, it is imperative to seek medical assistance or contact a Poison Control Center without delay.

Healthcare professionals should be aware that prompt action can significantly influence the outcome of an overdosage situation. Symptoms of overdosage may vary depending on the specific substance involved; therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous evaluation and appropriate interventions should be implemented based on the clinical presentation and severity of symptoms.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the compound in these areas.

Postmarketing Experience

No postmarketing experience details are available for SPL code 90375-7.

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 help or contact a Poison Control Center immediately.

Patients should be informed that this product is not intended for use in the eyes and should not be administered rectally using fingers, mechanical devices, or applicators. They should be instructed to discontinue use and consult a doctor if their condition worsens, persists for more than 7 days, or if the condition improves and then recurs within a few days. It is important to note that patients should not start using any other hydrocortisone product without first consulting a doctor.

When using this product, patients should be cautioned against exceeding the recommended dosage and should consult a doctor prior to doing so. Additionally, patients should be advised to seek medical advice before using the product if they experience vaginal discharge, rectal bleeding, or have a diaper rash.

Storage and Handling

The product is supplied in various packaging configurations, with specific NDC numbers available for identification. It should be stored at room temperature to maintain its integrity and efficacy. Healthcare professionals are advised to refer to the carton or tube crimp for the lot number and expiration date to ensure proper tracking and usage.

Additional Clinical Information

The product is administered topically, with a recommended application frequency of 3 to 4 times daily for adults and children aged 2 years and older. For external anal itching, it is advised that adults cleanse the affected area with mild soap and warm water, rinse thoroughly, and gently dry by patting or blotting with toilet tissue or a soft cloth prior to application.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for 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.