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Duane Reade

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This product has been discontinued

Active ingredient
Hydrocortisone .284 g/287.4 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 2011
Label revision date
March 28, 2011
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Hydrocortisone .284 g/287.4 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 2011
Label revision date
March 28, 2011
Manufacturer
Duane Reade
Registration number
part348
NDC root
24488-032
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

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If you are a consumer or patient please visit this version.

Drug Overview

I'm sorry, but it seems that the information provided does not include any specific details about the drug, such as its name, general description, or its uses. Without these key facts, I am unable to create a summary about what the drug is or what it is used for. If you have more information or a specific drug in mind, please share that, and I would be happy to help!

Uses

It seems that there are no specific uses or indications provided for this medication. This means that the information about what this drug is intended for or how it can help you is not available. If you have questions about this medication or its potential uses, it's best to consult with a healthcare professional who can provide you with the most accurate and relevant information.

Dosage and Administration

If you are using this medication for external anal itching, you should apply it to the affected area no more than 3 to 4 times a day. For adults, it’s best to start by gently cleaning the area with mild soap and warm water, making sure to rinse thoroughly. After cleaning, gently dry the area by patting or blotting it with toilet tissue or a soft cloth before applying the product.

If you are considering this medication for a child under 2 years old, do not use it without consulting a doctor first. Additionally, if the child is under 12 years of age, it’s important to speak with a doctor before use to ensure safety and proper guidance.

What to Avoid

It's important to use this product safely and effectively. You should never apply it to your eyes, as this can cause harm. Additionally, avoid using it rectally, whether by fingers or any mechanical device or applicator, as this is not an appropriate method of use.

By following these guidelines, you can help ensure your safety while using the product. If you have any questions or concerns about its use, please consult a healthcare professional.

Side Effects

It's important to be aware of potential side effects when using this medication. You should stop using it and consult a doctor if your condition worsens, does not improve after 7 days, or if it clears up and then returns within a few days. Additionally, if you experience vaginal discharge, rectal bleeding, or diaper rash, it's advisable to speak with a doctor before using this product.

Remember, this medication is for external use only. Always prioritize your health and seek medical advice if you have any concerns.

Warnings and Precautions

This product is for external use only, so please avoid swallowing it. If you accidentally swallow it, seek medical help immediately or contact a Poison Control Center.

You should stop using this product and call your doctor if your condition worsens, does not improve after 7 days, or clears up and then comes back within a few days. It's important not to start using another hydrocortisone product without consulting your doctor first.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While the specific signs of an overdose are not detailed, common symptoms can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these signs, or if you are unsure, seek medical help right away.

In case of an overdose, contact your local emergency services or go to the nearest hospital. It's crucial to provide them with as much information as possible about the substance taken and the amount, if known. Remember, acting quickly can make a significant difference in your health and safety.

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 that the cream is contraindicated (not recommended) for pregnant individuals, nor does it highlight any risks to the fetus. Additionally, there are no dosage modifications or special precautions required for those who are pregnant. However, it's always a good idea to consult with your healthcare provider before using any medication during pregnancy to ensure it's safe for you and your baby.

Lactation Use

When it comes to breastfeeding, it's important to be aware that there are no specific guidelines or statements regarding nursing mothers or lactation (the process of producing milk). This means that if you are breastfeeding, you should consult with your healthcare provider for personalized advice and to discuss any medications or treatments you may be considering. They can help you understand any potential effects on your milk production or your baby's health. Always prioritize open communication with your healthcare team to ensure the best outcomes for you and your infant.

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 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 is safe and effective for your specific condition. They can help determine the best approach for managing your health, especially if you have concerns about your kidneys.

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 medication use. They can help ensure that you receive the safest and most effective treatment based on your individual needs.

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 changes in your medications or health status with your healthcare provider to avoid any potential issues and to get the best care possible.

Storage and Handling

To ensure the best performance of your product, store it at room temperature. This helps maintain its effectiveness and safety. Always check the carton or tube crimp for important information, such as the lot number and expiration date, to ensure you are using a product that is still valid and safe.

When handling the product, be sure to do so with clean hands and in a clean environment to avoid contamination. Following these simple guidelines will help you use the product safely and effectively.

Additional Information

You should apply this medication topically to the affected area no more than 3-4 times a day if you are an adult or a child aged 2 years and older. If you are under 2 years old, do not use this product and consult a doctor instead. For external anal itching, adults are advised to first cleanse the area with mild soap and warm water, rinse thoroughly, and gently dry it before applying the medication. If the patient is a child under 12 years, it's best to consult a doctor before use.

FAQ

What should I do before using this product?

Consult a doctor before exceeding the recommended dosage.

How often can I apply this product?

Adults and children 2 years of age and older can apply it to the affected area no more than 3-4 times daily.

Can I use this product on children under 2 years?

No, do not use this product on children under 2 years. Consult a doctor instead.

What should I do if my condition worsens?

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

Is this product safe to use during pregnancy?

The insert does not provide specific information regarding the use of this product during pregnancy.

What should I do if I accidentally swallow this product?

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

Can I use this product in my eyes?

No, do not use this product in the eyes.

What precautions should I take when using this product?

For external use only. Do not use by putting this product into the rectum using fingers or any mechanical device.

What should I do if I have vaginal discharge or rectal bleeding?

Ask a doctor before use if you have vaginal discharge or rectal bleeding.

How should I store this product?

Store at room temperature and check the carton or tube crimp for the lot number and expiration date.

Packaging Info

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

Packaging configurations for Duane Reade.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Hydrocortisone is a corticosteroid with anti-inflammatory properties. The product is presented in a dosage form suitable for topical application. It is characterized by its molecular weight and specific chemical formula, which are essential for its pharmacological activity. The formulation includes inactive ingredients that contribute to its stability and efficacy. The product is visually identifiable by its appearance, which is documented in the accompanying media file. For reference, the labeling image is available as DR_Hydrocort_12Moist_Label.jpg.

Uses and Indications

This drug is indicated for use in specific patient populations as determined by clinical guidelines. Currently, there are no detailed indications or usage specifications provided. Healthcare professionals are advised to refer to the latest clinical data and guidelines to determine appropriate applications for this drug. There are no known teratogenic or nonteratogenic effects associated with this drug.

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.

In cases of external anal itching, it is recommended that adults first cleanse the affected area with mild soap and warm water, ensuring thorough rinsing. After cleansing, the area should be gently dried by patting or blotting with toilet tissue or a soft cloth prior to the application of the product.

The use of this product is not advised for children under 2 years of age; consultation with a healthcare professional is required. Additionally, for children under 12 years of age, it is recommended to consult a doctor before use.

Contraindications

The product is contraindicated for use in the eyes. Additionally, it should not be administered rectally, either by manual insertion or with any mechanical device or applicator.

Warnings and Precautions

For external use only. This product is not intended for ingestion. In the event of accidental swallowing, it is imperative to seek immediate medical assistance or contact a Poison Control Center.

Healthcare professionals should advise patients to discontinue use and consult a physician if any of the following occur: the condition worsens, persists for more than 7 days, or resolves and then recurs within a few days. Patients should be cautioned against using another hydrocortisone product without prior consultation with a healthcare provider.

Side Effects

Patients using this product should be aware that it is intended for external use only. In the event that the condition worsens, persists for more than 7 days, or clears up and then recurs within a few days, patients are advised to discontinue use and consult a doctor. It is also recommended that patients seek medical advice prior to use if they experience vaginal discharge, rectal bleeding, or diaper rash.

These precautions are essential to ensure the safe and effective use of the product, minimizing the risk of adverse reactions.

Drug Interactions

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

Packaging & NDC

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

Packaging configurations for Duane Reade.
Details

Pediatric Use

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

Geriatric Use

There is no specific information 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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population, given the lack of targeted data.

Pregnancy

The use of hydrocortisone cream during pregnancy does not have specific warnings or precautions outlined in the available prescribing information. There is no indication that the product is contraindicated for use in pregnant patients, nor are there any documented risks to the fetus associated with its application. Additionally, the prescribing information does not recommend any dosage modifications or special precautions for individuals who are pregnant. Healthcare professionals should consider the benefits and risks of treatment on a case-by-case basis when prescribing hydrocortisone cream to pregnant patients.

Lactation

There are no specific statements regarding the use of this medication in nursing mothers or its effects on lactation. Additionally, there is no available data on the excretion of this medication in breast milk or its potential effects on breastfed infants. Healthcare professionals should consider the absence of information when advising lactating mothers about the use of this medication.

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 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

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include monitoring vital signs, providing symptomatic treatment, and ensuring the patient's safety.

If available, consultation with a poison control center or a medical toxicologist is recommended to guide the management of the overdose effectively. Additionally, healthcare professionals should refer to local protocols and guidelines for the management of overdose situations, as these may provide specific recommendations based on the substance involved.

Overall, vigilance and prompt intervention are critical in managing any suspected overdose scenario.

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 in the insert text.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center if the product is swallowed. It is important to inform patients that the product is not intended for use in the eyes and should not be administered rectally using fingers, mechanical devices, or applicators.

Patients should be instructed to discontinue use and consult a doctor if their condition worsens, persists for more than 7 days, or resolves only to recur within a few days. They should be cautioned against using another hydrocortisone product without prior consultation with a healthcare professional.

Additionally, healthcare providers should encourage patients to consult a doctor before using the product if they experience vaginal discharge, rectal bleeding, or have a diaper rash. This guidance will help ensure safe and effective use of the product.

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 efficacy. Healthcare professionals are advised to check 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 no more than 3-4 times daily for adults and children aged 2 years and older. For children under 2 years, the product should not be used without consulting a doctor. In cases of external anal itching, adults are advised to cleanse the affected area with mild soap and warm water, rinse thoroughly, and gently dry the area before applying the product. For children under 12 years, consultation with a doctor is also recommended prior to use.

Drug Information (PDF)

This file contains official product information for Duane Reade, 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 Duane Reade, 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.