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Duane Reade

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This product has been discontinued

Active ingredient
Hydrocortisone .284 g/28.4 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 21, 2011
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Hydrocortisone .284 g/28.4 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 21, 2011
Manufacturer
Duane Reade
Registration number
part348
NDC root
24488-034
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

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Drug Overview

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Uses

It's important to consult your doctor if you're considering taking more than the recommended dosage of this medication. This ensures that you use it safely and effectively.

While there are no specific teratogenic effects (which means it doesn't cause birth defects) or nonteratogenic effects noted, it's always best to discuss any concerns with your healthcare provider, especially if you are pregnant or planning to become pregnant. Your health and safety are the top priority.

Dosage and Administration

If you are an adult or a child aged 2 years and older, you can apply the medication to the affected area up to 3 to 4 times a day. For those dealing with external anal itching, it’s important to start by gently cleaning the area with mild soap and warm water, making sure to rinse it thoroughly. After cleaning, gently dry the area by patting or blotting it with toilet tissue or a soft cloth before applying the medication.

If the person needing treatment is a child under 12 years old, it’s best to consult a doctor before use to ensure safety and proper care.

What to Avoid

It's important to use this product safely. You should not use it in your eyes or insert it into the rectum using your fingers or any device. These actions can lead to serious complications.

Additionally, before starting any other hydrocortisone product, make sure to consult your doctor. This is crucial to avoid potential misuse or complications related to dependence (a condition where your body becomes reliant on a substance). Always prioritize your health and safety by following these guidelines.

Side Effects

For your safety, this product is intended for external use only. If your condition worsens, persists for more than seven days, or clears up only to return within a few days, you should stop using the product and consult a doctor.

Before using this product, it's important to talk to your doctor if you have any vaginal discharge, rectal bleeding, or diaper rash, as these may require special attention.

Warnings and Precautions

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

You should stop using this product and call your doctor if your condition worsens, does not improve after 7 days, or clears up only to return within a few days. Additionally, do not start using any other hydrocortisone product without first consulting your doctor.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, it's always important to be aware of the signs of an overdose, which can include symptoms like extreme drowsiness, confusion, or difficulty breathing. If you suspect that you or someone else may have taken too much of a medication, it’s crucial to seek immediate medical help.

In case of an overdose, contact your local emergency services or go to the nearest hospital right away. Having the medication packaging or details on hand can help healthcare professionals provide the best care. Always remember that when it comes to medications, it's better to be safe and get help if you have any concerns.

Pregnancy Use

If you are pregnant or planning to become pregnant, it’s important to consult your doctor before using this medication. The safety of this drug during pregnancy has not been established, so it should only be used if it is clearly necessary. You should carefully consider the potential benefits against any risks to your fetus, as the possibility of harm cannot be completely ruled out. Always prioritize open communication with your healthcare provider to ensure the best outcomes for you and your baby.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to consult your doctor before using this product. There is a possibility that it may be excreted in breast milk, which means caution is advised. The effects on your nursing infant have not been thoroughly studied, so it's essential to weigh the potential risks against the benefits before making a decision.

Pediatric Use

When using this medication for children, it's important to follow specific guidelines. For children aged 2 years and older, you can apply it to the affected area no more than 3 to 4 times a day. However, if your child is under 12 years old, you should consult a doctor before use, especially for conditions like external anal itching.

Always keep this medication out of reach of children. If your child accidentally swallows it, seek medical help or contact a Poison Control Center immediately. Your child's safety is the top priority, so don't hesitate to reach out to a healthcare professional with any questions or concerns.

Geriatric Use

While there is no specific information about how this medication should be used by older adults, it’s important to approach any new treatment with caution. Since older adults may have different health needs and may be taking multiple medications, it’s always a good idea to discuss any new prescriptions with your healthcare provider. They can help ensure that the medication is safe and appropriate for you or your loved one, considering any existing health conditions or medications.

If you have concerns about how this medication might affect you or an older adult in your care, please consult with a healthcare professional for personalized advice.

Renal Impairment

If you have kidney problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment plan.

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

Storage and Handling

To ensure the best 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

It's important to consult your doctor before exceeding the recommended dosage of this medication. Additionally, if you're considering using any other hydrocortisone product, make sure to discuss it with your doctor first to ensure it's safe for you.

FAQ

What should I do before exceeding the recommended dosage?

You should consult a doctor before exceeding the recommended dosage.

How often can adults and children 2 years of age and older apply the medication?

Adults and children 2 years of age and older can apply the medication to the affected area not more than 3 to 4 times daily.

What should I do if I experience external anal itching?

For external anal itching, adults should cleanse the affected area with mild soap and warm water, rinse thoroughly, and gently dry before application.

What should I do if my condition worsens or persists?

You should 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.

Can I use this product if I am pregnant?

You should consult a doctor before use if you are pregnant or planning to become pregnant, as safety during pregnancy has not been established.

Is it safe to use this product while nursing?

Nursing mothers should consult a doctor before using this product, as there is a potential for excretion in breast milk.

What should I do if the product is swallowed?

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

What precautions should I take regarding children?

Keep the product out of reach of children, and consult a doctor before use for children under 12 years of age.

Where should I store this medication?

You should store the medication at room temperature.

Can I use other hydrocortisone products with this one?

You should not begin to use any other hydrocortisone product unless you have consulted a doctor.

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

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for use as directed by a healthcare professional. It is essential for patients to consult a doctor before exceeding the recommended dosage to ensure safety and efficacy.

There are no specific teratogenic or nonteratogenic effects associated with this drug. However, healthcare providers should remain vigilant and consider individual patient circumstances when prescribing.

Dosage and Administration

For adults and children aged 2 years and older, the medication should be applied to the affected area no more than 3 to 4 times daily.

In cases of external anal itching for adults, it is recommended to 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 application of the medication.

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

Contraindications

Use of this product is contraindicated in the eyes due to the potential for serious adverse effects. Additionally, administration via the rectum using fingers, mechanical devices, or applicators is not recommended, as it may lead to complications or ineffective treatment.

Patients should not initiate the use of any other hydrocortisone products without prior consultation with a healthcare professional to avoid potential interactions or exacerbation of conditions.

Warnings and Precautions

For external use only. It is imperative that healthcare professionals advise patients to adhere strictly to this guideline to prevent any adverse effects associated with inappropriate use.

In the event of accidental ingestion, immediate medical assistance should be sought. Patients should be instructed to contact a Poison Control Center or seek emergency medical help without delay.

Healthcare providers should counsel 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 only to recur within a few days. Additionally, patients should be cautioned against initiating the use of any other hydrocortisone products without prior consultation with a healthcare professional to ensure safety and efficacy.

Side Effects

For external use only. Patients should be advised to stop use and consult a doctor if the condition worsens, persists for more than 7 days, or if the condition clears up and then recurs within a few days.

Prior to use, patients are encouraged to seek medical advice if they experience vaginal discharge, rectal bleeding, or diaper rash. These precautions are essential to ensure the safe and effective use of the product.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring 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 aged 2 years and older may apply the medication to the affected area no more than 3 to 4 times daily. For children under 12 years of age, it is advised to consult a doctor prior to use, particularly for indications such as external anal itching.

It is important to keep the medication 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 recommended.

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.

Pregnancy

Pregnant patients or those planning to become pregnant should consult a healthcare professional before using this medication. The safety of this drug during pregnancy has not been established, and it should only be used if the potential benefits clearly outweigh the risks. The risk to the fetus cannot be ruled out, necessitating a careful evaluation of the potential benefits against the possible risks associated with use during pregnancy.

Lactation

Nursing mothers should consult a doctor before using this product. There is a potential for excretion in breast milk; therefore, caution is advised when administering to nursing mothers. The effects on the nursing infant are not well studied; thus, the risks versus benefits should be considered.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring of these patients.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

There is currently no specific information available regarding overdosage for this medication. In the absence of documented overdosage data, healthcare professionals are advised to exercise caution and monitor patients closely for any unusual symptoms or adverse effects that may arise following administration.

In the event of suspected overdosage, it is recommended that healthcare providers initiate supportive care and symptomatic treatment as necessary. Continuous monitoring of vital signs and clinical status is essential. If symptoms of overdosage are observed, appropriate interventions should be implemented based on the patient's condition.

Healthcare professionals should also consider contacting a poison control center or a medical toxicologist for further guidance on management strategies tailored to the specific situation.

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 use of the compound in these contexts.

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 should not be used in the eyes or 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 seven days, or resolves only to recur within a few days. Additionally, healthcare providers should emphasize the necessity of consulting a doctor before starting any other hydrocortisone product.

Patients should also be encouraged to seek medical advice prior to use if they experience vaginal discharge, rectal bleeding, or have a diaper rash. This guidance is essential to 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 and integrity. 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

Patients should be advised to consult a doctor before exceeding the recommended dosage of the medication. Additionally, it is important for patients to refrain from starting any other hydrocortisone product without prior consultation with a healthcare professional.

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.