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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 18, 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 18, 2011
Manufacturer
Duane Reade
Registration number
part348
NDC root
24488-033
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 ointment (a topical medication) is used to relieve inflammation and itching caused by various skin conditions. It works by reducing swelling, redness, and itching, helping to soothe irritated skin. This ointment is often recommended for conditions like eczema, dermatitis, and allergic reactions.

It's important to consult with your doctor before using hydrocortisone ointment, especially if you are considering using it for an extended period or in larger amounts than recommended.

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 (which refers to effects that are not related to birth defects) mentioned, 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 should always come first.

Dosage and Administration

If you are an adult or a child aged 2 years and older, you can apply this medication to the affected area up to 3 to 4 times a day. For external anal itching, 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 your child is under 2 years old, do not use this medication without consulting a doctor. Additionally, if your 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 serious harm. Additionally, avoid using it rectally, whether by hand or with any device, as this is not an appropriate method of application.

Be mindful that misuse of this product can lead to serious issues, including dependence (a condition where your body becomes reliant on a substance). Always follow these guidelines to ensure your safety and well-being.

Side Effects

When using this medication, it's important to be aware of potential side effects. 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 any vaginal discharge, rectal bleeding, or diaper rash, it's advisable to speak with a doctor before starting the treatment.

Remember, this product 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 any other hydrocortisone product without consulting your doctor first.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While there is no specific information available about the effects of an overdose for this medication, you should be aware of general signs that may indicate a problem. These can include unusual drowsiness, confusion, or difficulty breathing.

If you notice any of these symptoms or have concerns about a possible overdose, seek medical help right away. Contact your healthcare provider or go to the nearest emergency room. It's always better to be safe and get checked out if you think something might be wrong.

Pregnancy Use

When considering the use of Duane Reade Hydrocortisone cream during pregnancy, it's important to note that the drug insert does not provide specific information about its safety, dosage adjustments, or any special precautions for pregnant individuals. This means that there are no established guidelines or warnings regarding its use while you are pregnant.

If you are pregnant or planning to become pregnant, it's always best to consult with your healthcare provider before using any medication, including over-the-counter creams like hydrocortisone. They can help you weigh the potential benefits and risks based on your individual health needs.

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

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 up to 3 to 4 times a day. However, if your child is under 2 years old, you should not use this medication without first consulting a doctor. Additionally, if your child is under 12 years old, it's advisable to check with a doctor before use to ensure safety and proper dosage. Always prioritize your child's health by seeking 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 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 ensure that any medication you take is safe and appropriate for your liver health. They can help monitor your condition and make any necessary adjustments to your treatment plan.

Drug Interactions

It's great to know that there are no reported drug interactions or interactions with laboratory tests for this medication. However, it's still very important to discuss all medications you are taking, including over-the-counter drugs and supplements, with your healthcare provider. This ensures that your treatment is safe and effective, and helps avoid any potential issues.

Always keep your healthcare provider informed about any changes in your health or new medications you may start. Open communication is key to managing your health effectively.

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

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

FAQ

What is the recommended dosage for adults and children 2 years and older?

You should apply the ointment to the affected area no more than 3 to 4 times daily.

Can children under 2 years of age use this product?

No, do not use this product on children under 2 years of age; consult a doctor instead.

What should I do if my condition worsens or persists?

Stop using the product 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.

Are there any contraindications for using this ointment?

Yes, do not use it in the eyes or insert it into the rectum using fingers or any mechanical device.

What precautions should I take before using this product?

Consult a doctor before use if you have a vaginal discharge, rectal bleeding, or diaper rash.

What should I do if I accidentally swallow the ointment?

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

Is this ointment safe to use during pregnancy or while nursing?

There are no specific statements regarding safety during pregnancy or nursing in the provided information; consult a doctor for advice.

How should I store this ointment?

Store the ointment 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 ointment is formulated as a topical preparation for the management of inflammatory skin conditions. The product is presented in an ointment dosage form, characterized by its smooth, semi-solid consistency. The active ingredient, hydrocortisone, is a synthetic corticosteroid known for its anti-inflammatory properties. The formulation is designed to provide effective relief from symptoms associated with skin irritation and inflammation.

The product is identified by the label "DR_hydrocortisone_ointment_Max_Strength" and is visually represented in the reference image "DR_hydrocortisone_ointment_Max_Strength.jpg." Further details regarding the specific composition and concentration of the active ingredient are available in the product's labeling documentation.

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 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 recommended for children under 2 years of age; consultation with a healthcare professional is advised. Additionally, for children under 12 years of age, it is also recommended to consult a doctor before use.

Contraindications

Use of this product is contraindicated in the following situations:

The product should not be applied to the eyes due to the potential for irritation or damage to ocular tissues. Additionally, it is contraindicated for rectal administration, whether by fingers or any mechanical device or applicator, to prevent injury or adverse effects associated with improper use.

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 or caregivers are advised to contact a Poison Control Center without delay to ensure appropriate management of the situation.

Healthcare providers should instruct patients to discontinue use and consult a physician under the following circumstances: if the condition worsens, if symptoms persist for more than 7 days, or if the condition resolves and then recurs within a few days. It is crucial that patients refrain from using any other hydrocortisone products without prior consultation with a healthcare professional to avoid potential complications.

Side Effects

Patients using this product should be aware that it is intended for external use only. It is important 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. Additionally, patients should seek medical advice before using this product 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 documented drug interactions associated with the use of this medication. Additionally, there are no reported interactions between this drug and laboratory tests. Therefore, no specific dosage adjustments or monitoring recommendations are necessary based on drug interactions.

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 2 years of age, the use of this medication is not recommended, and a consultation with a doctor is advised. Additionally, for children under 12 years of age, it is also recommended 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.

Pregnancy

There are no specific statements regarding the use of Duane Reade Hydrocortisone cream during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients. It is advisable to weigh the potential benefits against any unknown risks to fetal outcomes. Women of childbearing potential should be counseled accordingly, and alternative treatments may be considered if necessary.

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 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

In the absence of specific information regarding overdosage in the provided sections of the Summary of Product Characteristics (SPL), healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdosage.

Recommended Actions In the event of an overdosage, it is essential for healthcare providers to assess the patient's clinical status and initiate appropriate supportive care. Monitoring of vital signs and symptomatic treatment should be implemented as necessary.

Potential Symptoms While specific symptoms of overdosage are not detailed, healthcare professionals should remain vigilant for any unusual or severe reactions that may arise, given the variability in individual responses to medication.

Management Procedures In the absence of specific antidotes or treatment protocols, healthcare professionals should consider contacting a poison control center for guidance on the management of overdosage. It is crucial to document the incident thoroughly and report any adverse effects to the relevant regulatory authorities as per local guidelines.

Overall, the lack of detailed overdosage information underscores the importance of careful dosing and monitoring of patients receiving this medication.

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 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.

Healthcare providers should instruct patients 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. Patients should also be cautioned against starting any other hydrocortisone product without prior consultation with a healthcare professional.

Additionally, patients should be encouraged 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 efficacy. For traceability, healthcare professionals are advised to refer to the carton or tube crimp for the lot number and expiration date. Proper handling and storage conditions are essential to ensure the product's integrity and effectiveness.

Additional Clinical Information

Patients aged 2 years and older are advised to apply the product to the affected area no more than 3 to 4 times daily. For adults experiencing external anal itching, it is recommended to 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 further information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

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.