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Hydrocortisone

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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
February 21, 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
February 21, 2013
Manufacturer
Meijer Distribution Inc
Registration number
part348
NDC root
41250-408
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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 is a topical medication that contains 1% hydrocortisone, designed to provide temporary relief from itching associated with minor skin irritations and rashes. This cream is formulated with aloe to soothe the skin and is effective for various conditions, including eczema, insect bites, and reactions to poison ivy, poison oak, or poison sumac. It can also help alleviate itching caused by soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis, and external genital and anal itching.

This maximum strength cream works as an antipruritic (anti-itch) agent, helping to calm irritated skin and reduce discomfort. While it is effective for many common skin issues, it's important to use it under the advice and supervision of a doctor for any other uses.

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

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 those experiencing external anal itching, it’s important to first clean 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 best to check 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 use it in your eyes or insert it into the rectum using your fingers or any mechanical device or applicator. These actions can lead to serious complications and are strictly contraindicated.

Additionally, be aware that misuse or abuse of this product can lead to dependence (a condition where your body becomes reliant on a substance). Always follow the instructions carefully to avoid any potential risks associated with improper use.

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, does not improve after 7 days, or clears up only to return within a few days, stop using the product and seek medical advice. Additionally, if the product is 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. Before using this product, it's important to consult your doctor if you have any vaginal discharge, rectal bleeding, or diaper rash.

While using this product, be sure to follow the recommended dosage and consult your doctor if you feel the need to exceed it. If your condition worsens, lasts longer than 7 days, or clears up only to return within a few days, stop using the product and contact your doctor. Additionally, 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 this 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.

Signs of an overdose can vary, but they may include unusual symptoms that are not typical for you. If you notice anything concerning, don’t hesitate to get help. Remember, acting quickly can make a significant difference in ensuring safety and health.

Pregnancy Use

You can use hydrocortisone with aloe during pregnancy, as there are no specific warnings or precautions mentioned regarding its use. The information available does not indicate that this product 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.

As always, it's 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 may not find detailed information about how certain medications or treatments could affect you or your baby.

If you have concerns about breastfeeding while taking any medication, it's always best to consult with your healthcare provider for personalized advice and to ensure the safety of both 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 of age, it's advisable to speak with a doctor before using it to ensure it's safe and appropriate for them. Always prioritize your child's health and safety by following these recommendations.

Geriatric Use

When it comes to using Hydrocortisone with Aloe, 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 an older adult or a caregiver, it's important to consult with a healthcare professional before starting any new medication, including Hydrocortisone with Aloe. They can provide personalized advice and ensure that the treatment is safe and appropriate for your individual health needs.

Renal Impairment

If you have kidney problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or safety considerations for your condition. This means that there are no tailored guidelines for how this medication may affect you if you have renal impairment (kidney issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your health situation. They can help monitor your kidney function and make any necessary adjustments to 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 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, even if there are no specific drug interactions or laboratory test interactions noted for your treatment. This ensures that your healthcare team can monitor your health effectively and make informed decisions about your care.

Always feel free to ask questions and share all the medications and supplements you are using. This way, you can work together to ensure your treatment is safe and effective.

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 product 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. If you are dealing with 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 used for?

Hydrocortisone Cream is used for 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?

You should apply Hydrocortisone Cream to the affected area not more than 3 to 4 times daily for adults and children 2 years of age and older.

Are there any age restrictions for using this cream?

Do not use Hydrocortisone Cream on children under 2 years of age without consulting a doctor, and consult a doctor for children under 12 years of age.

What should I do if my condition worsens?

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.

Can I use Hydrocortisone Cream in my eyes?

No, you should not use Hydrocortisone Cream in the eyes or insert it into the rectum using fingers or any device.

What should I do if I swallow Hydrocortisone Cream?

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

Is it safe to use Hydrocortisone Cream during pregnancy?

The provided information does not indicate any specific risks or contraindications for use during pregnancy, but consult a doctor for personalized advice.

What are the storage instructions for Hydrocortisone Cream?

Store Hydrocortisone Cream 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 Hydrocortisone. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Hydrocortisone.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

meijer™ Maximum Strength 1% Hydrocortisone Cream is formulated to provide effective anti-itch relief. The active ingredient, hydrocortisone, is an antipruritic agent that alleviates itching and discomfort associated with various skin irritations. This cream is enhanced with aloe to soothe the skin. The product is packaged in a net weight of 2 ounces (60 grams).

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, jewelry, 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. There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Adults and children aged 2 years and older are instructed to apply the product to the affected area no more than 3 to 4 times daily. For the treatment of external anal itching in adults, it is recommended to cleanse the affected area 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 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 doctor 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 manual insertion or through the use of any mechanical device or applicator, as this may lead to adverse effects or complications.

Warnings and Precautions

This product is intended for external use only. It is imperative that the product is not applied in or around the eyes, nor should it be administered rectally using fingers, mechanical devices, or applicators.

Prior to use, individuals should consult a healthcare professional if they are experiencing any of the following conditions: vaginal discharge, rectal bleeding, or diaper rash. These conditions may require further evaluation and management.

While using this product, it is crucial to adhere to the recommended dosage. Consultation with a healthcare provider is advised before exceeding the prescribed amount.

Users must discontinue use and seek medical advice if any of the following occur: the condition worsens, persists for more than seven days, or resolves only to recur within a few days. It is important not to initiate the use of any other hydrocortisone products without prior consultation with 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 recommended.

Side Effects

Patients should be aware that this product is intended for external use only. It is contraindicated for use in the eyes and should not be administered rectally using fingers, mechanical devices, or applicators.

Before using this product, patients are advised to consult a healthcare professional if they experience 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.

In the event of accidental ingestion, patients should seek immediate medical assistance or contact a Poison Control Center.

Drug Interactions

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

Packaging & NDC

Below are the non-prescription pack sizes of Hydrocortisone. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Hydrocortisone.
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 medication is not recommended, and a consultation with a doctor is advised. Additionally, for children under 12 years of age, it is important to consult a doctor prior to use to ensure safety and appropriateness of treatment.

Geriatric Use

Elderly patients may not have specific information regarding the use of Hydrocortisone with Aloe, 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 and to consider individual patient factors when determining the appropriateness of treatment.

Pregnancy

There are no specific warnings or precautions regarding the use of hydrocortisone with aloe during pregnancy. The available data does not indicate whether the product is contraindicated in pregnant patients or if there are any associated risks to the fetus. Additionally, no dosage modifications or special precautions for pregnant individuals are outlined in the prescribing information. Healthcare professionals should consider the absence of specific risk data when advising women of childbearing potential regarding the use of this product during pregnancy.

Lactation

There are no specific statements regarding the use of this medication in nursing mothers or its effects during 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 no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

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.

Overdosage

In the event of an overdosage, immediate medical intervention is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical assistance or contact a Poison Control Center without delay.

Prompt action is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved; therefore, a thorough assessment by a medical professional is recommended to determine the appropriate course of action and management strategies.

Healthcare providers should ensure that patients are aware of the importance of timely reporting of any suspected overdosage to facilitate effective treatment and minimize risks.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

No postmarketing experience details are available in the provided data.

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 or for rectal administration 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 resolves only to recur within a few days. It is important to note that patients should not begin using any other hydrocortisone product without prior consultation with a healthcare professional.

When using this product, patients should be cautioned against exceeding the recommended dosage and should consult a doctor before doing so. Additionally, patients should be advised to seek medical advice before use 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. 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

For patients 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 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 Hydrocortisone, 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 Hydrocortisone, 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

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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.