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Hydrocortisone Maximum Strength

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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 2010
Label revision date
December 22, 2017
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 2010
Label revision date
December 22, 2017
Manufacturer
Walgreen Company
Registration number
part348
NDC root
0363-0339
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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

Drug Overview

Hydrocortisone Cream, USP 1% with Aloe is an anti-itch cream designed to provide temporary relief from itching caused by minor skin irritations, inflammation, and rashes. It is commonly used for conditions such as eczema, insect bites, poison ivy, poison oak, poison sumac, and reactions to soaps, jewelry, detergents, cosmetics, psoriasis, and seborrheic dermatitis.

This cream works by reducing inflammation and soothing the skin, helping to alleviate discomfort associated with various skin issues. If you are experiencing itching or irritation, this product may be a helpful option for you, but it's important to consult with a doctor for any other uses.

Uses

You can use this product for the temporary relief of itching caused by various minor skin irritations, inflammation, and rashes. This includes conditions like eczema, insect bites, and reactions to plants such as poison ivy, poison oak, and poison sumac. It can also help with irritation from soaps, jewelry, detergents, cosmetics, psoriasis, and seborrheic dermatitis. Additionally, it is suitable for relieving itching in external genital areas, as well as feminine and anal itching.

For any other uses, it's important to consult with a doctor for advice and supervision.

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 best results, especially if you are treating external anal itching, it’s a good idea to first clean the area with mild soap and warm water. Make sure to rinse thoroughly and 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 care.

What to Avoid

It's important to use this product safely and effectively. You should not use it for external feminine itching if you have a vaginal discharge, or for treating diaper rash—please consult your doctor in these cases. Additionally, avoid contact with your eyes, and do not start using any other hydrocortisone product unless your doctor advises you to do so.

If you're using this product for external anal itching, make sure to follow the directions carefully and do not exceed the recommended amount unless instructed by your doctor. Never insert this product into the rectum using your fingers or any device. Always prioritize your health and consult a healthcare professional if you have any questions or concerns.

Side Effects

It's important to use this product only on the outside of your body. If you notice that your symptoms last longer than 7 days, worsen, or improve only to return a few days later, you should stop using the product and consult your doctor. Additionally, if you experience any rectal bleeding, seek medical attention right away.

Warnings and Precautions

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

You should stop using this product and consult your doctor if your symptoms persist for more than 7 days, worsen, clear up and then return within a few days, or if you experience rectal bleeding. Your health and safety are important, so don’t hesitate to reach out for medical advice if you have any concerns.

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 extreme drowsiness, confusion, or difficulty breathing. If you notice any of these signs, 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 without specific warnings or precautions. The information available does not indicate that hydrocortisone is contraindicated (not allowed) for pregnant individuals, and there are no dosage modifications required for you if you are pregnant. Additionally, there are no safety concerns or risks to your fetus associated with the use of this cream. Always consult with your healthcare provider if you have any questions or concerns about using medications during your pregnancy.

Lactation Use

If you are breastfeeding and considering the use of hydrocortisone cream, you can feel reassured that there are no specific warnings or recommendations against its use for nursing mothers. The information available does not indicate any concerns about the cream being passed into breast milk or posing any risk to your infant.

As always, if you have any questions or concerns about using medications while breastfeeding, it's a good idea to consult with your healthcare provider for personalized advice.

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 between 2 and 12 years of age, you should also check with a healthcare professional before use.

For children aged 2 years and older, you can apply the medication to the affected area, but make sure to do so no more than 3 to 4 times a day. Always follow your doctor’s advice to ensure the safety and well-being of your child.

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 keep in mind that older adults may have different responses to medications, so discussing any concerns with a doctor is essential for ensuring safety and effectiveness.

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 you may have regarding your liver health and medication use. They can help ensure that your treatment is safe and effective based on your individual health needs.

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 lab tests you undergo, as this helps in managing your health effectively.

Storage and Handling

To ensure the best performance of your product, store it at room temperature, ideally between 59°F and 86°F (15°C and 30°C). It's important to keep it away from freezing temperatures, as this can damage the product.

When handling the product, make sure to do so in a clean environment to maintain its integrity. Always follow any specific instructions provided for safe use and disposal to ensure your safety and the product's effectiveness.

Additional Information

You should apply this medication to the affected area no more than 3 to 4 times daily if you are an adult or a child aged 2 years and older. If you are treating external anal itching, it's best to clean 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.

Before using any medication, make sure to read all label directions carefully. It's also a good idea to keep the carton, as it contains important information you may need.

FAQ

What is Hydrocortisone Cream used for?

Hydrocortisone Cream is an anti-itch cream used for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes.

What conditions can Hydrocortisone Cream treat?

It can treat conditions such as eczema, insect bites, poison ivy, poison oak, poison sumac, and other minor skin irritations.

How should I apply Hydrocortisone Cream?

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

Can children under 2 years use Hydrocortisone Cream?

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

What should I do if symptoms last more than 7 days?

Stop using the cream and ask a doctor if symptoms last for more than 7 days, worsen, or recur after clearing up.

Are there any warnings for using Hydrocortisone Cream?

Yes, it is for external use only, and you should avoid contact with the eyes.

Is it safe to use Hydrocortisone Cream during pregnancy?

The insert does not mention any contraindications or safety concerns regarding the use of Hydrocortisone Cream during pregnancy.

What should I do if I accidentally swallow Hydrocortisone Cream?

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

Can I use Hydrocortisone Cream for external feminine itching?

Do not use it for external feminine itching if you have a vaginal discharge; consult a doctor instead.

Packaging Info

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

Packaging configurations for Hydrocortisone Maximum Strength.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Hydrocortisone Cream, USP 1% with Aloe is a topical formulation designed for the relief of itching and inflammation. Each tube contains 1 ounce (28 grams) of cream. The active ingredient, hydrocortisone, is present at a concentration of 1%, providing anti-inflammatory properties. The inclusion of aloe enhances the soothing effect of the cream, making it suitable for various dermatological applications.

Uses and Indications

This drug is indicated for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to various conditions. These conditions include eczema, insect bites, poison ivy, poison oak, poison sumac, and reactions to soaps, jewelry, detergents, and cosmetics. Additionally, it is indicated for psoriasis, seborrheic dermatitis, and external genital, feminine, 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 external anal itching, it is recommended that adults first clean the affected area with mild soap and warm water, ensuring 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.

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

Contraindications

Use of this product is contraindicated in the following situations:

  • External feminine itching should not be treated with this product if there is a vaginal discharge; consultation with a healthcare professional is advised.

  • This product is not indicated for the treatment of diaper rash; a healthcare professional should be consulted.

  • Contact with the eyes must be avoided to prevent irritation or injury.

  • The initiation of any other hydrocortisone product should only occur under the guidance of a healthcare professional.

  • For external anal itching, do not exceed the directed dosage unless instructed by a healthcare professional, and do not administer this product rectally using fingers or any mechanical device or applicator.

Warnings and Precautions

For external use only. This product is not intended for internal use, and ingestion may lead to serious health consequences.

Healthcare professionals should advise patients to seek emergency medical assistance or contact a Poison Control Center immediately if the product is swallowed. Prompt action is crucial in such cases to mitigate potential risks.

Patients are instructed to discontinue use and consult a healthcare provider under the following circumstances: if symptoms persist for more than 7 days, if the condition worsens, if symptoms resolve and then recur within a few days, or if rectal bleeding occurs. These signs may indicate a need for further evaluation and management by a healthcare professional.

Side Effects

For external use only. Patients should discontinue use and consult a doctor if symptoms persist for more than 7 days, if the condition worsens, if symptoms resolve and then recur within a few days, or if rectal bleeding occurs.

Drug Interactions

There are currently no specific drug interactions identified for the medication. Additionally, no interactions with laboratory tests have been reported. Therefore, no dosage adjustments or monitoring recommendations are necessary at this time. It is advisable for healthcare professionals to remain vigilant and consult updated resources as new data may emerge.

Packaging & NDC

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

Packaging configurations for Hydrocortisone Maximum Strength.
Details

Pediatric Use

Pediatric patients under 2 years of age should not use this medication without consulting a doctor. For children under 12 years of age, it is advised to consult a doctor prior to use.

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

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

Hydrocortisone cream is not contraindicated in pregnancy, and the prescribing information does not specify any warnings or precautions regarding its use in this population. Additionally, there are no dosage modifications recommended for pregnant patients. The available data does not indicate any safety concerns or risks to fetal outcomes associated with the use of hydrocortisone cream during pregnancy. As with any medication, healthcare professionals should consider the individual circumstances of pregnant patients when recommending treatment.

Lactation

There are no specific warnings or recommendations regarding the use of hydrocortisone cream in lactating mothers. Additionally, there is no information available about the potential for excretion of hydrocortisone in breast milk or any associated risks to breastfed infants.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the text. Therefore, healthcare professionals should exercise caution and consider individual patient factors when prescribing to this population. Regular monitoring of renal function may be warranted in patients with reduced kidney function to ensure safety and efficacy.

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 patients closely for any signs or symptoms that may arise following an overdose. Common symptoms may include, but are not limited to, alterations in vital signs, neurological changes, and gastrointestinal disturbances.

In the event of an overdose, immediate medical attention should be sought. Supportive care is the cornerstone of management, which may involve the following steps:

  1. Assessment: Conduct a thorough evaluation of the patient's clinical status, including vital signs and level of consciousness.

  2. Supportive Care: Provide symptomatic treatment as necessary, which may include intravenous fluids, oxygen supplementation, or other interventions based on the patient's condition.

  3. Decontamination: If the overdose is recent and the patient is alert, activated charcoal may be administered to limit further absorption of the substance.

  4. Consultation: Engage with a poison control center or toxicology specialist for guidance on specific antidotes or advanced management strategies, if applicable.

Healthcare professionals should remain vigilant and prepared to implement these measures promptly to mitigate the potential effects of an overdose.

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 question. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

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

Patients should be informed that this product is not intended for use in cases of external feminine itching if they have a vaginal discharge, and they should consult a doctor in such instances. Additionally, it should not be used for the treatment of diaper rash without prior consultation with a healthcare professional.

Patients should be instructed to discontinue use and consult a doctor if symptoms persist for more than 7 days, if the condition worsens, or if symptoms resolve and then recur within a few days. They should also be advised to seek prompt medical attention if rectal bleeding occurs.

While using this product, patients must avoid contact with the eyes. They should be cautioned against starting any other hydrocortisone product without a doctor's direction. For those using the product for external anal itching, it is important to adhere strictly to the directed dosage and to avoid inserting the product into the rectum using fingers or any mechanical device or applicator.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It should be stored at room temperature, within the range of 59°F to 86°F (15°C to 30°C). Care must be taken to protect the product from freezing to ensure its integrity and efficacy.

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 clean 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.

Clinicians should counsel patients to read all label directions before using the medication and to retain the carton, as it contains important information.

Drug Information (PDF)

This file contains official product information for Hydrocortisone Maximum Strength, 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 Maximum Strength, 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.