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Regular Strength Hydrocortisone Cream

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This product has been discontinued

Active ingredient
Hydrocortisone 0.51 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 2016
Label revision date
October 29, 2020
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Hydrocortisone 0.51 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 2016
Label revision date
October 29, 2020
Manufacturer
Walgreens
Registration number
part348
NDC root
0363-0639
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

This medication provides temporary relief from itching caused by minor skin irritations, inflammation, and rashes. It is particularly effective for conditions such as eczema, insect bites, and reactions to plants like poison ivy, poison oak, and poison sumac. Additionally, it can help alleviate itching associated with soaps, jewelry, detergents, cosmetics, psoriasis, and seborrheic dermatitis, as well as external genital, feminine, and anal itching.

While this product is useful for these specific issues, it's important to consult with a doctor for any other uses to ensure safe and appropriate treatment.

Uses

This product is designed to provide temporary relief from itching caused by various minor skin irritations, inflammation, and rashes. You can use it for conditions such as eczema, insect bites, and reactions to plants like 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 effective for external genital, feminine, and anal itching.

If you have other uses in mind, it's important to consult with your 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 children under 2 years old, it’s important not to use this product without first consulting a doctor.

If you are dealing with external anal itching, start by cleaning the affected 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 medication. If the person needing treatment is a child under 12 years old, please consult a doctor for guidance.

What to Avoid

It's important to be cautious when using this medication. You should not use it for external feminine itching if you have a vaginal discharge; in this case, it's best to consult a doctor. Additionally, do not use this medication for treating diaper rash without first speaking to a healthcare professional.

Always prioritize your health and safety by following these guidelines. If you have any questions or concerns about your symptoms or the appropriate treatment, please reach out to your doctor for advice.

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 call your doctor if your symptoms last more than 7 days, if your condition worsens, if symptoms improve and then return within a few days, or if you experience rectal bleeding. It's important to stay vigilant about your health and consult a healthcare professional if you have any concerns.

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 if you believe you have taken too much of the medication, 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 have concerns about an overdose.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to be cautious with any medications, including hydrocortisone cream. Currently, there is no specific information available about the safety of using hydrocortisone cream during pregnancy, including any necessary dosage adjustments or special precautions.

Before using this cream, you should consult with your healthcare provider to discuss any potential risks and to ensure that it is appropriate for your situation. Your health and the health of your baby are the top priority, so always seek professional advice when considering any treatment during pregnancy.

Lactation Use

If you are breastfeeding, you can use hydrocortisone cream without specific warnings or recommendations against it. The information available does not indicate any concerns about its use while nursing. Additionally, there are no noted precautions regarding the cream's potential to be passed into breast milk.

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

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 2 years old, you should not use this medication without first consulting a doctor.

If your child is experiencing external anal itching and is under 12 years old, it's best to consult a doctor before using the medication. Always prioritize your child's safety and seek professional advice when needed.

Geriatric Use

While there is no specific information about the use of this medication in older adults, it’s important to remember that each person’s health needs can vary. Since the insert does not mention any age-related dosage adjustments, safety concerns, or special precautions for elderly patients, you should still consult with a healthcare provider. They can help determine the best approach for you or your loved one, taking into account any unique health conditions or medications that may be involved. 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 be adjusted 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 changes to your medications.

Hepatic Impairment

If you have liver problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or precautions related to your condition. This means that there are no tailored recommendations for how the medication may affect you differently due to your liver health.

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your specific situation. They can help monitor your liver function and make any necessary adjustments to your care.

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 any necessary adjustments to your care.

Always feel free to ask questions and share all the medications and supplements you are using. This helps your provider give you the best advice tailored to your individual health needs.

Storage and Handling

To ensure the best performance and safety of your product, store it in a cool, dry place where the temperature does not exceed 30°C (86°F). It's important to protect it from freezing, as extreme cold can damage the product.

When handling the product, always do so with clean hands and in a clean environment to maintain its integrity. Following these guidelines will help you use the product safely and effectively.

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 before applying the product. If you are a parent, do not use this medication on children under 2 years of age without consulting a doctor, and consult a doctor for children under 12 years of age.

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 the primary use of this drug?

This drug is used for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes.

What conditions can this drug help relieve itching from?

It can relieve itching due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, jewelry, detergents, cosmetics, psoriasis, seborrheic dermatitis, and external genital, feminine, and anal itching.

How should adults and children over 2 years use this drug?

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 this drug?

No, children under 2 years of age should not use this drug and should consult a doctor.

What should you do if symptoms last for more than 7 days?

You should stop using the drug and consult a doctor if symptoms last for more than 7 days, worsen, or recur after clearing.

Are there any contraindications for using this drug?

Yes, do not use it for external feminine itching if you have a vaginal discharge or for the treatment of diaper rash without consulting a doctor.

What precautions should be taken when using this drug?

This drug is for external use only. Avoid contact with the eyes and do not use more than directed unless advised by a doctor.

What should you do if the drug is swallowed?

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

What is the storage requirement for this drug?

Store the drug at a temperature not exceeding 30°C (86°F) and protect it from freezing.

Packaging Info

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

Packaging configurations for Regular Strength Hydrocortisone Cream.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

This product is identified by the code 51945-4 and is associated with the effective date of October 29, 2020. The carton label is presented in a visual format, specifically as an image in JPEG media type. The label serves as the principal display panel for the product, providing essential identification and branding information. The referenced image file for the carton label is named 931428_Carton.jpg.

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, including but not limited to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, jewelry, detergents, cosmetics, psoriasis, and seborrheic dermatitis. Additionally, it is indicated for 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

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. For children under 2 years of age, the product is not recommended; consultation with a doctor is advised.

In cases of external anal itching, it is recommended that adults first clean the affected area with mild soap and warm water. The area should be rinsed thoroughly and gently dried by patting or blotting with toilet tissue or a soft cloth prior to the application of the product. For children under 12 years of age, it is essential to consult a doctor before use.

Contraindications

Use is contraindicated in the following situations:

External feminine itching should not be treated with this product in the presence of vaginal discharge; consultation with a healthcare professional is advised. Additionally, this product is contraindicated for the treatment of diaper rash, and a healthcare professional should be consulted in such cases.

Warnings and Precautions

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

Healthcare professionals should advise patients to discontinue use and consult a physician 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. Prompt medical consultation is essential in these situations to ensure appropriate management and care.

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

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions with laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the current information.

Packaging & NDC

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

Packaging configurations for Regular Strength Hydrocortisone Cream.
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 the treatment of external anal itching, it is recommended that children under 12 years of age consult a doctor prior to use.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, as the prescribing information does not provide any recommendations or considerations related to age. There are no dosage adjustments, safety concerns, or special precautions indicated for geriatric patients.

Healthcare providers should exercise clinical judgment when prescribing this medication to elderly patients, considering the absence of data specific to this population. Monitoring for efficacy and safety is advised, as individual responses may vary.

Pregnancy

There is no specific information available regarding the use of 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 appropriate.

Lactation

There are no specific warnings or recommendations regarding the use of hydrocortisone cream in lactating mothers. Additionally, there are no considerations or precautions related to lactation or the potential for excretion of hydrocortisone in breast milk mentioned in the prescribing information. Therefore, healthcare professionals may consider the use of this medication in nursing mothers without specific concerns related to breastfeeding.

Renal Impairment

Patients with renal impairment may not have specific dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. Therefore, healthcare professionals should exercise caution when prescribing to this population, as the absence of detailed guidance necessitates careful clinical judgment regarding the use of the medication in individuals with reduced kidney function. Regular monitoring of renal function is advisable to ensure patient safety and therapeutic 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 context of overdosage, it is important to note that there is currently no specific information available regarding the effects or management of an overdose for this medication. Healthcare professionals are advised to exercise caution and consider the individual patient's circumstances when faced with a potential overdosage scenario.

In the absence of detailed guidance, it is recommended that healthcare providers monitor the patient closely for any unusual symptoms or adverse reactions that may arise. Supportive care should be initiated as necessary, and symptomatic treatment should be provided based on the clinical presentation of the patient.

In cases of suspected overdosage, it is prudent to consult local poison control centers or relevant medical authorities for further assistance and guidance on management strategies.

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.

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.

Patients experiencing external feminine itching accompanied by vaginal discharge should be instructed to consult a doctor for appropriate evaluation and treatment. Similarly, for the treatment of diaper rash, patients are encouraged to seek medical advice to ensure proper care.

It is important for healthcare providers to inform patients that if symptoms persist for more than 7 days, worsen, resolve and then recur within a few days, or if rectal bleeding occurs, they should consult a doctor promptly. This guidance is essential for ensuring patient safety and effective management of their conditions.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a temperature not exceeding 30°C (86°F) to maintain its integrity. Additionally, the product must be protected from freezing to ensure optimal quality and efficacy. Proper handling and storage conditions are crucial for preserving the product's stability 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 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. The product is not recommended for children under 2 years of age, and those under 12 years should consult a doctor before use.

Clinicians should counsel patients to read all label directions before using the medication and to retain the carton, as it contains important information. No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Regular Strength Hydrocortisone Cream, 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 Regular Strength Hydrocortisone Cream, 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.