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Hydrocortisone

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Active ingredient
Hydrocortisone 1 g/100 g
Other brand names
Drug class
Corticosteroid
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 2025
Label revision date
February 17, 2026
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Hydrocortisone 1 g/100 g
Other brand names
Drug class
Corticosteroid
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 2025
Label revision date
February 17, 2026
Manufacturer
Medrock Pharmacy LLC
Registration number
M017
NDC root
85402-001
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 product is designed to help prevent and temporarily protect your skin and lips from becoming chafed, chapped, cracked, or wind-burned. It also provides temporary relief for minor skin irritations and inflammation, making it useful in various conditions such as weather-related issues, allergies, cold sores, eczema, and even cosmetic use.

By forming a protective barrier, this product helps to soothe and shield your skin from external irritants, ensuring that you feel more comfortable and cared for. If you have specific concerns or conditions, it's always a good idea to consult with a doctor for personalized advice.

Uses

This product is designed to help you prevent and temporarily protect your skin and lips from chafing, chapping, cracking, or windburn. If you experience minor skin irritations or inflammation caused by weather, allergies, cold sores, eczema, or cosmetics, this product can provide you with temporary relief.

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

Dosage and Administration

If you are an adult or a child aged 2 years and older, you can apply the medication to the affected area up to 3 to 4 times a day. Make sure to follow this guideline to ensure the best results.

For children under 2 years of age, it’s important to consult a physician (doctor) before using this medication. They can provide the best advice tailored to your child's needs. Always remember to use the medication as directed for safety and effectiveness.

What to Avoid

It's important to be aware of certain guidelines when using this medication. While there are no specific contraindications or concerns regarding abuse, misuse, or dependence, you should stop using the medication and consult your physician if your condition worsens, if symptoms persist for more than 7 days, or if your symptoms clear up and then return within a few days.

Always prioritize your health and safety by following these instructions closely. If you have any questions or concerns, don't hesitate to reach out to your healthcare provider for guidance.

Side Effects

This product is intended for external use only, so be sure to avoid contact with your eyes. If you notice that your condition worsens or if your symptoms persist for more than 7 days, it's important to stop using the product and consult a physician. Additionally, if your symptoms clear up and then return within a few days, you should also discontinue use and seek medical advice.

Warnings and Precautions

This product is intended for external use only, so please avoid applying it to any areas that may come into contact with your eyes. If you notice that your condition worsens, or if your symptoms persist for more than 7 days, or if they clear up and then return within a few days, it’s important to stop using the product and consult your doctor.

While there are no specific emergency instructions provided, always seek immediate medical help if you experience any severe reactions or unusual symptoms. Your health and safety are paramount, so don’t hesitate to reach out to a healthcare professional if you have any concerns.

Overdose

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

In case of an emergency, you should call your local emergency number or go to the nearest hospital. Always keep your medications in a safe place and follow the prescribed dosage to prevent any potential risks. If you have any concerns or questions about your medication, don’t hesitate to reach out to your healthcare provider for guidance.

Pregnancy Use

You can use hydrocortisone cream during pregnancy without specific warnings or dosage changes mentioned in the information provided. There are no indications that this cream is contraindicated (not recommended) for pregnant individuals, nor does it state any known risks to the fetus. However, it's always 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

If you are breastfeeding, you can use hydrocortisone cream without specific warnings or recommendations against it. The information available does not indicate any particular precautions or considerations for nursing mothers regarding this cream.

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

Pediatric Use

If you have a child who is 2 years old or older, you can apply the medication to the affected area up to 3 to 4 times a day. However, if your child is under 2 years old, it's important to consult a physician (a medical doctor) before using this product. Additionally, for children under 12 years of age, you should also check with a doctor to ensure it's safe for them to use. 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 healthcare providers may not have tailored guidelines for elderly patients.

If you or a loved one is an older adult considering this medication, it’s important to discuss any potential risks or concerns with your healthcare provider. They can help determine the best approach based on individual health needs and circumstances. Always prioritize open communication with your doctor 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 is safe and effective for your specific health needs. They can help determine the best approach for managing your condition while considering your kidney health.

Hepatic Impairment

If you have liver 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 standard recommendations apply, but you should always consult your healthcare provider for personalized advice. They can help determine the best approach for your treatment and monitor your liver function as needed.

Make sure to keep your doctor informed about your liver health, as they may want to conduct regular tests to ensure your safety while using any medication. Your well-being is a priority, so don't hesitate to ask questions or express any concerns you may have.

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 feel free to ask questions and share your complete list of medications and any lab tests you may be undergoing. This way, you can avoid any potential issues and ensure the best possible care.

Storage and Handling

To ensure the best performance of your product, store it at room temperature. It's important to keep the tube tightly closed when not in use to maintain its integrity. Additionally, protect it from excessive heat, as this can affect its effectiveness. Once you open the tube, please remember to discard it after use to ensure safety and prevent contamination. Following these simple guidelines will help you handle the product safely and effectively.

Additional Information

You can use this product for treating affected areas up to 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 recommended 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 primary use of this product?

This product helps prevent and temporarily protects chafed, chapped, cracked, or wind-burned skin and lips, and offers temporary relief of minor skin irritations and inflammation.

What conditions can this product help with?

It is indicated for use in conditions such as weather-related issues, allergies, cold sores, eczema, and cosmetics-related irritations.

How should I apply this product?

Adults and children 2 years of age and older should apply it to the affected area not more than 3 to 4 times daily. For children under 2 years, consult a physician.

Are there any warnings I should be aware of?

Yes, this product is for external use only, and you should avoid contact with your eyes.

What should I do if my condition worsens?

Stop use and ask a physician if your condition worsens or if symptoms persist for 7 days or clear up and occur again within a few days.

Is this product safe to use during pregnancy?

The insert does not mention any specific contraindications or risks associated with using this product during pregnancy.

Can nursing mothers use this product?

There are no specific warnings or recommendations regarding the use of this product in nursing mothers mentioned in the provided text.

How should I store this product?

Store at room temperature, keep the tube tightly closed when not in use, and protect it from excessive heat. Discard after opening.

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

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the prevention and temporary protection of chafed, chapped, cracked, or wind-burned skin and lips. It provides temporary relief from minor skin irritations and inflammation associated with various conditions, including weather changes, allergies, cold sores, eczema, and the use of cosmetics.

Other uses of this product should only be undertaken under the advice or 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 recommended application is to the affected area not more than 3 to 4 times daily. It is important to ensure that the application is limited to the specified frequency to avoid potential adverse effects.

For children under 2 years of age, it is advised to consult a physician prior to use to determine the appropriate course of action and ensure safety.

Contraindications

There are no contraindications listed for this product. However, it is advised to discontinue use and consult a physician if the condition worsens, if symptoms persist for 7 days, or if symptoms resolve and then recur within a few days.

Warnings and Precautions

The product is intended for external use only. Healthcare professionals should advise patients to avoid contact with the eyes to prevent irritation or injury.

Patients are instructed to discontinue use and consult a physician if the condition worsens, if symptoms persist for more than 7 days, or if the condition clears up and then recurs within a few days. This precaution is essential to ensure appropriate medical evaluation and management.

While no specific emergency medical instructions are provided, healthcare professionals should remain vigilant and encourage patients to seek immediate medical assistance if they experience severe reactions or complications.

General precautions have not been specified; however, practitioners should always consider individual patient circumstances and potential contraindications when recommending this product.

Currently, there are no laboratory tests recommended for monitoring the use of this product. Healthcare providers should use clinical judgment to assess the need for any additional evaluations based on the patient's condition and response to treatment.

Side Effects

Patients should be aware that the product is for external use only and should avoid contact with the eyes. In the event that the condition worsens, or if symptoms persist for more than 7 days, patients are advised to discontinue use and consult a physician. Additionally, if the condition clears up and then recurs within a few days, it is recommended to stop use and seek medical advice.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted 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, it is recommended to consult a physician prior to use. Additionally, for children under 12 years of age, consultation with a doctor is advised.

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

Hydrocortisone cream has not been associated with specific warnings, precautions, or dosage modifications for use during pregnancy. The prescribing information does not indicate whether the product is contraindicated in pregnant patients or if there are any known risks to the fetus. As with any medication, healthcare professionals should weigh the potential benefits against any unknown risks when considering the use of hydrocortisone cream in pregnant patients. Women of childbearing potential should be counseled on the importance of discussing any medications with their healthcare provider.

Lactation

There are no specific warnings or recommendations regarding the use of hydrocortisone cream in lactating mothers. Additionally, there are no specific considerations or precautions related to lactation mentioned in the provided text. Therefore, healthcare professionals may consider the use of hydrocortisone cream in nursing mothers without specific concerns for breastfed infants.

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 for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

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

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

Healthcare professionals should also consider contacting a poison control center or a medical toxicologist for guidance on management strategies tailored to the specific situation. It is crucial to document any overdosage incidents thoroughly and report them to the relevant regulatory authorities as part of ongoing pharmacovigilance efforts.

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.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion or misuse.

Patients should be instructed to stop using the product and consult a physician if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. It is important for patients to understand the significance of these signs and to seek medical advice promptly to ensure appropriate care.

Storage and Handling

The product is supplied in a tube that must be kept tightly closed when not in use to maintain its integrity. It should be stored at room temperature, away from excessive heat. Once opened, the product should be discarded to ensure safety 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 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

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.