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Hydrocortisone

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Active ingredient
Hydrocortisone 10 mg/1 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 2022
Label revision date
February 2, 2026
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Hydrocortisone 10 mg/1 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 2022
Label revision date
February 2, 2026
Manufacturer
CVS PHARMACY, INC
Registration number
M017
NDC root
51316-230
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 is designed to provide temporary relief from external anal itching and itching associated with minor skin irritations and rashes. It works by soothing the affected area, helping to alleviate discomfort and promote a sense of relief.

If you are experiencing these symptoms, it’s important to use this product as directed and consult with a doctor for any other uses or if your symptoms persist.

Uses

If you're experiencing external anal itching or minor skin irritations and rashes, this product can provide temporary relief. It's designed to help soothe discomfort and reduce itching, allowing you to feel more comfortable.

However, for any other uses beyond these, it's important to consult with your doctor for guidance and supervision. This ensures that you're using the product safely and effectively for your specific needs.

Dosage and Administration

Before using this medication, it's important to prepare the affected area properly. If possible, start by gently cleaning the area with a suitable cleansing wipe. After cleaning, make sure to dry the area by patting or blotting it with a tissue or a soft cloth.

For adults and children aged 12 years and older, you can apply the medication to the affected area up to 3 to 4 times a day. However, if the person is under 12 years old, it's best to consult a doctor before using this product.

What to Avoid

It's important to use this medication safely. You should not use it for treating diaper rash; instead, consult your doctor for appropriate advice. Additionally, avoid starting any other hydrocortisone product without first discussing it with your healthcare provider.

Make sure to keep the medication away from your eyes and do not exceed the recommended daily dosage unless your doctor instructs you to do so. Lastly, never insert the medication into the rectum using your fingers or any device. Following these guidelines will help ensure your safety and the effectiveness of your treatment.

Side Effects

When using this product, it's important to be aware of some potential side effects and precautions. You should avoid contact with your eyes and not exceed the recommended daily dosage unless directed by a doctor. If you experience any bleeding, if your condition worsens, or if symptoms persist for more than 7 days or return shortly after improvement, stop using the product and consult a doctor.

This product is for external use only and should not be used for treating diaper rash. Additionally, keep it out of reach of children; if swallowed, seek medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Warnings and Precautions

This product is for external use only, so please avoid using it on diaper rashes without consulting a doctor first. When applying, be careful not to get it in your eyes, and stick to the recommended daily dosage unless your doctor advises otherwise. It's important not to insert the product into the rectum using fingers or any devices.

If you notice any bleeding, if your condition worsens, or if your symptoms last more than 7 days or return after clearing up, stop using the product and contact your doctor. Additionally, keep this product out of reach of children. If a child accidentally swallows it, seek medical help or call Poison Control at 1-800-222-1222 immediately.

Overdose

If you or someone else has swallowed too much of this medication, it’s important to seek medical help immediately. You can contact a Poison Control Center at 1-800-222-1222 for guidance.

Signs of an overdose may include unusual symptoms, but specific details on these symptoms are not provided here. If you notice anything concerning, don’t hesitate to reach out for help. Remember, acting quickly can make a significant difference in ensuring safety and health.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that there are no specific warnings or dosage changes mentioned for hydrocortisone cream in relation to pregnancy. The product insert does not indicate whether it is unsafe for use during pregnancy or if it poses any risks to your baby.

However, it is always a good idea to consult your doctor before using any medication, including hydrocortisone cream, to ensure it is appropriate for your situation. Your healthcare provider can offer personalized advice and guidance based on your health needs 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 particular concerns or precautions for nursing mothers regarding the use of this cream.

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 12 years old, it's important not to use this medication without first consulting a doctor. For those aged 12 and older, you can apply the medication to the affected area, but be sure to limit it to no more than 3 to 4 times a day. Always follow these guidelines to ensure your child's safety and well-being.

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, it’s important to consult with a healthcare provider for personalized advice. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

Renal Impairment

If you have kidney problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to change based on your kidney function.

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

Hepatic Impairment

If you have liver problems, it's important to know that the 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.

It's always best to discuss your liver condition with your healthcare provider before starting any new medication. They can provide personalized advice and ensure that your treatment is safe and effective for you.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. Currently, there are no specific drug interactions or laboratory test interactions noted for this medication. However, your healthcare provider can help ensure that your treatment plan is safe and effective, taking into account all the medications and tests you may be using. Always feel free to ask questions and share your complete health history to avoid any potential issues.

Storage and Handling

To ensure the best performance of your product, store it at room temperature, specifically between 68° and 77° F (20° and 25° C). This temperature range helps maintain the integrity and effectiveness of the device.

When handling the product, make sure to do so in a clean environment to avoid contamination. Always follow any specific instructions provided for safe use and disposal to ensure your safety and the safety of others.

Additional Information

You should apply this medication topically to the affected area, using it no more than 3 to 4 times a day if you are an adult or a child aged 12 years and older. If the patient is under 12 years old, it's important to consult a doctor before use. There are no additional details available regarding laboratory tests, abuse potential, or postmarketing experiences related to this medication.

FAQ

What is the primary use of this product?

This product provides temporary relief of external anal itching and itching associated with minor skin irritations and rashes.

How should I apply this product?

Adults and children 12 years of age and older should apply it to the affected area not more than 3 to 4 times daily. For children under 12, consult a doctor before use.

What should I do before applying the product?

When practical, cleanse the affected area by patting or blotting with a cleansing wipe and gently dry it before application.

Are there any contraindications for using this product?

Do not use this product for the treatment of diaper rash; consult a doctor instead.

What precautions should I take while using this product?

Avoid contact with the eyes, do not exceed the recommended dosage, and do not put it into the rectum using fingers or any device.

When should I stop using this product and consult a doctor?

Stop use if bleeding occurs, the condition worsens, or symptoms persist for more than 7 days or recur within a few days.

What should I do if the product is swallowed?

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

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

Consult a doctor for any use during pregnancy or nursing, as specific warnings or recommendations are not provided.

How should I store this product?

Store at room temperature between 68° - 77° F (20° - 25° C).

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 temporary relief of external anal itching. It is also indicated for the temporary relief of itching associated with minor skin irritations and rashes.

Limitations of Use: Other uses of this product should be undertaken only under the advice and supervision of a healthcare professional.

Dosage and Administration

For adults and children aged 12 years and older, the recommended application frequency is 3 to 4 times daily to the affected area. It is important to ensure that the area is prepared prior to application. When practical, the affected area should be cleansed by patting or blotting with an appropriate cleansing wipe. After cleansing, the area should be gently dried by patting or blotting with a tissue or soft cloth before applying the product.

For children under 12 years of age, the use of this product is not recommended without consulting a healthcare professional.

Contraindications

The product is contraindicated for the treatment of diaper rash; consultation with a doctor is advised in such cases.

Additionally, the following contraindications apply:

  • The use of any other hydrocortisone product should not be initiated without prior consultation with a doctor.

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

  • The recommended daily dosage should not be exceeded unless directed by a doctor.

  • The product should not be administered rectally using fingers, mechanical devices, or applicators.

Warnings and Precautions

For external use only. This product is not intended for the treatment of diaper rash; consultation with a healthcare professional is advised prior to use in such cases.

When utilizing this product, it is imperative to avoid contact with the eyes. Users should adhere strictly to the recommended daily dosage and should not exceed this amount unless specifically directed by a healthcare provider. Additionally, the product should not be administered rectally using fingers, mechanical devices, or applicators.

In the event of bleeding, worsening of the condition, or if symptoms persist for more than 7 days or resolve only to recur within a few days, users must discontinue use and consult a healthcare professional. It is advised not to initiate the use of any other hydrocortisone product without prior consultation with a doctor.

This product should be kept out of reach of children. In the case of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center should be made at 1-800-222-1222.

Side Effects

Patients using this product should be aware that it is intended for external use only. It is contraindicated for the treatment of diaper rash, and consultation with a healthcare provider is advised in such cases.

While using this product, patients should avoid contact with the eyes and adhere strictly to the recommended daily dosage. Exceeding the recommended dosage should only occur under the guidance of a healthcare professional. Additionally, patients are cautioned against inserting the product into the rectum using fingers or any mechanical device or applicator.

Patients are advised to discontinue use and seek medical attention if any of the following occur: bleeding, worsening of the condition, or if symptoms persist for more than 7 days. If symptoms resolve and then recur within a few days, patients should not resume use of any other hydrocortisone product without consulting a doctor.

It is crucial to keep this product out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center should be made at 1-800-222-1222.

Drug Interactions

There are currently no documented drug interactions associated with the use of 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 under 12 years of age should not use this medication without consulting a healthcare professional. For adolescents and adults aged 12 years and older, the recommended application is to the affected area not more than 3 to 4 times daily.

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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

Pregnancy

Hydrocortisone cream has not been associated with specific pregnancy-related warnings, precautions, or dosage modifications in the available prescribing information. There is no indication that the product is contraindicated during pregnancy, nor are there documented risks to the fetus. However, healthcare professionals are advised to consult with a physician regarding any alternative uses of this product during pregnancy, as medical guidance may be necessary. It is important for pregnant patients to discuss their individual circumstances with their healthcare provider to ensure safe and appropriate use.

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 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 event of an overdosage, immediate medical assistance is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical help or contact a Poison Control Center without delay. The national Poison Control Center can be reached at 1-800-222-1222.

Prompt intervention 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.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and evaluation are advised to ensure patient safety and effective resolution of any complications arising from the overdosage.

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 seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 if the product is swallowed. It is important to inform patients that this product is intended for the treatment of diaper rash and that they should consult a doctor for appropriate guidance.

Patients should be instructed to discontinue use and consult a doctor if any bleeding occurs, if the condition worsens, or if symptoms persist for more than 7 days. Additionally, they should be made aware that if symptoms clear up and then recur within a few days, they should also seek medical advice before resuming use. Healthcare providers should emphasize that patients must not begin using any other hydrocortisone product without prior consultation with a doctor.

While using this product, patients should be cautioned to avoid contact with the eyes. They should also be reminded not to exceed the recommended daily dosage unless specifically directed by a healthcare professional. Furthermore, patients must be advised against 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 is essential to store the product at room temperature, maintaining a range of 68° to 77° F (20° to 25° C). Proper storage conditions are crucial to ensure the integrity and efficacy of the product.

Additional Clinical Information

The medication is administered topically, with a recommended application frequency of 3 to 4 times daily for adults and children aged 12 years and older. For children under 12 years of age, it is advised to consult a doctor before use. There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

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.