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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
October 7, 2025
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
October 7, 2025
Manufacturer
CVS PHARMACY, INC
Registration number
M017
NDC root
51316-227
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 temporarily relieve itching caused by minor skin irritations, inflammation, and rashes. You may find it helpful for conditions such as eczema, psoriasis, and reactions to poison ivy, oak, or sumac. It can also provide relief from itching due to insect bites, sunburn, and irritations from detergents, jewelry, cosmetics, soaps, and seborrheic dermatitis. Additionally, it can help with external anal and genital itching.

While this product is effective for these uses, it's important to consult with a doctor for any other applications to ensure safe and appropriate use.

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, psoriasis, and reactions to poison ivy, oak, or sumac. It also helps soothe itching from insect bites, sunburn, and irritations caused by detergents, jewelry, cosmetics, soaps, and seborrheic dermatitis.

Additionally, this product can temporarily relieve itching in external anal and genital areas. For any other uses, it's important to consult with your doctor for guidance and supervision.

Dosage and Administration

If you're dealing with itching from skin irritation, inflammation, or rashes, you can apply the medication to the affected area up to 3 to 4 times a day if you are an adult or a child aged 2 years and older. However, if your child is under 2 years old, it's best to consult a doctor before using it.

For external itching in the anal and genital areas, adults should first clean the area with mild soap and warm water, rinsing thoroughly. After gently drying the area by patting it with toilet tissue or a soft cloth, you can apply the medication up to 3 to 4 times daily. If the person needing treatment is under 12 years old, please consult a doctor for guidance.

What to Avoid

You should avoid using this product in the genital area if you have a vaginal discharge; it's important to consult a doctor in this case. Additionally, do not use it for treating diaper rash without medical advice. Always keep the product away from your eyes, and follow the usage instructions carefully—do not exceed the recommended amount unless directed by a healthcare professional. Lastly, avoid inserting the product directly into the rectum using fingers or any devices. If you have any questions or concerns, please reach out to your doctor for guidance.

Side Effects

When using this product, it's important to be aware of some potential side effects and warnings. You should avoid contact with your eyes and not use it more than directed unless advised by a doctor. If you notice that your condition worsens, symptoms last longer than 7 days, or if you experience rectal bleeding, stop using the product and consult a doctor. Additionally, do not use it in the genital area if you have a vaginal discharge or for diaper rash without consulting a healthcare professional.

Keep this product out of reach of children. If swallowed, seek medical help or contact a Poison Control Center immediately.

Warnings and Precautions

This product is for external use only, so please avoid applying it to your eyes or using it in the genital area if you have a vaginal discharge. If you have diaper rash, consult your doctor before using this product. Always follow the directions provided and do not use more than recommended unless your doctor advises otherwise. Avoid inserting the product directly into the rectum with your fingers or any device.

If your condition worsens, symptoms last longer than 7 days, or if they clear up and then return within a few days, stop using the product and consult your doctor. Additionally, if you experience rectal bleeding, seek medical advice immediately. Keep this product out of reach of children, and if swallowed, contact a Poison Control Center or seek medical help right away.

Overdose

If you or someone else has swallowed too much of this medication, it’s important to seek medical help immediately. You can do this by contacting a Poison Control Center or going to the nearest emergency room.

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

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to be cautious with hydrocortisone cream, as its safety during pregnancy has not been established. You should consult your doctor before using this medication, as there may be potential risks to your fetus that are not clearly defined.

If your healthcare provider determines that you need to use hydrocortisone cream, they may recommend dosage adjustments and will supervise your use of the medication. Always use it only if it is clearly needed and under the guidance of a healthcare professional.

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. Additionally, there is no information indicating that hydrocortisone cream is passed into breast milk or poses any risk to your infant.

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

If your child is under 2 years old, it's important to consult a doctor before using this medication. For children aged 2 years and older, you can apply the medication to the affected area, but make sure to do this no more than 3 to 4 times a day. If your child is under 12 years old, it's also advisable to check with a doctor for guidance. Always prioritize your child's safety and well-being by seeking professional advice when needed.

Geriatric Use

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. If you or a loved one is an older adult, be sure to discuss any potential risks or concerns with your healthcare provider. They can help determine the best approach for your individual health needs, especially since older adults may have different responses to medications compared to younger individuals. Always keep an open line of communication with your doctor about any changes in health or medication effects.

Renal Impairment

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

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your health situation. They can help monitor your kidney function and make any necessary adjustments to your treatment plan.

Hepatic Impairment

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

Before starting any new medication, including this one, you should discuss your liver health with your healthcare provider. They can help determine the best approach for your treatment and ensure your safety.

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 discuss your full list of medications, including over-the-counter drugs and supplements, as well as any lab tests you may need. This way, you can avoid any potential issues and receive the best care possible.

Storage and Handling

To ensure the safety and effectiveness of your product, store it at room temperature, ideally between 68°F and 77°F (20°C to 25°C). This temperature range helps maintain the product's integrity.

When handling the product, be sure to check the packaging carefully. It is tamper-evident, meaning you should not use it if the foil seal is broken or missing, as this could indicate that the product has been compromised. Following these guidelines will help you use the product safely and effectively.

Additional Information

You should apply this medication topically to the affected area, using it no more than 3 to 4 times daily. This applies to both adults and children aged 2 years and older. If you are treating external anal and genital itching, adults should also follow the same application frequency. Always ensure you are using the medication as directed for the best results.

FAQ

What conditions can this drug help relieve?

This drug temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to conditions like eczema, psoriasis, insect bites, and sunburn.

How should I use this product?

For adults and children 2 years and older, apply to the affected area not more than 3 to 4 times daily. For children under 2 years, consult a doctor.

Are there any contraindications for using this drug?

Do not use in the genital area if you have a vaginal discharge or for the treatment of diaper rash without consulting a doctor.

What should I do if my condition worsens?

Stop use and ask a doctor if your condition worsens, symptoms persist for more than 7 days, or if rectal bleeding occurs.

Is this drug safe to use during pregnancy?

The safety of this drug during pregnancy has not been established, so consult a doctor before use if you are pregnant or planning to become pregnant.

What precautions should I take when using this product?

Avoid contact with eyes, do not use more than directed, and do not apply directly into the rectum using fingers or any device.

What should I do if I accidentally swallow this product?

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

Can I use this product for external anal and genital itching?

Yes, for external anal and genital itching, adults should clean the area and apply the product not more than 3 to 4 times daily.

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 itching associated with minor skin irritations, inflammation, and rashes due to various conditions, including eczema, psoriasis, poison ivy, oak, sumac, insect bites, sunburn, and reactions to detergents, jewelry, cosmetics, and soaps. Additionally, it provides temporary relief for external anal and genital itching.

Other uses of this product should be undertaken only under the advice and supervision of a healthcare professional. There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

For the treatment of itching associated with skin irritation, inflammation, and rashes, the recommended dosage for adults and children aged 2 years and older is to apply the medication to the affected area no more than 3 to 4 times daily. For children under 2 years of age, it is advised to consult a physician prior to use.

In cases of external anal and genital itching in adults, it is recommended to first clean the affected area with mild soap and warm water, ensuring thorough rinsing. After cleansing, the area should be gently dried by patting or blotting with toilet tissue or a soft cloth. The medication should then be applied to the affected area no more than 3 to 4 times daily. For children under 12 years of age, consultation with a physician is also recommended before use.

Contraindications

Use is contraindicated in the following situations:

The product should not be applied to the genital area in the presence of vaginal discharge; medical consultation is advised. Additionally, it is contraindicated for the treatment of diaper rash, and a healthcare professional should be consulted in such cases.

Contact with the eyes must be avoided. The product should not be used in excess of the directed dosage unless specifically instructed by a physician. Furthermore, direct application into the rectum using fingers, mechanical devices, or applicators is prohibited.

Warnings and Precautions

For external use only. This product is contraindicated for use in the genital area if a vaginal discharge is present; consultation with a healthcare professional is advised. It is also not recommended for the treatment of diaper rash without prior medical consultation.

When utilizing this product, it is imperative to avoid contact with the eyes. Users should adhere strictly to the recommended dosage and should not exceed the directed amount unless specifically instructed by a healthcare provider. Direct application into the rectum using fingers, mechanical devices, or applicators is contraindicated.

Patients should discontinue use and seek medical advice if the condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. Additionally, the use of any other hydrocortisone product should not commence without consulting a healthcare professional. Immediate medical attention is required if rectal bleeding occurs.

This product must be kept out of reach of children. In the event of accidental ingestion, it is crucial to seek medical assistance or contact a Poison Control Center without delay.

Side Effects

Patients should be aware that this product is intended for external use only. It is contraindicated for use in the genital area if there is a vaginal discharge, and patients are advised to consult a doctor in such cases. Additionally, this product should not be used for the treatment of diaper rash without prior consultation with a healthcare professional.

While using this product, patients should avoid contact with the eyes and adhere strictly to the recommended dosage. It is important not to exceed the directed use unless specifically instructed by a doctor. Furthermore, patients should refrain from inserting the product directly into the rectum using fingers or any mechanical device or applicator.

Patients are advised to discontinue use and consult a doctor 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 also crucial to seek medical advice if rectal bleeding occurs.

This product should be kept out of reach of children. In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center immediately.

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 2 years of age should consult a healthcare professional before use. For children aged 2 years and older, the medication may be applied to the affected area no more than 3 to 4 times daily. Additionally, children under 12 years of age are advised to seek medical advice prior to use.

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 potential adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

The safety of hydrocortisone cream during pregnancy has not been established. Pregnant patients or those planning to become pregnant should consult a healthcare provider before use. While potential risks to the fetus are not clearly defined, caution is advised when considering the use of this medication. Dosage adjustments may be necessary, and it is important for healthcare providers to guide any modifications. Hydrocortisone cream should only be used if clearly needed and under the supervision of a healthcare professional to ensure the safety of both the patient and the fetus.

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 not been specifically addressed in the drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of data necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients, although specific recommendations are not provided.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to 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 prescribing 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.

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. It is imperative that healthcare providers remain vigilant and prepared to address any complications that may arise from an overdosage scenario.

Nonclinical Toxicology

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

Postmarketing Experience

No postmarketing experience details are provided in the insert.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center if the product is swallowed. It is important to inform patients that the product should not be used in the genital area if they have a vaginal discharge and that they should consult a doctor in such cases. Additionally, patients should be cautioned against using the product for the treatment of diaper rash and should seek medical advice if they are considering its use for this purpose.

Patients should be instructed to discontinue use and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. They should also be advised not to begin the use of any other hydrocortisone product without first consulting a healthcare professional. Furthermore, patients should be made aware that they need to stop using the product and seek medical attention if rectal bleeding occurs.

While using the product, patients should be reminded to avoid contact with their eyes. It is essential to emphasize that they should not exceed the recommended dosage unless directed by a doctor. Lastly, patients should be informed that the product should not be inserted directly into the rectum using fingers or any mechanical device or applicator.

Storage and Handling

The product is supplied in a tamper-evident container. It is essential to inspect the foil seal prior to use; the product should not be utilized if the seal is broken or missing.

For optimal storage, the product must be kept at room temperature, specifically within the range of 68° to 77°F (20° to 25°C). Proper adherence to these storage conditions is crucial to maintain 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 both adults and children aged 2 years and older. For external anal and genital itching, adults should also apply the medication to the affected area no more than 3 to 4 times daily. There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Hydrocortisone, retrieved by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

Learn more in our Editorial Policy

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Primary FDA sources:

Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.