Symptom checker
Select audience type

Switch between content for healthcare professionals (PRO) and general audience (GEN).

ADD CONDITION

items per page

Hydrocortisone

Last content change checked dailysee data sync status

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 2023
Label revision date
December 10, 2024
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 2023
Label revision date
December 10, 2024
Manufacturer
J&A Digital Inc.
Registration number
M017
NDC root
82942-1003
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 itching caused by minor irritations and rashes. It can help soothe discomfort, allowing you to feel more at ease. However, for any other uses, it is important to consult with a doctor for proper guidance and supervision.

Uses

You can use this product for the temporary relief of itching caused by minor irritations and rashes. It's important to note that if you have other uses in mind for this product, you should consult with your doctor for advice and supervision. This ensures that you use it safely and effectively.

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 of your skin. Make sure to do this no more than 3 to 4 times each day. It’s important to follow this guideline to ensure safe and effective use.

However, if your child is under 2 years old, you should not use this medication. Always consult with a healthcare professional if you have any questions or concerns about using this treatment for yourself or your child.

What to Avoid

It's important to be aware of specific instructions regarding the use of this medication. You should not use it for treating diaper rash; if you have concerns about this condition, please consult your doctor for appropriate advice and treatment options.

Currently, there are no specified contraindications, controlled substance classifications, or noted risks of abuse, misuse, or dependence associated with this medication. Always prioritize your health and safety by following these guidelines.

Side Effects

When using this product, it's important to be aware of potential side effects. You should stop using it and consult a doctor if your condition worsens, lasts more than 7 days, or improves and then returns within a few days. Additionally, if you start using any other hydrocortisone product or experience any bleeding, seek medical advice.

This product is for external use only and should not be used for treating diaper rash. Keep it out of reach of children, and if swallowed, contact a Poison Control Center immediately.

Warnings and Precautions

This product is intended for external use only, so please avoid using it on diaper rashes. If you have any concerns, it's best to consult your doctor.

You should stop using this product and contact your doctor if your condition worsens, lasts more than 7 days, or if it clears up and then comes back within a few days. Additionally, if you start using any other hydrocortisone product or if you notice any bleeding, reach out to your healthcare provider.

Keep this product out of reach of children. If it is swallowed, seek immediate help from a Poison Control Center.

Overdose

If you or someone else has swallowed too much of a medication, it's important to act quickly. Contact a Poison Control Center immediately for guidance. They can provide you with the necessary steps to take based on the specific situation.

Signs of an overdose can vary, but they may include unusual symptoms or changes in behavior. If you notice any concerning signs, don't hesitate to seek immediate medical help. Your safety is the top priority, so getting professional assistance is crucial.

Pregnancy Use

There is no specific information available about the use of Hydrocortisone cream during pregnancy, including safety concerns, dosage adjustments, or any special precautions you should take. If you are pregnant or planning to become pregnant, it’s important to consult your healthcare provider before using this medication to ensure it is safe for you and your baby. Always prioritize open communication with your doctor regarding any medications you may be considering during this time.

Lactation Use

If you are breastfeeding and considering using Hydrocortisone cream, it's important to note that the drug insert does not provide specific information about its effects on nursing mothers or lactation (the process of producing milk). Since there are no guidelines or precautions mentioned, it’s advisable to consult your healthcare provider for personalized advice. They can help you weigh the benefits and potential risks based on your individual situation.

Pediatric Use

If you are considering using this medication for your child, it's important to know that it should not be used in children under 2 years of age. For children aged 2 years and older, you can apply it to the affected area, but make sure to do so no more than 3 to 4 times a day. Always follow these guidelines to ensure your child's safety and well-being.

Geriatric Use

While there is no specific information about how this medication should be used by older adults, it’s important to approach any new treatment with caution. Since older adults may have different health needs and may be taking multiple medications, it’s always a good idea to discuss any concerns with your healthcare provider. They can help ensure that the medication is safe and appropriate for you or your loved one, considering any existing health conditions or medications.

If you or someone you care for is an older adult, make sure to monitor for any unusual side effects or changes in health after starting a new medication, and report these to a healthcare professional promptly.

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 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 differently due to your liver health.

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver function and how it relates to your treatment. They can help ensure that your medication 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. In this case, there are no known drug interactions or laboratory test interactions associated with the medication. However, every individual is different, and your healthcare provider can help ensure that your treatment is safe and effective for you. Always feel free to ask questions and share your complete list of medications and tests during your appointments.

Storage and Handling

To ensure the best performance of your product, store it at room temperature and keep it away from direct light. It's important not to freeze the product, as this can affect its effectiveness. Once you open the product, be sure to discard it after use to maintain safety and quality. Following these simple guidelines will help you use the product safely and effectively.

Additional Information

For adults and children aged 2 years and older, you should apply the medication to the affected area no more than 3 to 4 times a day. However, it is important to avoid using this medication on children under 2 years of age. There are no additional details available regarding laboratory tests, abuse potential, or patient counseling information.

FAQ

What is the primary use of this drug?

The drug is indicated for the temporary relief of itching associated with minor irritations and rashes.

Can I use this drug for other purposes?

Other uses of this product should only be under the advice and supervision of a doctor.

How should I apply this drug?

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

Are there any contraindications for this drug?

No specific contraindications are mentioned for this drug.

What should I do if my condition worsens?

Stop use and ask a doctor if your condition worsens, lasts more than 7 days, or clears up and occurs again within a few days.

Is this drug safe for pregnant or nursing women?

No specific information regarding use during pregnancy or nursing is provided in the drug insert.

What should I do if the drug is swallowed?

Keep out of reach of children. If swallowed, contact a Poison Control Center right away.

Can I use this drug for diaper rash?

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

How should I store this drug?

Store at room temperature, protect from light, and do not freeze. 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

The product is identified by the SPL code 34089-3. No additional specific description details are provided in the available data.

Uses and Indications

This drug is indicated for the temporary relief of itching associated with minor 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 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.

The product is not recommended for use in children under 2 years of age. Healthcare professionals should advise caregivers accordingly to prevent misuse in this age group.

Contraindications

The product is contraindicated for the treatment of diaper rash. Consultation with a healthcare professional is advised for appropriate management in such cases.

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.

Healthcare professionals should instruct patients to discontinue use and seek medical advice if any of the following occur: the condition worsens or persists for more than 7 days, or if the condition appears to improve and then recurs within a few days. Additionally, patients should be advised to stop use if they begin using any other hydrocortisone product or if any bleeding occurs.

It is imperative to keep this product out of the reach of children. In the event of accidental ingestion, immediate contact with a Poison Control Center is essential.

Side Effects

Patients should be aware that the product is intended for external use only. It is contraindicated for the treatment of diaper rash, and individuals are advised to consult a doctor if such a condition arises.

Participants are instructed to discontinue use and seek medical advice if the condition worsens or persists for more than 7 days, or if symptoms resolve and then recur within a few days. Additionally, patients should stop using the product if they begin using any other hydrocortisone product or if any bleeding occurs.

It is crucial to keep the product out of reach of children. In the event of accidental ingestion, immediate contact with a Poison Control Center is recommended.

Drug Interactions

No drug interactions or drug and laboratory test interactions have been identified in the available data. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary 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 not use this medication. For children aged 2 years and older, the recommended application is to the affected area no 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, given the lack of targeted data for this population.

Pregnancy

There is no specific information 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. The potential risks and benefits should be carefully evaluated, and alternative treatments may be considered if necessary. Women of childbearing potential should be counseled on the absence of established safety data for the use of Hydrocortisone cream during pregnancy.

Lactation

There is no specific information regarding the use of Hydrocortisone cream in lactating mothers or any lactation considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution and consider the potential risks and benefits when recommending this medication to lactating mothers. The effects on breastfed infants have not been established, and further research may be necessary to determine the safety profile in this population.

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 this medication to patients with reduced kidney function, as the lack of data necessitates careful clinical judgment. 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 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 action is crucial. If the substance is ingested, it is imperative to contact a Poison Control Center without delay.

Healthcare professionals should be aware that symptoms of overdosage may vary depending on the specific substance involved. Monitoring the patient for any adverse effects is essential, and supportive care should be provided as necessary.

Management of overdosage may include symptomatic treatment and monitoring of vital signs. It is important to assess the patient's condition continuously and to implement appropriate interventions based on the severity of symptoms presented.

In all cases of suspected overdosage, prompt communication with a Poison Control Center is recommended to ensure the patient receives the most effective care.

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 these contexts.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to contact a Poison Control Center immediately if the product is swallowed. It is important to inform patients that this product is not intended for the treatment of diaper rash, and they should consult a doctor for appropriate alternatives.

Patients should be instructed to discontinue use and seek medical advice if their condition worsens or persists for more than 7 days, or if the condition improves and then recurs within a few days. Additionally, they should be cautioned to stop using the product if they begin using any other hydrocortisone product or if any bleeding occurs.

Storage and Handling

The product is supplied in packaging that includes specific NDC numbers. It should be stored at room temperature, ensuring that it is protected from light exposure. Freezing the product is not permitted, as it may compromise its integrity. Additionally, it is important to discard the product after opening to maintain safety and efficacy.

Additional Clinical Information

Patients aged 2 years and older are advised to apply the medication to the affected area no more than 3 to 4 times daily. The use of this medication is not recommended for children under 2 years of age. 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

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.