ADD CONDITION

items per page

Hydrocortisone

Last content change checked dailysee data sync status

Active ingredient
Hydrocortisone 10 mg/1 mL
Other brand names
Drug class
Corticosteroid
Dosage form
Spray
Route
Topical
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2024
Label revision date
October 30, 2025
Active ingredient
Hydrocortisone 10 mg/1 mL
Other brand names
Drug class
Corticosteroid
Dosage form
Spray
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2024
Label revision date
October 30, 2025
Manufacturer
Meijer Distribution Inc.
Registration number
M017
NDC root
79481-9967

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

Hydrocortisone 1% is an anti-itch spray designed to provide temporary relief from itching caused by minor skin irritations and rashes. It is effective for conditions such as eczema, insect bites, and reactions to poison ivy, oak, and sumac, as well as irritations from soaps, detergents, cosmetics, jewelry, and seborrheic dermatitis. This product works by calming irritated skin, making it a helpful option for soothing discomfort.

The spray is ozone-friendly and comes in a convenient no-touch, no-mess application, allowing you to easily apply it where needed. While it is primarily used for minor skin issues, any other uses should be discussed with a doctor.

Uses

You can use this product for the temporary relief of itching caused by various minor skin irritations, inflammation, and rashes. This includes conditions like eczema, insect bites, and reactions to plants such as poison ivy, poison oak, and poison sumac. It can also help with irritation from soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, and psoriasis.

If you have other uses in mind for this product, 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 use the spray on the affected area up to 3 to 4 times a day. Make sure to apply it only to the specific area that needs treatment.

However, if your child is under 2 years old, it’s important not to use this spray without first consulting a doctor. Always follow these guidelines to ensure safe and effective use of the medication.

What to Avoid

It's important to know that this medication should not be used for treating diaper rash. If you have concerns about diaper rash or any other skin condition, please consult your doctor for appropriate advice and treatment options. Always prioritize your health and safety by following these guidelines.

Side Effects

When using this product, it's important to remember that it is for external use only and should be kept away from fire or flames, as it is flammable. Avoid contact with your eyes, and do not use it for treating diaper rash without consulting a doctor.

If your condition worsens, persists for more than 7 days, or clears up only to return within a few days, stop using the product and speak with a doctor. Additionally, 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 areas that are not intended. It is flammable, so keep it away from fire or flames. Do not use it to treat diaper rash; if you have concerns, consult your doctor. Be careful to avoid contact with your eyes while using this product.

If your condition worsens, if symptoms last more than 7 days, or if they clear up and then return within a few days, stop using the product and consult your doctor. Additionally, keep this product out of reach of children. If it is swallowed, seek medical help or contact a Poison Control Center immediately.

Overdose

If you or someone else has swallowed too much of a 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 drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms, don’t hesitate to get help right away. Remember, acting quickly can make a significant difference in the outcome.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that there is no specific information available about the use of this product during pregnancy. The insert does not indicate whether the product is safe or poses any risks to your developing baby. Additionally, there are no recommendations for dosage changes or special precautions for pregnant individuals.

As always, it's best to consult with your healthcare provider before using any medication during pregnancy to ensure the safety of both you and your baby.

Lactation Use

If you are breastfeeding, you can use hydrocortisone spray without specific warnings or recommendations against it. The information available does not indicate any concerns about the spray being passed into breast milk or posing any risk to your nursing infant.

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

Pediatric Use

If your child is under 2 years old, it's important not to use this product without consulting a doctor first. For children aged 2 years and older, you can apply the spray to the affected area, but make sure to do this no more than 3 to 4 times a day.

Always keep this product out of reach of children. If your child accidentally swallows it, seek medical help or contact a Poison Control Center immediately. Your child's safety is a priority, so please follow these guidelines carefully.

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 considering this medication, it’s important to consult with a healthcare provider. 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 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 should be used 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 you understand how to manage your treatment effectively while considering your kidney health.

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

Storage and Handling

To ensure the safety and effectiveness of your product, it’s important to store it away from any sources of fire or flame. This precaution helps prevent any potential hazards that could arise from exposure to heat or open flames.

When handling the product, always maintain a safe distance from fire to avoid accidents. By following these simple guidelines, you can help ensure a safe experience with your device.

Additional Information

No further information is available.

FAQ

What is Hydrocortisone 1% used for?

Hydrocortisone 1% is an anti-itch spray used for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to conditions like eczema, insect bites, and poison ivy.

How should I use Hydrocortisone 1%?

For adults and children 2 years of age and older, spray the affected area not more than 3 to 4 times daily. Do not use it for children under 2 years of age without consulting a doctor.

Are there any contraindications for using this product?

Do not use Hydrocortisone 1% for the treatment of diaper rash. Always consult a doctor for other uses.

What should I do if my condition worsens?

Stop using the product and consult a doctor if your condition worsens or if symptoms persist for more than 7 days.

Is Hydrocortisone 1% safe to use during pregnancy?

The insert does not provide specific information regarding the use of Hydrocortisone 1% during pregnancy, so consult your doctor for advice.

Can nursing mothers use Hydrocortisone 1%?

There are no specific warnings or recommendations regarding the use of Hydrocortisone 1% in nursing mothers mentioned in the insert.

What precautions should I take when using this product?

Keep Hydrocortisone 1% away from fire or flame, avoid contact with the eyes, and keep it out of the reach of children.

What should I do if I accidentally swallow Hydrocortisone 1%?

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

Packaging Info

Below are the non-prescription pack sizes of Hydrocortisone (hydrocortisone spray). 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, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, and psoriasis.

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 adults and children aged 2 years and older, the recommended dosage is to spray the affected area no more than 3 to 4 times daily. It is important to ensure that the application does not exceed this frequency to avoid potential adverse effects.

For children under 2 years of age, the product is not recommended for use. Healthcare professionals should advise caregivers to consult a doctor for appropriate alternatives or guidance.

Contraindications

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

Warnings and Precautions

This product is intended for external use only. It is important to note that the formulation is flammable; therefore, it should be kept away from fire or flame to prevent any hazards.

The product is not indicated for the treatment of diaper rash. Healthcare professionals should advise patients to consult a doctor for appropriate treatment options in such cases.

While using this product, it is crucial to avoid contact with the eyes. If contact occurs, immediate rinsing with water is recommended.

Patients should be instructed to discontinue use and seek medical advice if any of the following occur: the condition worsens, symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. Additionally, patients should refrain from using any other hydrocortisone products without prior consultation with a healthcare provider.

To ensure safety, this product must be kept out of the 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 without delay.

Side Effects

Patients should be aware of several important warnings and precautions associated with the use of this product. It is intended for external use only and should be kept away from fire or flame due to its flammable nature. The product is not recommended for the treatment of diaper rash; patients are advised to consult a doctor for appropriate alternatives.

While using this product, patients should avoid contact with the eyes. If the condition being treated worsens, or if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days, patients should discontinue use and consult a doctor. It is also important to refrain from using any other hydrocortisone product without prior consultation with a healthcare professional.

Additionally, this product should be kept out of the 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 this medication. Additionally, there are no known 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 (hydrocortisone spray). 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 product; consultation with a healthcare professional is advised. For adults and children aged 2 years and older, the recommended dosage is to spray the affected area no more than 3 to 4 times daily.

It is important to keep this product out of the reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact a Poison Control Center without delay.

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

Pregnancy

Pregnant patients should be aware that no specific information regarding the use of this product during pregnancy is provided in the prescribing information. There are no statements indicating whether the product is contraindicated in pregnancy or any associated risks to the fetus. Additionally, no dosage modifications or special precautions regarding the use of this product during pregnancy are mentioned. Healthcare professionals should consider the lack of data when advising women of childbearing potential and weigh the potential benefits against any unknown risks.

Lactation

There are no specific warnings or recommendations regarding the use of hydrocortisone spray 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 no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment.

Hepatic Impairment

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

Overdosage

In the event of an overdosage, immediate medical assistance is crucial. If the substance is ingested, it is imperative to seek medical help or contact a Poison Control Center without delay.

Healthcare professionals should be aware that prompt intervention can significantly impact the outcome of an overdosage situation. Symptoms may vary depending on the specific substance involved, and monitoring for any adverse effects is essential.

Management procedures should include a thorough assessment of the patient's condition, including vital signs and any presenting symptoms. Supportive care may be necessary, and specific treatment protocols should be followed as per established guidelines for the substance in question.

In all cases of suspected overdosage, the involvement of poison control and emergency medical services is recommended to ensure appropriate care and intervention.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this product out of the reach of children to prevent accidental ingestion. In the event of swallowing the product, patients should seek medical assistance or contact a Poison Control Center immediately.

Patients should be informed that this product is not intended for the treatment of diaper rash and that they should consult a doctor for appropriate alternatives. It is important to instruct patients to discontinue use and consult a healthcare professional if their condition worsens.

Additionally, patients should be made aware that if their symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days, they should stop using the product and consult a doctor before using any other hydrocortisone products.

While using this product, patients must be cautioned to avoid contact with the eyes to prevent irritation or injury.

Storage and Handling

The product is supplied in various configurations, with specific NDC numbers available for identification. It is essential to store the product in a cool, dry place, away from fire or flame to ensure safety and integrity. Proper handling should be observed to maintain the quality of the product throughout its shelf life.

Additional Clinical Information

No further data are available.

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.