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Hydrocortisone

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Active ingredient
Hydrocortisone 10 mg/1 mL
Other brand names
Drug class
Corticosteroid
Dosage form
Spray
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
August 19, 2025
Drug Information (PDF)
Prescribing information, PDF file
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
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2025
Label revision date
August 19, 2025
Manufacturer
FSA Store Inc.
Registration number
M017
NDC root
81522-914
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

Hydrocortisone 1% is an anti-itch spray designed to provide temporary relief from itching caused by minor skin irritations, inflammation, and rashes. It is particularly effective for conditions such as eczema, insect bites, poison ivy, poison oak, poison sumac, and reactions to soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, and psoriasis.

This non-aerosol, ozone-friendly spray calms irritated skin without the need for direct contact, making it a convenient option for soothing discomfort. If you have persistent skin issues, it's important to consult with a doctor for further advice.

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, insect bites, and reactions to plants like poison ivy, poison oak, and poison sumac. It can also help soothe irritation from soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, and psoriasis.

For any other uses, it's important to consult with your doctor for guidance 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 directly to the 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 be cautious when using this medication. You should not use it for treating diaper rash; instead, consult your doctor for appropriate advice. Following this guidance helps 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 safety warnings. You should avoid contact with your eyes, and if your condition worsens or symptoms persist for more than 7 days, consult a doctor. If your symptoms clear up and then return within a few days, do not use any other hydrocortisone product without first speaking to a healthcare professional.

This product is for external use only and is flammable, so keep it away from fire or flame. Additionally, it should not be used for treating diaper rash. Always keep it out of reach of children, and 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.

While using this product, be careful to avoid contact with your eyes. 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. It's important not to start any other hydrocortisone product without your doctor's advice. Always keep this product out of reach of children, and if it is swallowed, seek medical help or contact a Poison Control Center immediately.

Overdose

If you or someone else has swallowed a medication and you suspect an overdose, it’s important to act quickly. Contact a medical professional or call 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 that are not typical for the medication. If you notice any concerning changes in behavior or health, do not hesitate to seek immediate medical attention. Your safety is the top priority, so getting help quickly can make a significant difference.

Pregnancy Use

When it comes to using this medication during pregnancy, there are no specific guidelines or safety concerns outlined in the drug insert. This means that there are no known dosage modifications or special precautions recommended for pregnant individuals. However, it’s always best to consult with your healthcare provider before starting any new medication if you are pregnant or planning to become pregnant. They can provide personalized advice based on your health and circumstances.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to be aware that there are no specific guidelines or statements regarding the use of this medication during nursing. This means that the effects on breast milk and your nursing infant have not been clearly established.

As always, it's best to consult with your healthcare provider about any medications you are considering while breastfeeding to ensure the safety and well-being of both you and your baby.

Pediatric Use

When using this medication for children aged 2 years and older, you can apply the spray to the affected area up to 3 to 4 times a day. However, if your child is under 2 years old, it's important not to use this product without first consulting a doctor. Additionally, this medication should not be used for treating diaper rash, so be sure to speak with a healthcare professional if you have questions about that.

Always keep this medication out of reach of children. If it is accidentally swallowed, seek medical help or contact a Poison Control Center immediately. Your child's safety is the top priority, so following these guidelines is essential.

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 there are no specific guidelines, dosage adjustments, or monitoring requirements mentioned for your condition in the provided information. This means that the standard recommendations for the medication may apply to you without any special considerations. However, always consult your healthcare provider for personalized advice and to ensure your treatment is safe and effective based on 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 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 condition and the use of this medication. They can help ensure that you receive the safest and most effective treatment.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking, even if there are no known drug interactions or laboratory test interactions associated with them. This ensures that your treatment plan is safe and effective for your individual health needs.

Always keep your healthcare team informed about all the medications and supplements you use, as well as any lab tests you may undergo. This way, they can provide the best care tailored to you.

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 environment to avoid accidents. By following these simple guidelines, you can help ensure that the product remains safe for use.

Additional Information

No further information is available.

FAQ

What is Hydrocortisone 1% used for?

Hydrocortisone 1% is 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 and older, spray to the affected area not more than 3 to 4 times daily. Do not use on 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?

If your condition worsens or symptoms persist for more than 7 days, stop using the product and consult a doctor.

Is Hydrocortisone 1% safe for external use?

Yes, Hydrocortisone 1% is for external use only, but it is flammable, so keep it away from fire or flame.

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

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

Can I use Hydrocortisone 1% while pregnant or nursing?

There are no specific statements regarding the use of Hydrocortisone 1% during pregnancy or nursing in the provided information.

What are the side effects of Hydrocortisone 1%?

The provided information does not list specific side effects, but you should stop use and consult a doctor if your condition worsens.

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)

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, 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 medication onto the affected area no more than 3 to 4 times daily. It is important to ensure that the spray is applied directly to the area of concern for optimal effectiveness.

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

Contraindications

The use of this 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 recommended for the treatment of diaper rash. Healthcare professionals should advise patients to consult a doctor for appropriate alternatives in such cases.

While using this product, it is crucial to avoid contact with the eyes. In the event of accidental contact, immediate rinsing with water is advised.

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. It is also essential to inform patients not to initiate the use of any other hydrocortisone product without prior consultation with a healthcare provider.

To ensure safety, this product must be kept out of the reach of children. In the case of ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center should be made without delay.

Side Effects

Patients using this product should be aware of several important safety warnings and potential adverse reactions. This product is intended for external use only and should not be used for the treatment of diaper rash; consultation with a doctor is advised in such cases.

Participants are cautioned that the product is flammable and should be kept away from fire or flame. During use, it is essential to avoid contact with the eyes.

Patients are advised to discontinue use and seek medical advice 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 recommended that patients do not begin the use of any other hydrocortisone product without prior consultation with a healthcare professional.

Additionally, this product should be kept 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.

Drug Interactions

No specific drug interactions have been identified for this medication. Additionally, there are no reported interactions with laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

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 aged 2 years and older may use the spray on the affected area up to 3 to 4 times daily. For children under 2 years of age, the product is not recommended, and consultation with a doctor is advised. The spray should not be used for the treatment of diaper rash; medical consultation is necessary in such cases. Additionally, the product should be kept out of the reach of children, and if ingested, immediate medical assistance or contact with a Poison Control Center is required.

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

There are no specific statements regarding the use of this drug during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the absence of data when prescribing this medication to pregnant patients. It is advisable to weigh the potential benefits against any unknown risks to fetal outcomes. Women of childbearing potential should be counseled on the lack of information available regarding the effects of this drug during pregnancy.

Lactation

There are no specific statements regarding the use of this medication in nursing mothers or during lactation. Consequently, the effects on breastfed infants and the excretion of the drug in human milk remain undetermined. Healthcare professionals should consider the lack of data when advising lactating mothers about the use of this medication.

Renal Impairment

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

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, 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, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

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

Nonclinical Toxicology

No teratogenic effects were observed in animal studies. Additionally, there was no increase in fetal malformations noted in these studies. The available data do not indicate any concerns regarding teratogenicity or non-teratogenic effects in the context of nonclinical toxicology. Information regarding animal pharmacology and toxicology was not provided in the insert.

Postmarketing Experience

No postmarketing experience details are available in the insert.

Patient Counseling

Healthcare providers should advise patients to keep this product out of the reach of children to prevent accidental ingestion. In the event that the product is swallowed, patients should seek medical help 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. Additionally, healthcare providers should instruct patients to discontinue use and consult a doctor if their condition worsens.

It is important to inform patients that they should stop using the product and seek medical advice if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. Patients should also be cautioned against using any other hydrocortisone products without prior consultation with a healthcare professional.

Finally, healthcare providers should emphasize the importance of avoiding contact with the eyes while using this product to prevent irritation or injury.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product in a cool, dry place, away from any sources of ignition, including fire or flame, to ensure safety and maintain product integrity. Proper handling procedures should be followed to prevent exposure to hazardous conditions.

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

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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.