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Hydrocortisone

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Active ingredient
Hydrocortisone 0.0102 g/1 g
Other brand names
Drug class
Corticosteroid
Dosage form
Ointment
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
July 10, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Hydrocortisone 0.0102 g/1 g
Other brand names
Drug class
Corticosteroid
Dosage form
Ointment
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
July 10, 2024
Manufacturer
NeilMed Pharmaceuticals Inc
Registration number
M017
NDC root
13709-316
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 ointment is a topical medication designed to provide temporary relief from itching caused by minor skin irritations, inflammation, and rashes. It is commonly used for conditions such as eczema, insect bites, and reactions to plants like poison ivy, poison oak, and poison sumac. Additionally, it can help alleviate itching related to soaps, jewelry, detergents, cosmetics, psoriasis, seborrheic dermatitis, and external genital or anal itching.

This ointment works by reducing inflammation and suppressing the immune response in the affected area, which helps to relieve discomfort. While it is effective for these uses, it's important to consult with a doctor for any other applications.

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, jewelry, detergents, and cosmetics, as well as skin issues like psoriasis and seborrheic dermatitis. Additionally, it is suitable for relieving external genital, feminine, and anal itching.

For any other uses, it's important to consult with a doctor for advice and supervision.

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 up to 3 to 4 times a day. Before applying, it's best to clean the area with mild soap and warm water, rinse it thoroughly, and gently dry it by patting or blotting with toilet tissue or a soft cloth.

If you have a child under 2 years of age, do not use this product without consulting a doctor first. Additionally, if you are pregnant or breastfeeding, it's important to ask a health professional for advice before using this medication. For children under 12 years of age, it's also recommended to consult a doctor before application, especially for issues like external anal itching.

What to Avoid

It's important to use this product safely and as directed. You should not start using any other hydrocortisone product without your doctor's guidance. If you're using it for external anal itching, make sure to follow the instructions carefully and do not exceed the recommended amount unless your doctor advises you to do so. Additionally, avoid inserting this product into the rectum using your fingers or any devices, as this can lead to complications.

By following these guidelines, you can help ensure that you use the product effectively and safely. If you have any questions or concerns, don't hesitate to reach out to your healthcare provider for more information.

Side Effects

You should only use this product externally. It's important not to use it for external feminine itching if you have a vaginal discharge, or for treating diaper rash—please consult a doctor in these cases.

If your symptoms last longer than 7 days, worsen, or clear up only to return in a few days, stop using the product and consult a doctor. Additionally, if you experience rectal bleeding, seek medical attention promptly.

Warnings and Precautions

This product is for external use only. You should not use it for external feminine itching if you have a vaginal discharge or for treating diaper rash without consulting a doctor first. Be careful to avoid contact with your eyes while using this product. If you are using it for external anal itching, do not exceed the recommended amount and do not insert it into the rectum using fingers or any device unless directed by a doctor.

If your symptoms last longer than 7 days, worsen, or clear up only to return a few days later, stop using the product and consult your doctor. Additionally, if you experience rectal bleeding, seek medical attention promptly.

In case of accidental swallowing, get emergency medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While there is no specific information available about the effects of an overdose for this medication, you should be aware of general signs that may indicate a problem. These can include unusual drowsiness, confusion, or difficulty breathing.

If you notice any of these symptoms or have concerns about a possible overdose, seek medical help right away. It's always better to err on the side of caution when it comes to your health. Remember, if you are ever in doubt, contacting a healthcare professional is the best course of action.

Pregnancy Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using this medication. They can provide guidance on whether it’s safe for you and your baby. Always prioritize your health and the health of your child by seeking expert advice.

Lactation Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using any medication. This ensures that you understand any potential risks and can make informed decisions about your health and the health of your baby. Always prioritize open communication with your doctor regarding your breastfeeding journey.

Pediatric Use

If your child is under 2 years old, it's important not to use this medication without first consulting a doctor. For children aged 2 years and older, you can apply the medication to the affected area up to 3 to 4 times a day. However, if your child is under 12 years old and is experiencing external anal itching, you should also consult a doctor before use. Always prioritize your child's safety and seek professional advice when needed.

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 there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

It's always best to discuss your individual situation with your healthcare provider, who can offer personalized advice and ensure that any medications you take are safe and appropriate for 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 if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to discuss any concerns regarding your liver health and how it may relate to your treatment. They can help ensure that you receive the safest and most effective care.

Drug Interactions

It's important to talk to your healthcare provider before starting any new medications, especially if you're considering using another hydrocortisone product. Your doctor can guide you on the best course of action to ensure your safety and the effectiveness of your treatment.

Currently, there are no specific interactions with laboratory tests mentioned, but maintaining open communication with your healthcare provider about all medications and tests is crucial for your overall health. Always consult with them to avoid any potential issues.

Storage and Handling

To ensure the best performance and safety of your product, store it in a cool, dry place where the temperature does not exceed 30°C (86°F). Keeping it within this temperature range helps maintain its effectiveness and integrity.

When handling the product, always do so with clean hands and in a sterile field (a clean area free from germs) to prevent contamination. If you have any specific disposal instructions, be sure to follow them carefully to ensure safe and responsible disposal.

Additional Information

No further information is available.

FAQ

What is Hydrocortisone Ointment used for?

Hydrocortisone Ointment is used for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes.

What conditions can Hydrocortisone Ointment help with?

It can help with itching due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, jewelry, detergents, cosmetics, psoriasis, seborrheic dermatitis, and external genital, feminine, and anal itching.

How should I use Hydrocortisone Ointment?

Adults and children 2 years of age and older should apply it to the affected area not more than 3 to 4 times daily. Children under 2 years of age should not use it without consulting a doctor.

Can I use Hydrocortisone Ointment if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, you should ask a health professional before using Hydrocortisone Ointment.

Are there any warnings associated with Hydrocortisone Ointment?

Yes, it is for external use only, and you should not use it for external feminine itching if you have a vaginal discharge or for the treatment of diaper rash without consulting a doctor.

What should I do if my symptoms do not improve?

You should stop using the ointment and ask a doctor if symptoms last for more than 7 days, worsen, or if rectal bleeding occurs.

What should I do if I accidentally swallow Hydrocortisone Ointment?

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

Are there any contraindications for using Hydrocortisone Ointment?

There are no specific contraindications listed, but you should not begin using any other hydrocortisone product unless directed by a doctor.

Packaging Info

Below are the non-prescription pack sizes of Hydrocortisone (anti itch). 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

Hydrocortisone Ointment is a topical formulation containing hydrocortisone as the active ingredient. It is utilized for its anti-inflammatory and antipruritic properties. The ointment is typically presented in a semi-solid dosage form, allowing for easy application to affected areas of the skin. Hydrocortisone has a molecular weight of 362.46 g/mol and a chemical formula of C21H30O5. The ointment's appearance is characterized by a smooth, homogeneous texture, which facilitates its use in dermatological conditions.

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. These conditions include eczema, insect bites, poison ivy, poison oak, poison sumac, and reactions to soaps, jewelry, detergents, and cosmetics. Additionally, it is indicated for the management of itching related to psoriasis, seborrheic dermatitis, and external genital, feminine, and anal itching.

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

Dosage and Administration

Adults and children aged 2 years and older are instructed to apply the product to the affected area no more than 3 to 4 times daily. For children under 2 years of age, the product should not be used without consulting a doctor.

In cases of external anal itching, adults should first clean the affected area with mild soap and warm water, ensuring thorough rinsing. The area should then be gently dried by patting or blotting with toilet tissue or a soft cloth prior to the application of the product. For children under 12 years of age, it is recommended to consult a doctor before use.

Pregnant or breastfeeding individuals should seek advice from a health professional prior to using this product.

Contraindications

The use of this product is contraindicated in the following situations:

  • Initiation of any other hydrocortisone product should only occur under the guidance of a healthcare professional.

  • For the treatment of external anal itching, the product should not be used in excess of the directed dosage unless specifically instructed by a physician.

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

Warnings and Precautions

For external use only. This product is contraindicated for the treatment of external feminine itching in the presence of vaginal discharge; healthcare professionals should advise patients to consult a doctor in such cases. Additionally, it is not indicated for the treatment of diaper rash, and patients should be directed to seek medical advice before use in this context.

Healthcare professionals should instruct patients to avoid contact with the eyes while using this product. It is imperative that patients do not initiate the use of any other hydrocortisone product unless specifically directed by a healthcare provider. For external anal itching, patients must adhere strictly to the recommended dosage and should not exceed the directed use unless advised by a doctor. Furthermore, patients should be cautioned against inserting this product into the rectum using fingers or any mechanical device or applicator.

Patients should be advised to discontinue use and consult a healthcare professional if symptoms persist for more than 7 days, if the condition worsens, if symptoms resolve and then recur within a few days, or if rectal bleeding occurs, which necessitates prompt medical attention.

In the event of accidental ingestion, patients should seek emergency medical assistance immediately or contact a Poison Control Center at 1-800-222-1222.

Side Effects

Patients should be aware that the product is intended for external use only. It is contraindicated for use in cases of external feminine itching accompanied by vaginal discharge, and for the treatment of diaper rash; in such instances, consultation with a healthcare professional is advised.

Participants are instructed to discontinue use and seek medical advice if symptoms persist for more than 7 days, if the condition worsens, if symptoms resolve and then recur within a few days, or if rectal bleeding occurs, which requires prompt medical attention.

Drug Interactions

The initiation of any hydrocortisone product should not occur without prior consultation and direction from a healthcare professional. This precaution is essential to avoid potential adverse effects or interactions with other medications.

No specific drug or laboratory test interactions have been identified in the available data. Therefore, routine monitoring or dosage adjustments related to drug interactions are not indicated at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Hydrocortisone (anti itch). 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 and must consult a doctor for guidance. For children aged 2 years and older, the recommended application is to the affected area no more than 3 to 4 times daily. In the case of external anal itching, children under 12 years of age should also consult a doctor before 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

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data regarding the excretion of this medication in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

There is no specific information regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in 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 absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and consider general principles of management for potential overdose situations.

It is essential to monitor patients closely for any signs or symptoms that may arise following an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of suspected overdosage, immediate medical attention should be sought. Healthcare providers should implement supportive care measures and consider symptomatic treatment as necessary.

For further guidance, consultation with a poison control center or a medical toxicologist is recommended to ensure appropriate management strategies are employed.

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 provided data.

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. Patients should be informed to discontinue use and consult a doctor if symptoms persist for more than 7 days, if the condition worsens, or if symptoms resolve only to reoccur within a few days. Additionally, patients should be instructed to stop use and promptly consult a doctor if rectal bleeding occurs.

It is important to emphasize to patients the necessity of avoiding contact with the eyes while using this product. They should also be cautioned against initiating the use of any other hydrocortisone product unless specifically directed by a healthcare professional. For those using the product for external anal itching, patients should be advised not to exceed the directed dosage unless instructed by a doctor. Furthermore, patients must be informed that the product should not be inserted into the rectum using fingers, mechanical devices, or applicators.

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 under conditions that do not exceed a temperature of 30°C (86°F) to maintain its integrity and efficacy. Proper storage practices should be followed to ensure optimal product quality.

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.