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Hydrocortisone

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Active ingredient
Hydrocortisone 1 g/100 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 2020
Label revision date
July 15, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Hydrocortisone 1 g/100 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 2020
Label revision date
July 15, 2025
Manufacturer
TARGET Corporation
Registration number
M017
NDC root
11673-399
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 cream 1% is a topical medication designed to provide maximum strength relief from itching and discomfort associated with minor skin irritations, inflammation, and rashes. It contains hydrocortisone, a type of corticosteroid that helps reduce inflammation, and is effective for conditions such as eczema, psoriasis, and reactions to poison ivy, oak, or sumac. Additionally, it can relieve itching from insect bites, detergents, jewelry, cosmetics, soaps, and seborrheic dermatitis, as well as external anal and genital itching.

This cream is formulated with 12 moisturizers to help soothe and hydrate the skin while alleviating discomfort. For any other uses, it is important to consult with a doctor for proper guidance and supervision.

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 like eczema, psoriasis, and reactions to poison ivy, oak, or sumac. It also helps soothe itching from insect bites, as well as irritation caused by detergents, jewelry, cosmetics, soaps, and seborrheic dermatitis.

Additionally, this product can relieve external itching in the anal and genital areas. If you have other uses in mind, it's best to consult with your doctor for advice 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. This is suitable for adults and children who are 2 years old and older. However, if your child is under 2 years of age, it's best to consult a doctor before use.

For external itching around the anal and genital areas in adults, start by gently cleaning the area with mild soap and warm water, then rinse thoroughly. After cleaning, pat or blot the area dry with toilet tissue or a soft cloth. You can then apply the medication to the affected area, again up to 3 to 4 times daily. If the person 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 or for treating diaper rash; it's important to consult a doctor in these cases. Additionally, do not use this product if you experience rectal bleeding or if your condition worsens, persists for more than 7 days, or clears up only to return shortly after. Always seek medical advice before starting any other hydrocortisone product.

While using this product, be careful to avoid contact with your eyes, and do not exceed the recommended dosage unless directed by a doctor. It's also crucial not to insert the product directly into the rectum using fingers or any devices.

Side Effects

When using this product, it's important to remember that it is for external use only. Avoid contact with your eyes, and do not apply it directly to the rectum using fingers or any devices. 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 this product in the genital area if you have a vaginal discharge or for treating diaper rash without first consulting a healthcare professional. 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 the genital area if you have a vaginal discharge or for treating diaper rash—consult your doctor in these cases. Be careful to keep it away from your eyes, and do not use more than the recommended amount unless your doctor advises otherwise. It's important not to insert the product directly into the rectum using fingers or any devices.

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

Overdose

It's important to keep this medication out of reach of children. If a child accidentally swallows it, you should seek medical help or contact a Poison Control Center immediately.

In case of an overdose, you may notice signs such as unusual drowsiness, confusion, or difficulty breathing. If you or someone else experiences these symptoms, it's crucial to get medical assistance right away. Always prioritize safety and act quickly in these situations.

Pregnancy Use

When it comes to using Hydrocortisone Plus 12 Moisturizers during pregnancy, there is currently no specific information available about its safety, recommended dosage, or any special precautions you should take. This means that if you are pregnant or planning to become pregnant, it’s important to consult with your healthcare provider before using this product. They can help you understand any potential risks and guide you on the best options for your skin care during this time. Always prioritize your health and the health of your baby by seeking professional advice.

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 while you are lactating.

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 experiencing itching from skin irritation, inflammation, or rashes, you can apply the treatment to the affected area up to 3 to 4 times a day for children aged 2 years and older. However, if your child is under 2 years old, it's important to consult a doctor before using the product.

For external anal and genital itching, the same guideline applies: adults can use it up to 3 to 4 times daily, but for children under 12 years, you should also check with a doctor first. Always prioritize your child's safety and seek professional advice when needed.

Geriatric Use

When it comes to using Hydrocortisone Plus 12 Moisturizers, there is no specific information available about how it should be used by older adults. This means that there are no special dosage adjustments, safety concerns, or precautions outlined for elderly patients.

If you are an older adult or a caregiver, it's always a good idea to consult with a healthcare professional before starting any new medication or treatment. They can provide personalized advice based on individual health needs and conditions.

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 if you have hepatic impairment (issues with liver function).

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver health and medication use. They can help ensure that you receive the safest and most effective treatment based on your individual needs.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking, even if there are no specific drug interactions or laboratory test interactions noted for your treatment. This ensures that your healthcare team has a complete understanding of your health and can provide the best care possible.

Always feel free to ask questions and share all the medications and supplements you are using. This helps prevent any potential issues and supports your overall well-being.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 20° to 25° C (68° to 77° F). It's important to check the carton or tube crimp for the lot number and expiration date, as this information helps you keep track of the product's safety and effectiveness.

When handling the product, always do so with clean hands and in a clean environment to maintain its integrity. If you have any questions about disposal or specific safety measures, please refer to the product guidelines or consult a healthcare professional.

Additional Information

This medication is applied directly to the skin (topical use). If your condition worsens, persists for more than 7 days, or clears up only to return within a few days, you should stop using it and consult your doctor. It's important not to start using any other hydrocortisone product without first speaking to your healthcare provider.

Make sure to keep this medication out of reach of children. If it is swallowed, seek medical help or contact a Poison Control Center immediately.

FAQ

What is hydrocortisone cream 1% used for?

Hydrocortisone cream 1% is used to temporarily relieve itching associated with minor skin irritations, inflammation, and rashes due to conditions like eczema, psoriasis, and insect bites.

How should I apply hydrocortisone cream?

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 warnings when using this product?

Yes, avoid contact with eyes, do not use more than directed, and do not apply directly into the rectum. Consult a doctor if you have a vaginal discharge or are treating diaper rash.

What should I do if my condition worsens?

Stop using the cream and consult a doctor if your condition worsens, symptoms persist for more than 7 days, or if rectal bleeding occurs.

Is hydrocortisone cream safe to use during pregnancy?

There is no specific information regarding the use of hydrocortisone cream during pregnancy in the provided text, so consult your doctor for advice.

How should I store hydrocortisone cream?

Store the cream at 20° to 25° C (68° to 77° F).

What should I do if I accidentally swallow hydrocortisone cream?

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

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

Hydrocortisone cream 1% is a topical formulation designed for the relief of itching and rashes. This maximum strength cream incorporates 12 moisturizers to enhance skin hydration while providing anti-itch benefits. The product is presented in a net weight of 1 ounce (28.4 grams).

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, detergents, jewelry, cosmetics, soaps, and seborrheic dermatitis. Additionally, it provides temporary relief for external anal and genital 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

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 of this product is contraindicated in the following situations:

  • Application in the genital area is contraindicated in patients with vaginal discharge; medical consultation is advised.

  • This product should not be used for the treatment of diaper rash; consultation with a healthcare professional is recommended.

Additionally, if the condition worsens, symptoms persist for more than 7 days, or if symptoms clear and recur within a few days, discontinue use and consult a doctor. The use of any other hydrocortisone product should not be initiated without medical advice. Rectal bleeding is also a contraindication for use, necessitating immediate consultation with a healthcare provider.

Warnings and Precautions

For external use only. This product is contraindicated for application in the genital area 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 during application. It is imperative that patients adhere strictly to the recommended dosage; they should not exceed the directed amount unless specifically instructed by a physician.

The product should not be administered directly into the rectum using fingers, mechanical devices, or applicators. Patients must be advised to discontinue use and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve only to recur within a few days. Furthermore, patients should refrain from using any other hydrocortisone products without prior consultation with a healthcare provider.

In the event of rectal bleeding, patients should stop use immediately and seek medical attention. It is essential to keep this product out of reach of children. In cases of accidental 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 that it is 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. Patients should also 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 the condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. Furthermore, if rectal bleeding occurs, patients should seek medical advice immediately.

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 without delay.

Drug Interactions

There are no specific drug interactions identified for this medication. Additionally, no laboratory test interactions have been noted in the available data. 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. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Hydrocortisone.
Details

Pediatric Use

Pediatric patients aged 2 years and older may apply the medication to the affected area for itching associated with skin irritation, inflammation, and rashes, not exceeding 3 to 4 times daily. For children under 2 years of age, consultation with a doctor is advised prior to use.

In cases of external anal and genital itching, adults may apply the medication to the affected area up to 3 to 4 times daily. However, for children under 12 years of age, it is recommended to seek a doctor's advice before application.

Geriatric Use

There is no specific information regarding the use of Hydrocortisone Plus 12 Moisturizers in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this product to elderly patients, as the absence of data necessitates careful monitoring for any potential adverse effects or reactions. It is advisable to consider the overall health status and individual needs of geriatric patients when determining the appropriateness of this treatment.

Pregnancy

There is no specific information available regarding the use of Hydrocortisone Plus 12 Moisturizers during pregnancy. As such, the safety of this product in pregnant patients has not been established. Healthcare professionals should consider the lack of data when prescribing this product to women of childbearing potential and weigh the potential benefits against any unknown risks. It is advisable to exercise caution and discuss any concerns with patients who are pregnant or planning to become pregnant.

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. Therefore, healthcare professionals may consider the use of hydrocortisone cream in nursing mothers on a case-by-case basis, taking into account the clinical situation and the absence of documented risks.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to 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 event of an overdosage, it is imperative to keep the product out of reach of children. Should ingestion occur, immediate medical assistance is required. Healthcare professionals should advise caregivers to contact a Poison Control Center without delay.

Prompt intervention is crucial to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved; therefore, a thorough assessment and appropriate management strategies should be implemented based on clinical presentation and established protocols.

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 compound in these areas.

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 reach of children to prevent accidental ingestion. In the event of swallowing the product, patients should seek medical help or contact a Poison Control Center immediately.

Patients should be informed not to use the product in the genital area if they have a vaginal discharge and to consult a doctor in such cases. Additionally, it is important to emphasize that the product should not be used for the treatment of diaper rash without prior consultation with a healthcare professional.

Patients should be instructed to stop using the product 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 unless directed by a doctor.

Healthcare providers should caution patients to stop using the product and seek medical advice if rectal bleeding occurs. While using the product, patients should avoid contact with their eyes and should not exceed the recommended dosage unless specifically instructed to do so by a healthcare professional. Furthermore, patients should be advised against inserting the product directly into the rectum using fingers or any mechanical device or applicator.

Storage and Handling

The product is supplied in various packaging configurations, with specific NDC numbers available for identification. It should be stored at a controlled room temperature of 20° to 25° C (68° to 77° F) to maintain its integrity and efficacy.

Healthcare professionals are advised to check the carton or tube crimp for the lot number and expiration date to ensure proper tracking and usage. Special handling requirements are not specified; however, standard precautions should be taken to protect the product from extreme temperatures and environmental conditions.

Additional Clinical Information

The product is administered topically. Clinicians should advise patients to discontinue use and consult a doctor if the condition worsens, if symptoms persist for more than seven days, or if symptoms clear up and then recur within a few days. Patients are also cautioned not to start any other hydrocortisone product without consulting a healthcare professional. It is important to keep the product out of reach of children, and if ingested, medical assistance or contact with a Poison Control Center should be sought immediately.

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.

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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.