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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 2018
Label revision date
November 15, 2024
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 2018
Label revision date
November 15, 2024
Manufacturer
Walgreen Company
Registration number
M017
NDC root
0363-1973
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (3 NDCs)
Packaging & NDC Codes (3)

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If you are a consumer or patient please visit this version.

Drug Overview

Hydrocortisone Cream is a topical medication designed to provide fast relief from itching and discomfort caused by various skin irritations, including rashes, redness, inflammation, eczema, and psoriasis. This cream contains hydrocortisone (a type of corticosteroid that helps reduce inflammation) at a strength of 1%, along with moisturizing ingredients like Vitamins A, D, E, and aloe, which help soothe and hydrate the skin.

You can use Hydrocortisone Cream to temporarily relieve itching associated with minor skin issues such as insect bites, poison ivy, and reactions to soaps or cosmetics. It is important to follow your doctor's advice for any other uses of this product.

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

Additionally, this product can temporarily relieve itching in external anal and genital areas. For any other uses, it's important 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 if you are an adult or a child aged 2 years and older. However, if your child is under 2 years old, it's important to consult a doctor before using this treatment.

For external itching in the anal and genital areas, adults should first clean the area with mild soap and warm water, making sure to rinse thoroughly. After cleaning, gently dry the area by patting or blotting it 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 needing treatment is under 12 years old, please consult a doctor for guidance.

What to Avoid

It's important to use this medication safely. You should not apply it in the genital area if you have a vaginal discharge or use it for diaper rash without consulting a doctor. Additionally, avoid contact with your eyes, and do not exceed the recommended dosage unless directed by your healthcare provider. Never insert the medication directly into the rectum using your fingers or any device.

If you have any questions or concerns about using this medication, please reach out to your doctor for guidance. Your health and safety are the top priority.

Side Effects

When using this product, it's important to be aware of potential side effects. You should stop using it and consult a doctor if your condition worsens, if you experience rectal bleeding, or if your symptoms persist for more than seven days. Additionally, if your symptoms clear up and then return within a few days, do not start using any other hydrocortisone product without first speaking to a doctor.

This product is for external use only and should not be applied in the genital area if you have a vaginal discharge or used for diaper rash without consulting a doctor. Avoid contact with your eyes, and do not exceed the recommended dosage unless directed by a healthcare professional. Keep this product out of reach of children, and if swallowed, seek medical help immediately or contact a Poison Control Center.

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 you notice that your condition worsens, experience rectal bleeding, or if your symptoms last longer than 7 days or return after clearing up, stop using the product and contact your doctor. Additionally, if the product is swallowed, seek medical help immediately or call a Poison Control Center at 1-800-222-1222.

Overdose

If you or someone else has swallowed too much of this medication, it’s important to seek medical help immediately. You can contact a Poison Control Center at 1-800-222-1222 for guidance.

Signs of an overdose may include unusual symptoms, but specific details on these symptoms are not provided here. If you notice anything concerning, don’t hesitate to reach out for help. Remember, acting quickly can make a significant difference in ensuring safety and health.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to be cautious with hydrocortisone cream, as its safety during pregnancy has not been established. You should consult your doctor before using this medication, as there may be potential risks to your fetus that are not clearly defined.

Your healthcare provider may recommend dosage adjustments or special precautions, so it's essential to use hydrocortisone cream only under their guidance and supervision. 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.

As always, if you have any concerns or questions about using this cream 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, adults should first clean the area with mild soap and warm water, then gently dry it before applying the treatment. This can also be done up to 3 to 4 times daily. If your child is under 12 years old, please consult a doctor for guidance before use.

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 healthcare providers may not have tailored guidelines for elderly patients.

If you or a loved one is an older adult considering this medication, it’s important to discuss any potential risks and benefits with your healthcare provider. They can help determine the best approach based on individual health needs and circumstances. Always prioritize open communication with your doctor to ensure safe and effective treatment.

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 (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 have open conversations with your healthcare provider about any medications or tests you may be taking. In this case, there are no known drug interactions or laboratory test interactions associated with the medication. However, every individual is different, and your healthcare provider can help ensure that your treatment is safe and effective for you. Always feel free to ask questions and share your complete list of medications and any tests you may be undergoing.

Storage and Handling

To ensure the best performance of your product, store it at a temperature between 20°-25°C (68°-77°F). This temperature range helps maintain the integrity and effectiveness of the device.

When handling the product, be sure to do so with care to avoid any damage. Always follow any specific instructions provided for use and disposal to ensure safety and effectiveness.

Additional Information

You can use this medication topically to relieve itching caused by skin irritation, inflammation, and rashes. For adults and children aged 2 years and older, apply it to the affected area no more than 3 to 4 times a day. If the patient is under 2 years old, consult a doctor before use.

For external anal and genital itching in adults, first clean the area with mild soap and warm water, then gently dry it before applying the medication. Again, apply it no more than 3 to 4 times daily. If the patient is under 12 years old, it's best to ask a doctor for guidance.

FAQ

What is Hydrocortisone Cream used for?

Hydrocortisone Cream 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 contraindications for using this cream?

Do not use Hydrocortisone Cream in the genital area if you have a vaginal discharge or for the treatment of diaper rash without consulting a doctor.

What should I do if my condition worsens?

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

Is it safe to use Hydrocortisone Cream during pregnancy?

The safety of Hydrocortisone Cream during pregnancy has not been established. Consult a doctor before use if you are pregnant or planning to become pregnant.

What precautions should I take when using this product?

Avoid contact with the eyes, do not use more than directed unless advised by a doctor, and do not apply directly into the rectum.

What should I do if I swallow Hydrocortisone Cream?

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

How should I store Hydrocortisone Cream?

Store Hydrocortisone Cream at 20°-25°C (68°-77°F).

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 is a topical formulation containing 1% hydrocortisone, designed for anti-itch relief. This cream is enriched with 10 moisturizers, vitamins, and aloe to enhance skin hydration and support skin health. The product is presented in a net weight of 1 ounce (28 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 following dosing guidelines are recommended:

Adults and children aged 2 years and older should apply the medication to the affected area no more than 3 to 4 times daily. For children under 2 years of age, the use of this medication is not recommended; consultation with a healthcare professional is advised.

In cases of external anal and genital itching in adults, it is advisable 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 prior to application. The medication should be applied to the affected area no more than 3 to 4 times daily. For children under 12 years of age, it is recommended to consult a healthcare professional before use.

Contraindications

Use is contraindicated in the following situations:

The product should not be applied to the genital area in the presence of vaginal discharge; consultation with a healthcare professional is advised. Additionally, it is contraindicated for the treatment of diaper rash, and a doctor should be consulted for appropriate alternatives.

Contact with the eyes must be avoided. The product should not be used in excess of the directed dosage unless specifically instructed by a healthcare provider. Furthermore, direct application into the rectum using fingers or any mechanical device or applicator is prohibited.

Warnings and Precautions

This product is intended for external use only. It 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, this product is not recommended for the treatment of diaper rash, and patients should seek medical advice before use.

Healthcare professionals should instruct patients to avoid contact with the eyes during application. It is imperative that patients adhere to the recommended dosage and not exceed the directed amount unless specifically advised by a healthcare provider.

Direct application into the rectum using fingers, mechanical devices, or applicators is prohibited. Patients should be advised to discontinue use and consult a doctor if any of the following occur: worsening of the condition, rectal bleeding, or if symptoms persist beyond 7 days. If symptoms resolve and then recur within a few days, patients should refrain from using any other hydrocortisone products without prior consultation with a healthcare professional.

In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center should be contacted at 1-800-222-1222.

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 for the treatment of diaper rash; in such cases, consultation with a doctor is advised.

During the use of this product, patients should avoid contact with the eyes and adhere strictly to the directed dosage. It is important not to apply 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 any of the following occur: the condition worsens, rectal bleeding is observed, symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. Additionally, patients should not begin the use of any other hydrocortisone product without first consulting a doctor.

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 right away at 1-800-222-1222.

Drug Interactions

No drug interactions or drug and laboratory test interactions have been identified in the available data. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Hydrocortisone. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Hydrocortisone.
Details

Pediatric Use

Pediatric patients aged 2 years and older may use the medication for the relief of itching associated with skin irritation, inflammation, and rashes. The recommended application is to the affected area not more than 3 to 4 times daily. For children under 2 years of age, the use of this medication is not recommended; consultation with a doctor is advised.

In cases of external anal and genital itching, the same application frequency applies for adults. It is recommended that the affected area be cleaned with mild soap and warm water, rinsed thoroughly, and gently dried by patting or blotting with toilet tissue or a soft cloth prior to application. For pediatric patients under 12 years of age, it is advised to 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 adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

The safety of hydrocortisone cream during pregnancy has not been established. Pregnant patients or those planning to become pregnant should consult a healthcare provider before use. Potential risks to the fetus are not clearly defined; therefore, caution is advised. Dosage adjustments may be necessary, and it is essential to seek medical advice for appropriate use during pregnancy. Hydrocortisone cream should only be used under the advice and supervision of a healthcare provider in this population.

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.

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, immediate medical assistance is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical help without delay. Contacting a Poison Control Center is recommended, with the national hotline available at 1-800-222-1222.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Healthcare providers should be prepared to assess the patient's condition and initiate appropriate management procedures based on the severity of symptoms presented.

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 specific postmarketing experience details are available. As such, there are no additional adverse events or rare case reports to summarize at this time.

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 not to use the product in the genital area if they have a vaginal discharge and to consult a doctor in such cases. It is important to clarify that this product is not intended for the treatment of diaper rash, and patients should also seek medical advice if they have questions regarding its use in this context.

Patients should be instructed to discontinue use and consult a doctor if their condition worsens or if rectal bleeding occurs. Additionally, they should be advised to stop using the product and seek medical attention if symptoms persist for more than 7 days, or if symptoms improve and then recur within a few days. Patients should not begin using any other hydrocortisone product without first consulting a healthcare provider.

While using this product, patients must be cautioned to avoid contact with the eyes. They should also be reminded not to exceed the recommended dosage unless directed by a doctor. Furthermore, patients should be informed that the product should not be inserted directly into the rectum using fingers or any mechanical device or applicator.

Storage and Handling

The product is supplied in various package 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). Care should be taken to ensure that the product is kept within this temperature range to maintain its integrity and efficacy.

Additional Clinical Information

The product is administered topically for the relief of itching associated with skin irritation, inflammation, and rashes. For adults and children aged 2 years and older, it should be applied to the affected area no more than 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 in adults, it is recommended to clean the affected area with mild soap and warm water, rinsing thoroughly. After gently drying the area by patting or blotting with toilet tissue or a soft cloth, the product should be applied to the affected area no more than 3 to 4 times daily. For children under 12 years of age, a doctor's consultation is also recommended.

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.