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Hydrocortisone 1

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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 2019
Label revision date
October 3, 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 2019
Label revision date
October 3, 2024
Manufacturer
Kroger Company
Registration number
M017
NDC root
30142-369
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 cream designed to provide temporary relief from itching caused by minor skin irritations, inflammation, and rashes. It is formulated with an intensive healing formula enriched with vitamins A, C, and E, making it a maximum strength option that lasts for up to 10 hours. This cream can help soothe dry, itchy skin, rashes, insect bites, eczema, psoriasis, and redness.

In addition to its soothing properties, Hydrocortisone 1% acts to reduce inflammation and irritation, helping to restore comfort to affected areas. While it is effective for various skin issues, it's important to consult with a doctor for any other uses beyond those indicated.

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, detergents, jewelry, seborrheic dermatitis, cosmetics, and soaps.

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 guidance 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 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 use it for treating diaper rash; if you have any concerns, please consult your doctor. Additionally, avoid using it in the genital area if you have a vaginal discharge, and always ask a doctor if you're unsure.

Make sure to keep the medication away from your eyes and follow the dosage instructions carefully—do not exceed the recommended amount unless directed by your doctor. Lastly, do not insert the medication directly into the rectum using your fingers or any device. Your safety is a priority, so if you have any questions, don't hesitate to reach out to a healthcare professional.

Side Effects

When using this product, it's important to be aware of some potential side effects and warnings. You should only use it externally and avoid contact with your eyes. 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 it for diaper rash or in the genital area if you have a vaginal discharge without first asking a doctor.

Keep this product out of reach of children, as swallowing it can be harmful. If a child accidentally swallows it, seek medical help or contact a Poison Control Center immediately. Always follow the directions provided and do not use more than recommended unless directed by a healthcare professional.

Warnings and Precautions

This product is for external use only, so please avoid using it on diaper rashes or in the genital area if you have a vaginal discharge—consult your doctor in these cases. When applying the product, be careful not to get it in your eyes, and do not exceed the recommended dosage unless directed by your doctor. It's important not to insert the product directly into the rectum using fingers or any devices.

If your condition worsens, 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, seek medical advice immediately. Always keep this product out of reach of children, and if swallowed, contact a Poison Control Center or seek medical help right away.

Overdose

If you or someone else has swallowed too much of this medication, it’s important to seek medical help immediately. You can do this by contacting a Poison Control Center or going to the nearest emergency room.

Signs of an overdose may include unusual symptoms, so it's crucial to be aware of how you or the affected person is feeling. If you notice anything concerning, don’t hesitate to get help right away. 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 know that there are no specific guidelines or safety concerns mentioned regarding the use of hydrocortisone cream during this time. The information available does not indicate any contraindications (situations where the cream should not be used) or special precautions for pregnant individuals. Additionally, there are no recommended dosage modifications for those who are pregnant.

As always, it's a good idea to consult with your healthcare provider before using any medication, including hydrocortisone cream, to ensure it is safe for your specific situation.

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 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 this treatment.

For external anal and genital itching, children under 12 years old should also check with a doctor before use. Always prioritize your child's safety and seek professional advice when needed.

Geriatric Use

While there is no specific information about the use of Hydrocortisone 1% cream in older adults, it’s important to approach its use with caution. Since the drug insert does not mention any dosage adjustments or safety concerns for elderly patients, you should consult with a healthcare provider before using this cream. They can help determine if it’s appropriate for your needs and ensure that it’s used safely, considering any other medications or health conditions you may have. Always prioritize open communication with your healthcare team to address any concerns you might have.

Renal Impairment

If you have kidney problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or safety considerations for your condition. This means that there are no tailored guidelines for how this medication may affect you if you have renal impairment (kidney issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your health situation. They can help monitor your kidney function and make any necessary adjustments to your treatment plan.

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 can monitor your health effectively and make informed decisions about your care.

Always feel free to ask questions and share all the medications and supplements you are using. This helps to avoid any potential issues and ensures that you receive the best possible treatment tailored to your needs.

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 its effectiveness and safety.

When handling the product, be sure to do so with clean hands and in a clean environment to avoid contamination. Always follow any specific disposal instructions provided to ensure safe and responsible disposal.

Additional Information

You can use this medication for treating affected areas, applying it no more than 3 to 4 times daily if you are an adult or a child aged 2 years and older. If you are treating external anal and genital itching, it's best to clean the area with mild soap and warm water, rinse thoroughly, and gently dry it before applying the medication. If you are a child under 2 years old or under 12 years old, consult a doctor before use.

FAQ

What is Hydrocortisone 1% used for?

Hydrocortisone 1% is an anti-itch cream that temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to conditions like eczema, psoriasis, insect bites, and more.

How should I use Hydrocortisone 1%?

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 before use.

Are there any contraindications for using Hydrocortisone 1%?

Do not use Hydrocortisone 1% for the treatment of diaper rash or in the genital area if you have a vaginal discharge. Always consult a doctor if unsure.

What should I do if my condition worsens?

Stop using Hydrocortisone 1% and consult a doctor if your condition worsens, symptoms persist for more than 7 days, or if rectal bleeding occurs.

Can I use Hydrocortisone 1% during pregnancy or while nursing?

The insert does not provide specific information regarding the use of Hydrocortisone 1% during pregnancy or lactation. Consult your doctor for advice.

What precautions should I take when using this product?

Avoid contact with the eyes, do not use more than directed, and do not apply directly into the rectum. If swallowed, seek medical help immediately.

How should I store Hydrocortisone 1%?

Store Hydrocortisone 1% at a temperature between 20°-25°C (68°-77°F).

Packaging Info

Below are the non-prescription pack sizes of Hydrocortisone 1 (hydrocortisone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Hydrocortisone 1.
Details

Drug Information (PDF)

This file contains official product information for Hydrocortisone 1, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

Hydrocortisone 1% is an anti-itch cream formulated to provide temporary relief from dry, itchy skin, rashes, insect bites, eczema, psoriasis, inflammation, irritation, and redness. This intensive healing formula is enriched with vitamins A, C, and E, contributing to its skin-soothing properties. It functions as a 24-hour moisturizer, ensuring prolonged hydration. The product is available 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, seborrheic dermatitis, cosmetics, and soaps. 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, 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 then 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

The product is contraindicated in the following situations:

Use is not recommended for the treatment of diaper rash; consultation with a healthcare professional is advised. Additionally, the product should not be applied in the genital area if there is a vaginal discharge, and a healthcare professional should be consulted in such cases.

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, it is contraindicated to administer the product directly into the rectum using fingers, mechanical devices, or applicators.

Warnings and Precautions

For external use only. This product is not intended for the treatment of diaper rash; consultation with a healthcare professional is advised in such cases. Additionally, it should not be applied in the genital area if there is a vaginal discharge; again, a doctor's advice is recommended.

When using this product, it is imperative to avoid contact with the eyes. Users should adhere strictly to the recommended dosage and should not exceed the directed amount unless specifically instructed by a healthcare provider. It is also important to refrain from inserting the product directly into the rectum using fingers or any mechanical device or applicator.

Users must discontinue use and seek medical advice if the condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up only to recur within a few days. It is crucial not to initiate the use of any other hydrocortisone product without consulting a healthcare professional. Immediate medical attention should be sought if rectal bleeding occurs.

This product should be kept out of reach of children. In the event of accidental ingestion, it is essential to seek medical assistance or contact a Poison Control Center without delay.

Side Effects

Patients using this product should be aware that it is intended for external use only. It is contraindicated for the treatment of diaper rash and should not be applied in the genital area if there is a vaginal discharge; in such cases, consultation with a healthcare provider is advised.

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 healthcare professional. Additionally, the product should not be administered directly into the rectum using fingers or any mechanical device or applicator.

Patients are advised to discontinue use and consult a healthcare provider 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, immediate medical attention should be sought.

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 the product, nor are there any noted interactions with laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the available data.

Packaging & NDC

Below are the non-prescription pack sizes of Hydrocortisone 1 (hydrocortisone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Hydrocortisone 1.
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, the use of this medication is not recommended; consultation with a doctor is advised.

In cases of external anal and genital itching, the medication is not recommended for children under 12 years of age without prior consultation with a doctor.

Geriatric Use

Elderly patients may not have specific information regarding the use of Hydrocortisone 1% cream, including dosage adjustments, safety concerns, or special precautions. As such, healthcare providers should exercise caution when prescribing this medication to geriatric patients.

Due to the lack of available data, it is advisable for clinicians to closely monitor elderly patients for any potential adverse effects or changes in therapeutic response. Individual patient factors, including comorbidities and concurrent medications, should be considered when determining the appropriateness of Hydrocortisone 1% cream for this population.

Pregnancy

There are no specific statements regarding the use of hydrocortisone cream during pregnancy in the available prescribing information. The insert does not mention any safety concerns, contraindications, or special precautions related to the use of hydrocortisone cream in pregnant patients. Additionally, there are no dosage modifications provided for individuals who are pregnant. As such, healthcare professionals should consider the absence of specific data when advising women of childbearing potential regarding the use of this medication during pregnancy.

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 drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication 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 these patients to ensure safety and efficacy.

Hepatic Impairment

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

Patients should be advised to seek medical help or contact a Poison Control Center immediately if the product is swallowed. It is important to inform patients that this product is intended for the treatment of diaper rash, and they should consult a doctor if they have any questions regarding its use.

Healthcare providers should emphasize that patients should not use the product in the genital area if they have a vaginal discharge without first consulting a doctor. Patients must be instructed to stop using the product 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. Additionally, patients should be cautioned against using any other hydrocortisone product unless they have consulted a doctor.

Patients should be made aware that rectal bleeding is a serious concern, and they should discontinue use and seek medical attention if this occurs. When using the product, patients must be advised to avoid contact with the eyes to prevent irritation.

It is crucial to inform patients not to exceed the recommended dosage unless directed by a doctor. Furthermore, they should be instructed not to insert the product 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 is essential to store the product at a controlled temperature range of 20° to 25°C (68° to 77°F) to maintain its efficacy and stability. Proper storage conditions should be ensured to prevent exposure to extreme temperatures.

Additional Clinical Information

Patients aged 2 years and older are advised to apply the medication to the affected area no more than 3 to 4 times daily. For children under 2 years of age, use is not recommended without consulting a doctor. In cases of external anal and genital itching, adults should first clean the affected area with mild soap and warm water, rinse thoroughly, and gently dry by patting or blotting with toilet tissue or a soft cloth before application. For children under 12 years, it is recommended to consult a doctor prior to use.

Drug Information (PDF)

This file contains official product information for Hydrocortisone 1, 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 1, 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.