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Procure 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 2025
Label revision date
June 17, 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 2025
Label revision date
June 17, 2025
Manufacturer
Twin Med LLC
Registration number
M017
NDC root
55681-018
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

This medication is designed to provide temporary relief from itching caused by various minor skin irritations and conditions. You might find it helpful for issues related to eczema, psoriasis, poison ivy, poison oak, poison sumac, insect bites, and even reactions to detergents, jewelry, or soaps. Additionally, it can be used for external genital, feminine, and anal itching.

While it effectively alleviates discomfort, it's important to remember that any other uses should be discussed with a doctor to ensure safety and appropriateness.

Uses

This product is designed to provide temporary relief from itching caused by various minor skin irritations, including conditions like eczema, psoriasis, and rashes from poison ivy, poison oak, or poison sumac. It can also help soothe itching from insect bites, reactions to detergents or soaps, and even external genital, feminine, and anal itching.

If you have other uses in mind for this product, it's important to consult with your doctor first to ensure it's appropriate for your situation.

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 around the anal and genital areas, adults and children aged 12 years and older should first clean the 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, you can apply the medication up to 3 to 4 times daily. If your child is under 12 years old, please consult a doctor for guidance.

What to Avoid

It's important to use this product safely. You should not use it for treating diaper rash or if you have vaginal discharge; in these cases, please consult your doctor. Additionally, avoid starting any other hydrocortisone products without first talking to your healthcare provider.

While using this product, be careful to avoid contact with your eyes, and do not exceed the recommended dosage unless directed by your doctor. Never insert the product into the rectum using your fingers or any device. Following these guidelines will help ensure your safety and the effectiveness of the treatment.

Side Effects

You should be aware that this product is for external use only. It is important not to use it for treating diaper rash or if you have vaginal discharge without consulting a doctor first. While using this product, avoid contact with your eyes and do not exceed the recommended dosage unless directed by a healthcare professional. Additionally, do not insert it into the rectum using fingers or any device. If you experience any bleeding, seek medical attention immediately.

If your condition worsens, if symptoms last more than 7 days, or if they improve and then return within a few days, stop using the product and consult a doctor. Also, do not start using any other hydrocortisone products without first discussing it with your healthcare provider.

Warnings and Precautions

This product is for external use only, so please avoid applying it to any internal areas. Be careful not to get it in your eyes, and only use it as directed. If you experience any bleeding, it's important to consult a doctor right away.

If you accidentally swallow the product, seek emergency medical help immediately or contact a Poison Control Center. You should also stop using the product and call your doctor if your condition worsens, if symptoms last longer than 7 days, or if symptoms improve and then return within a few days. Additionally, do not start using any other hydrocortisone products without first talking to your doctor.

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 signs of overdose for this medication, general symptoms can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these signs, seek medical help right away.

In case of an overdose, contact your local emergency services or go to the nearest hospital. It's always better to err on the side of caution when it comes to your health. Remember, timely intervention can make a significant difference.

Pregnancy Use

When considering the use of PROCURE HYDROCORTISONE 1% hydrocortisone cream during pregnancy, it's important to note that the drug insert does not provide specific information about its safety, dosage adjustments, or any special precautions for pregnant individuals. This means that there are no established guidelines or warnings regarding its use while you are pregnant.

If you are pregnant or planning to become pregnant, it is always best to consult with your healthcare provider before using any medication, including over-the-counter creams like hydrocortisone. They can help you weigh the potential benefits and risks based on your individual health needs.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of this product while nursing. Additionally, the information provided does not mention any concerns about the product being present in breast milk or any precautions you should take while lactating.

Always consult with your healthcare provider if you have any questions or concerns about using medications while breastfeeding to ensure the best for you and your baby.

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 it to areas of skin irritation, inflammation, or rashes up to 3 to 4 times a day.

However, if your child is experiencing itching in the anal or genital area, you should consult a doctor if they are under 12 years old. For those 12 and older, it's recommended to clean the area gently with mild soap and warm water before applying the medication, also up to 3 to 4 times daily. 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 healthcare providers may not have tailored guidelines for elderly patients, which can be important given the unique health considerations that often come with aging.

If you or a caregiver are considering this medication for an older adult, it’s essential to consult with a healthcare professional. They can provide personalized advice and monitor for any potential issues, ensuring that the treatment is safe and effective for the individual’s specific health needs.

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.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect 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 differently due to your liver health.

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

Drug Interactions

It's important to talk to your healthcare provider before starting any new hydrocortisone products. Using these products without guidance can lead to complications or reduce their effectiveness. Your doctor can help ensure that any medications you take work well together and are safe for you.

While there are no specific interactions with laboratory tests mentioned, it's always a good practice to inform your healthcare provider about all the medications you are using. This way, they can provide the best care tailored to your needs.

Storage and Handling

To ensure the best performance of your product, store it at room temperature and keep it away from direct light. It's important to keep the tube tightly closed when not in use to maintain its integrity. Once you open the tube, please remember to discard it after use to ensure safety and effectiveness. Following these simple guidelines will help you handle the product safely and effectively.

Additional Information

For treating itching caused by 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. If you are dealing with external anal or genital itching and are 12 years or older, it's best to first cleanse the area with mild soap and warm water, rinse thoroughly, and gently dry it before applying the medication, also up to 3 to 4 times daily.

FAQ

What is this product used for?

This product is used for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to conditions like eczema, psoriasis, and insect bites.

Who should not use this product?

Do not use this product for the treatment of diaper rash or if you have vaginal discharge; consult a doctor instead.

How should I apply this product?

For adults and children 2 years and older, apply to the affected area not more than 3 to 4 times daily. For external anal and genital itching, cleanse the area first and then apply.

What should I do if my condition worsens?

Stop using the product and consult a doctor if your condition worsens, symptoms persist for more than 7 days, or if symptoms clear up and then occur again within a few days.

Are there any precautions I should take while using this product?

Avoid contact with eyes, do not use more than directed unless advised by a doctor, and do not insert into the rectum using fingers or any device.

Is this product safe to use during pregnancy or while nursing?

There are no specific warnings or recommendations regarding the use of this product during pregnancy or lactation in the provided information.

What should I do if I accidentally swallow this product?

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

How should I store this product?

Store at room temperature, protect from light, and keep the tube tightly closed when not in use.

Packaging Info

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

Packaging configurations for Procure Hydrocortisone 1%.
Details

Drug Information (PDF)

This file contains official product information for Procure Hydrocortisone 1%, 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 corticosteroid formulated at a concentration of 1%. The cream exhibits a white to off-white appearance. Inactive ingredients include Aloe Vera Gel, Cetyl Alcohol, Dimethicone, Glycerin, Mineral Oil, Propylene Glycol, Purified Water, Stearyl Alcohol, and Triethanolamine. The product is packaged in a 1 oz tube.

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, poison oak, poison sumac, insect bites, reactions to detergents, jewelry, soaps, and seborrheic dermatitis. It is also indicated for external genital, feminine, and anal itching.

Other uses of this product should only be undertaken under the advice and supervision of a healthcare professional.

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; a consultation with a healthcare professional is advised.

In cases of external anal and genital itching, adults and children aged 12 years and older should first cleanse 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, consultation with a healthcare professional is necessary before use.

Contraindications

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

Patients should not use this product for the treatment of diaper rash; consultation with a healthcare professional is advised. Additionally, the product is contraindicated in individuals presenting with vaginal discharge, and medical advice should be sought in such cases.

Furthermore, the initiation of any other hydrocortisone products is contraindicated unless a healthcare professional has been consulted.

Warnings and Precautions

For external use only. Healthcare professionals should advise patients to avoid contact with the eyes to prevent irritation or injury. It is imperative that patients do not exceed the recommended dosage unless specifically directed by a healthcare provider. Additionally, patients should be cautioned against inserting the product into the rectum using fingers, mechanical devices, or applicators, as this may lead to complications.

In the event of bleeding, patients must be instructed to consult a physician promptly to address any potential underlying issues. If the product is ingested, immediate medical assistance should be sought, or the patient should contact a Poison Control Center without delay.

Patients should be advised to discontinue use and contact their healthcare provider if their condition worsens, if symptoms persist for more than seven days, or if symptoms resolve only to recur within a few days. Furthermore, patients should refrain from initiating the use of any other hydrocortisone products without prior consultation with a healthcare professional to avoid potential interactions or adverse effects.

Side Effects

Patients should be aware that this product is for external use only. It is contraindicated for the treatment of diaper rash; patients should consult a doctor in such cases. Additionally, individuals experiencing vaginal discharge should seek medical advice before using this product.

While using this product, patients are advised to avoid contact with the eyes and to adhere strictly to the recommended dosage. It is important not to exceed the directed use unless specifically instructed by a healthcare professional. Patients should refrain from inserting the product into the rectum using fingers or any mechanical device or applicator. In the event of bleeding, it is crucial to consult a doctor promptly.

Patients should discontinue use and seek medical advice if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. Furthermore, patients should not initiate the use of any other hydrocortisone products without prior consultation with a healthcare provider.

Drug Interactions

The initiation of any additional hydrocortisone products should only occur after consultation with a healthcare professional. This precaution is essential to avoid potential adverse effects or interactions that may arise from concurrent use.

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 Procure Hydrocortisone 1% (hydrocortisone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Procure Hydrocortisone 1%.
Details

Pediatric Use

Pediatric patients under 2 years of age should not use this product; consultation with a healthcare professional is advised. For the treatment of itching associated with skin irritation, inflammation, and rashes, the product may be applied to the affected area by children aged 2 years and older, not exceeding 3 to 4 applications daily.

In cases of external anal and genital itching, adults and children 12 years of age and older should first cleanse 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 of age, consultation with a healthcare professional is recommended prior to 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

There are no specific statements regarding the use of PROCURE HYDROCORTISONE 1% hydrocortisone cream during pregnancy. The prescribing information does not provide safety concerns, dosage modifications, or special precautions for pregnant patients. As such, healthcare professionals should consider the lack of data when prescribing this medication to women of childbearing potential and weigh the potential benefits against any unknown risks to fetal outcomes. It is advisable to exercise caution and consult relevant clinical guidelines when treating pregnant patients with this product.

Lactation

There are no specific warnings or recommendations regarding the use of this product by nursing mothers. Additionally, there are no considerations or precautions mentioned concerning lactation or the potential for excretion in breast milk.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data 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 lack of information necessitates careful clinical judgment and monitoring.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this medication. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the prescribing information.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

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

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include monitoring vital signs, providing symptomatic treatment, and ensuring the patient's safety.

If available, consultation with a poison control center or a medical toxicologist is recommended to guide the management of the overdose. Additionally, healthcare professionals should refer to local protocols and guidelines for the management of overdose situations, as these may provide specific recommendations based on the substance involved.

Documentation of the incident, including the amount and timing of the substance taken, is crucial for effective management and follow-up care.

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 in these areas limits the understanding of the compound's safety profile in nonclinical settings.

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. In the event of accidental ingestion, patients should seek medical assistance immediately or contact a Poison Control Center.

Patients should be informed that this product is not intended for the treatment of diaper rash and that they should consult a doctor for appropriate guidance. Additionally, if patients experience vaginal discharge, they should refrain from using the product and seek medical advice.

Healthcare providers should instruct patients to discontinue use 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. It is also important to advise patients against the use of any other hydrocortisone products without prior consultation with a healthcare professional.

While using this product, patients should be cautioned to avoid contact with the eyes. They should not exceed the recommended dosage unless directed by a doctor. Furthermore, patients should be informed that the product should not be inserted into the rectum using fingers or any mechanical device or applicator. In the case of any bleeding, patients should seek medical attention promptly.

Storage and Handling

The product is supplied in a tube format. It should be stored at room temperature, away from direct light exposure. To maintain product integrity, the tube must be kept tightly closed when not in use. It is important to discard the product after opening to ensure safety and efficacy.

Additional Clinical Information

For the treatment of itching associated with skin irritation, inflammation, and rashes, patients aged 2 years and older should apply the medication to the affected area no more than 3 to 4 times daily. For external anal and genital itching, patients aged 12 years and older are advised to cleanse 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. This medication should also be applied to the affected area no more than 3 to 4 times daily.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Procure 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 Procure 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.

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.