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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
55681-019
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 minor skin irritations, inflammation, and rashes. It can be helpful for conditions such as eczema, psoriasis, and reactions to plants like poison ivy, poison oak, and poison sumac, as well as insect bites and irritations from detergents, jewelry, and soaps.

While it is effective for these uses, it's important to consult with a doctor for any other applications to ensure safe and appropriate use.

Uses

You can use this product for the temporary relief of itching caused by minor skin irritations, inflammation, and rashes. This includes conditions like eczema, psoriasis, and reactions to plants such as poison ivy, poison oak, and poison sumac. It can also help with itching from insect bites, detergents, jewelry, seborrheic dermatitis, and soaps.

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 are an adult or a child aged 2 years and older, you can apply the medication to the affected area up to 3 to 4 times a day. Make sure to follow this guideline to ensure the best results.

However, if your child is under 2 years old, it’s important not to use this medication without first consulting a doctor. Always prioritize safety and seek professional advice when it comes to younger children.

What to Avoid

It's important to use this medication safely. You should not use it for treating diaper rash; instead, consult your doctor for appropriate advice. Additionally, avoid contact with your eyes, as this can cause irritation. If you're considering using any other hydrocortisone product, make sure to talk to your doctor first to ensure it's safe for you.

Side Effects

When using this product, it's important to be aware of some potential side effects. You should stop using it and consult a doctor if your condition worsens, if symptoms last more than 7 days, or if they clear up and then return within a few days. Additionally, avoid contact with your eyes and do not use any other hydrocortisone products without first talking to your doctor.

This product is for external use only and should not be used for diaper rash. 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 intended for external use only. It should not be used to treat diaper rash; if you have concerns about diaper rash, please consult your doctor.

If your condition worsens, or if your symptoms last longer than 7 days or improve and then return within a few days, stop using the product and contact your doctor for further advice. Always keep this product out of reach of children. If it is swallowed, seek medical help immediately or contact a Poison Control Center.

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 symptoms such as unusual drowsiness, confusion, or difficulty breathing. If you or someone else experiences these signs, it's crucial to get emergency assistance right away. Always prioritize safety and act quickly in these situations.

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 PROCURE HYDROCORTISONE 1% during pregnancy. This means that the information available does not provide clear recommendations on dosage adjustments or special precautions for pregnant individuals.

As always, it's best to consult with your healthcare provider before using any medication during pregnancy to ensure it is safe for you and your baby. They can provide personalized advice based on your health needs.

Lactation Use

There is no specific information available about the use of PROCURE HYDROCORTISONE 1% (hydrocortisone cream) for nursing mothers or its effects during lactation. This means that if you are breastfeeding, it’s important to consult with your healthcare provider before using this cream. They can help you understand any potential risks and make the best decision for you and your baby. Always prioritize your health and your infant's safety when considering any medication while breastfeeding.

Pediatric Use

If your child is under 2 years old, it's important not to use this medication without first consulting a doctor. For children aged 2 years and older, you can apply the medication to the affected area, but be sure to do this no more than 3 to 4 times a day. Always follow these guidelines to ensure your child's safety and well-being.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that if you or a loved one is an older adult, it’s important to consult with a healthcare provider for personalized advice. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

Renal Impairment

If you have kidney problems, it's important to know that 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 your kidneys are not functioning properly.

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

Hepatic Impairment

If you have liver 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 standard recommendations apply, but you should always consult your healthcare provider for personalized advice. They can help determine the best approach for your treatment and monitor your liver function as needed.

Make sure to keep your doctor informed about your liver health, as they may need to conduct regular tests to ensure your safety while using any medication. Your well-being is a priority, so don't hesitate to ask questions or express any concerns you may have.

Drug Interactions

It's important to talk to your healthcare provider before starting any other hydrocortisone product. Mixing medications can lead to unexpected interactions that may affect how well they work or increase the risk of side effects. Your doctor can help ensure that any new treatments are safe and appropriate for your health needs. Always prioritize open communication about your medications to maintain your well-being.

Storage and Handling

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

Additional Information

You should apply this medication topically to the affected area, using it no more than 3 to 4 times a day if you are an adult or a child aged 2 years and older. If your child is under 2 years old, it's important to consult a doctor before use. There are no additional details available regarding laboratory tests, abuse potential, or postmarketing experiences related to this medication.

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.

How should I use this product?

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

Are there any contraindications for this product?

Yes, do not use it for the treatment of diaper rash and consult a doctor if needed.

What should I do if my condition worsens?

Stop use and ask a doctor if your condition worsens or if symptoms persist for more than 7 days.

What precautions should I take when using this product?

Avoid contact with eyes and do not begin use of any other hydrocortisone product unless you have consulted a doctor.

How should I store this product?

Store at room temperature, protect from light, and keep the container tightly closed. Discard after opening.

What should I do if this product is swallowed?

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

Can I use this product during pregnancy or while nursing?

There is no specific information regarding the use of this product during pregnancy or lactation in the provided text.

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 for dermatological use. Each packet contains 0.9 grams of hydrocortisone. The cream exhibits a color range from white to off-white. Inactive ingredients include cetyl alcohol, glyceryl monostearate, mineral oil, propylene glycol, purified water, sodium phosphate dibasic, sodium phosphate monobasic, stearyl alcohol, and trolamine.

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, seborrheic dermatitis, and soaps.

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

Dosage and Administration

For adults and children aged 2 years and older, the recommended application is to the affected area not more than 3 to 4 times daily. It is important to ensure that the application is limited to the specified frequency to avoid potential adverse effects.

For children under 2 years of age, the product should not be used without consulting a healthcare professional.

Contraindications

The product is contraindicated for the treatment of diaper rash; consultation with a healthcare professional is advised in such cases. Additionally, contact with the eyes should be avoided. The initiation of any other hydrocortisone product should only occur after consulting a doctor.

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.

Healthcare professionals should instruct patients to discontinue use and seek medical advice if the condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days.

It is imperative to keep this product out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

Side Effects

Patients using this product should be aware that it is for external use only. It is contraindicated for the treatment of diaper rash, and individuals are advised to consult a doctor before use in such cases.

Participants are instructed to 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. While using this product, it is important to avoid contact with the eyes. Additionally, patients should not initiate the use of any other hydrocortisone product without prior consultation with a healthcare professional.

This product should be kept out of reach of children. In the event of accidental ingestion, it is crucial to seek medical assistance or contact a Poison Control Center immediately.

Drug Interactions

The use of hydrocortisone in conjunction with other hydrocortisone products should be approached with caution. It is advised that patients do not initiate the use of any additional hydrocortisone formulations without prior consultation with a healthcare professional. This precaution is essential to avoid potential adverse effects associated with excessive corticosteroid exposure, which may lead to increased risk of systemic side effects or diminished therapeutic efficacy. Monitoring and dosage adjustments may be necessary based on the clinical scenario and the specific hydrocortisone products involved.

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 medication without consulting a doctor. For children aged 2 years and older, the recommended application is to the affected area no more than 3 to 4 times daily.

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 therapeutic response, given the lack of targeted data for this population.

Pregnancy

There are no specific statements regarding the use of PROCURE HYDROCORTISONE 1% during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients. It is advisable to weigh the potential benefits against any unknown risks to fetal outcomes. Women of childbearing potential should be counseled on the importance of discussing any medications with their healthcare provider during pregnancy.

Lactation

There is no specific information regarding the use of PROCURE HYDROCORTISONE 1% (hydrocortisone cream) in lactating mothers or lactation considerations. The prescribing information does not address the excretion of hydrocortisone in breast milk or its effects on breastfed infants. Healthcare professionals should exercise caution and consider the potential risks and benefits when recommending this medication to lactating mothers.

Renal Impairment

Patients with renal impairment have not been specifically studied in relation to dosage adjustments, special monitoring, or safety considerations for this medication. As such, there is no available information regarding the use of this drug in individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing this medication to patients with renal impairment.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there is no information available regarding dosage adjustments, special monitoring requirements, or precautions 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.

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 are advised to contact a Poison Control Center without delay to ensure appropriate management and intervention.

Prompt action is crucial in mitigating potential adverse effects associated with overdosage. The symptoms may vary depending on the specific substance involved; therefore, a thorough assessment and appropriate treatment plan should be initiated based on the clinical presentation and guidance from poison control experts.

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. Instruct patients that if the product is swallowed, they should seek medical help or contact a Poison Control Center immediately.

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 alternatives.

Healthcare providers should counsel patients 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.

While using this product, patients should be cautioned to avoid contact with their eyes. Additionally, they should not begin using any other hydrocortisone product without first consulting a doctor.

Storage and Handling

The product is supplied in a container that must be kept tightly closed to maintain its integrity. It should be stored at room temperature, away from direct light exposure to protect its quality. Once opened, the product should be discarded to ensure safety and efficacy.

Additional Clinical Information

The medication is administered topically, with a recommended application frequency of 3 to 4 times daily for adults and children aged 2 years and older. For children under 2 years of age, it is advised to consult a doctor before use. There is no additional information 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

Last AI update:

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.