Symptom checker
Select audience type

Switch between content for healthcare professionals (PRO) and general audience (GEN).

ADD CONDITION

items per page

Hydrocortisone 1%

Last content change checked dailysee data sync status

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 2023
Label revision date
March 4, 2026
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 2023
Label revision date
March 4, 2026
Manufacturer
Trifecta Pharmaceuticals Usa Llc
Registration number
M017
NDC root
69396-118
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

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

Drug Overview

Hydrocortisone Cream Without Aloe is a topical medication designed to provide temporary relief from itching caused by minor skin irritations and rashes. It is particularly effective for external feminine, genital, and anal itching. This cream works by reducing inflammation and soothing the affected area, helping to alleviate discomfort.

While it can be beneficial for these specific 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 temporary relief from itching caused by minor skin irritations and rashes. It is also effective for external itching in feminine, genital, and anal areas. However, for any other uses, it's important to consult with your doctor for advice and supervision.

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. Before applying, it’s important to clean the area with mild soap and warm water, then rinse it thoroughly. After cleaning, gently dry the area by patting or blotting it with toilet tissue or a soft cloth.

If your child is under 2 years old, do not use this medication without consulting a doctor. Additionally, if you are treating external or anal itching in children under 12 years, it’s best to ask a doctor for guidance. Always follow these instructions to ensure safe and effective use of the medication.

What to Avoid

It's important to be cautious when using this medication. You should not use it for treating diaper rash without first consulting a doctor. Additionally, avoid using it alongside any other hydrocortisone products unless directed by a healthcare professional. If you experience a vaginal discharge, it's essential to speak with your doctor before using this medication.

If your condition worsens, symptoms last longer than seven days, or if symptoms improve and then return shortly after, stop using the product and consult your doctor. You should also stop using it if you notice any rectal bleeding. While using this medication, keep it away from your eyes, do not exceed the recommended dosage unless advised by a doctor, and avoid inserting it into the rectum with fingers or devices.

Side Effects

This product is intended for external use only. You should stop using it and consult a doctor if your condition worsens, if symptoms last longer than 7 days, or if your symptoms improve and then come back within a few days. Additionally, if you experience rectal bleeding, seek medical advice immediately. It's important not to start using any other hydrocortisone product without consulting a healthcare professional.

Warnings and Precautions

This product is for external use only, so please avoid applying it to any areas that may be ingested. Keep it out of reach of children, and if it is swallowed, seek medical help or contact a Poison Control Center right away.

You should stop using this product and consult your doctor if your condition worsens, if symptoms last longer than 7 days, or if symptoms improve and then come back within a few days. Additionally, if you experience rectal bleeding, it’s important to stop use and call your doctor immediately.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, it's important to be aware of the general signs of an overdose, which can include symptoms like extreme drowsiness, confusion, or difficulty breathing. If you suspect an overdose, it is crucial to seek immediate medical help.

In case of an emergency, call your local emergency number or go to the nearest hospital. Always keep medications out of reach of children and follow the prescribed dosage to prevent any potential risks. If you have any concerns or questions about your medication, don’t hesitate to reach out to your healthcare provider for guidance.

Pregnancy Use

If you are pregnant or breastfeeding, it is important to consult your doctor before using this product. The safety of this product during pregnancy has not been established, so it's best to err on the side of caution.

Please remember that this product is for external use only, and you should avoid using it without professional guidance during this sensitive time. Your health and the health of your baby are the top priority, so always seek medical advice when considering any new treatments.

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 under 2 years old, it's important not to use this medication without consulting a doctor first. For children under 12 who are experiencing itching in the anal or genital areas, you should also seek advice from a healthcare professional before using it.

For children aged 2 years and older, you can apply the medication to the affected area, but be sure to limit the application to 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 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 kidney function might affect the use of this medication.

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your specific condition. They can help determine the best approach based on your kidney health.

Hepatic Impairment

If you have liver problems, it's important to know that the information provided does not include specific guidelines about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no detailed recommendations available for how your liver health might affect the use of this medication.

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for you, especially if you have concerns about your liver function.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you. Always share your complete list of medications and any health conditions you have to receive the best care possible.

Storage and Handling

To ensure the safety and effectiveness of your product, store it at a controlled room temperature between 20°-25°C (68°-77°F). It's important to keep it away from excessive heat and humidity, as these conditions can affect its quality.

When handling the product, always check the packaging for any signs of tampering. Do not use it if the packet is torn, cut, or opened, as this could compromise its safety. Following these guidelines will help you use the product safely and effectively.

Additional Information

For adults and children aged 2 years and older, you should apply the medication to the affected area no more than 3 to 4 times a day. If the patient is under 2 years old, do not use this medication without consulting a doctor first. There are no additional details available regarding laboratory tests, abuse potential, or patient counseling.

FAQ

What is Hydrocortisone Cream Without Aloe used for?

Hydrocortisone Cream Without Aloe is used for temporary relief of itching associated with minor skin irritations and rashes, as well as external feminine, genital, and anal itching.

How should I apply Hydrocortisone Cream Without Aloe?

Adults and children 2 years of age and older should apply it to the affected area not more than 3 to 4 times daily. For children under 2 years of age, do not use and ask a doctor.

Are there any contraindications for using this cream?

Do not use this cream for the treatment of diaper rash, with any other Hydrocortisone product unless advised by a doctor, or if you have a vaginal discharge.

What should I do if my symptoms worsen?

Stop using the product and ask a doctor if conditions worsen, symptoms persist for more than 7 days, or if rectal bleeding occurs.

Is it safe to use Hydrocortisone Cream Without Aloe during pregnancy?

Consult a doctor before using this product if you are pregnant or breastfeeding, as safety during pregnancy has not been established.

What precautions should I take when using this cream?

For external use only; avoid contact with the eyes, do not exceed the recommended dosage, and do not use fingers or devices to apply it rectally.

How should I store Hydrocortisone Cream Without Aloe?

Store at controlled room temperature between 20°-25°C (68°-77°F) and avoid excessive heat and humidity.

What should I do if I accidentally swallow the cream?

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

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

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the temporary relief of itching associated with minor skin irritations and rashes. It is also indicated for external feminine, genital, and anal itching.

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

Dosage and Administration

Adults and children aged 2 years and older are instructed to apply the medication to the affected area no more than 3 to 4 times daily. For optimal results in adults experiencing external and anal itching, it is recommended to first clean the affected area with mild soap and warm water, followed by thorough rinsing. The area should then be gently dried by patting or blotting with toilet tissue or a soft cloth prior to application.

For children under 2 years of age, the use of this medication is not advised; healthcare professionals should be consulted. Additionally, for external anal and genital itching in children under 12 years of age, it is essential to seek medical advice before use.

Contraindications

Use of this product is contraindicated in the following situations:

  • Treatment of diaper rash should only be undertaken after consulting a healthcare professional.

  • Concurrent use with any other hydrocortisone product is contraindicated unless a doctor has been consulted.

  • Patients presenting with vaginal discharge should seek medical advice prior to use.

Additionally, if conditions worsen, symptoms persist for more than 7 days, or if symptoms resolve and then reappear within a few days, discontinue use and do not initiate any other hydrocortisone product. Rectal bleeding is also a contraindication for use.

Warnings and Precautions

For external use only. This product is intended solely for topical application and should not be ingested.

General precautions must be observed to ensure safe use. It is imperative to keep this product out of the reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact a Poison Control Center without delay.

Healthcare professionals should advise patients to discontinue use and consult a physician if any of the following occur: the condition worsens, symptoms persist for more than 7 days, or if symptoms resolve and then reappear within a few days. Patients should also be instructed not to initiate the use of any other hydrocortisone product during this time. Additionally, if rectal bleeding is experienced, patients must stop using the product and seek medical advice promptly.

In cases of ingestion, it is crucial to obtain emergency medical help or contact a Poison Control Center immediately.

Side Effects

Patients should be aware that this product is intended for external use only.

In clinical practice, it is advised that patients discontinue use and consult a healthcare professional if any of the following occur: if conditions worsen, if symptoms persist for more than 7 days, or if symptoms resolve and then reappear within a few days. Additionally, patients should seek medical advice if rectal bleeding occurs. These precautions are essential to ensure patient safety and to prevent potential complications associated with the use of this product.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

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 under 2 years of age should not use this medication without consulting a doctor. For the treatment of external anal and genital itching, children under 12 years of age are advised to seek medical advice prior to use. For patients aged 2 years and older, the medication may be applied 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 efficacy, given the lack of targeted data for this population.

Pregnancy

Pregnant patients should be advised to consult a healthcare professional before using this product, as safety during pregnancy has not been established. The product is for external use only, and there is insufficient data to determine potential risks or fetal impacts associated with its use during pregnancy. Women of childbearing potential should exercise caution and seek medical advice if they are pregnant or breastfeeding.

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 clinical trials for 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. Regular monitoring of liver function may be warranted in these patients, although specific parameters are not defined in the available information.

Overdosage

There is currently no specific information available regarding overdosage for this medication. In the absence of documented overdosage data, healthcare professionals are advised to exercise caution and monitor patients closely for any unusual symptoms or adverse effects that may arise following administration.

In the event of suspected overdosage, it is recommended that healthcare providers initiate supportive care and symptomatic treatment as necessary. Monitoring of vital signs and laboratory parameters may be warranted to assess the patient's condition and guide further management.

Healthcare professionals should also consider contacting a poison control center or a medical toxicologist for additional guidance on the management of potential overdosage scenarios. It is essential to document any incidents of overdosage and report them to the appropriate regulatory authorities to enhance the understanding of the medication's safety profile.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the compound in these areas.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this product out of the reach of children. Instruct patients that if the product is swallowed, they should seek medical help or contact a Poison Control Center immediately.

For patients using this product for the treatment of diaper rash, it is important to recommend consulting a doctor prior to use. Additionally, patients should be informed that they should not use this product in conjunction with any other Hydrocortisone product unless they have first consulted a doctor.

Patients experiencing vaginal discharge should also be advised to consult a doctor. Healthcare providers should instruct patients to discontinue use and seek medical advice if conditions worsen, if symptoms persist for more than 7 days, or if symptoms clear up and then reappear within a few days. Patients should not begin the use of any other hydrocortisone product without prior consultation with a healthcare professional.

It is crucial to inform patients to seek medical attention if rectal bleeding occurs. While using this product, patients should be cautioned to avoid contact with the eyes. Providers should emphasize the importance of not exceeding the recommended daily dosage unless directed by a doctor. Furthermore, patients should be advised against inserting this product into the rectum using fingers or any mechanical device or applicator.

Storage and Handling

The product is supplied in tamper-evident packaging. It is essential to inspect the packaging prior to use; do not utilize the product if the packet is torn, cut, or opened.

For optimal storage, the product should be maintained at a controlled room temperature of 20°-25°C (68°-77°F). It is crucial to avoid exposure to excessive heat and humidity to ensure the integrity and efficacy of the product.

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, the product should not be used without consulting a doctor. 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 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.

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.