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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
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 2019
Label revision date
March 4, 2026
Manufacturer
Trifecta Pharmaceuticals Usa Llc
Registration number
M017
NDC root
69396-050
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, inflammation, and rashes. It is commonly used for conditions such as eczema (a skin condition that causes inflammation and irritation), seborrheic dermatitis (a type of skin rash), psoriasis (a chronic skin condition), insect bites, and reactions to plants like poison ivy, oak, and sumac, as well as irritations from soaps, detergents, cosmetics, and jewelry.

This cream works by reducing inflammation and alleviating discomfort in the affected areas. While it can be effective for these common skin issues, it's important to use it under the guidance of a healthcare professional for any other uses.

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, seborrheic dermatitis, and psoriasis. It can also help soothe itching from insect bites and reactions to plants like poison ivy, oak, or sumac. Additionally, it may relieve discomfort caused by soaps, detergents, cosmetics, jewelry, and external feminine genital and anal itching.

For any other uses, it's important to consult with your doctor 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 this medication to the affected area up to 3 to 4 times a day. For best results, especially for external and anal itching, it’s a good idea to first clean the area with mild soap and warm water, then rinse thoroughly. You can also gently pat or blot the area with toilet tissue or a soft cloth before applying the product.

If your child is under 2 years old, do not use this medication without consulting a doctor. Additionally, if a child under 12 years is experiencing external anal itching, it’s important to speak with a doctor before using this product. Always follow these guidelines to ensure safe and effective use.

What to Avoid

It's important to use this product safely and as directed. You should not start using any other hydrocortisone product unless your doctor tells you to do so. Additionally, make sure not to exceed the recommended daily dosage for treating itching in the external genital area, feminine area, or anal area unless specifically instructed by your doctor.

Also, avoid inserting this product into the rectum using your fingers or any medicated device or applicator. Following these guidelines will help ensure your safety and the effectiveness of the treatment.

Side Effects

This product is intended for external use only. You should stop using it and consult a doctor if your condition worsens, if your symptoms last longer than 7 days, or if they improve and then return within a few days. It's important not to start using any other hydrocortisone product without your doctor's guidance in these situations.

Warnings and Precautions

This product is for external use only, so please avoid using it on diaper rashes or for external genital itching if you have a vaginal discharge; in these cases, consult your doctor. Always keep this product out of the reach of children. 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 more than 7 days, or if symptoms clear up and then return within a few days. Do not start using any other hydrocortisone product without your doctor's guidance.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, it’s always important to be aware of the signs of an overdose, which can include unusual drowsiness, confusion, or difficulty breathing. If you suspect that you or someone else may have taken too much of a medication, it’s crucial to seek immediate medical help.

In case of an overdose, contact your local emergency services or go to the nearest hospital. Having the medication packaging or information on hand can help medical professionals provide the best care. Always remember that when it comes to medications, it’s better to be safe and get help if you have any concerns.

Pregnancy Use

You can use hydrocortisone cream during pregnancy without specific warnings or precautions mentioned in the information provided. There are no indications that it is contraindicated (not recommended) for pregnant individuals, nor are there known risks to the fetus associated with its use. Additionally, you do not need to make any dosage modifications or take special precautions while using this cream during your pregnancy. However, it's always a good idea to consult with your healthcare provider before using any medication.

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 first consulting a doctor. For children aged 2 years and older, you can apply the medication to the affected area up to 3 to 4 times a day. However, if your child is under 12 years old and is experiencing external anal itching, you should also consult a doctor before use. 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 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 treatment may need to change based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective for your specific situation. They can help monitor your kidney health and make any necessary adjustments to your medications.

Hepatic Impairment

If you have liver problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or precautions related to your condition. This means that there are no tailored recommendations for how the medication may affect you differently due to your liver health.

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

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 feel free to ask questions and share your complete list of medications and any lab tests you may be undergoing. This way, you can receive the best possible care tailored to your needs.

Storage and Handling

To ensure the best performance of your product, store it at a controlled room temperature between 20° and 25°C (68° and 77°F). This temperature range helps maintain the product's 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

No further information is available.

FAQ

What is Hydrocortisone Cream Without Aloe used for?

It is used for temporary relief of itching associated with minor skin irritations, inflammation, and rashes.

What conditions can Hydrocortisone Cream Without Aloe treat?

It is indicated for eczema, seborrheic dermatitis, psoriasis, insect bites, poison ivy, soaps, detergents, cosmetics, jewelry, and 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.

Can children under 2 years use this cream?

No, children under 2 years of age should not use this product and should consult a doctor.

What should I do if my symptoms persist?

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

Are there any specific warnings for using this cream?

Yes, it is for external use only and should not be used for diaper rash or external genital itching if there is a vaginal discharge.

What should I do if I accidentally swallow the cream?

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

Is there any information about using this cream during pregnancy?

The insert does not mention any specific warnings or contraindications regarding its use during pregnancy.

What about nursing mothers?

There are no specific warnings or recommendations regarding the use of this cream in nursing mothers mentioned in the insert.

How should I store Hydrocortisone Cream Without Aloe?

Store it at controlled room 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

No description information is available for the drug.

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, seborrheic dermatitis, psoriasis, insect bites, and contact with poison ivy, oak, or sumac. It is also effective for itching resulting from exposure to soaps, detergents, cosmetics, jewelry, and external feminine genital and anal areas.

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 adults and children aged 2 years and older, the product should be applied to the affected area no more than 3 to 4 times daily. For optimal results in managing external and anal itching, it is recommended that adults cleanse the affected area with mild soap and warm water, rinsing thoroughly, or patting or blotting with toilet tissue or a soft cloth prior to application.

Children under 2 years of age should not use this product without consulting a doctor. Additionally, for children under 12 years of age experiencing external anal itching, it is advised to consult a doctor before use.

Contraindications

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

  • Initiation of any other hydrocortisone product should only occur under the guidance of a healthcare professional.

  • Exceeding the recommended daily dosage for external genital, feminine, and anal itching is contraindicated unless specifically directed by a healthcare provider.

  • Administration of this product into the rectum using fingers or any medicated device or applicator is not permitted.

Warnings and Precautions

For external use only. This product is not intended for the treatment of diaper rash; healthcare professionals should advise patients to consult a doctor for appropriate management. Additionally, it is contraindicated for use in cases of external genital itching accompanied by vaginal discharge; a consultation with a healthcare provider is recommended in such instances.

General precautions must be observed to ensure safety. This product should be kept out of the reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

Patients should be instructed to discontinue use and seek medical advice if any of the following occur: conditions worsen, symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. Under no circumstances should patients resume use of this product or initiate any other hydrocortisone product without prior consultation with a healthcare professional.

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

Side Effects

For external use only. Patients are advised to discontinue use and consult a healthcare professional if conditions worsen or if symptoms persist for more than 7 days. Additionally, if symptoms clear up and then recur within a few days, patients should stop using this product and refrain from starting any other hydrocortisone product unless directed by a doctor.

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 and must consult a doctor for guidance. For children aged 2 years and older, the recommended application is to the affected area no more than 3 to 4 times daily. Additionally, pediatric patients under 12 years of age experiencing external anal itching are advised to consult a doctor before use.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

Hydrocortisone cream is not associated with specific warnings or precautions for use during pregnancy. The prescribing information does not indicate any contraindications for pregnant patients or provide evidence of known risks to the fetus associated with its use. Additionally, there are no recommended dosage modifications or special precautions for individuals who are pregnant. Healthcare professionals should consider the overall clinical context when prescribing this medication to women of childbearing potential.

Lactation

There are no specific warnings or recommendations regarding the use of hydrocortisone cream in lactating mothers. Additionally, there is no information available about the potential for excretion of hydrocortisone in breast milk or any associated risks to breastfed infants.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

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

Overdosage

There is currently no specific information available regarding overdosage for this medication. Healthcare professionals are advised to monitor patients closely for any signs of adverse effects or symptoms that may arise from excessive dosing.

In the event of suspected overdosage, it is recommended that healthcare providers initiate supportive care and symptomatic treatment as necessary. Patients should be evaluated for potential complications, and appropriate interventions should be implemented based on clinical judgment.

For further guidance, healthcare professionals may refer to established protocols for managing drug overdosage or consult a poison control center.

Nonclinical Toxicology

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

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of the product. Reports have included skin irritation, allergic contact dermatitis, and hypopigmentation. Additionally, cases of secondary infections, striae (stretch marks), and acneiform eruptions have been documented. Telangiectasia and perioral dermatitis have also been reported. Furthermore, systemic effects, such as adrenal suppression, have been noted in instances of prolonged use or application over large areas.

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.

Patients should be informed to discontinue use and consult a doctor if their condition worsens. Additionally, they should stop using the product and seek medical advice if symptoms persist for more than 7 days or if symptoms clear up and then recur within a few days. It is important to emphasize that patients should not begin the use of any other hydrocortisone product unless directed by a healthcare professional.

When using this product, patients should be cautioned to avoid contact with the eyes. For those using the product for external genital, feminine, and anal itching, it is crucial to adhere to the recommended daily dosage and not exceed it unless directed by a doctor. In the event of bleeding, patients should stop use and consult a healthcare provider.

Finally, patients must be advised not to insert this product into the rectum using fingers or any medicated 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 room temperature, maintaining a range of 20° to 25°C (68° to 77°F). Proper storage conditions are crucial to ensure the integrity and efficacy of the product.

Additional Clinical Information

No further data are available.

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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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.