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Hydrocortisone 1% with Healing Aloe

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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 2015
Label revision date
December 18, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Hydrocortisone 1 g/100 g
Other brand names
Drug class
Corticosteroid
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2015
Label revision date
December 18, 2024
Manufacturer
Trifecta Pharmaceuticals Usa Llc
Registration number
M017
NDC root
69396-005
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 is a medication that temporarily relieves itching associated with minor skin irritations, inflammation, and rashes. It is commonly used for conditions such as eczema, seborrheic dermatitis, psoriasis, insect bites, and reactions to poison ivy, oak, or sumac. Additionally, it can help alleviate itching caused by soaps, detergents, cosmetics, jewelry, and external genital and anal areas.

While hydrocortisone 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 to temporarily relieve itching caused by various minor skin irritations, inflammation, and rashes. This includes conditions like eczema, seborrheic dermatitis, and psoriasis, as well as itching from insect bites and contact with plants like poison ivy, oak, or sumac. It can also help with irritation from soaps, detergents, cosmetics, jewelry, and even external genital and anal itching.

For any other uses, it's important to consult with your doctor for advice and supervision.

Dosage and Administration

To use this medication effectively, start by cleansing the affected area with mild soap and warm water. Make sure to rinse thoroughly when possible. After cleaning, gently dry the area by patting or blotting it with toilet tissue or a soft cloth.

For adults and children aged 12 years and older, you can apply the medication to the affected area up to 3 to 4 times a day. However, if the patient is under 12 years old, it’s important not to use this medication without consulting a doctor first. Following these steps will help ensure the best results from your treatment.

What to Avoid

It's important to keep this medication out of the reach of children to ensure their safety. If a child accidentally swallows it, seek medical help or contact a Poison Control Center right away.

There are no specific contraindications, risks of abuse or misuse, or concerns about dependence associated with this medication. However, always use it responsibly and as directed.

Side Effects

This product is intended for external use only, so be sure to avoid contact with your eyes and do not insert it into the rectum using fingers or any devices. If you experience any bleeding, or if your condition worsens or does not improve after 7 days, stop using the product and consult a doctor.

You should also avoid using this product if you have a vaginal discharge, are treating diaper rash, or if the user is a child under 2 years old. For those using it for external anal itching, do not exceed the recommended daily dosage unless directed by a doctor. If the user is under 12 years of age, please consult a doctor before use.

Warnings and Precautions

This product is intended for external use only, so be sure to avoid contact with your eyes. Do not insert it into the rectum using fingers or any devices. If you experience any bleeding, stop using the product and consult your doctor right away. It's also important to seek medical advice if your condition worsens, if symptoms last more than 7 days, or if they clear up and then return within a few days.

Before using this product, especially if you have a vaginal discharge, are treating diaper rash, or are considering use on children under 2 years old, please consult your doctor. If you are under 12 years of age, it's essential to talk to a doctor before use. For those using it for external anal itching, do not exceed the recommended dosage unless directed by a healthcare professional.

In case of accidental swallowing, seek emergency medical help or contact a Poison Control Center immediately.

Overdose

If you are using this medication for external anal itching, it’s important not to exceed the recommended daily dosage unless your doctor specifically instructs you to do so. Taking more than the recommended amount can lead to an overdose, which may cause unwanted side effects.

If you suspect an overdose, look out for signs such as unusual discomfort or worsening symptoms. In such cases, it’s crucial to seek immediate medical help. Always prioritize your health and consult a healthcare professional if you have any concerns about your dosage or experience any adverse effects.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that there is no specific information available about the use of Hydrocortisone 1% with Healing Aloe during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions related to its use in pregnant individuals have not been established.

Before using this product, you should consult with your healthcare provider to discuss any potential risks and to ensure that it is safe for you and your baby. Always prioritize open communication with your doctor about any medications or treatments you are considering during pregnancy.

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

It's important to keep this product out of the reach of children. If a child accidentally swallows it, seek medical help or contact a Poison Control Center right away. For diaper rash treatment, consult a doctor before using this product, especially for children under 2 years old.

If your child is under 12 years of age, you should also consult a doctor before using this product. For adults and children aged 12 and older, it can be applied to the affected area up to 3 to 4 times a day. Always prioritize safety and seek professional advice when it comes to treating your child's health concerns.

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 considering this medication, it’s important to consult with a healthcare provider. 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 there are no specific guidelines or dosage adjustments mentioned for your condition. This means that the information available does not provide special monitoring or safety considerations tailored for patients with renal impairment (kidney issues).

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 there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations for the medication do not change based on liver impairment. However, it’s always a good idea to discuss your liver health with your healthcare provider, as they can offer personalized advice and monitor your condition appropriately.

Make sure to keep your doctor informed about any liver issues you may have, as they can help ensure that your treatment is safe and effective for you.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking. In this case, there are no specific drug interactions or laboratory test interactions noted, which means that this medication is generally considered safe to use alongside other treatments and tests. However, every individual is different, and your healthcare provider can help ensure that your overall treatment plan is safe and effective for you. Always feel free to ask questions or express any concerns you may have regarding your medications or tests.

Storage and Handling

To ensure the best performance and safety of your product, store it at a controlled room temperature between 15° and 30°C (59° and 86°F). This temperature range helps maintain the product's effectiveness. If you notice that the seal has been broken, it is important not to use the product. Instead, please return it to the store where you purchased it for a replacement or refund. Following these 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 daily if you are an adult or a child aged 12 years and older. If the patient is under 12 years old, consult a doctor before use.

It's important to keep this medication out of the reach of children. If swallowed, seek medical help or contact a Poison Control Center right away. Always read the label directions carefully and keep the carton, as it contains important information.

FAQ

What is Hydrocortisone used for?

Hydrocortisone temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to conditions like eczema, psoriasis, and insect bites.

How should I apply Hydrocortisone?

Cleanse the affected area with mild soap and warm water, then gently dry it. Apply Hydrocortisone to the affected area not more than 3 to 4 times daily for adults and children 12 years and older.

Can children use Hydrocortisone?

Children under 12 years of age should not use Hydrocortisone without consulting a doctor.

What should I do if I accidentally swallow Hydrocortisone?

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

Are there any warnings I should be aware of?

Yes, avoid contact with the eyes, do not use in the rectum, and stop using the product if bleeding occurs or if symptoms worsen.

Is there any information about using Hydrocortisone during pregnancy or while nursing?

The insert does not provide specific information regarding the use of Hydrocortisone during pregnancy or lactation.

How should I store Hydrocortisone?

Store Hydrocortisone at controlled room temperature between 15°-30°C (59°-86°F). If the seal is broken, do not use the product.

Packaging Info

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

Packaging configurations for Hydrocortisone 1% with Healing Aloe.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Hydrocortisone is a corticosteroid with anti-inflammatory and immunosuppressive properties. It is utilized in various therapeutic applications, including the treatment of inflammatory and autoimmune conditions. The molecular weight of hydrocortisone is 362.46 g/mol, and its chemical formula is C21H30O5. Hydrocortisone is typically available in a dosage form suitable for topical application, characterized by a white to off-white appearance.

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 caused by soaps, detergents, cosmetics, jewelry, and external genital and anal areas.

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

Dosage and Administration

The affected area should be cleansed with mild soap and warm water, followed by thorough rinsing when practical. After cleansing, gently dry the area by patting or blotting with toilet tissue or a soft cloth prior to application.

For adults and children aged 12 years and older, the product may be applied to the affected area up to 3 to 4 times daily. For children under 12 years of age, the product is not recommended; consultation with a healthcare professional is advised before use.

Contraindications

Use is contraindicated in children due to the risk of accidental ingestion. In the event of ingestion, immediate medical assistance or contact with a Poison Control Center is advised.

Warnings and Precautions

For external use only, this product must be applied with caution to avoid contact with the eyes. It is imperative that the product is not introduced into the rectum using fingers, mechanical devices, or applicators. In the event of bleeding, the user should discontinue use immediately and consult a healthcare professional.

Should the condition worsen, or if symptoms persist beyond 7 days or resolve only to recur within a few days, medical advice should be sought. Prior to initiating treatment with any other hydrocortisone product, consultation with a healthcare provider is recommended.

This product is contraindicated for individuals with vaginal discharge, for the treatment of diaper rash, and for use in children under 2 years of age. For users addressing external anal itching, it is crucial not to exceed the recommended daily dosage unless specifically directed by a physician.

In cases of bleeding, prompt consultation with a healthcare provider is essential. Additionally, for children under 12 years of age, a doctor's advice should be obtained before use.

Emergency medical assistance should be sought immediately if the product is swallowed, or contact with a Poison Control Center is advised.

Side Effects

Patients should be aware that this product is for external use only and must avoid contact with the eyes. It is imperative that the product not be inserted into the rectum using fingers or any mechanical device or applicator.

In the event of bleeding, patients are advised to stop using the product and consult a doctor promptly. Additionally, if the condition worsens, or if symptoms persist for more than 7 days or resolve and then recur within a few days, medical advice should be sought.

Patients should refrain from using this product and consult a doctor if they experience vaginal discharge, are considering treatment for diaper rash, or if the patient is a child under 2 years of age. For those using the product for external anal itching, it is crucial not to exceed the recommended daily dosage unless directed by a healthcare professional.

Furthermore, it is recommended that children under 12 years of age consult a doctor before using this product.

Drug Interactions

No specific drug interactions have been identified for this medication. Additionally, there are no reported interactions with laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

Packaging & NDC

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

Packaging configurations for Hydrocortisone 1% with Healing Aloe.
Details

Pediatric Use

Pediatric patients should not have access to this product, and it must be kept out of their reach. In the event of accidental ingestion, immediate medical assistance or contact with a Poison Control Center is advised.

For the treatment of diaper rash, this product should not be used without consulting a healthcare professional, particularly in children under 2 years of age. Additionally, children under 12 years of age should not use this product without prior consultation with a doctor.

For adults and children aged 12 years and older, the recommended application is to the affected area no more than 3 to 4 times daily.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

There is no specific information available regarding the use of Hydrocortisone 1% with Healing Aloe during pregnancy. As such, safety concerns, dosage modifications, or special precautions for pregnant patients have not been established. Healthcare professionals should weigh the potential benefits against any unknown risks when considering this medication for women of childbearing potential. It is advisable to exercise caution and to discuss any concerns with patients who are pregnant or planning to become pregnant.

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 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 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

In cases of overdosage, particularly for users experiencing external anal itching, it is crucial to adhere to the recommended daily dosage. Exceeding this dosage should only occur under the guidance of a healthcare professional.

Healthcare providers should be vigilant for potential symptoms that may arise from overdosage, which can include increased irritation or discomfort in the affected area.

Management of overdosage should focus on symptomatic relief and may involve discontinuation of the product. If symptoms persist or worsen, it is advisable to seek medical attention promptly. Monitoring the patient for any adverse reactions is essential, and appropriate interventions should be implemented based on the severity of the symptoms.

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

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of the reach of children to prevent accidental ingestion. It is crucial to emphasize the importance of safety in the home environment, particularly for households with young children.

In the event that the medication is swallowed, healthcare providers should instruct patients to seek medical help or contact a Poison Control Center immediately. This prompt action is essential to ensure appropriate care and management of any potential adverse effects.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It should be stored at a controlled room temperature between 15° and 30°C (59° and 86°F).

In the event that the seal has been broken, the product should not be used and must be returned to the store where it was purchased. Proper handling and adherence to these storage conditions are essential to maintain product integrity.

Additional Clinical Information

The medication is administered topically, with a recommended application frequency of 3 to 4 times daily for adults and children aged 12 years and older. For children under 12 years of age, consultation with a doctor is advised prior to use.

Clinicians should counsel patients to keep the medication out of reach of children and to seek medical assistance or contact a Poison Control Center immediately if the product is swallowed. It is also important for patients to read all label directions carefully and retain the carton, as it contains essential information.

Drug Information (PDF)

This file contains official product information for Hydrocortisone 1% with Healing Aloe, 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% with Healing Aloe, 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.