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Aloe Cort

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Active ingredient
Hydrocortisone 0.57 g/57 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 1990
Label revision date
September 17, 2019
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Hydrocortisone 0.57 g/57 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 1990
Label revision date
September 17, 2019
Manufacturer
Topiderm, Inc.
Registration number
M017
NDC root
51326-108
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

DERMA TOPIX is a topical cream that contains hydrocortisone USP, 1%, which is a mild corticosteroid. This cream is designed to provide temporary relief from itching caused by minor skin irritations and rashes. It can help soothe discomfort and promote healing in affected areas of the skin. For any other uses, it is recommended to consult with a doctor for proper guidance.

Uses

You can use this product for the temporary relief of itching caused by minor skin irritations and rashes. It’s important to note that if you have other uses in mind, you should consult with your doctor first to ensure it’s safe and appropriate for your situation. Always prioritize your health and seek professional guidance when needed.

Dosage and Administration

You can use this medication for treating affected areas on your skin. If you are an adult or a child who is 2 years old or older, apply it to the affected area no more than 3 to 4 times a day, or follow your doctor's specific instructions.

If you have a child under 2 years of age, it's important to consult a physician (a medical doctor) before using this medication to ensure it's safe and appropriate for them. Always follow the guidance provided by your healthcare provider for the best results.

What to Avoid

There are no specific contraindications, controlled substance classifications, or risks of abuse, misuse, or dependence associated with this medication. This means that, based on the available information, there are no particular situations or conditions under which you should avoid using it. Always consult with your healthcare provider for personalized advice and to ensure that this medication is appropriate for you.

Side Effects

You should be aware that this product is for external use only and should not come into contact with your eyes. If your condition worsens, symptoms persist for more than seven days, or if they clear up and then return within a few days, it’s important to stop using the product and consult a physician. Additionally, this product is not intended for treating diaper rash.

Keep this product out of reach of children. If it is swallowed, seek professional help or contact a Poison Control Center right away.

Warnings and Precautions

This product is intended for external use only, so please avoid applying it to your eyes. If your condition worsens, symptoms last longer than 7 days, or if they improve and then return within a few days, stop using the product and consult your doctor.

It's important not to use this product for treating diaper rash. Always keep it out of reach of children. If a child accidentally swallows it, seek professional help or contact a Poison Control Center right away.

Overdose

If you or someone else has swallowed too much of a medication, it’s important to act quickly. Seek professional assistance or contact a Poison Control Center right away. They can provide guidance on what to do next.

Signs of an overdose can vary, but it’s crucial to be aware of any unusual symptoms. If you notice anything concerning, don’t hesitate to reach out for help. Remember, getting prompt assistance can make a significant difference in ensuring safety and health.

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 Aloe Cort (hydrocortisone cream) during pregnancy. The information available does not indicate any contraindications or special precautions for pregnant individuals, nor does it suggest any changes to the usual dosage.

While the absence of warnings may seem reassuring, it's always best to consult with your healthcare provider before using any medication during pregnancy to ensure it is safe for you and your baby.

Lactation Use

If you are breastfeeding, you can use Aloe Cort (hydrocortisone cream) without specific warnings or recommendations against it. The information available does not indicate any particular concerns or precautions for nursing mothers regarding this product.

As always, if you have any questions or concerns about using medications while breastfeeding, it's a good idea to consult with your healthcare provider for personalized advice.

Pediatric Use

When using this medication for children aged 2 years and older, you can apply it to the affected area up to 3 to 4 times a day, or as your healthcare provider directs. However, if your child is under 2 years old, it’s important to consult a physician (a medical doctor) before use to ensure safety and proper guidance. Always follow your doctor’s recommendations to ensure the best care for your child.

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 ensure that your healthcare provider is aware of your age and any existing health conditions, as they can provide personalized advice and monitor for any potential issues. Your safety and well-being are the top priority.

Renal Impairment

It appears that there is no specific information regarding renal impairment (kidney problems) in the provided text. Therefore, there are no guidelines, dosage adjustments, or monitoring instructions to share for patients with kidney issues. If you have concerns about how your kidney health may affect your treatment, it's important to discuss this with your healthcare provider for personalized advice and recommendations.

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, and there are no special monitoring or precautions outlined for patients with liver impairment.

However, it's always a good idea to discuss your liver health with your healthcare provider before starting any new medication. They can provide personalized advice and 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, even if there are no known drug interactions or laboratory test interactions associated with them. This ensures that your treatment plan is safe and effective for your individual health needs.

Always feel free to ask questions and share any concerns you may have regarding your medications or tests. Your healthcare provider is there to help you understand how to manage your health safely.

Storage and Handling

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

Additional Information

You should apply this medication topically to the affected area, using it no more than 3 to 4 times a day. If you are using it for a child under 2 years old, it's important to consult a physician first for guidance. There are no additional details available regarding laboratory tests, abuse potential, or postmarketing experiences related to this medication.

FAQ

What is DERMA TOPIX used for?

DERMA TOPIX is used for the temporary relief of itching from minor skin irritations and rashes.

What is the active ingredient in DERMA TOPIX?

The active ingredient in DERMA TOPIX is Hydrocortisone USP, 1%.

How should I apply DERMA TOPIX?

Adults and children 2 years of age and older should apply it to the affected area not more than 3 to 4 times daily, or as directed.

Is DERMA TOPIX safe for children under 2 years of age?

You should consult a physician for children under 2 years of age before using DERMA TOPIX.

Are there any warnings associated with DERMA TOPIX?

Yes, it is for external use only, should not come into contact with the eyes, and should not be used for diaper rash.

What should I do if my condition worsens or persists?

If your condition worsens, or if symptoms persist for more than 7 days, stop using the product and consult a physician.

What should I do if DERMA TOPIX is swallowed?

If swallowed, seek professional assistance or contact a Poison Control Center immediately.

How should I store DERMA TOPIX?

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

Can I use DERMA TOPIX during pregnancy or while nursing?

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

Who manufactures DERMA TOPIX?

DERMA TOPIX is manufactured by Topix Pharmaceuticals, Inc. in N. Amityville, NY.

Packaging Info

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

Packaging configurations for Aloe Cort.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Aloe cort cream contains Hydrocortisone USP at a concentration of 1%. The product is packaged in a net weight of 2 ounces (57 grams). It is manufactured by Topix Pharmaceuticals, Inc., located in North Amityville, NY 11701.

Uses and Indications

This drug is indicated for the temporary relief of itching associated with minor skin irritations and rashes.

Limitations of Use Other uses of this product should be undertaken only under the 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, or as directed by a healthcare professional.

For children under 2 years of age, it is advised to consult a physician prior to use to determine appropriate treatment and dosage.

Contraindications

There are no contraindications associated with the use of this product. It is deemed safe for use in the absence of specific conditions or situations that would warrant avoidance.

Warnings and Precautions

This product is intended for external use only. Healthcare professionals should advise patients to avoid contact with the eyes. In the event that the condition worsens, or if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days, patients should discontinue use and consult a physician.

It is important to note that this product is not indicated for the treatment of diaper rash.

Additionally, this product should be kept out of reach of children. In cases of accidental ingestion, immediate professional assistance should be sought, or the patient should contact a Poison Control Center without delay.

Side Effects

Patients using this product may experience various adverse reactions. It is important to note that this product is for external use only, and contact with the eyes should be avoided. In the event that the condition worsens, symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days, patients are advised to discontinue use and consult a physician.

Additionally, this product should not be used for the treatment of diaper rash. Care should be taken to keep the product out of reach of children. If the product is swallowed, it is imperative to seek professional assistance or contact a Poison Control Center immediately.

Drug Interactions

There are no specific drug interactions identified for this medication. Additionally, no laboratory test interactions have been reported. 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 Aloe Cort (hydrocortisone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Aloe Cort.
Details

Pediatric Use

Pediatric patients aged 2 years and older may apply the medication to the affected area no more than 3 to 4 times daily, or as directed by a healthcare professional. For infants and children under 2 years of age, it is recommended to consult a physician prior to use.

Geriatric Use

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

Pregnancy

There are no specific statements regarding the use of Aloe Cort (hydrocortisone cream) during pregnancy. The available prescribing information does not mention any safety concerns, contraindications, or special precautions associated with the use of this product in pregnant patients. Additionally, no dosage modifications for pregnant individuals are provided. Healthcare professionals should consider the absence of data when advising women of childbearing potential regarding the use of Aloe Cort during pregnancy.

Lactation

There are no specific warnings or recommendations regarding the use of Aloe Cort (hydrocortisone cream) in lactating mothers. Additionally, there are no specific considerations or precautions related to lactation mentioned in the provided text. Therefore, healthcare professionals may consider the use of this product in nursing mothers without specific concerns related to breastfeeding.

Renal Impairment

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

Hepatic Impairment

There is no information available regarding the use of this medication in patients with hepatic impairment. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions specified for individuals with compromised liver function. Healthcare professionals should exercise clinical judgment when considering the use of this medication in patients with liver problems, as the absence of data does not preclude the need for careful evaluation and monitoring based on individual patient circumstances.

Overdosage

In the event of an overdosage, it is imperative that healthcare professionals take immediate action. If the substance is ingested, the individual should seek professional assistance without delay. Contacting a Poison Control Center is strongly recommended to ensure appropriate management and guidance.

Symptoms of overdosage may vary depending on the specific substance involved; therefore, a thorough assessment of the patient's condition is essential. Healthcare providers should monitor for any adverse effects and be prepared to implement supportive care as necessary.

Management procedures should include the following steps:

  1. Assessment: Evaluate the patient's clinical status, including vital signs and level of consciousness.

  2. Supportive Care: Provide symptomatic treatment as required, which may include airway management, intravenous fluids, or other interventions based on the symptoms presented.

  3. Consultation: Engage with a Poison Control Center for specialized advice on further management and potential antidotes, if applicable.

Prompt recognition and intervention are critical in mitigating the effects of an overdosage and ensuring the best possible outcome for the patient.

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.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. In the event that the medication is swallowed, patients should be instructed to seek professional assistance or contact a Poison Control Center immediately. It is essential for patients to understand the importance of these precautions to ensure their safety and the safety of others.

Storage and Handling

The product is supplied in a tube format, with specific handling and storage requirements to ensure its integrity and efficacy. It should be stored at room temperature, away from direct light exposure. To maintain the quality of the product, it is essential to keep the tube tightly closed when not in use. Additionally, the product should be discarded after opening to prevent any potential degradation or contamination.

Additional Clinical Information

The medication is administered topically, with the recommended application frequency for adults and children aged 2 years and older being no more than 3 to 4 times daily, or as directed by a physician. For children under 2 years of age, consultation with a physician is advised prior to use.

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 Aloe Cort, 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 Aloe Cort, 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.