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Corticol-Aloe

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This product has been discontinued

Active ingredient
Hydrocortisone 1 g/100 g
Other brand names
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2019
Label revision date
August 9, 2021
Active ingredient
Hydrocortisone 1 g/100 g
Other brand names
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2019
Label revision date
August 9, 2021
Manufacturer
MENPER DISTRIBUTORS INC.
Registration number
part348
NDC root
53145-430

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Drug Overview

Corticol is a medication designed to temporarily relieve itching associated with various minor skin irritations, inflammation, and rashes. It can help soothe itching caused by conditions such as eczema, psoriasis, and reactions to poison ivy, oak, and sumac. Additionally, it is effective for alleviating discomfort from insect bites, detergents, jewelry, cosmetics, soaps, and seborrheic dermatitis. Corticol can also provide temporary relief for external anal and genital itching.

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

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, psoriasis, and reactions to poison ivy, oak, or sumac. It also helps soothe itching from insect bites, as well as irritations caused by detergents, jewelry, cosmetics, soaps, and seborrheic dermatitis.

Additionally, this product can temporarily relieve itching in external anal and genital areas. For any other uses, it's important to consult with your doctor for guidance and supervision.

Dosage and Administration

If you're dealing with itching from skin irritation, inflammation, or rashes, you can apply the medication to the affected area up to 3 to 4 times a day if you are an adult or a child aged 2 years and older. However, if your child is under 2 years old, it's best to consult a doctor before using it.

For external itching in the anal and genital areas, adults should first clean the area with mild soap and warm water, rinsing thoroughly. After cleaning, gently dry the area by patting it with toilet tissue or a soft cloth. You can then apply the medication to the affected area, again up to 3 to 4 times daily. If the person needing treatment is under 12 years old, please consult a doctor for guidance.

What to Avoid

It's important to be aware of specific instructions regarding the use of this medication. If you accidentally swallow it, seek medical help immediately or contact a Poison Control Center. This is crucial for your safety.

Currently, there are no listed contraindications, controlled substance classifications, or concerns about abuse, misuse, or dependence (a condition where your body becomes reliant on a substance). However, always follow the guidance provided to ensure safe use.

Side Effects

When using this product, it's important to remember that it is for external use only. Avoid applying it in the genital area if you have a vaginal discharge or for treating diaper rash; consult a doctor in these cases. Be careful to keep the product away from your eyes, and do not exceed the recommended dosage unless directed by a healthcare professional.

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 a doctor. Additionally, if you experience rectal bleeding, seek medical advice immediately.

Warnings and Precautions

This product is for external use only, so please avoid using it on sensitive areas like the genital region if you have a vaginal discharge or for treating diaper rash—consult your doctor in these cases. While using this product, be careful to keep it away from your eyes, and do not exceed the recommended dosage unless directed by your doctor. Additionally, do not insert it directly into the rectum using fingers or any devices.

If your condition worsens, if symptoms last longer than 7 days, or if they improve and then return within a few days, stop using the product and contact your doctor. You should also reach out to your doctor if you experience any rectal bleeding. In case of accidental swallowing, seek emergency medical help or contact a Poison Control Center immediately.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While there is no specific information available about the signs of overdose for this medication, general symptoms can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these signs, or if you are concerned about a possible overdose, seek medical help right away.

In case of an overdose, contacting your local emergency services or going to the nearest hospital is crucial. Always keep the medication packaging with you, as it can help healthcare professionals understand what you've taken. Remember, it's better to be safe and get checked out if you have any doubts.

Pregnancy Use

You can use CORTICOL-ALOE (hydrocortisone cream) during pregnancy without specific warnings or dosage changes mentioned in the information provided. There are no indications that this product is contraindicated for pregnant individuals, nor does it state any risks to the fetus associated with its use.

However, it's always a good idea to consult with your healthcare provider before using any medication during pregnancy to ensure it’s safe for you and your baby.

Lactation Use

If you are breastfeeding, it's important to consult your doctor before using this product. There is a possibility that it may be excreted in breast milk, which means it could pass to your baby. Therefore, exercising caution while using this product during breastfeeding is advised to ensure the safety and well-being of both you and your infant.

Pediatric Use

If your child is experiencing itching from skin irritation, inflammation, or rashes, you can apply the treatment to the affected area up to 3 to 4 times a day for children aged 2 years and older. However, if your child is under 2 years old, it's important to consult a doctor before using the product.

For external anal and genital itching, you should also consult a doctor if your child is under 12 years of age. Always prioritize your child's safety and seek professional advice when needed.

Geriatric Use

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. If you or a loved one is an older adult, be sure to discuss any potential risks or concerns with your healthcare provider. They can help determine the best approach for your individual health needs, especially since older adults may have different responses to medications compared to younger individuals. Always keep an open line of communication with your doctor about any changes in health or medication effects.

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 in the available information. This means that the usual recommendations for monitoring or safety considerations for patients with renal impairment (kidney issues) are not provided.

It's always best to consult with your healthcare provider about your specific situation, as they can offer personalized advice and ensure that any medications you take are safe and effective for you.

Hepatic Impairment

If you have liver problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication may affect you if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to discuss any concerns regarding your liver health and how it may relate to your treatment. They can help ensure that your medication is safe and effective for you.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. In this case, there are no known drug interactions or laboratory test interactions associated with the medication. However, always ensure that your healthcare provider is aware of all the medications you are using, as this helps them provide the best care tailored to your needs.

By discussing your full medical history and any other treatments, you can help prevent potential issues and ensure your safety.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 20°C to 25°C (68°F to 77°F). It's important to protect it from light to maintain its effectiveness. When you're not using the product, make sure to keep the tube tightly closed to prevent contamination. Remember to discard the product after opening to ensure safety and effectiveness. 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 2 years and older. For specific issues like external anal and genital itching, adults can also apply it to the affected area up to 3 to 4 times daily. Always follow the recommended usage to ensure safety and effectiveness.

FAQ

What is corticol used for?

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

How should I apply corticol?

For adults and children 2 years and older, apply to the affected area not more than 3 to 4 times daily. For children under 2 years, consult a doctor.

Are there any warnings I should be aware of?

Corticol is for external use only. Avoid contact with eyes, and do not use in the genital area if you have a vaginal discharge or for diaper rash without consulting a doctor.

What should I do if I swallow corticol?

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

Can I use corticol while pregnant or breastfeeding?

There are no specific warnings regarding the use of corticol during pregnancy, but nursing mothers should consult a doctor before use due to potential excretion in breast milk.

What should I do if my condition worsens?

Stop using corticol and consult a doctor if your condition worsens, symptoms persist for more than 7 days, or if rectal bleeding occurs.

How should I store corticol?

Store corticol at 20°C to 25°C (68°F to 77°F), protect it from light, and keep the tube tightly closed when not in use.

Packaging Info

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

Packaging configurations for Corticol-Aloe.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Corticol is a pharmaceutical compound characterized by its specific chemical properties. The molecular weight of corticol is not specified in the provided data. The chemical formula is also not detailed. Corticol is available in a dosage form suitable for its intended therapeutic use. The appearance of corticol is not described in the provided information. Further details regarding inactive ingredients or specific formulation characteristics are not included.

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, oak, sumac, insect bites, detergents, jewelry, cosmetics, soaps, and seborrheic dermatitis. Additionally, it provides temporary relief for external anal and genital itching.

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 the treatment of itching associated with skin irritation, inflammation, and rashes, the recommended dosage for adults and children aged 2 years and older is to apply the medication to the affected area no more than 3 to 4 times daily. For children under 2 years of age, it is advised to consult a physician prior to use.

In cases of external anal and genital itching in adults, it is recommended to first clean the affected area with mild soap and warm water, ensuring thorough rinsing. After cleansing, the area should be gently dried by patting or blotting with toilet tissue or a soft cloth. The medication should then be applied to the affected area, not exceeding 3 to 4 applications per day. For children under 12 years of age, consultation with a physician is also recommended before use.

Contraindications

There are no contraindications listed for this product. However, it is imperative to seek immediate medical assistance or contact a Poison Control Center if the product is swallowed.

Warnings and Precautions

For external use only. This product is contraindicated for use in the genital area if there is a vaginal discharge; consultation with a healthcare professional is advised. It should not be used for the treatment of diaper rash without prior medical consultation.

When utilizing this product, it is imperative to avoid contact with the eyes. Users should adhere strictly to the recommended dosage and should not exceed the directed amount unless specifically instructed by a healthcare provider. Additionally, the product should not be inserted directly into the rectum using fingers, mechanical devices, or applicators.

Patients are advised to discontinue use and contact their healthcare provider 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 also important to refrain from using any other hydrocortisone products without consulting a doctor. Immediate medical attention should be sought if rectal bleeding occurs.

In the event of accidental ingestion, it is crucial to seek emergency medical assistance or contact a Poison Control Center without delay.

Side Effects

Patients using this product should be aware of several important warnings and precautions. This product is intended for external use only and should not be applied in the genital area if there is a vaginal discharge; consultation with a doctor is advised in such cases. Additionally, it is not recommended for the treatment of diaper rash without prior medical advice.

While using this product, patients should avoid contact with the eyes and adhere strictly to the directed usage. It is crucial not to exceed the recommended dosage unless specifically instructed by a healthcare professional. Furthermore, patients should refrain from inserting the product directly into the rectum using fingers or any mechanical device or applicator.

Patients are advised to discontinue use and consult a doctor if any of the following occur: the condition worsens, symptoms persist for more than 7 days, symptoms clear up and then recur within a few days, or if rectal bleeding is experienced. It is important not to initiate the use of any other hydrocortisone product without first consulting a healthcare provider.

Drug Interactions

No drug interactions or drug and laboratory test interactions have been identified in the available data. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

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

Packaging configurations for Corticol-Aloe.
Details

Pediatric Use

Pediatric patients aged 2 years and older may apply the medication to the affected area for itching associated with skin irritation, inflammation, and rashes, not exceeding 3 to 4 times daily. For children under 2 years of age, consultation with a doctor is advised prior to use.

In cases of external anal and genital itching, it is recommended that children under 12 years of age also seek medical advice before using the product.

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

The use of CORTICOL-ALOE (hydrocortisone cream) during pregnancy has not been associated with specific warnings, precautions, or dosage modifications. The prescribing information does not indicate whether the product is contraindicated in pregnant patients or if there are any known risks to fetal outcomes associated with its use.

Healthcare professionals should consider the lack of specific data regarding the safety of CORTICOL-ALOE in pregnant patients when making treatment decisions. As with any medication, the potential benefits must be weighed against any unknown risks, particularly in women of childbearing potential.

Lactation

Lactating mothers should consult a doctor before using this product. There is a potential for excretion in breast milk, and caution is advised when using this product while breastfeeding.

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 clinical trials for this medication. Consequently, there is no available information 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 based on clinical judgment.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should initiate supportive care, which may include maintaining airway patency, ensuring adequate ventilation, and monitoring vital signs.

If available, specific antidotes or treatments should be administered as per established protocols. Additionally, healthcare professionals should consider contacting a poison control center for guidance on the management of overdose cases.

Documentation of the incident, including the substance involved, the amount taken, and the time of ingestion, is crucial for effective treatment and follow-up care.

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 this medication out of reach of children to prevent accidental ingestion. It is important to emphasize that if the medication is swallowed, patients should seek medical help or contact a Poison Control Center immediately. This guidance is crucial for ensuring patient safety and minimizing potential risks associated with accidental exposure.

Storage and Handling

The product is supplied in a tube format, with specific storage and handling requirements to ensure its integrity and efficacy. It should be stored at a temperature range of 20°C to 25°C (68°F to 77°F) and must be protected from light exposure. To maintain the product's quality, the tube should be kept tightly closed when not in use. Additionally, it is important to discard the product after opening to prevent contamination and ensure safety.

Additional Clinical Information

The medication is administered topically, with a recommended application frequency of 3 to 4 times daily for both adults and children aged 2 years and older. For adults experiencing external anal and genital itching, the same application frequency applies.

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 Corticol-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 Corticol-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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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.