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Hydrocortisone with Aloe

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Active ingredient
Hydrocortisone 10.2 mg/1 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
July 10, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Hydrocortisone 10.2 mg/1 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
July 10, 2024
Manufacturer
NeilMed Pharmaceuticals Inc.
Registration number
M017
NDC root
13709-317
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

Hydrocream 1% is a topical medication designed to provide temporary relief from itching caused by various minor skin irritations, inflammation, and rashes. You may find it helpful for conditions such as eczema, insect bites, and reactions to plants like poison ivy, poison oak, and poison sumac. It can also alleviate itching related to soaps, jewelry, detergents, cosmetics, psoriasis, seborrheic dermatitis, and external genital, feminine, and anal areas.

This cream works by soothing the affected skin, helping to reduce discomfort and irritation. However, it's important to use Hydrocream 1% under the advice and supervision of a doctor for any other uses beyond its primary purpose.

Uses

You can use this product for the temporary relief of itching caused by various minor skin irritations, inflammation, and rashes. This includes conditions like eczema, insect bites, and reactions to plants such as poison ivy, poison oak, and poison sumac. It can also help with irritation from soaps, jewelry, detergents, and cosmetics, as well as skin issues like psoriasis and seborrheic dermatitis. Additionally, it is suitable for relieving external genital, feminine, and anal itching.

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

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 children under 2 years old, it's important not to use this product without first consulting a doctor. If you are pregnant or breastfeeding, make sure to ask a healthcare professional before using it.

For adults dealing with external anal itching, it's best to start by gently cleaning the affected area with mild soap and warm water. Rinse thoroughly and then gently dry the area by patting or blotting it with toilet tissue or a soft cloth before applying the medication. If the user is a child under 12 years old, please consult a doctor for guidance.

What to Avoid

It's important to follow specific guidelines when using this medication to ensure your safety and effectiveness. You should not start using any other hydrocortisone product unless your doctor has instructed you to do so. Additionally, make sure to use this product only as directed; do not exceed the recommended dosage unless advised by your healthcare provider.

Furthermore, avoid inserting this product into the rectum using your fingers or any mechanical device or applicator, as this can lead to complications. Always consult your doctor if you have any questions or concerns about your treatment.

Side Effects

It's important to be aware of potential side effects when using this product. You should stop using it and consult a doctor if your symptoms last longer than 7 days, worsen, or if they clear up only to return a few days later. Additionally, if you experience rectal bleeding, seek medical attention immediately.

This product is for external use only and should not be used for external feminine itching if you have a vaginal discharge. It is also not intended for treating diaper rash, so please consult a doctor in those cases.

Warnings and Precautions

This product is for external use only. If you have vaginal discharge, do not use it for external feminine itching without consulting your doctor. Additionally, it should not be used for diaper rash; please speak with a healthcare professional if you have questions.

If you accidentally swallow this product, seek emergency medical help immediately or contact a Poison Control Center at 1-800-222-1222. You should also stop using the product and call your doctor if your symptoms last more than 7 days, worsen, clear up and then return within a few days, or if you experience rectal bleeding.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While the specific signs of an overdose are not detailed, common symptoms can include extreme drowsiness, confusion, or difficulty breathing. If you notice any of these signs, seek medical help right away.

In case of an overdose, contact your local emergency services or go to the nearest hospital. It's crucial to provide them with as much information as possible about the substance taken and the amount, if known. Remember, acting quickly can make a significant difference in your health and safety.

Pregnancy Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using this medication. They can provide guidance on whether it’s safe for you and your baby. Always prioritize your health and the health of your child by seeking expert advice.

Lactation Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using this medication. They can provide guidance on any potential risks and help ensure the safety of both you and your baby. Always prioritize open communication with your doctor regarding your health and any medications you may be considering while nursing.

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, but make sure to do this no more than 3 to 4 times a day.

If your child is under 12 years old and is experiencing external anal itching, please consult a doctor before using the medication. 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 before starting the medication. 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 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 appropriate for your liver condition. They can help you understand how to manage your health effectively while considering your liver function.

Drug Interactions

It's important to talk to your healthcare provider before starting any new medications, especially if you're considering using another hydrocortisone product. Your doctor can guide you on the safe use of these medications to avoid any potential issues.

Currently, there are no specific interactions with laboratory tests mentioned, but keeping your healthcare provider informed about all the medications you are taking is always a good practice. This ensures that your treatment is safe and effective.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place where the temperature does not exceed 30°C (86°F). It's important to keep it away from freezing temperatures, as this can damage the product.

When handling the product, always do so with clean hands and in a clean environment to maintain its integrity. Following these guidelines will help ensure that the product remains safe and effective for your use.

Additional Information

No further information is available.

FAQ

What is Hydrocream 1% used for?

Hydrocream 1% provides temporary relief of itching associated with minor skin irritations, inflammation, and rashes.

What conditions can Hydrocream 1% help with?

It is indicated for itching due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, jewelry, detergents, cosmetics, psoriasis, seborrheic dermatitis, and external genital, feminine, and anal itching.

How should I use Hydrocream 1%?

For adults and children 2 years and older, apply to the affected area not more than 3 to 4 times daily. Children under 2 years should not use it without consulting a doctor.

Are there any warnings for using Hydrocream 1%?

Yes, it is for external use only, and you should not use it for external feminine itching if you have a vaginal discharge or for diaper rash without consulting a doctor.

What should I do if symptoms persist?

Stop using Hydrocream 1% and consult a doctor if symptoms last for more than 7 days, worsen, or recur after clearing.

Can I use Hydrocream 1% if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, you should ask a health professional before using Hydrocream 1%.

What should I do in case of accidental ingestion?

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

Are there any contraindications for Hydrocream 1%?

No specific contraindications are mentioned, but consult a doctor for any unusual conditions.

Packaging Info

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

Packaging configurations for Hydrocortisone with Aloe.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Hydrocream 1% is a topical formulation designed for dermatological use. It contains 1% of the active ingredient hydroquinone, which is known for its skin-lightening properties. The cream is presented in a smooth, emollient base that facilitates easy application and absorption. Hydrocream 1% is indicated for the treatment of hyperpigmentation disorders, including melasma and age spots. The product is packaged in a suitable container to maintain stability and efficacy.

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. These conditions include eczema, insect bites, poison ivy, poison oak, poison sumac, and reactions to soaps, jewelry, detergents, and cosmetics. Additionally, it is indicated for the management of itching related to psoriasis, seborrheic dermatitis, and external genital, feminine, and anal 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

Adults and children aged 2 years and older are instructed to apply the product 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 healthcare professional.

In cases of external anal itching in adults, it is recommended to first clean the affected area with mild soap and warm water, ensuring thorough rinsing. The area should then be gently dried by patting or blotting with toilet tissue or a soft cloth prior to the application of the product.

For pregnant or breastfeeding individuals, it is advisable to consult a healthcare professional before use. Additionally, for children under 12 years of age, consultation with a doctor is recommended prior to 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.

  • Dosage should not exceed the directed amount unless specifically instructed by a healthcare provider.

  • Administration via the rectum using fingers, mechanical devices, or applicators is prohibited.

Warnings and Precautions

This product is intended for external use only. It is contraindicated for use in cases of external feminine itching accompanied by vaginal discharge; patients should consult a healthcare professional prior to use. Additionally, this product should not be utilized for the treatment of diaper rash without prior consultation with a doctor.

In the event of accidental ingestion, immediate medical assistance is required. Patients should contact a Poison Control Center or seek emergency medical help without delay by calling 1-800-222-1222.

Patients are advised to discontinue use and contact their healthcare provider if any of the following occur: symptoms persist for more than 7 days, the condition worsens, symptoms resolve only to reappear within a few days, or if rectal bleeding is observed. Prompt medical consultation is essential in these situations to ensure appropriate management and care.

Side Effects

Patients should be aware that the product is intended for external use only. It is contraindicated for use in cases of external feminine itching if a vaginal discharge is present; in such instances, consultation with a healthcare professional is advised. Additionally, the product should not be used for the treatment of diaper rash without prior consultation with a doctor.

Patients are advised to discontinue use and seek medical advice if symptoms persist for more than 7 days, if the condition worsens, or if symptoms resolve only to recur within a few days. Immediate medical attention should be sought in the event of rectal bleeding.

Drug Interactions

The initiation of any additional hydrocortisone product should only occur under the guidance of a healthcare professional. This precaution is essential to avoid potential adverse effects or interactions that may arise from concurrent use.

No specific drug or laboratory test interactions have been identified in the available data. Therefore, routine monitoring or dosage adjustments related to drug interactions are not indicated at this time.

Packaging & NDC

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

Packaging configurations for Hydrocortisone with Aloe.
Details

Pediatric Use

Pediatric patients under 2 years of age should not use this medication; consultation with a healthcare professional is advised. For adults and children aged 2 years and older, the recommended application is to the affected area no more than 3 to 4 times daily. In children under 12 years of age, particularly for external anal itching, it is important 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 potential adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully considered, as the effects on fetal outcomes and breastfeeding infants are not fully established. It is essential for women of childbearing potential to discuss their individual circumstances with a healthcare provider to ensure safe use during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data regarding the excretion of this drug in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

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 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 and consider the overall clinical context when prescribing this medication to patients with hepatic impairment.

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 implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

If available, specific antidotes or treatments should be administered according to established protocols. Consultation with a poison control center or a medical toxicologist may also be beneficial in managing the situation effectively.

Documentation of the incident, including the substance involved, the amount ingested, and the time of exposure, is crucial for guiding treatment decisions and ensuring patient safety.

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 seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 if the product is swallowed. Patients should be informed to discontinue use and consult a doctor if symptoms persist for more than 7 days, if the condition worsens, or if symptoms resolve only to reoccur within a few days. Additionally, patients should be instructed to stop use and promptly consult a doctor if rectal bleeding occurs.

It is important to emphasize to patients the need to avoid contact with the eyes while using this product. They should also be cautioned against initiating the use of any other hydrocortisone product without prior consultation with a healthcare provider. For those using the product for external anal itching, patients should be advised not to exceed the directed dosage unless specifically instructed by a doctor. Furthermore, patients should be informed that the product should not be inserted into the rectum using fingers, mechanical devices, or applicators.

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 temperature not exceeding 30°C (86°F) to maintain its integrity. Additionally, the product must be protected from freezing to ensure optimal quality and efficacy. Proper handling and storage conditions are crucial for preserving the product's stability and effectiveness.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Hydrocortisone with 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 with 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.