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Anti-Itch with 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)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2020
Label revision date
May 23, 2023
Drug Information (PDF)
Prescribing information, PDF file
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
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2020
Label revision date
May 23, 2023
Manufacturer
Chain Drug Marketing Association Inc.
Registration number
part348
NDC root
63868-688
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

This medication is designed to provide temporary relief from itching caused by minor skin irritations, inflammation, and rashes. You might find it helpful for conditions such as insect bites, eczema, poison ivy, poison oak, poison sumac, and reactions to soaps, detergents, cosmetics, or jewelry. It can also be used for seborrheic dermatitis, psoriasis, and external feminine genital and anal itching.

While it effectively alleviates itching, it's important to use this product under the guidance of a doctor for any other uses. Always consult with a healthcare professional if you have questions about your specific situation.

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 discomfort related to insect bites, eczema, and reactions to plants like poison ivy, poison oak, and poison sumac. It can also help with irritation from soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis, and even external feminine genital and anal itching.

If you have other uses in mind, it's important to consult with your 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. Before applying, especially for external or anal itching, it’s best to clean the area with mild soap and warm water, rinsing thoroughly. You can also gently pat or blot the area with toilet tissue or a soft cloth to ensure it’s clean.

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

What to Avoid

It's important to be cautious when using this product. If your symptoms last more than 7 days, or if they improve and then come back within a few days, you should stop using it and consult your doctor before starting any other hydrocortisone product. This ensures your safety and helps manage your condition effectively. Always follow your healthcare provider's guidance to avoid any potential issues.

Side Effects

You should only use this product on the skin and not for treating diaper rash. If you have vaginal discharge and are experiencing external genital itching, it's important to consult a doctor.

If your condition worsens or if your symptoms last more than 7 days, stop using the product. Additionally, if your symptoms improve and then return within a few days, discontinue use and do not start any other hydrocortisone product unless your doctor advises you to do so.

Warnings and Precautions

This product is intended for external use only. It should not be used to treat diaper rash, and if you have vaginal discharge along with external genital itching, please consult your doctor before use.

If you accidentally swallow this product, seek emergency medical help or contact a Poison Control Center right away. You should also stop using the product and call your doctor if your condition worsens, if symptoms last more than 7 days, or if symptoms improve and then return within a few days. Do not start using any other hydrocortisone product unless directed by your doctor.

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 unusual drowsiness, confusion, or difficulty breathing. If you notice any of these signs, or if you are unsure, 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 planning to become pregnant, it's important to know that the safety of hydrocortisone 1% cream during pregnancy has not been established. Before using this cream, you should consult your doctor, as there may be potential risks to your fetus. Your healthcare provider can help you weigh the benefits against the risks and determine if this treatment is necessary for you.

Additionally, dosage adjustments may be required, so it's essential to seek guidance from your healthcare provider. Always use this medication only if it is clearly needed and the benefits outweigh any potential risks.

Lactation Use

When it comes to breastfeeding, it's important to be aware that there are no specific guidelines or statements regarding nursing mothers or lactation (the process of producing milk). This means that if you are breastfeeding, you may not find detailed information about how certain medications or treatments could affect you or your baby.

If you have concerns about breastfeeding while taking any medication, it's always best to consult with your healthcare provider. They can provide personalized advice based on your situation and help ensure the safety and well-being of both you and your infant.

Pediatric Use

If your child is under 2 years old, it's important not to use this medication without consulting a doctor first. For children between 2 and 12 years old who are experiencing external anal itching, you should also reach out to a healthcare professional for guidance.

For children aged 2 years and older, you can apply the medication to the affected area, but be sure to limit the application to no more than 3 to 4 times a day. Always follow your doctor’s advice to ensure the safety and well-being of 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 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 be adjusted 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 condition. They can help monitor your kidney health and make any necessary changes to your medications.

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 ensure that any medication you take is safe and appropriate for your liver health. They can help monitor your condition and make any necessary adjustments to your treatment plan.

Drug Interactions

It's important to talk to your healthcare provider before starting any new hydrocortisone product. Using multiple hydrocortisone products at the same time can lead to complications, so consulting with your doctor ensures that you are using the right treatment safely.

While there are no specific interactions with other drugs or lab tests noted, it's always a good practice to discuss all medications and tests you are undergoing with your healthcare provider. This helps to avoid any potential issues and ensures your treatment plan is effective and safe.

Storage and Handling

To ensure the best performance and safety of your product, store it at a controlled room temperature between 20º-25ºC (68º-77ºF). This temperature range helps maintain the integrity of the device.

When handling the product, make sure to do so in a clean environment to avoid contamination. Always follow any specific instructions provided for use and disposal to ensure safety and effectiveness.

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 an adult or a child aged 2 years and older. It's important to avoid contact with your eyes and to consult a doctor before starting any other hydrocortisone product. If you are using it for external genital, feminine, or anal itching, do not exceed the recommended dosage unless directed by a doctor. If you experience any bleeding, stop using the product and consult a doctor. Additionally, do not insert this product into the rectum using fingers or any device.

FAQ

What is the primary use of this product?

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

What conditions can this product help relieve itching from?

It can relieve itching from conditions such as insect bites, eczema, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis, and external feminine genital and anal itching.

How often can adults and children over 2 years apply this product?

Adults and children 2 years and older can apply it to the affected area not more than 3 to 4 times daily.

Is this product safe for children under 2 years?

No, do not use this product on children under 2 years of age without consulting a doctor.

What should I do if symptoms persist for more than 7 days?

Discontinue use and do not begin any other hydrocortisone product unless directed by a doctor.

What precautions should I take if I am pregnant?

Consult a doctor before use if you are pregnant or planning to become pregnant, as there may be potential risks to the fetus.

What should I do if I accidentally swallow this product?

Get medical help or contact a Poison Control Center immediately if swallowed.

Can I use this product for diaper rash?

No, do not use this product for the treatment of diaper rash; consult a doctor instead.

What should I do if I experience worsening conditions?

If conditions worsen or symptoms persist, stop using the product and consult a doctor.

How should I store this product?

Store at controlled room temperature between 20º-25ºC (68º-77ºF).

Packaging Info

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

Packaging configurations for Anti-Itch with Aloe.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

qc anti itch cream aloe is presented in a 1 oz dosage form. The product is designed for topical application and is formulated to provide relief from itching. The media type associated with this product is image/jpeg, indicating that visual representations are available for reference.

Uses and Indications

This drug is indicated for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes resulting from various conditions, including but not limited to insect bites, eczema, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis, and external feminine genital and anal itching.

Other uses of this product should only be undertaken under the advice and supervision of a healthcare professional.

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. Prior to application for 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.

For children under 2 years of age, the product is not recommended; consultation with a healthcare professional is advised. Additionally, for children under 12 years of age experiencing external anal itching, it is essential to consult a doctor before use.

Contraindications

There are no specific contraindications identified for this product. However, it is advised to discontinue use and refrain from initiating any other hydrocortisone product without medical guidance if symptoms persist for more than 7 days or if symptoms resolve and then recur within a few days.

Warnings and Precautions

For external use only. This product is not intended for the treatment of diaper rash; patients should consult a healthcare professional for appropriate management. In cases of external genital itching accompanied by vaginal discharge, it is imperative to seek medical advice prior to use.

In the event of accidental ingestion, immediate medical assistance should be sought, or the local Poison Control Center should be contacted without delay.

Patients are advised to discontinue use and consult their healthcare provider if any of the following occur: worsening of conditions, persistence of symptoms beyond 7 days, or if symptoms resolve and then recur within a few days. Under no circumstances should the use of this product or any other hydrocortisone product be resumed without the explicit direction of a healthcare professional.

Side Effects

Patients should be aware that the product is intended for external use only. It is contraindicated for the treatment of diaper rash, and individuals should consult a doctor if they are considering its use for this condition. Additionally, patients experiencing external genital itching accompanied by vaginal discharge are advised to seek medical consultation prior to use.

In the event that symptoms worsen or persist for more than 7 days, patients should discontinue use of the product. If symptoms clear up and then recur within a few days, it is recommended that patients refrain from using any other hydrocortisone product unless directed by a healthcare professional.

Drug Interactions

The use of hydrocortisone products should be approached with caution. It is advised that patients do not initiate the use of any other hydrocortisone product without prior consultation with 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 for interactions with other medications or laboratory tests is not indicated at this time. However, healthcare providers should remain vigilant and consider individual patient circumstances when prescribing hydrocortisone.

Packaging & NDC

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

Packaging configurations for Anti-Itch 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 children under 12 years of age experiencing external anal itching, it is recommended to consult a doctor prior to use.

In patients aged 2 years and older, the medication may be applied to the affected area no more than 3 to 4 times daily.

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 therapeutic response, given the lack of targeted data for this population.

Pregnancy

The safety of hydrocortisone 1% cream during pregnancy has not been established. Pregnant patients or those planning to become pregnant should consult a healthcare provider before use. There may be potential risks to the fetus; therefore, the use of this medication should be carefully considered. Dosage adjustments may be necessary, and it is essential to seek guidance from a healthcare provider regarding appropriate dosing. Special precautions should be taken to use this medication only if clearly needed, ensuring that the benefits outweigh the risks.

Lactation

There are no specific statements regarding the use of this medication in lactating mothers or its effects on breastfed infants. Healthcare professionals should consider the absence of data when advising lactating mothers about the use of this medication.

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 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 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.

Additionally, it is recommended to consult local poison control centers or relevant toxicology resources for guidance on specific management protocols and antidotes, if applicable.

Documentation of the incident, including the amount and timing of the substance taken, 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 provided in the insert.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center if the product is swallowed. It is important for patients to be aware that they should discontinue use and consult a doctor if their condition worsens. Additionally, patients should be instructed to stop using the product and seek medical advice if their symptoms persist for more than 7 days, or if symptoms improve and then recur within a few days. Patients must be cautioned against starting any other hydrocortisone product without prior consultation with a healthcare professional.

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 of 20º-25ºC (68º-77ºF) to maintain its integrity and efficacy. Proper container requirements must be adhered to, ensuring that the product is kept in a suitable environment. Special handling needs should be observed to prevent exposure to extreme temperatures or conditions that may compromise the product's quality.

Additional Clinical Information

The product is administered topically, with a recommended application frequency of 3 to 4 times daily for adults and children aged 2 years and older. Clinicians should advise patients to avoid contact with the eyes and to refrain from using any other hydrocortisone products without prior consultation with a healthcare professional.

For patients experiencing external genital, feminine, or anal itching, it is crucial not to exceed the recommended dosage unless directed by a physician. In the event of bleeding, patients should discontinue use and seek medical advice. Additionally, patients should be cautioned against inserting the product into the rectum using fingers or any mechanical device or applicator.

Drug Information (PDF)

This file contains official product information for Anti-Itch 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 Anti-Itch 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.