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Westlake Anti-Itch

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Active ingredient
Hydrocortisone 1 g/100 g
Other brand names
Drug class
Corticosteroid
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2023
Label revision date
December 12, 2023
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Hydrocortisone 1 g/100 g
Other brand names
Drug class
Corticosteroid
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2023
Label revision date
December 12, 2023
Manufacturer
Westlake Pharma LLC
Registration number
M017
NDC root
82895-716
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

Hydrocortisone Cream 1% with Aloe Vera is a topical medication designed to provide temporary relief from itching associated with various minor skin irritations, inflammation, and rashes. It can help soothe itching caused by conditions such as eczema, seborrheic dermatitis, and psoriasis, as well as reactions to insect bites, poison ivy, poison oak, and poison sumac. Additionally, it may alleviate itching related to cosmetics, jewelry, detergents, and soaps, and can also be used for external anal and genital itching.

This cream works by reducing inflammation and calming the skin, making it a helpful option for managing discomfort from these common skin issues. However, it's important to use this product under the advice and supervision of a doctor for any other uses.

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 like eczema, seborrheic dermatitis, and psoriasis, as well as for relief from insect bites and reactions to plants such as poison ivy, poison oak, and poison sumac. It can also help soothe itching caused by cosmetics, jewelry, detergents, and soaps.

Additionally, this product offers temporary relief for external anal and genital 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 experiencing discomfort from external anal itching, you can apply the medication to the affected area up to 3 to 4 times a day. Before applying, it's important to clean the area gently with mild soap and warm water, rinsing thoroughly. You can also use a suitable cleansing pad. After cleaning, make sure to dry the area by patting it with toilet tissue or a soft cloth before applying the medication.

If your child is under 2 years old or if you have any concerns about treating a child under 12, it's best to consult a doctor for guidance. Always follow these steps to ensure safe and effective use of the medication.

What to Avoid

It's important to use this product safely and effectively. You should not use it for treating diaper rash, external genital itching with vaginal discharge, or external anal itching if you experience rectal bleeding—always consult a doctor in these cases.

While using this product, avoid getting it in your eyes. For external anal itching, follow the directions carefully and do not exceed the recommended amount unless your doctor advises otherwise. Additionally, never insert the product into the rectum using your fingers or any device. These precautions help prevent misuse and ensure your safety.

Side Effects

When using this product, it's important to be aware of some potential side effects and warnings. This product is for external use only, so avoid getting it in your eyes. If you're treating external anal itching, do not exceed the recommended amount unless directed by a doctor. Additionally, do not use it for diaper rash or if you have vaginal discharge or rectal bleeding; consult a doctor in these cases.

If your condition worsens, symptoms last more than 7 days, or if they improve and then return within a few days, stop using the product and consult your doctor. Always keep this product out of reach of children, and if swallowed, seek medical help or contact a Poison Control Center immediately.

Warnings and Precautions

This product is for external use only, so please avoid getting it in your eyes. If you're using it for external anal itching, make sure to follow the directions carefully and do not exceed the recommended amount unless your doctor advises otherwise. It's important not to insert the product into the rectum using fingers or any devices.

You should not use this product for diaper rash or for external genital itching if you have a vaginal discharge. If you experience rectal bleeding while using it for anal itching, consult your doctor immediately. If your condition worsens, lasts more than 7 days, or improves and then returns within a few days, stop using the product and contact your doctor. Avoid starting any other hydrocortisone products without guidance.

If the product is swallowed, seek emergency medical 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 seek medical help immediately. You can do this by contacting a Poison Control Center or going to the nearest emergency room. Acting quickly can make a significant difference in the outcome.

Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms, don’t hesitate to get help right away. Remember, it’s always better to be safe and get checked by a medical professional.

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 about using hydrocortisone cream during pregnancy. This means that the information available does not indicate any need for dosage changes or special precautions when using this cream.

However, as with any medication, it's always best to consult with your healthcare provider before using hydrocortisone cream or any other treatment during pregnancy. They can provide personalized advice based on your individual health needs.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of this product while nursing. Additionally, there is no information available about whether this product is passed into breast milk or any potential risks to your infant.

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

Pediatric Use

If your child is under 2 years old, it's important to consult a doctor before using this medication. For children under 12 who are experiencing external anal itching, you should also seek advice from a healthcare professional.

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 these guidelines to ensure your child's safety and well-being.

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 for personalized advice. 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 drug insert does not provide specific information about dosage adjustments, special monitoring, or safety considerations for your condition. This means that there are no tailored guidelines for how this medication may affect you if your kidneys are not functioning properly.

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your kidney health. They can help monitor your condition and make any necessary adjustments to your treatment plan.

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 should be used if you have hepatic impairment (issues with liver function).

Before starting any new medication, including this one, you should discuss your liver health with your healthcare provider. They can help determine the best approach for your treatment and ensure your safety.

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 your complete list of medications and any lab tests you may undergo. Your healthcare provider can help you understand how these factors may affect your health and treatment.

Storage and Handling

To ensure the best performance of your product, store it at a temperature between 20 °C to 25 °C (68 °F to 77 °F). This temperature range helps maintain the integrity and effectiveness 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 safe use and disposal to ensure your safety and the safety of others.

Additional Information

You can use this medication topically, applying it to the affected area no more than 3 to 4 times a day if you are an adult or a child aged 2 years and older. If the patient is under 2 years old, it's important to consult a doctor before use. For adults experiencing external anal itching, it's recommended to first cleanse the area with mild soap and warm water, rinse thoroughly, and gently dry it before applying the medication. If the patient is a child under 12 years, consult a doctor for guidance.

FAQ

What is Hydrocortisone Cream 1% with Aloe Vera used for?

It provides temporary relief of itching associated with minor skin irritations, inflammation, and rashes.

What conditions can Hydrocortisone Cream relieve itching from?

It can relieve itching due to eczema, seborrheic dermatitis, psoriasis, insect bites, poison ivy, poison oak, cosmetics, jewelry, detergents, soaps, and external anal and genital itching.

How should I apply Hydrocortisone Cream?

For adults and children 2 years and over, 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 when using this product?

Yes, it is for external use only. Avoid contact with eyes and do not use for diaper rash or if you have a vaginal discharge.

What should I do if my condition worsens or does not improve?

Stop use and consult your doctor if your condition worsens, symptoms last more than 7 days, or if they clear up and occur again within a few days.

What should I do if I accidentally swallow Hydrocortisone Cream?

Get medical help or contact a Poison Control Center immediately.

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

There are no specific warnings or recommendations regarding the use of this product during pregnancy or lactation.

How should I store Hydrocortisone Cream?

Store it at 20 °C to 25 °C (68 °F to 77 °F).

Packaging Info

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

Packaging configurations for Westlake Anti-Itch.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Hydrocortisone Cream 1% with Aloe Vera is a topical formulation containing hydrocortisone as the active ingredient at a concentration of 1%. This cream is designed for dermatological use and incorporates aloe vera, known for its soothing properties. The formulation is intended to provide relief from inflammation and irritation associated with various skin conditions. The cream is typically presented in a smooth, emollient base that facilitates easy application and absorption.

Uses and Indications

This drug is indicated for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to various conditions, including eczema, seborrheic dermatitis, psoriasis, insect bites, and contact with poison ivy, poison oak, or poison sumac. It is also effective for itching related to cosmetics, jewelry, detergents, and soaps. Additionally, this drug 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

Adults and children aged 2 years and older are instructed 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 recommended to consult a physician prior to use.

In cases of external anal itching in adults, it is advisable to cleanse the affected area with mild soap and warm water when practical, ensuring thorough rinsing. Alternatively, the area may be cleansed by patting or blotting with an appropriate cleansing pad. After cleansing, the area should be gently dried by patting or blotting with toilet tissue or a soft cloth before the application of the medication.

For external anal itching in children under 12 years, consultation with a physician is also recommended prior to use.

Contraindications

The product is contraindicated in the following situations:

Use is not recommended for the treatment of diaper rash; consultation with a healthcare professional is advised. It should not be used for external genital itching in the presence of vaginal discharge; a doctor should be consulted. Additionally, the product is contraindicated for external anal itching if rectal bleeding occurs; prompt medical consultation is necessary.

When using this product, it must not come into contact with the eyes. For external anal itching, do not exceed the directed dosage unless instructed by a healthcare professional. The product should not be inserted into the rectum using fingers or any mechanical device or applicator.

Warnings and Precautions

For external use only. It is imperative that the product is not allowed to come into contact with the eyes. In cases of external anal itching, the product should not be used in excess of the directed dosage unless specifically instructed by a healthcare professional. Additionally, it is crucial to avoid inserting the product into the rectum using fingers, mechanical devices, or applicators.

The product is contraindicated for the treatment of diaper rash; consultation with a healthcare provider is advised in such cases. It should also not be used for external genital itching if there is a presence of vaginal discharge, nor for external anal itching if rectal bleeding occurs. In these situations, prompt medical consultation is necessary.

Healthcare professionals should advise patients to discontinue use and seek medical attention if the condition worsens, if symptoms persist beyond 7 days, or if symptoms resolve only to recur within a few days. Patients should be cautioned against initiating the use of any other hydrocortisone products without prior consultation.

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

Side Effects

Patients using this product should be aware that it is intended for external use only. It is crucial to avoid contact with the eyes. For the treatment of external anal itching, patients should adhere strictly to the directed usage and should not exceed the recommended dosage unless advised by a healthcare professional. Additionally, patients are cautioned against inserting the product into the rectum using fingers or any mechanical device or applicator.

This product is not indicated for the treatment of diaper rash; patients should consult a doctor for such conditions. It is also contraindicated for external genital itching in the presence of vaginal discharge, and for external anal itching if rectal bleeding occurs; in these cases, prompt medical consultation is advised.

Patients are instructed to discontinue use and seek medical advice if their condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. It is important not to initiate the use of any other hydrocortisone product without consulting a healthcare provider.

To ensure safety, this product should be kept out of reach of children. In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center immediately.

Drug Interactions

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

Packaging & NDC

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

Packaging configurations for Westlake Anti-Itch.
Details

Pediatric Use

Pediatric patients under 2 years of age should consult a healthcare professional before use. For the treatment of external anal itching, children under 12 years should also seek medical advice prior to application. For children aged 2 years and older, the medication may be applied to the affected area no more than 3 to 4 times daily.

Geriatric Use

There is no specific information available regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

Pregnancy

Hydrocortisone cream has not been specifically studied in pregnant patients, and there are no established safety concerns, dosage modifications, or special precautions regarding its use during pregnancy. As such, the potential risks and benefits should be carefully considered by healthcare professionals when prescribing this medication to women of childbearing potential. It is advisable to weigh the necessity of treatment against any potential unknown fetal impacts, given the lack of data on its safety profile in this population.

Lactation

There are no specific warnings or recommendations regarding the use of this product in nursing mothers. Additionally, there is no information available about the potential for excretion in breast milk or any associated risks to breastfed infants during lactation.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the prescribing information.

Overdosage

In the event of an overdosage, immediate medical intervention is crucial. If the substance is ingested, it is imperative to seek medical assistance or contact a Poison Control Center without delay.

Healthcare professionals should be aware that prompt action can significantly influence the outcome of an overdosage situation. Symptoms of overdosage may vary depending on the specific substance involved; therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous evaluation and appropriate interventions should be implemented based on the clinical presentation and severity of symptoms.

In all cases of suspected overdosage, the involvement of poison control and emergency medical services is recommended to ensure optimal patient care and 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 provided in the insert.

Patient Counseling

Patients should be advised to seek immediate medical assistance or contact a Poison Control Center if the product is swallowed. It is important to inform patients that this product is intended for the treatment of diaper rash, and they should consult a doctor for further guidance.

Healthcare providers should discuss with patients the appropriate use of the product for external genital itching, particularly if they have a vaginal discharge, and recommend consulting a doctor in such cases. Additionally, patients experiencing external anal itching should be instructed to consult a doctor promptly if rectal bleeding occurs.

Patients should be made aware that if their condition worsens, or if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days, they should discontinue use and not begin any other hydrocortisone product without medical advice. It is crucial to emphasize that the product should not come into contact with the eyes.

For those using the product for external anal itching, patients should be cautioned not to exceed the directed dosage unless specifically instructed by a doctor. Furthermore, they should be advised against inserting the product into the rectum using fingers or any mechanical device or applicator.

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 controlled temperature range of 20 °C to 25 °C (68 °F to 77 °F) to maintain its efficacy and stability. Proper storage conditions must be adhered to, ensuring that the product is kept in a suitable container that protects it from environmental factors. Special handling requirements should be observed to prevent any compromise to the product's integrity.

Additional Clinical Information

The product is administered topically, with specific guidelines for different age groups. Adults and children aged 2 years and older should apply the medication to the affected area no more than 3 to 4 times daily. For children under 2 years, consultation with a doctor is advised. In adults experiencing external anal itching, it is recommended to cleanse the affected area with mild soap and warm water, rinse thoroughly, and gently dry before application. For children under 12 years with external anal itching, a doctor's advice is also necessary.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

Drug Information (PDF)

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