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Audiologist 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 2013
Label revision date
December 13, 2024
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 2013
Label revision date
December 13, 2024
Manufacturer
OAKTREE PRODUCTS, INC.
Registration number
M017
NDC root
59256-004
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. It can help with various conditions, including eczema (a condition that makes your skin red and itchy), seborrheic dermatitis (a skin condition that causes scaly patches), psoriasis (a chronic skin disease that causes rapid skin cell production), insect bites, and reactions to plants like poison ivy, poison oak, and poison sumac. Additionally, it can alleviate itching related to reactions from cosmetics, jewelry, detergents, and soaps.

You may also find this drug helpful for temporary relief of external anal and genital itching. However, it's important to use this product under the advice and supervision of a doctor for any other uses.

Uses

You can use this product for temporary relief from itching caused by various minor skin irritations, including conditions like eczema, seborrheic dermatitis, and psoriasis. It can also help soothe itching from insect bites and reactions to plants such as poison ivy, poison oak, and poison sumac. Additionally, if you experience irritation from cosmetics, jewelry, detergents, or soaps, this product may provide relief.

This product is also effective for temporarily relieving external anal and genital itching. However, for any other uses, 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 the medication to the affected area up to 3 to 4 times a day. For children under 2 years old, it’s important to consult a doctor before use.

If you are dealing with external anal itching, start by gently cleansing the area with mild soap and warm water, then rinse thoroughly. You can also use a suitable cleansing pad. After cleaning, make sure to gently dry the area by patting or blotting it with toilet tissue or a soft cloth before applying the medication. If the patient is a child under 12 years, please consult a doctor for guidance.

What to Avoid

It's important to use this medication safely. You should not use it for treating diaper rash or for external genital itching if you have a vaginal discharge—please consult your doctor in these cases. If you experience rectal bleeding, do not use it for external anal itching and seek medical advice immediately.

Additionally, avoid getting the medication in your eyes, and do not exceed the recommended dosage for external anal itching unless directed by your doctor. Never insert the medication into the rectum using your fingers or any device. Following these guidelines will help ensure your safety and the effectiveness of the treatment.

Side Effects

When using this product, it's important to remember that it is for external use only. Avoid getting it in your eyes, and if you're treating external anal itching, do not exceed the recommended amount unless directed by a doctor. You should not use this product for diaper rash or if you have a vaginal discharge or rectal bleeding; in these cases, consult a doctor.

If your condition worsens, symptoms last more than 7 days, or if they improve and then return shortly after, stop using the product and speak with 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, 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 if you have vaginal discharge with external genital itching. 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 this 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.

Signs of an overdose can vary, but they may include unusual symptoms that are not typical for you. If you notice anything concerning, don’t hesitate to get help. Remember, acting quickly can make a significant difference in ensuring safety and health.

Pregnancy Use

Currently, there is no information available about the use of Audiologist Anti-Itch hydrocortisone cream during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions for pregnant individuals have not been addressed in the drug insert.

If you are pregnant or planning to become pregnant, it is important to consult with your healthcare provider before using this cream or any medication. They can provide guidance tailored to your specific situation and help ensure the safety of both you and your baby.

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 a good idea 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 you have a child under 2 years old, it's important to consult with a doctor before using this medication. For children aged 2 years and older, you can apply it to the affected area, but make sure to do so no more than 3 to 4 times a day. If your child is under 12 years old and is experiencing external anal itching, please seek advice from a doctor before proceeding with treatment. Always prioritize your child's safety and well-being by following these guidelines.

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, always consult with a healthcare provider before starting a new medication. They can help determine the best dosage and monitor for any potential safety concerns or side effects that may arise.

Remember, your healthcare team is there to support you, so don’t hesitate to ask questions or express any concerns about medications and their effects on your health.

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 is safe and effective for your specific condition. They can help you understand any necessary precautions or adjustments based on your kidney health.

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).

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. In this case, there are no specific drug interactions or laboratory test interactions noted, which means that this medication is generally considered safe to use alongside other treatments and tests. However, every individual is different, and your healthcare provider can help ensure that your overall treatment plan is safe and effective for you. Always feel free to ask questions or express any concerns you may have regarding your medications or tests.

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, always do so with clean hands and in a clean environment to avoid contamination. If you have any specific disposal instructions, please follow them carefully to ensure safety and compliance with local regulations.

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. If the patient is under 2 years old, 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, you should also consult a doctor for guidance.

FAQ

What is the drug indicated for?

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

What specific conditions can this drug help relieve?

It can relieve itching from eczema, seborrheic dermatitis, psoriasis, insect bites, poison ivy, poison oak, poison sumac, and reactions to cosmetics, jewelry, detergents, and soaps.

Can this drug be used for external anal and genital itching?

Yes, the drug temporarily relieves external anal and genital itching.

How should adults and children over 2 years use this drug?

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

What should I do if I have a child under 2 years?

For children under 2 years, you should ask a doctor before use.

Are there any contraindications for this drug?

No specific contraindications are mentioned.

What should I avoid while using this product?

Do not get the product into your eyes, and do not use it 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 call your doctor if your condition gets worse, or if symptoms last for more than 7 days.

How should I store this drug?

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

Is there any information regarding use during pregnancy or lactation?

There is no specific information regarding use during pregnancy or lactation in the provided text.

Packaging Info

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

Packaging configurations for Audiologist Anti-Itch.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The product is identified by the SPL code 34089-3. It is associated with the content of labeling version 61-292-51v3.0. Additionally, it is represented visually by the image file named Audiologist Choice Hydro Oats 59256-004-01.jpg.

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

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, 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; consult a healthcare professional for appropriate alternatives.

  • External genital itching should not be treated if there is a vaginal discharge; seek medical advice.

  • External anal itching treatment is contraindicated in the presence of rectal bleeding; prompt consultation with a healthcare provider is advised.

  • Contact with the eyes must be avoided.

  • Do not exceed the recommended dosage for external anal itching unless directed by a healthcare professional.

  • The product should not be administered rectally using fingers or any mechanical device or applicator.

Warnings and Precautions

For external use only. It is imperative to avoid 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, the product should not be administered rectally using fingers, mechanical devices, or applicators.

This product is contraindicated for the treatment of diaper rash; consultation with a healthcare provider is advised. It should also not be used for external genital itching in the presence of vaginal discharge, nor for external anal itching if rectal bleeding occurs. In such instances, 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 contact with a Poison Control Center is recommended.

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 those experiencing external anal itching, it is advised not to exceed the directed dosage unless instructed by a healthcare professional. Additionally, patients should refrain from inserting the product into the rectum using fingers or any mechanical devices or applicators.

The product is not recommended for the treatment of diaper rash; patients should consult a doctor for such conditions. It should also not be used for external genital itching if there is a vaginal discharge, nor for external anal itching if rectal bleeding occurs; in these cases, prompt consultation with a healthcare provider is necessary.

Patients are advised to discontinue use and seek medical advice if their condition worsens, if symptoms persist for more than seven 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 medical guidance.

This product should be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance or contact with a Poison Control Center is essential.

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 Audiologist Anti-Itch (hydrocortisone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Audiologist Anti-Itch.
Details

Pediatric Use

Pediatric patients under 2 years of age should consult a healthcare professional before use. For children aged 2 years and older, the recommended application is to the affected area no more than 3 to 4 times daily. In cases of external anal itching in children under 12 years, it is advised to seek guidance from a healthcare provider.

Geriatric Use

There is no specific information 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

There is currently no information available regarding the use of Audiologist Anti-Itch hydrocortisone cream during pregnancy. This includes any safety concerns, dosage modifications, or special precautions that may be necessary for pregnant patients. Healthcare professionals should consider the lack of data when prescribing this medication to women of childbearing potential and weigh the potential benefits against any unknown risks to fetal outcomes. It is advisable to exercise caution and consult relevant clinical guidelines when making treatment decisions for pregnant patients.

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 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 of the patient's condition is essential.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and evaluation are recommended to address any complications that may arise during the management of an overdosage.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the compound in these areas.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

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 to inform patients that this product is not intended for the treatment of diaper rash, and they should consult a doctor for appropriate alternatives.

Patients should be cautioned against using the product for external genital itching if they have a vaginal discharge, and they should seek medical advice in such cases. Similarly, for external anal itching, patients must be instructed to consult a doctor promptly if rectal bleeding occurs.

Healthcare providers should emphasize that patients need to stop using the product and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. Patients should be advised not to initiate the use of any other hydrocortisone product without medical guidance.

While using this product, patients should be reminded to avoid contact with the eyes. For those using the product for external anal itching, it is crucial to adhere strictly to the directed dosage and not exceed it unless specifically instructed by a doctor. Additionally, patients must be informed that the product should not be inserted 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 medication is administered topically, with specific guidelines for different age groups. Adults and children aged 2 years and older should apply the product to the affected area no more than 3 to 4 times daily. For children under 2 years, consultation with a doctor is advised prior to use. In cases of external anal itching in adults, 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 experiencing 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 Audiologist 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 Audiologist 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.