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Itch Fixer

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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 2021
Label revision date
February 25, 2021
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 2021
Label revision date
February 25, 2021
Manufacturer
Welly Health PBC
Registration number
part348
NDC root
72663-493
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 and rashes. It can be helpful for various conditions, including eczema, insect bites, poison ivy, poison oak, poison sumac, and reactions to soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis, and external feminine, genital, and anal itching.

While it is effective for these issues, 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 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, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis, and 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. For children under 2 years old, it’s important not to use this product without first consulting a doctor.

If you are dealing with external anal itching, it’s best to start by gently cleaning the area with mild soap and warm water, then rinse thoroughly. Alternatively, you can pat or blot the area with toilet tissue or a soft cloth before applying the medication. If the person experiencing external anal itching is a child under 12 years old, please consult a doctor for guidance.

What to Avoid

It’s important to prioritize your health and safety when considering medication. You should not use this medication if you are pregnant or breastfeeding, as it may pose risks to your baby.

Additionally, be aware that this medication is classified as a controlled substance, which means it has the potential for abuse or misuse. This can lead to dependence (a condition where your body becomes reliant on the drug). Always follow your healthcare provider's guidance and avoid using this medication inappropriately.

Side Effects

When using this product, it's important to be aware of potential side effects and warnings. This medication is for external use only and should not be used for treating diaper rash or external genital itching, especially if you have a vaginal discharge—consult a doctor in such cases. Avoid contact with your eyes, and do not use any other hydrocortisone products without consulting a healthcare professional. If you experience any bleeding, stop using the product and seek medical advice.

You should also stop using this product and consult a doctor if your condition worsens, if symptoms last more than 7 days, or if they clear up and then return. Additionally, this product is not recommended for use during pregnancy or while breastfeeding.

Warnings and Precautions

This product is for external use only and should not be used for treating diaper rash or external genital itching, especially if you have a vaginal discharge—please consult your doctor in that case. While using this product, avoid contact with your eyes and do not start any other hydrocortisone product without first talking to your doctor. If you are treating external genital, feminine, or anal itching, do not exceed the recommended daily dosage unless directed by a healthcare professional.

If you experience any bleeding, stop using the product and consult your doctor immediately. You should also stop use and contact your doctor if your condition worsens, if symptoms last more than 7 days, or if they clear up and then come back. Always keep this product out of reach of children, and do not use it if you are pregnant or breastfeeding.

Overdose

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

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

Pregnancy Use

If you are pregnant or breastfeeding, it is important to avoid using this medication. The potential risks to your baby during pregnancy and while nursing are significant, and it is best to prioritize their safety. Always consult with your healthcare provider for guidance on safe treatment options during this time.

Lactation Use

It is important to note that you should not use this medication if you are pregnant or breastfeeding. This precaution is in place to ensure the safety of both you and your baby. If you have any concerns or questions about medications while nursing, it's best to consult with your healthcare provider for guidance tailored to your situation.

Pediatric Use

When using this medication for children, it's important to follow specific guidelines. For children aged 2 years and older, you can apply it to the affected area up to 3 to 4 times a day. However, if your child is under 2 years old, you should not use this medication and should consult a doctor instead.

If your child is experiencing external anal itching and is under 12 years old, it's best to consult a doctor before using the medication. Always prioritize your child's safety and seek professional advice when needed.

Geriatric Use

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. If you or a loved one is an older adult, it’s always wise to discuss any medications with a healthcare provider, especially considering factors like kidney function and changes in cognition (thinking and memory) that can occur with age.

Make sure to inform your doctor about any other medications being taken, as well as any health conditions, to ensure the safest and most effective treatment plan. Always prioritize open communication with your healthcare team to address any concerns or questions you may have.

Renal Impairment

If you have kidney problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

It's always best to discuss your individual situation with your healthcare provider, who can offer personalized advice and ensure that any medications you take are safe and effective for you.

Hepatic Impairment

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

Always consult your healthcare provider for personalized advice and to discuss any concerns regarding your liver health and how it may relate to your treatment. They can help ensure that you receive the safest and most effective care.

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 unwanted side effects or complications, so consulting your doctor ensures that you are using the right treatment safely.

While there are no specific interactions with laboratory tests mentioned, it's always a good practice to inform your healthcare provider about all medications you are taking. This helps them provide the best care and avoid any potential issues.

Storage and Handling

To ensure the best performance of your product, store it at a controlled room temperature between 68°F and 77°F (20°C and 25°C). This temperature range helps maintain the product's effectiveness and safety.

When handling the product, make sure to do so in a clean environment to avoid contamination. Always follow any specific instructions provided with the product for safe use and disposal. Keeping these guidelines in mind will help you use the product safely and effectively.

Additional Information

You should apply the medication 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. There are no additional details available regarding laboratory tests, abuse potential, or patient counseling information.

FAQ

What is the primary use of this drug?

This drug is used for temporary relief of itching associated with minor skin irritations and rashes.

What conditions can this drug help relieve itching for?

It can help relieve itching from conditions such as eczema, insect bites, 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 use this drug?

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

Are there any age restrictions for using this drug?

Children under 2 years of age should not use this drug and should consult a doctor.

What should you do if you experience bleeding while using this product?

If you experience bleeding, stop use immediately and consult a doctor.

Can this drug be used during pregnancy or breastfeeding?

No, you should not use this drug if you are pregnant or breastfeeding.

What precautions should you take when using this drug?

Avoid contact with eyes, do not exceed the recommended dosage, and do not use for diaper rash or external genital itching if you have a vaginal discharge.

What should you do if your condition worsens or symptoms persist?

If your condition worsens or symptoms persist for more than 7 days, stop use and consult a doctor.

How should this drug be stored?

Store this drug at a controlled room temperature of 68°–77°F (20°–25°C).

Packaging Info

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

Packaging configurations for Itch Fixer.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The provided data does not specify the chemical name, physical characteristics, or inactive ingredients of the drug. Therefore, a detailed description cannot be formulated based on the available information. Further details are required to create a comprehensive description.

Uses and Indications

This drug is indicated for the temporary relief of itching associated with minor skin irritations and rashes due to various conditions, including eczema, insect bites, 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

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 doctor.

In cases of external anal itching, it is recommended that adults, when practical, cleanse the affected area with mild soap and warm water, rinsing thoroughly. Alternatively, the area may be patted or blotted with toilet tissue or a soft cloth prior to the application of the product. For children under 12 years experiencing external anal itching, consultation with a doctor is advised before use.

Contraindications

Use is contraindicated in patients who are pregnant or breastfeeding.

Warnings and Precautions

This product is intended for external use only. It is contraindicated for the treatment of diaper rash and external genital itching. In cases of vaginal discharge, it is imperative to consult a healthcare professional prior to use.

When utilizing this product, it is essential to avoid contact with the eyes. Users should refrain from initiating the use of any other hydrocortisone product without prior consultation with a healthcare provider. For external genital, feminine, and anal itching, the recommended daily dosage should not be exceeded unless directed by a physician. In the event of bleeding, the use of this product must be discontinued immediately, and a doctor should be consulted.

Healthcare professionals should advise patients to stop using the product and seek medical advice if the condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then reoccur. In such cases, patients should not begin the use of any other hydrocortisone product unless directed by a healthcare provider.

It is crucial to keep this product out of the reach of children. Additionally, it should not be used by individuals who are pregnant or breastfeeding.

Side Effects

Patients should be aware that this product is for external use only and is not intended for the treatment of diaper rash or external genital itching. In the event of vaginal discharge, patients are advised to consult a doctor prior to use.

When using this product, it is crucial to avoid contact with the eyes. Patients should not initiate the use of any other hydrocortisone product without prior consultation with a healthcare professional. For external genital, feminine, and anal itching, it is important not to exceed the recommended daily dosage unless directed by a doctor. Should any bleeding occur, patients must stop use immediately and seek medical advice.

Patients are also instructed to discontinue use and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then reoccur. In such cases, patients should refrain from starting any other hydrocortisone product unless directed by a healthcare provider.

Additionally, this product is contraindicated for use during pregnancy or while breastfeeding.

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 Itch Fixer (hydrocortisone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Itch Fixer.
Details

Pediatric Use

Pediatric patients aged 2 years and older may apply the medication to the affected area no more than 3 to 4 times daily. For children under 2 years of age, the use of this medication is not recommended, and a consultation with a doctor is advised. Additionally, for external anal itching, it is important for children under 12 years to consult a doctor before use.

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, given the lack of targeted data for this population.

Pregnancy

Pregnant patients and those who are breastfeeding should not use this medication. The potential risks associated with the use of this drug during pregnancy have not been established, and its safety profile in lactating women is also unclear. Healthcare professionals are advised to consider alternative treatments for women who are pregnant or breastfeeding to avoid any potential adverse effects on fetal outcomes or infant health.

Lactation

Lactating mothers are advised against the use of this medication while breastfeeding. There is no available data on the excretion of this drug in human breast milk or its effects on breastfed infants. Therefore, caution is warranted, and alternative treatments should be considered for lactating mothers.

Renal Impairment

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in 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 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 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 initiate supportive care, which may include maintaining airway patency, ensuring adequate ventilation, and monitoring vital signs.

If available, the use of specific antidotes or treatments should be considered based on the clinical scenario and the substance involved. Consultation with a poison control center or a medical toxicologist may provide additional guidance on the management of overdose cases.

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

Nonclinical Toxicology

The use of this product is contraindicated in pregnant or breastfeeding individuals due to potential teratogenic effects. No non-teratogenic effects have been specified in the available data. Additionally, there are no details provided regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of the reach of children to prevent accidental ingestion or misuse. It is important to emphasize that the medication should not be used during pregnancy or while breastfeeding, as it may pose risks to the developing fetus or nursing infant. Providers should encourage patients to discuss any concerns or questions regarding the use of this medication in these specific circumstances.

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 room temperature, maintaining a range of 68°–77°F (20°–25°C). Proper storage conditions are crucial to ensure the integrity and efficacy of the product.

Additional Clinical Information

Patients aged 2 years and older are advised to apply the medication to the affected area no more than 3 to 4 times daily. There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Itch Fixer, 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 Itch Fixer, 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.

Learn more in our Editorial Policy

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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.