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Welly Itch Fix

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This product has been discontinued

Active ingredient
Hydrocortisone 10 mg/1 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 2019
Label revision date
February 23, 2019
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Hydrocortisone 10 mg/1 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 2019
Label revision date
February 23, 2019
Manufacturer
Welly Health PBC
Registration number
part348
NDC root
72663-155
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

Welly First Aid Itch Fix is a hydrocortisone 1% anti-itch cream designed to provide temporary relief from itching caused by minor skin irritations, inflammation, and rashes. You can use it for various conditions, including eczema, insect bites, poison ivy, poison oak, poison sumac, and reactions to soaps, detergents, cosmetics, jewelry, as well as seborrheic dermatitis and psoriasis.

This cream works by reducing inflammation and soothing the affected area, helping to alleviate discomfort. While it is effective for many common skin issues, it's important to consult 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 such as eczema, insect bites, and reactions to plants like poison ivy, poison oak, and poison sumac. It can also help soothe itching 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 best results, especially if you are treating external anal itching, it’s a good idea to first clean the area gently with mild soap and warm water. Make sure to rinse thoroughly or pat the area dry with toilet tissue or a soft cloth before applying the product.

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

What to Avoid

It's important to use this product safely and effectively. You should not use it for treating diaper rash or external genital itching if you have a vaginal discharge; in these cases, please consult your doctor. Additionally, avoid contact with your eyes and do not start using any other hydrocortisone product without first consulting a healthcare professional.

When using this product for external genital, feminine, or anal itching, make sure not to exceed the recommended daily dosage unless directed by your doctor. If you experience any bleeding, stop using the product and consult your doctor. Lastly, do not insert this product into the rectum using your fingers or any device. Your safety is a priority, so always follow these guidelines.

Side Effects

When using this product, it's important to be aware of potential side effects. You should stop using it and consult a doctor if your condition worsens, if symptoms last more than 7 days, or if they clear up and then return within a few days. Additionally, avoid using this product for diaper rash or external genital itching if you have a vaginal discharge without first consulting a doctor.

Make sure to keep the product away from your eyes and do not exceed the recommended dosage for external genital, feminine, or anal itching unless directed by a doctor. If you experience any bleeding, discontinue use immediately and seek medical advice. Always keep this product out of reach of children, and if swallowed, contact a medical professional or Poison Control Center right away.

Warnings and Precautions

This product is for external use only, so please avoid using it on diaper rashes or for external genital itching if you have a vaginal discharge—consult your doctor in these cases. When applying, be careful to keep it away from your eyes. If you experience any bleeding, stop using the product and consult your doctor. It’s important not to exceed the recommended dosage for external genital, feminine, and anal itching unless directed by a healthcare professional.

If your condition worsens or does not improve after 7 days, or if symptoms clear up and then return within a few days, stop using the product and talk to your doctor. Additionally, do not use this product in the rectum with fingers or any device. Always keep it out of reach of children, and if swallowed, seek medical help or contact a Poison Control Center immediately.

Overdose

It's important to keep this medication out of reach of children. If a child accidentally swallows it, you should seek medical help or contact a Poison Control Center immediately.

In case of an overdose, you may notice symptoms such as unusual drowsiness, confusion, or difficulty breathing. If you or someone else experiences these signs, it's crucial to get medical assistance right away. Always prioritize safety and act quickly in these situations.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that there are no specific warnings, precautions, or dosage changes related to the use of this product during pregnancy. This means that, based on the available information, it is considered safe to use as directed. However, always consult with your healthcare provider before starting any new medication or treatment to ensure it is appropriate for your individual situation. Your health and the health of your baby are the top priority.

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 are no known concerns about the product being passed into breast milk or any associated risks for your infant. This means you can use the product without worrying about its effects on your milk production or your baby's health.

Pediatric Use

If your child is under 2 years old, it's important not to use this medication and to consult a doctor for guidance. For children aged 2 years and older, you can apply the medication to the affected area, but make sure to do this no more than 3 to 4 times a day.

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

Geriatric Use

While there is no specific information about the use of Welly Itch Fix (hydrocortisone anti-itch cream) in older adults, it’s important to approach its use with care. Since the drug insert does not provide any age-related guidelines, dosage adjustments, or safety concerns for elderly patients, you should consult with a healthcare professional before using this product. This ensures that it is appropriate for your needs and that any potential interactions with other medications or health conditions are considered. Always prioritize safety and seek advice tailored to your individual health situation.

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

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 determine the best course of action based on your individual situation.

Drug Interactions

It's important to be cautious when using this product. You should not use it at the same time as other hydrocortisone products unless your doctor specifically tells you to do so. Mixing medications can lead to unexpected side effects or reduce their effectiveness.

Always discuss any medications you are taking with your healthcare provider. They can help ensure that your treatment is safe and effective, taking into account all the products you may be using.

Storage and Handling

To ensure the best performance and safety of your product, store it at a controlled room temperature between 68°F and 77°F (20°C to 25°C). 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 to ensure safety and effectiveness. If you have any questions about disposal or further handling, please refer to the guidelines provided with your product.

Additional Information

You should apply this medication topically 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 you are treating external anal itching, it's recommended to first cleanse the area with mild soap and warm water, then rinse thoroughly or gently pat dry with toilet tissue or a soft cloth before applying the product. If the patient is a child under 12 years old experiencing external anal itching, consult a doctor for guidance.

FAQ

What is Welly First Aid Itch Fix?

Welly First Aid Itch Fix is a hydrocortisone 1% anti-itch cream used for temporary relief of itching associated with minor skin irritations, inflammation, and rashes.

What conditions can Welly First Aid Itch Fix help relieve?

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

How should I use Welly First Aid Itch Fix?

For adults and children 2 years and older, apply to the affected area not more than 3 to 4 times daily. Children under 2 years of age should not use it and should consult a doctor.

Are there any contraindications for using Welly First Aid Itch Fix?

Yes, do not use it for the treatment of diaper rash or for external genital itching if you have a vaginal discharge without consulting a doctor.

What should I do if my condition worsens while using this product?

Stop use and ask a doctor if your condition worsens or if symptoms persist for more than 7 days.

Can I use Welly First Aid Itch Fix if I am pregnant or nursing?

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

What precautions should I take when using Welly First Aid Itch Fix?

Avoid contact with eyes, do not use concurrently with other hydrocortisone products unless directed by a doctor, and do not apply it into the rectum using fingers or any device.

How should I store Welly First Aid Itch Fix?

Store it at a controlled room temperature of 68° - 77ºF (20°-25°C).

Packaging Info

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

Packaging configurations for Welly Itch Fix.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Hydrocortisone 1% Anti-itch Cream is formulated to provide relief from itching and inflammation. Each package contains two tubes, with each tube containing 0.57 oz (16 g) of the cream, resulting in a total net weight of 1.14 oz (32 g). The active ingredient, hydrocortisone, is present at a concentration of 1%, which is effective in reducing symptoms associated with various skin conditions.

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, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis, and external feminine, genital, and anal itching.

Limitations of use: Other applications of this product should only be undertaken under the advice and supervision of a healthcare professional.

No teratogenic or nonteratogenic effects have been reported.

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.

In the case of external 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 prior to the application of the product.

For children under 2 years of age, the product is not recommended, and consultation with a doctor is advised. Additionally, for children under 12 years of age experiencing external anal itching, it is also necessary to consult a doctor before 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. Additionally, the product should not be used for external genital itching in the presence of vaginal discharge without prior consultation with a doctor.

Contact with the eyes must be avoided. The initiation of any other hydrocortisone product should only occur after consulting a healthcare professional. For external genital, feminine, and anal itching, do not exceed the recommended daily dosage unless directed by a doctor. In the event of bleeding, discontinue use and seek medical advice. The product should not be administered rectally using fingers or any mechanical device or applicator.

Warnings and Precautions

For external use only, this product is not intended for the treatment of diaper rash. Healthcare professionals should advise patients to consult a doctor before using this product for such conditions. Additionally, it is contraindicated for external genital itching in the presence of vaginal discharge; patients should seek medical advice in these cases.

When applying this product, it is crucial to avoid contact with the eyes. Patients should be cautioned against initiating the use of any other hydrocortisone product without prior consultation with a healthcare provider. For indications of external genital, feminine, and anal itching, patients must adhere to the recommended daily dosage and should not exceed it unless directed by a physician. In the event of bleeding, the use of this product should be discontinued immediately, and medical advice should be sought.

Patients are advised to stop using the product and consult a doctor if their condition worsens or if symptoms persist for more than 7 days. If symptoms resolve and then recur within a few days, patients should discontinue use and refrain from starting any other hydrocortisone product unless directed by a healthcare professional.

This product should be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended. Furthermore, it is imperative that this product not be inserted into the rectum using fingers, mechanical devices, or applicators.

Side Effects

Patients using this product should be aware that it is intended for external use only. It is contraindicated for the treatment of diaper rash and external genital itching in the presence of vaginal discharge; in such cases, consultation with a doctor is advised.

During the use of this product, patients are cautioned to avoid contact with the eyes. It is also recommended that patients do not initiate the use of any other hydrocortisone product without prior consultation with a healthcare professional. For those experiencing external genital, feminine, or anal itching, it is important not to exceed the recommended daily dosage unless directed by a doctor. In the event of bleeding, patients should discontinue use and seek medical advice.

Patients are instructed to stop using the product and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. Under these circumstances, it is also advised not to begin the use of any other hydrocortisone product without medical guidance.

Additionally, this product should be kept out of reach of children. In the case of accidental ingestion, immediate medical assistance should be sought or contact with a Poison Control Center is recommended.

Drug Interactions

Concurrent use of this product with other hydrocortisone formulations is not recommended unless specifically directed by a healthcare professional. The combination may lead to an increased risk of systemic side effects associated with hydrocortisone, necessitating careful monitoring of the patient’s response and potential adverse effects. It is advisable to consult a healthcare provider for appropriate dosage adjustments and to ensure safe use.

Packaging & NDC

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

Packaging configurations for Welly Itch Fix.
Details

Pediatric Use

Pediatric patients under 2 years of age should not use this medication and must consult a doctor for guidance. For children aged 2 years and older, the recommended application is to the affected area no more than 3 to 4 times daily. Additionally, children under 12 years of age experiencing external anal itching should also consult a doctor prior to use.

Geriatric Use

Elderly patients may use Welly Itch Fix (hydrocortisone anti-itch cream) as no specific information regarding geriatric use is provided in the drug insert. The prescribing information does not include recommended age considerations, dosage adjustments, safety concerns, or special precautions for this population.

Healthcare providers should exercise standard clinical judgment when prescribing this medication to geriatric patients, considering individual patient factors and overall health status. Monitoring for efficacy and potential adverse effects is advisable, as with any medication used in elderly patients.

Pregnancy

The available data does not indicate any specific warnings, precautions, or dosage modifications for the use of this product during pregnancy. As such, healthcare professionals should consider the absence of documented risks when prescribing this product to pregnant patients. However, it is essential to evaluate the potential benefits against any unknown risks, as the effects on fetal outcomes have not been extensively studied. Women of childbearing potential should be counseled regarding the importance of informing their healthcare provider if they become pregnant or plan to become pregnant while using this product.

Lactation

There are no specific warnings or recommendations regarding the use of this product by lactating mothers. Additionally, there are no statements concerning the potential for excretion in breast milk or any associated risks to breastfed infants during the use of this product in lactation.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the prescribing information regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment and monitoring of these patients.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to 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 prescribing information.

Overdosage

In the event of an overdosage, it is imperative to keep the product out of reach of children. Should ingestion occur, immediate medical assistance is required. Healthcare professionals should advise caregivers to contact a Poison Control Center without delay.

Prompt intervention is crucial in managing potential overdosage situations to mitigate risks and ensure patient safety.

Nonclinical Toxicology

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

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children. Instruct patients that if the product is swallowed, they should seek medical help or contact a Poison Control Center immediately.

For patients using the product for the treatment of diaper rash, it is important to recommend consulting a doctor prior to use. Similarly, for those experiencing external genital itching accompanied by vaginal discharge, a consultation with a healthcare professional is necessary.

Patients should be informed that if their condition worsens, they must stop using the product and consult a doctor. Additionally, if symptoms persist for more than 7 days or if they clear up and then recur within a few days, they should discontinue use and refrain from starting any other hydrocortisone product unless directed by a healthcare provider.

Emphasize the importance of avoiding contact with the eyes. Patients should not begin using any other hydrocortisone product without prior consultation with a doctor. For those using the product for external genital, feminine, and anal itching, it is crucial to adhere to the recommended daily dosage and not exceed it unless directed by a healthcare professional. In the event of bleeding, patients should stop use and seek medical advice.

Finally, instruct patients not to insert this 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 should be stored at a controlled room temperature, maintained between 68° - 77°F (20° - 25°C). Proper storage conditions are essential to ensure the integrity and efficacy of the product.

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. For adults experiencing external anal itching, it is advised to cleanse the affected area with mild soap and warm water, rinsing thoroughly or patting dry with toilet tissue or a soft cloth prior to application. For children under 12 years of age with external anal itching, consultation with a doctor is recommended.

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 Welly Itch Fix, 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 Welly Itch Fix, 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.