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Anti-Itch

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This product has been discontinued

Active ingredient
Hydrocortisone 1 g/1 mL
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 25, 2019
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Hydrocortisone 1 g/1 mL
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 25, 2019
Manufacturer
Welly Health PCB
Registration number
part348
NDC root
72663-580
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™ is a 1% hydrocortisone cream designed to provide temporary relief from itching caused by minor skin irritations, inflammation, or rashes. Hydrocortisone is a type of medication that helps reduce inflammation and soothe the skin, making it useful for various mild skin conditions.

While Welly™ can be effective for these purposes, it's important to consult with a doctor for any other uses to ensure safe and appropriate treatment.

Uses

You can use this product for temporary relief from itching caused by minor skin irritations, inflammation, or rashes. It's important to remember that if you have other uses in mind for this product, you should consult with your doctor for advice and supervision.

Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) associated with this product, and there are also no reported nonteratogenic effects. Always prioritize your health and safety by following professional guidance when using any medication.

Dosage and Administration

You should apply the medication to the affected area no more than 3 to 4 times a day. This helps ensure that you get the best results while minimizing the risk of side effects. If you are considering using this medication for a child under the age of 2, it’s important to consult with a doctor first to ensure it’s safe and appropriate for them. Always follow these guidelines to use the medication effectively and safely.

What to Avoid

It's important to use this product safely. You should never apply it to your eyes, as this can cause irritation or harm. Additionally, avoid using it for treating diaper rash or feminine itching, as it is not intended for these conditions. Following these guidelines will help ensure your safety and the effectiveness of the product.

Side Effects

You should only use this medication externally and avoid applying it to your eyes, treating diaper rash, or addressing feminine itching. If your condition worsens, lasts more than seven days, or clears up only to return shortly after, it's important to stop using the product and consult a doctor. Additionally, be cautious if you are using other hydrocortisone products, as this may require medical advice.

Keep this medication out of reach of children. If a child accidentally ingests it, contact a Poison Control Center immediately for assistance.

Warnings and Precautions

This product is intended for external use only, so please avoid applying it to your eyes or using it for diaper rash or feminine itching. If you notice that your condition worsens, lasts more than seven days, or clears up only to return within a few days, stop using the product and consult your doctor. Additionally, be cautious if you are using other hydrocortisone products, as this may not be safe.

If the product is accidentally ingested, it’s important to seek emergency medical help immediately by contacting a Poison Control Center. Your safety is a priority, so please follow these guidelines carefully.

Overdose

If you suspect an overdose has occurred, it’s important to act quickly. Contact a Poison Control Center immediately for guidance. They can provide you with the necessary steps to take based on the situation.

Signs of an overdose can vary, but they may include unusual symptoms that are not typical for you. If you notice any concerning changes in your health or behavior, don’t hesitate to seek immediate medical help. Your safety is the top priority, so getting professional assistance as soon as possible is crucial.

Pregnancy Use

When it comes to using hydrocortisone cream during pregnancy, there is currently no specific information available about its safety, recommended dosage, or any special precautions you should take. This means that the effects of this medication on you and your developing baby are not well understood.

If you are pregnant or planning to become pregnant, it’s important to consult with your healthcare provider before using hydrocortisone cream or any medication. They can help you weigh the potential benefits and risks based on your individual situation.

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, the information provided does not mention any particular considerations or precautions for lactation. This means that, based on the available data, you can use this product without concern for its effects on your milk production or your nursing infant. Always consult with your healthcare provider if you have any questions or concerns about your specific situation.

Pediatric Use

If you have a child under the age of 2, it's important to consult with a doctor before using this medication. This ensures that the treatment is safe and appropriate for your child's specific needs. Always prioritize your child's health by seeking professional advice when it comes to their medication.

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 healthcare providers may not have tailored guidelines for elderly patients.

If you or a loved one is an older adult considering this medication, it’s important to discuss any potential risks and benefits with your healthcare provider. They can help determine the best approach based on individual health needs and circumstances.

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).

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 your medication is safe and effective for you.

Drug Interactions

It's great to know that there are no known interactions between this medication and other drugs or laboratory tests. However, it's still very important to discuss all medications you are taking, including over-the-counter drugs and supplements, with your healthcare provider. This ensures that your treatment is safe and effective.

Always keep your healthcare provider informed about any changes in your health or new medications you start. Open communication helps prevent any potential issues and supports your overall well-being.

Storage and Handling

To ensure the best quality and safety of your product, store it at room temperature, away from direct light. It's important to keep the container tightly closed when not in use to prevent contamination. Once you open the container, please remember to discard it after use to maintain safety and effectiveness. Following these simple steps will help you use the product safely and effectively.

Additional Information

No further information is available.

FAQ

What is Welly™?

Welly™ is a 1% Hydrocortisone Cream used for temporary relief of itching associated with minor skin irritations, inflammation, or rashes.

How should I use Welly™?

Apply Welly™ to the affected area not more than 3 to 4 times daily. For children under 2, consult a doctor before use.

Are there any contraindications for Welly™?

No specific contraindications are mentioned for Welly™.

What should I avoid while using Welly™?

Do not use Welly™ in the eyes, for treatment of diaper rash, or for feminine itching.

What should I do if my condition worsens?

Stop using Welly™ and ask a doctor if your condition worsens, lasts more than 7 days, or clears up and occurs again within a few days.

Is Welly™ safe to use during pregnancy or while nursing?

There is no specific information regarding the use of Welly™ during pregnancy or by nursing mothers in the provided text.

What should I do if Welly™ is ingested?

If Welly™ is ingested, contact a Poison Control Center immediately.

How should I store Welly™?

Store Welly™ at room temperature, protect it from light, and keep the container tightly closed. Discard after opening.

Packaging Info

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

Packaging configurations for Anti-Itch.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Welly™ is a topical cream formulation containing 1% hydrocortisone as the active ingredient. Each unit of the product weighs 0.9 grams (1/32 ounce). The cream is designed for local application to provide anti-inflammatory effects.

Uses and Indications

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

Limitations of Use: Other uses of this product should be undertaken only under the advice and supervision of a healthcare professional. There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

The medication should be applied to the affected area no more than 3 to 4 times daily. For children under the age of 2, it is advised to consult a physician prior to use.

Contraindications

Use of this product is contraindicated in the following situations:

  • Application in the eyes is prohibited due to potential for irritation or damage.

  • The product should not be used for the treatment of diaper rash, as it is not indicated for this condition.

  • It is contraindicated for use in cases of feminine itching, as it is not formulated for this purpose.

Warnings and Precautions

External use only. This product is contraindicated for application in the eyes and should not be used for the treatment of diaper rash or feminine itching.

Healthcare professionals should advise patients to discontinue use and consult a physician if the condition worsens, persists for more than 7 days, or resolves and then recurs within a few days. Additionally, caution is warranted if the patient is concurrently using other hydrocortisone products, as this may lead to increased risk of adverse effects.

In the event of ingestion, it is imperative to seek emergency medical assistance immediately by contacting a Poison Control Center.

Side Effects

Patients using this product should be aware that it is intended for external use only. It is contraindicated for application in the eyes, for the treatment of diaper rash, and for feminine itching.

In the event that a patient's condition worsens, persists for more than 7 days, or resolves only to recur within a few days, it is advised that they discontinue use and consult a healthcare professional. Additionally, patients should refrain from using this product concurrently with other hydrocortisone products.

It is crucial to keep this product out of the reach of children. Ingestion of the product necessitates immediate contact with a Poison Control Center.

Drug Interactions

No drug interactions or drug and laboratory test interactions have been identified for this product. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

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

Packaging configurations for Anti-Itch.
Details

Pediatric Use

Pediatric patients under the age of 2 years should consult a healthcare professional before use. It is important to assess the appropriateness of treatment in this age group, as specific dosing and safety considerations may apply.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients.

Due to the lack of data, it is advisable to closely monitor elderly patients for any potential adverse effects and to consider individual patient factors when determining the appropriateness of therapy.

Pregnancy

There is currently no information available regarding the use of hydrocortisone cream during pregnancy, including safety concerns, dosage modifications, or any special precautions that should be taken. Healthcare professionals should consider this lack of data when prescribing hydrocortisone cream to pregnant patients. It is advisable to weigh the potential benefits against any unknown risks to fetal outcomes. Women of childbearing potential should be counseled accordingly.

Lactation

There are no specific warnings or recommendations regarding the use of this product by lactating mothers. Additionally, no specific considerations or precautions related to lactation are mentioned in the provided information. Therefore, healthcare professionals may consider the use of this product in nursing mothers without specific concerns related to breastfeeding.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no 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 action is crucial. Healthcare professionals are advised to contact a Poison Control Center without delay if an overdose is suspected.

Prompt communication with a Poison Control Center can facilitate the assessment of the situation and guide the appropriate management of the patient. It is essential to provide detailed information regarding the substance involved, the amount ingested, and the time of ingestion to ensure effective intervention.

Potential symptoms of overdosage may vary depending on the specific substance involved, and healthcare providers should be vigilant in monitoring for any signs of toxicity. Management procedures will be determined based on the clinical presentation and the guidance provided by the Poison Control Center.

In summary, swift action and collaboration with poison control experts are vital components in the effective management of overdosage cases.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available in the provided data.

Patient Counseling

Healthcare providers should advise patients that in the event of ingestion, it is crucial to contact a Poison Control Center immediately. This action is essential to ensure prompt and appropriate medical guidance. Providers should emphasize the importance of acting quickly and not waiting for symptoms to appear, as timely intervention can be critical in managing potential risks associated with ingestion.

Storage and Handling

The product is supplied in a container that must be kept tightly closed to maintain its integrity. It should be stored at room temperature, away from direct light exposure to protect its quality. Once opened, the product should be discarded to ensure safety and efficacy.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for 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 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.

Learn more in our Editorial Policy

Last AI update:

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.