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Analgesic

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This product has been discontinued

Active ingredient
Lidocaine Hydrochloride 2 g/1 mL
Other brand names
Dosage form
Gel
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
Lidocaine Hydrochloride 2 g/1 mL
Other brand names
Dosage form
Gel
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 PBC
Registration number
part348
NDC root
72663-500
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 burn gel designed to provide temporary pain relief for minor burns. This soothing gel helps to alleviate discomfort associated with burns, making it a helpful option for managing minor injuries. If you experience a minor burn, Welly™ can assist in easing the pain while your skin begins to heal.

Uses

You can use this medication for temporary relief from pain caused by minor burns. It helps soothe discomfort and makes it easier for you to manage your daily activities while healing.

Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) associated with this medication, making it a safer option for those who may be pregnant.

Dosage and Administration

If you or your child is 2 years old or older and need to use this medication, you can apply it to the affected area up to 3 to 4 times a day. Make sure to follow this guideline to ensure safe and effective use.

However, if your child is under 2 years old, it’s important not to use this medication without first consulting a doctor. Always prioritize safety and seek professional advice when it comes to younger children.

What to Avoid

It's important to use this product safely to avoid any potential issues. You should never apply it near your eyes; if it accidentally gets into your eyes, rinse them thoroughly with water. Additionally, avoid using large amounts of the product, especially on raw or blistered skin, as this could lead to irritation or other complications. Always follow these guidelines to ensure your safety and well-being.

Side Effects

It's important to use this product only on the skin and keep it out of reach of children. Avoid applying it near your eyes; if contact occurs, rinse thoroughly with water. Additionally, do not use it in large amounts, especially on raw or blistered skin.

If your condition worsens, lasts more than 7 days, or improves and then returns, stop using the product and consult a doctor. If ingested, contact a Poison Control Center immediately for assistance.

Warnings and Precautions

This product is for external use only, so please keep it out of reach of children. Avoid applying it near your eyes; if it does come into contact with your eyes, rinse them thoroughly with water. Additionally, do not use this product in large amounts, especially on raw or blistered skin.

If your condition worsens, lasts more than 7 days, or clears up and then returns, stop using the product and consult your doctor. If you accidentally ingest it, contact a Poison Control Center immediately for assistance.

Overdose

If you suspect an overdose has occurred, it’s important to act quickly. The first step is to 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, do not 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 considering the use of lidocaine hydrochloride gel during pregnancy, it's important to note that there is no specific information available regarding its safety, dosage adjustments, or any special precautions for pregnant individuals. This means that the effects of this medication on pregnancy have not been clearly studied or established.

If you are pregnant or planning to become pregnant, it is always best to consult with your healthcare provider before using any medication, including lidocaine hydrochloride gel. They can provide personalized advice and help you weigh the potential risks and benefits 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 lidocaine hydrochloride gel for nursing mothers. The information available does not indicate any particular considerations or precautions you need to take while using this gel during lactation (the period of breastfeeding).

Always consult with your healthcare provider if you have any concerns about medications and their effects on breastfeeding, but based on the current information, you can use lidocaine hydrochloride gel without specific worries related to nursing.

Pediatric Use

This medication is intended for external use only, so it's important to keep it out of reach of children. For adults and 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 product without consulting a doctor first. Always prioritize safety and follow these guidelines to ensure proper use.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that if you or a loved one is an older adult considering this medication, it’s important to consult with a healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

Renal Impairment

It appears that there is no specific information regarding renal impairment (kidney problems) in the provided text. Therefore, there are no dosage adjustments, special monitoring, or safety considerations to discuss for patients with kidney issues. If you have concerns about how your kidney health may affect your treatment, it's important to consult your healthcare provider for personalized advice and guidance.

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 (liver issues).

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 you understand how to manage your treatment effectively.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking, even if there are no known drug interactions or laboratory test interactions associated with them. This ensures that your treatment plan is safe and effective for your individual health needs.

Always keep your healthcare team informed about all the medications and supplements you use, as well as any lab tests you may undergo. This way, they can provide the best care tailored to you.

Storage and Handling

To ensure the best performance of your product, store it at room temperature and keep it away from direct light. It's important not to freeze the product, as this can affect its effectiveness. Once you open the product, be sure to discard any unused portion to maintain safety and quality.

By following these simple storage and handling guidelines, you can help ensure that the product remains safe and effective for your use.

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 your child is under 2 years old, it's important to consult a doctor before use. There are no additional details available regarding laboratory tests, abuse potential, or patient counseling.

FAQ

What is Welly™ used for?

Welly™ is a burn gel used for temporary pain relief for minor burns.

How should I use Welly™?

For adults and children 2 years and older, apply to the affected area not more than 3 to 4 times daily. Do not use in children under 2 without consulting a doctor.

Are there any contraindications for using Welly™?

No specific contraindications are mentioned for Welly™.

What should I do if I accidentally get Welly™ in my eyes?

If Welly™ gets in your eyes, rinse thoroughly with water.

What precautions should I take when using Welly™?

Welly™ is for external use only. Keep it out of reach of children and do not use in large quantities, especially over raw or blistered areas.

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

If your condition worsens or lasts more than 7 days, or if it clears up and returns, stop use and ask a doctor.

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

There are no specific warnings or recommendations regarding the use of Welly™ during pregnancy or lactation.

How should I store Welly™?

Store Welly™ at room temperature, protect it from light, and do not freeze. Discard after opening.

Packaging Info

Below are the non-prescription pack sizes of Analgesic (lidocaine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Analgesic.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Welly™ Burn Gel is a topical formulation designed for the management of minor burns. It is available in a dosage form of 0.9 ounces (26.8 grams) and 1/32 ounces (0.9 grams). The gel is specifically formulated to provide soothing relief and promote healing for affected skin areas.

Uses and Indications

This drug is indicated for the temporary relief of pain associated with minor burns.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

For adults and children aged 2 years and older, the recommended application is to the affected area not more than 3 to 4 times daily. It is important to ensure that the application is limited to the specified frequency to avoid potential adverse effects.

For children under the age of 2 years, the product should not be used unless directed by a healthcare professional. In such cases, it is advisable to consult a doctor for appropriate guidance.

Contraindications

Use is contraindicated in the following situations:

  • Application near the eyes is contraindicated; in the event of contact, rinse thoroughly with water to mitigate potential irritation.

  • Use in large quantities is contraindicated, especially over raw or blistered areas, due to the risk of exacerbating skin irritation or damage.

Warnings and Precautions

External use only; this product must be kept out of reach of children to prevent accidental ingestion or misuse.

It is imperative that this product not be applied near the eyes. In the event of contact with the eyes, it is essential to rinse thoroughly with water to mitigate potential irritation or damage. Additionally, the product should not be used in large quantities, especially over raw or blistered areas, as this may exacerbate adverse effects.

Healthcare professionals should advise patients to discontinue use and seek medical advice if the condition worsens, persists for more than 7 days, or if symptoms resolve and then recur. In cases of ingestion, immediate contact with a Poison Control Center is recommended to ensure appropriate management and care.

Side Effects

Patients should be aware of the following warnings and precautions associated with the use of this product. It is intended for external use only and must be kept out of reach of children to prevent accidental ingestion or misuse.

The product should not be applied near the eyes. In the event of contact with the eyes, it is imperative to rinse thoroughly with water. Additionally, the product should not be used in large quantities, particularly over raw or blistered areas, as this may lead to adverse effects.

Patients are advised to discontinue use and consult a healthcare professional if their condition worsens, persists for more than 7 days, or if symptoms clear up and then return. In cases of ingestion, it is crucial to contact a Poison Control Center immediately for guidance.

Drug Interactions

There are no specific drug interactions identified for this medication. Additionally, no laboratory test interactions have been reported. 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 Analgesic (lidocaine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Analgesic.
Details

Pediatric Use

Pediatric patients aged 2 years and older may use the product externally, applying it to the affected area no more than 3 to 4 times daily. For children under 2 years of age, the product is not recommended, and consultation with a healthcare professional is advised. It is important to keep the product out of reach of children to ensure safety.

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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population, given the lack of targeted data.

Pregnancy

There is no specific information available regarding the use of lidocaine hydrochloride gel during pregnancy. Consequently, the safety concerns, dosage modifications, or special precautions related to pregnancy have not been established. Healthcare professionals should exercise caution when prescribing this medication to pregnant patients, as the potential effects on fetal outcomes remain unclear. Women of childbearing potential should be informed of the lack of data and advised to discuss any concerns with their healthcare provider.

Lactation

There are no specific warnings or recommendations regarding the use of lidocaine hydrochloride gel in lactating mothers. Additionally, there are no specific considerations or precautions related to lactation mentioned in the provided text. Therefore, healthcare professionals may consider the use of this medication in nursing mothers without specific concerns related to breastfeeding.

Renal Impairment

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

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 take immediate action. Healthcare professionals should advise patients or caregivers to contact a Poison Control Center directly for guidance.

Potential symptoms of overdosage may vary depending on the substance involved and the amount ingested. It is crucial for healthcare providers to assess the patient's condition thoroughly and monitor for any adverse effects that may arise.

Management of overdosage should be tailored to the specific circumstances, including the substance involved and the severity of symptoms. Prompt intervention and appropriate medical care are essential to mitigate potential risks associated with 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 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 that the product is for external use only and must be kept out of reach of children to prevent accidental ingestion or misuse.

Patients should be instructed not to apply the product near the eyes. In the event of contact with the eyes, they should rinse thoroughly with water to mitigate any potential irritation.

It is important to inform patients to avoid using the product in large quantities, especially on raw or blistered areas, as this may lead to adverse effects.

Patients should be counseled to discontinue use and consult a healthcare professional if their condition worsens, persists for more than 7 days, or if symptoms resolve and then return. Additionally, if the product is ingested, patients should be directed to contact a Poison Control Center immediately for further assistance.

Storage and Handling

The product is supplied in packaging that includes specific NDC numbers. It should be stored at room temperature, ensuring that it is protected from light exposure. Freezing the product is not permitted, as it may compromise its integrity. Additionally, the product must be discarded after opening to ensure safety and efficacy.

Additional Clinical Information

The medication is administered topically, with a recommended application frequency of 3 to 4 times daily for adults and children aged 2 years and older. For children under 2 years of age, it is advised to consult a doctor before use. 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 Analgesic, 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 Analgesic, 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.