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Launch Medical

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Active ingredient
Lidocaine Hydrochloride 4 g/100 mL
Other brand names
Drug classes
Amide Local Anesthetic, Antiarrhythmic
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 2024
Label revision date
November 12, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Lidocaine Hydrochloride 4 g/100 mL
Other brand names
Drug classes
Amide Local Anesthetic, Antiarrhythmic
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 2024
Label revision date
November 12, 2025
Manufacturer
Sambria Pharmaceuticals, LLC
Registration number
M015
NDC root
54723-018
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

You can use this medication for temporary relief of pain and itching. It is designed to help alleviate discomfort, making it easier for you to manage symptoms associated with various conditions. If you're experiencing pain or itching, this drug may provide the relief you need.

Uses

If you're experiencing pain and itching, this medication can provide you with temporary relief. It's designed to help soothe discomfort, allowing you to feel more comfortable in your daily activities. Whether it's due to a minor injury, skin irritation, or another cause, this treatment can help alleviate those bothersome symptoms.

Dosage and Administration

To use this medication effectively, you should apply it directly to the affected area of your skin. Make sure to do this in a circular motion for about 30 to 60 seconds. This helps ensure that the medication is absorbed properly.

If you are an adult or a child aged two years and older, you can apply the medication up to 3 to 4 times a day. However, if the person using the medication is under 2 years old, it’s important to consult a physician (doctor) before use to ensure safety and proper guidance.

What to Avoid

You can feel reassured that there are no specific contraindications, controlled substance classifications, or risks of abuse or misuse associated with this medication. Additionally, there are no concerns regarding dependence (a condition where your body becomes reliant on a substance).

Since there are no explicit "do not take" or "do not use" instructions, it suggests that this medication is generally safe for use as directed. However, always consult with your healthcare provider for personalized advice and to ensure it’s appropriate for your situation.

Side Effects

Using this product may lead to some side effects, especially if not used as directed. It's important to remember that this product is for external use only, so avoid getting it in your eyes. You should also refrain from applying it in large amounts, particularly on raw or blistered skin. If your condition worsens, or if symptoms last more than seven days or return shortly after improvement, stop using the product and consult a doctor.

In case of accidental ingestion, seek medical assistance immediately or contact a Poison Control Center. Always prioritize your safety and well-being while using this product.

Warnings and Precautions

This product is intended for external use only, so please avoid applying it to your eyes. It's important not to use large amounts, especially on raw or blistered skin, as this can lead to irritation or other issues.

If your condition worsens, or if symptoms last longer than 7 days, or if they improve and then return within a few days, stop using the product and consult your doctor. Additionally, if you accidentally swallow the product, seek medical help immediately or contact a Poison Control Center. Your safety is important, so please take these precautions seriously.

Overdose

If you or someone else has swallowed this product, it’s important to seek medical help immediately or contact a Poison Control Center. Acting quickly can make a significant difference in ensuring safety and proper care.

Signs of an overdose may not always be obvious, so it's crucial to be vigilant. If you notice unusual symptoms or feel unwell after taking the product, don’t hesitate to reach out for help. Remember, your health and safety are the top priority.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the safety of lidocaine hydrochloride cream during pregnancy has not been established. This cream is generally not recommended for use while pregnant due to potential risks to your developing baby. If you are considering using this product, you should consult your healthcare provider to discuss any possible risks and to determine if it is necessary for your situation.

Additionally, if your healthcare provider does recommend its use, be aware that dosage adjustments may be needed. Always prioritize open communication with your doctor to ensure the best care for both you and your baby.

Lactation Use

If you are breastfeeding and considering the use of lidocaine hydrochloride cream, you can feel reassured that there are no specific warnings or recommendations against its use for nursing mothers. The information available does not indicate any concerns about the cream being passed into breast milk or posing any risk to your infant while you are lactating.

As always, it's a good idea to consult with your healthcare provider if you have any questions or concerns about using any medication while breastfeeding.

Pediatric Use

When using this medication for children aged two years and older, you can apply it to the affected area no more than 3 to 4 times a day. However, if your child is under 2 years old, it’s important to consult a physician (doctor) before use to ensure safety and proper guidance. Always follow these recommendations to help keep your child safe and healthy.

Geriatric Use

When considering the use of lidocaine hydrochloride cream for older adults, it's important to note that the drug insert does not provide specific information about how it should be used in this age group. This means there are no special dosage adjustments, safety concerns, or precautions outlined specifically for elderly patients.

As always, if you or a caregiver are considering this treatment, it's wise to consult with a healthcare professional. They can provide personalized advice based on individual health needs and any other medications you may be taking.

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.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment plan.

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

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you. Always feel free to ask questions and share your complete list of medications and supplements during your appointments. This way, you can receive the best possible care tailored to your needs.

Storage and Handling

To ensure the best performance of your product, it's important to store it in a cool, dry place. Protect it from excessive heat and direct sunlight, as these conditions can damage the product.

When handling the product, always do so with care to maintain its integrity. Following these simple guidelines will help ensure that your product remains safe and effective for use.

Additional Information

You should apply the medication in a circular motion for 30 to 60 seconds on intact skin. For both adults and children aged two years and older, use it on the affected area no more than 3 to 4 times a day. There are no additional details regarding laboratory tests, abuse potential, or patient counseling information available at this time.

FAQ

What is the primary use of this drug?

This drug is used for temporary relief of pain and itching.

How should I apply this drug?

You should apply it in a circular motion for 30 to 60 seconds over intact skin.

How often can I use this drug?

For adults and children two years and older, apply to the affected area not more than 3 to 4 times daily.

What should I do if I am under 2 years old?

If you are under 2 years of age, consult a physician before use.

Are there any warnings I should be aware of?

Yes, this product is for external use only, avoid contact with eyes, and do not use in large quantities over raw surfaces or blistered areas.

What should I do if my condition worsens?

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

Is this drug safe to use during pregnancy?

The safety of this drug during pregnancy has not been established, and it is contraindicated due to potential risks to the fetus.

What precautions should pregnant women take?

Pregnant women should use this product only if clearly needed and after discussing with their healthcare provider.

Is there any information about using this drug while nursing?

There are no specific warnings or recommendations regarding the use of this drug in nursing mothers.

How should I store this product?

Protect this product from excessive heat and direct sunlight.

Packaging Info

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

Packaging configurations for Launch Medical.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

No description information is available for the drug.

Uses and Indications

This drug is indicated for the temporary relief of pain and itching. It is intended for use in patients experiencing these symptoms due to various conditions.

Dosage and Administration

For adults and children aged two years and older, the recommended application is to the affected area not more than 3 to 4 times daily. The product should be applied in a circular motion for a duration of 30 to 60 seconds over intact skin to ensure proper absorption and effectiveness.

For children under the age of two years, it is advised to consult a physician prior to use to determine the appropriateness of treatment and to receive specific guidance.

Contraindications

There are no contraindications associated with the use of this product. It is not classified as a controlled substance, and there are no known risks of abuse, misuse, or dependence.

Warnings and Precautions

This product is intended for external use only. Healthcare professionals should advise patients to avoid contact with the eyes to prevent irritation or injury. It is crucial to instruct patients not to apply the product in large quantities, especially over raw surfaces or blistered areas, as this may exacerbate the condition or lead to adverse effects.

Patients should be monitored for any worsening of their condition. If symptoms persist for more than 7 days, or if there is a recurrence of symptoms after a temporary improvement, it is recommended that the use of this product be discontinued and a healthcare provider be consulted for further evaluation and management.

In the event of accidental ingestion, immediate medical assistance should be sought, or the patient should contact a Poison Control Center without delay.

Side Effects

Patients using this product may experience various adverse reactions. It is important to note that this product is for external use only, and contact with the eyes should be avoided.

In clinical practice, patients are advised not to use this product in large quantities, especially over raw surfaces or blistered areas, as this may exacerbate adverse effects. If a patient's condition worsens, or if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days, it is recommended that the patient discontinue use and consult a healthcare professional.

In the event that the product is swallowed, immediate medical assistance should be sought, or the patient should contact a Poison Control Center without delay. These precautions are essential to ensure patient safety and to mitigate potential risks associated with the use of this product.

Drug Interactions

There are currently no documented drug interactions or interactions with laboratory tests associated with this medication. As such, no specific recommendations for dosage adjustments or monitoring are necessary at this time. Healthcare professionals should continue to assess individual patient circumstances and consider any potential interactions based on the patient's overall medication regimen.

Packaging & NDC

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

Packaging configurations for Launch Medical.
Details

Pediatric Use

Pediatric patients aged two years and older may apply the medication to the affected area no more than 3 to 4 times daily. For children under the age of 2 years, it is advised to consult a physician prior to use.

Geriatric Use

Elderly patients may not have specific dosage adjustments or safety concerns outlined in the prescribing information for lidocaine hydrochloride cream. As there is no dedicated information regarding geriatric use, healthcare providers should exercise caution when prescribing this medication to elderly patients.

It is advisable to monitor these patients closely for any potential adverse effects, given the lack of targeted clinical findings or recommendations for this population. Individual patient factors, including comorbidities and concurrent medications, should be considered when determining the appropriateness of lidocaine hydrochloride cream for geriatric patients.

Pregnancy

The safety of lidocaine hydrochloride cream during pregnancy has not been established. Due to potential risks to the fetus, lidocaine hydrochloride cream is contraindicated in pregnancy. There may be risks associated with the use of lidocaine during this period; therefore, it is essential for pregnant patients to consult a healthcare provider for personalized advice.

Dosage adjustments may be necessary for pregnant individuals, and specific recommendations should be obtained from a physician. Pregnant women should use this product only if clearly needed and after thorough discussion with their healthcare provider to weigh the potential benefits against the risks.

Lactation

There are no specific warnings or recommendations regarding the use of lidocaine hydrochloride cream in lactating mothers. Additionally, there is no information available concerning the potential for excretion of lidocaine hydrochloride in breast milk or any associated risks to breastfed infants.

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 available information.

Overdosage

In the event of an overdosage, immediate medical assistance is crucial. If the product is ingested, healthcare professionals should advise patients or caregivers to seek medical help or contact a Poison Control Center without delay.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. It is recommended that healthcare providers monitor the patient for any symptoms that may arise and initiate appropriate management procedures based on the clinical presentation.

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 provided in the insert.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of the reach of children to prevent accidental ingestion or misuse. It is important for patients to understand the potential risks associated with improper access to the medication by children. Providers should emphasize the necessity of storing the medication in a secure location, away from children's sight and reach, to ensure safety.

Storage and Handling

This product is supplied in packaging that ensures its integrity during storage and handling. It is essential to protect the product from excessive heat and direct sunlight to maintain its efficacy and safety.

For optimal storage conditions, it is recommended to keep the product in a cool, dry place, away from sources of heat and light. Proper handling practices should be observed to prevent any degradation of the product.

Additional Clinical Information

Patients should apply the medication in a circular motion for 30 to 60 seconds over intact skin. For adults and children aged two years and older, the application should be limited to the affected area no more than 3 to 4 times daily. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Launch Medical, 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 Launch Medical, 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.