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Medi-First Topical Analgesic

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Active ingredient
Lidocaine Hydrochloride 20 mg/1 mL
Other brand names
Drug classes
Amide Local Anesthetic, Antiarrhythmic
Dosage form
Spray
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2020
Label revision date
April 7, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Lidocaine Hydrochloride 20 mg/1 mL
Other brand names
Drug classes
Amide Local Anesthetic, Antiarrhythmic
Dosage form
Spray
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 2020
Label revision date
April 7, 2025
Manufacturer
Ultra Distributors Inc
Registration number
M017
NDC root
78495-142
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

If you are experiencing minor burns, there is a medication designed to provide temporary pain relief. This drug works specifically to alleviate the discomfort associated with these types of injuries, helping you feel more comfortable as you heal. While the exact mechanism of action isn't detailed, its primary purpose is to ease the pain you may be feeling from minor burns.

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 symptoms while your skin heals. There are no known risks of teratogenic effects (which means it doesn't cause birth defects) associated with this medication, so it is considered safe in that regard.

Dosage and Administration

To use the burn spray effectively, start by cleaning the affected area thoroughly. Once it's clean, spray an even layer of the burn spray over the area. You can do this up to 3 to 4 times a day, depending on your needs.

It's important to note that this spray is not recommended for children under 12 years of age, so make sure to keep it out of reach of younger kids. Always follow these guidelines to ensure safe and effective use of the product.

What to Avoid

It's important to use this product safely. Avoid applying it in large amounts, especially on raw or blistered skin, as this can lead to irritation or other issues. Additionally, be careful not to use it near your eyes; if contact occurs, rinse your eyes thoroughly with water to prevent discomfort.

While there are no specific contraindications or concerns about abuse, misuse, or dependence mentioned, always follow the usage instructions carefully to ensure your safety and well-being.

Side Effects

It's important to note that this product is for external use only. If you notice that your condition worsens or does not improve after 7 days, or if it seems to clear up and then comes back, you should stop using the product and consult a doctor.

Warnings and Precautions

This product is intended for external use only, so please avoid swallowing it. If you accidentally ingest it, seek medical help or contact a Poison Control Center immediately.

You should stop using this product and call your doctor if your condition worsens, persists for more than 7 days, or if it seems to improve and then returns. Your health and safety are important, so don’t hesitate to reach out for professional advice if you have any concerns.

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 effects of an overdose for this medication, you should be aware of general signs that may indicate a problem. These can include unusual drowsiness, confusion, or difficulty breathing.

If you notice any of these symptoms or if you believe you have taken too much of the medication, seek medical help right away. Contact your healthcare provider or go to the nearest emergency room. It's always better to be safe and get checked out if you have concerns about an overdose.

Pregnancy Use

Currently, there is no information available about the use of MEDI-FIRST TOPICAL ANALGESIC (lidocaine hci spray) during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions for pregnant individuals have not been addressed in the drug insert.

If you are pregnant or planning to become pregnant, it is important to consult with your healthcare provider before using this product to ensure it is safe for you and your baby. Always prioritize open communication with your doctor regarding any medications you may consider during this time.

Lactation Use

If you are breastfeeding, it's important to know that lidocaine can be passed into breast milk. Because the effects of this medication on nursing infants haven't been thoroughly studied, caution is advised when using it while you are nursing. To ensure the safety of both you and your baby, it's best to consult your healthcare provider before using this product. They can help you weigh the benefits and risks based on your specific situation.

Pediatric Use

It's important to know that this medication should not be used in children under 12 years of age. If you have a child in this age group, please consult your healthcare provider for alternative options that are safe and appropriate for their age. Always prioritize your child's health and follow medical advice regarding their treatment.

Geriatric Use

When considering medication for older adults, it's important to note that this particular drug should not be used in children under 12 years of age. If you are caring for an older adult, ensure that they are aware of this guideline, as it helps prevent potential complications and ensures safe use of the medication. Always consult with a healthcare provider to discuss any specific concerns or questions regarding medication use in older individuals.

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 health needs. They can help determine the best approach for managing your condition while considering 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 (issues with liver function).

Always consult your healthcare provider for personalized advice and to discuss any concerns regarding your liver health and medication use. They can help ensure that your treatment is safe and effective based on your individual health needs.

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 feel free to ask questions and share any concerns you may have regarding your medications or tests. Your healthcare provider is there to help you understand how to manage your health safely.

Storage and Handling

To ensure the best performance and safety of your product, store it in a cool, dry place at a 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, be sure to do so with clean hands and in a sterile field (a clean area free from germs) to prevent contamination. Always follow any specific disposal instructions provided to ensure safe and responsible disposal of any components.

Additional Information

You should apply the burn spray by spraying an even layer over the cleaned affected area. This can be done up to 3-4 times a day. Make sure to follow these instructions for the best results. If you have any questions or concerns about using the spray, consult your healthcare provider for guidance.

FAQ

What is the primary use of this drug?

This drug is used for temporary pain relief associated with minor burns.

How should I apply the burn spray?

You should spray an even layer of the burn spray over the cleaned affected area no more than 3-4 times daily.

Is this product safe for children?

This product should not be used on children under 12 years of age.

What should I do if the condition worsens?

You should stop using the product and ask a doctor if the condition worsens or persists for more than 7 days.

Can I use this product while breastfeeding?

Caution is advised when using this product while breastfeeding, as lidocaine may be excreted in breast milk. It's recommended to consult a healthcare provider before use.

What should I do if I accidentally swallow the product?

If swallowed, get medical help or contact a Poison Control Center right away.

Are there any specific storage instructions for this drug?

You should store the product at 68°-77°F (20°-25°C).

Is there any information about drug interactions?

No specific drug interactions are mentioned for this product.

What precautions should I take when using this product?

This product is for external use only. Do not use it in large quantities, particularly over raw or blistered areas, and avoid contact with eyes.

Packaging Info

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

Packaging configurations for Medi-First Topical Analgesic.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The product is a clear, colorless to pale yellow liquid. It contains the active ingredient: insert active ingredient name here. Inactive ingredients include: insert inactive ingredients here. The product is packaged in a insert packaging details here. The SPL code for this product is 34089-3.

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

Healthcare professionals are advised to apply an even layer of the burn spray to the cleaned affected area. This application should not exceed 3 to 4 times daily.

It is important to note that this product is contraindicated for use in children under 12 years of age.

Contraindications

The product should not be used in large quantities, particularly over raw or blistered areas, due to the potential for exacerbating irritation or injury. Additionally, application near the eyes is contraindicated; in the event of contact, the area should be rinsed thoroughly with water to mitigate any adverse effects.

Warnings and Precautions

For external use only. It is imperative that healthcare professionals advise patients to adhere strictly to this guideline to prevent any adverse effects associated with inappropriate use.

In the event of accidental ingestion, immediate medical assistance should be sought. Patients should be instructed to contact a Poison Control Center or seek medical help without delay to ensure appropriate management of potential toxicity.

Healthcare providers should monitor patients closely and advise them to discontinue use and consult a physician if their condition worsens, persists for more than 7 days, or if symptoms resolve only to return. This vigilance is essential to ensure patient safety and effective management of their condition.

Side Effects

For external use only. Patients should discontinue use and consult a doctor if the condition worsens or persists for more than 7 days, or if the condition clears up and then returns.

Drug Interactions

There are no specific drug interactions or laboratory test interactions identified in the available data. Therefore, no dosage adjustments or monitoring recommendations are necessary at this time.

Packaging & NDC

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

Packaging configurations for Medi-First Topical Analgesic.
Details

Pediatric Use

Pediatric patients under 12 years of age should not use this medication. Safety and efficacy have not been established in this population, and therefore, it is contraindicated for children in this age group. Healthcare professionals are advised to consider alternative treatments for pediatric patients under 12.

Geriatric Use

Elderly patients may require careful consideration when prescribing this medication. It is important to note that this medication is not indicated for use in children under 12 years of age.

Healthcare providers should assess the overall health status and comorbidities of geriatric patients, as these factors may influence the safety and efficacy of the treatment. Monitoring for potential adverse effects is recommended, given that elderly patients may have altered pharmacokinetics and pharmacodynamics.

Dosage adjustments may be necessary based on individual patient response and tolerance. Regular evaluation of the patient's condition and medication regimen is advised to ensure optimal therapeutic outcomes while minimizing risks.

Pregnancy

There is currently no information available regarding the use of MEDI-FIRST TOPICAL ANALGESIC (lidocaine hci spray) during pregnancy. This includes a lack of data on safety concerns, dosage modifications, or any special precautions that should be taken when considering the use of this medication in pregnant patients. Healthcare professionals are advised to exercise caution and consider the potential risks and benefits when prescribing this medication to women of childbearing potential. Further studies may be necessary to fully understand the implications of lidocaine hci spray use during pregnancy.

Lactation

Nursing mothers should be aware of the potential for excretion of lidocaine in breast milk. Caution is advised when using this product while breastfeeding, as the effects on a nursing infant are not well studied. It is recommended to consult a healthcare provider before using this product if you are nursing.

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 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 excessive dosing. Symptoms of overdosage 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 monitoring vital signs, providing symptomatic treatment, and ensuring the patient's safety.

If available, consultation with a poison control center or a medical toxicologist is recommended to guide further management. It is crucial to document the circumstances of the overdose, including the amount ingested, the time of ingestion, and any symptoms observed, to facilitate appropriate treatment decisions.

Overall, while specific overdosage information is not provided, vigilance and prompt intervention remain key components in managing potential overdose situations.

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 question. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center if the product is swallowed. It is important to emphasize that the product should not be used in large quantities, especially on raw or blistered areas of the skin.

Patients should be cautioned against using the product near the eyes. In the event of accidental contact with the eyes, they should rinse thoroughly with water to mitigate any potential irritation.

Additionally, healthcare providers should instruct patients to discontinue use and consult a doctor if their condition worsens, persists for more than 7 days, or if the condition clears up and then returns. This guidance is crucial for ensuring patient safety and effective management of their condition.

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 temperature range of 68° to 77°F (20° to 25°C) to maintain its integrity and efficacy. Proper storage conditions should be ensured to prevent any degradation of the product.

Additional Clinical Information

Patients should apply an even layer of the burn spray over the cleaned affected area, not exceeding 3-4 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 Medi-First Topical 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 Medi-First Topical 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.