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Medi-First

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Active ingredients
  • Lidocaine Hydrochloride 5 mg/1 g
  • Benzalkonium Chloride 1.3 mg/1 g
Other brand names
Drug classes
Amide Local Anesthetic, Antiarrhythmic
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2025
Label revision date
September 3, 2025
Active ingredients
  • Lidocaine Hydrochloride 5 mg/1 g
  • Benzalkonium Chloride 1.3 mg/1 g
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
Marketed in the U.S.
Since 2025
Label revision date
September 3, 2025
Manufacturer
Orazen Inc
Registration number
M017
NDC root
71927-019

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Drug Overview

This medication is designed to provide temporary relief from pain associated with minor burns. In addition to alleviating pain, it also helps protect the affected area from harmful bacteria, promoting a safer healing environment. If you’re dealing with a minor burn, this drug can be a supportive option to help manage your discomfort while protecting your skin.

Uses

If you're dealing with minor burns, this medication can provide temporary relief from the pain associated with those injuries. In addition to easing discomfort, it also helps protect your skin from harmful bacteria, which can prevent infections and promote healing. Always remember to follow the guidance of your healthcare provider when using any medication.

Dosage and Administration

To use this medication effectively, start by cleaning the affected area thoroughly. For adults and children aged 2 years and older, apply a small amount of the medication to the area. You can do this up to 3 to 4 times each day, ensuring you don’t use more than the recommended amount.

If you have a child under 2 years old, it’s important not to use this medication without first consulting a doctor. Always follow these guidelines to ensure safe and effective use.

What to Avoid

It's important to use this product safely to avoid potential issues. You should never use it in your eyes or apply it in large quantities. Additionally, avoid using it on raw or blistered skin, deep puncture wounds, animal bites, or serious burns. If you find that you need to use it for more than one week, please consult your doctor for guidance. Following these instructions will help ensure your safety and the effectiveness of the product.

Side Effects

This product is intended for external use only. If your condition worsens, or if your symptoms last longer than 7 days, or if they improve and then return within a few days, you should stop using the product and consult a doctor. It's important to monitor your symptoms closely to ensure your health and safety.

Warnings and Precautions

This product is for external use only, so please avoid using it on any internal areas of your body. It's important to keep it out of reach of children. If someone accidentally swallows 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, if symptoms last longer than 7 days, or if your symptoms improve and then return within a few days. Your health and safety are important, so don’t hesitate to reach out for professional advice if needed.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, if you suspect an overdose, it is important to be aware of potential signs, which may include unusual drowsiness, confusion, or difficulty breathing.

If you or someone else may have taken too much of the medication, seek immediate medical help. You can call your local emergency number or go to the nearest hospital. Always keep medications out of reach of children and follow the prescribed dosage to prevent any risk of overdose.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the safety of this product during pregnancy has not been established. In fact, its use is contraindicated, meaning it should not be used during pregnancy due to potential risks to the developing fetus.

Before considering this product, you should consult your healthcare provider to discuss any concerns and explore safer alternatives. Your health and the health of your baby are the top priority, so always seek professional advice when it comes to medication during pregnancy.

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 is no information available about whether this product is excreted in breast milk or any potential risks it may pose to your infant.

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

Pediatric Use

If your child is under 2 years old, it's important not to use this product without first consulting a doctor. For children aged 2 years and older, you can apply a small amount to the affected area, but make sure to clean the area first. You should limit the application to no more than 3 to 4 times a day. Always follow these guidelines to ensure your child's safety and well-being.

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, it’s important to consult with a healthcare provider for personalized advice. 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

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 plan is safe and effective for your specific situation. They can help monitor your kidney health and make any necessary adjustments to your medications.

Hepatic Impairment

If you have liver problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or precautions related to your condition. This means that there are no tailored recommendations for how the medication may affect you differently due to your liver health.

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your specific situation. They can help determine the best approach based on your liver function and overall health.

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 any tests you might be undergoing. This way, you can avoid any potential issues and ensure the best possible care.

Storage and Handling

To ensure the best quality and safety of your product, store it at room temperature and avoid freezing. Each packet is sealed to show that it hasn't been tampered with, so it's important to only use packets that are intact. If you find any packets that are opened or torn, please do not use them, as this could compromise the product's safety and effectiveness.

By following these simple storage and handling guidelines, you can help maintain the integrity of the product and ensure its safe use.

Additional Information

No further information is available.

FAQ

What is the drug indicated for?

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

How does the drug help protect you?

The drug helps protect against harmful bacteria.

What should you do if you are under 2 years old?

If you are under 2 years old, do not use this drug and consult a doctor.

How should adults and children over 2 years use the drug?

Clean the affected area and apply a small amount not more than 3 to 4 times daily.

What are the warnings associated with this drug?

This drug is for external use only. Keep it out of reach of children.

What should you do if your condition worsens?

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

Is this drug safe to use during pregnancy?

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

What precautions should nursing mothers take?

There are no specific warnings or recommendations regarding the use of this product by nursing mothers.

How should the drug be stored?

Store at room temperature and do not freeze. Do not use any opened or torn packets.

Packaging Info

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

Packaging configurations for Medi-First.
Details

Drug Information (PDF)

This file contains official product information for Medi-First, 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 associated with minor burns. Additionally, it helps protect against harmful bacteria, contributing to the overall management of minor burn injuries.

There are no teratogenic or nonteratogenic effects mentioned in the available data.

Dosage and Administration

For adults and children aged 2 years and older, the affected area should be cleaned prior to application. A small amount of the medication should be applied, not exceeding 3 to 4 times daily.

In children under 2 years of age, the use of this medication is not recommended without prior consultation with a healthcare professional.

Contraindications

Use is contraindicated in the following situations:

  • Application in the eyes is prohibited due to potential harm.

  • The product should not be applied in large quantities, as this may lead to adverse effects.

  • Avoid use over raw or blistered areas, deep puncture wounds, animal bites, or serious burns to prevent complications.

  • Prolonged use beyond one week is contraindicated unless directed by a healthcare professional to mitigate risks associated with extended application.

Warnings and Precautions

For external use only. This product is not intended for internal use, and caution should be exercised to prevent accidental ingestion.

General precautions must be observed to ensure safety. It is imperative to keep this product out of reach of children. In the event of ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

Healthcare professionals should advise patients to discontinue use and consult a physician if the condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. Monitoring for these signs is essential to ensure appropriate management and intervention.

Side Effects

For external use only. Patients should discontinue use and consult a doctor if the condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then occur again within a few days.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

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

Packaging configurations for Medi-First.
Details

Pediatric Use

Pediatric patients under 2 years of age should not use this product without consulting a healthcare professional. For children aged 2 years and older, the affected area should be cleaned prior to application. A small amount of the product may be applied up to 3 to 4 times daily.

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. It is advisable to monitor these patients closely for any potential adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

The safety of this product during pregnancy has not been established. Use is contraindicated in pregnancy due to potential risks to the fetus. Pregnant patients or those planning to become pregnant should consult a healthcare provider before use to discuss potential risks and benefits.

Lactation

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

Renal Impairment

Patients with renal impairment may not have specific dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. Therefore, healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment and individualized patient assessment. Regular monitoring of renal function is advisable to ensure patient safety and therapeutic efficacy.

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 overdosage information, it is essential for healthcare professionals to remain vigilant and prepared for potential scenarios involving overdose.

Healthcare providers should be aware that the clinical presentation of an overdose may vary significantly depending on the substance involved and the individual patient’s characteristics. Symptoms of overdose can range from mild to severe and may include altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

In the event of suspected overdosage, immediate medical evaluation is recommended. Healthcare professionals should assess the patient's vital signs and conduct a thorough clinical examination. Supportive care should be initiated as necessary, which may include airway management, intravenous fluids, and monitoring of vital parameters.

If specific antidotes or treatments are available for the substance involved, they should be administered according to established protocols. Consultation with a poison control center or toxicology expert may also be beneficial in managing the case effectively.

It is crucial to document all findings and interventions thoroughly, as this information may be vital for ongoing patient management and for any necessary reporting to regulatory authorities.

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 provided in the insert.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. In the event that the medication is ingested, patients should be instructed to seek medical help immediately or contact a Poison Control Center for assistance. It is important for patients to understand the potential risks associated with improper use and to take necessary precautions to ensure safety.

Storage and Handling

The product is supplied in tamper-evident sealed packets to ensure integrity and safety. It is essential to store the packets at room temperature and to avoid freezing. Healthcare professionals should not use any packets that are opened or torn, as this may compromise the product's quality and efficacy.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Medi-First, 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, 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.