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Unishield First Aid Burn

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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 2023
Label revision date
September 28, 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 2023
Label revision date
September 28, 2025
Manufacturer
Unishield
Registration number
M017
NDC root
49314-0002
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 looking for relief from minor burns, this medication can help provide temporary pain relief. It is specifically designed to ease the discomfort associated with these types of injuries, allowing you to feel more comfortable as you heal.

Uses

If you’re dealing with minor burns, this medication can provide temporary relief from the pain associated with those injuries. It’s designed to help ease your discomfort, allowing you to go about your day with less irritation.

Rest assured, there are no known teratogenic effects (which means it doesn’t cause birth defects) or other nonteratogenic effects associated with this medication. This makes it a safe option for managing pain from minor burns without additional concerns.

Dosage and Administration

To use the burn spray effectively, first clean the affected area thoroughly. After that, you can spray a light layer of the burn spray over the area. You should do this no more than 3 to 4 times a day to ensure proper healing without overuse.

It's important to note that this burn spray is not recommended for children under 12 years of age. Always follow these guidelines to help manage your burn safely and effectively.

What to Avoid

It's important to use this product safely to avoid any potential issues. You should not apply it in large amounts, especially on raw or blistered skin, as this could lead to irritation or other complications. Additionally, be careful not to use it near your eyes; if it accidentally comes into contact with your eyes, rinse them thoroughly with water to prevent discomfort.

While there are no specific contraindications or concerns about abuse, misuse, or dependence associated with this product, following these guidelines will help ensure your safety and well-being.

Side Effects

This product is intended for external use only. If your condition worsens or does not improve after 7 days, or if it seems to clear up and then return, you should stop using it and consult a doctor. It's important to pay attention to these signs to ensure your health and safety.

Warnings and Precautions

This product is for external use only, so please avoid swallowing it. Keep it out of reach of children, and if it is swallowed, seek medical help or contact a Poison Control Center immediately.

Be cautious when applying the product. Do not use it in large amounts, especially on raw or blistered skin, and avoid contact with your eyes. If the product accidentally gets into your eyes, rinse them thoroughly with water.

If your condition worsens, persists for more than 7 days, or clears up and then returns, stop using the product and consult your doctor for further advice.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, it's important to be aware of the general signs of an overdose, which can include symptoms like extreme drowsiness, confusion, or difficulty breathing. If you suspect an overdose, it is crucial to seek immediate medical help.

In case of an emergency, you should 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 potential risks. If you have any concerns or questions about your medication, don’t hesitate to reach out to your healthcare provider for guidance.

Pregnancy Use

When it comes to using Unishield First Aid Burn Spray (Lidocaine HCL 2.0%) during pregnancy, there is no specific information available regarding its safety, dosage adjustments, or any special precautions you should take. This means that the effects of this product on you and your developing baby are not well-studied or documented.

If you are pregnant or planning to become pregnant, it's important to consult with your healthcare provider before using this spray. They can help you weigh the potential risks and benefits based on your individual situation. Always prioritize open communication with your doctor about any medications or treatments you are considering during pregnancy.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or considerations mentioned regarding nursing mothers or lactation in the information provided. This means that, based on the available data, there are no known risks associated with breastfeeding while using this medication. Always consult with your healthcare provider if you have any concerns or questions about 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 younger children, make sure to keep the medication out of their reach to prevent accidental ingestion. In the event that a child swallows it, seek medical help immediately or contact a Poison Control Center for guidance. Your child's safety is a top priority, so always follow these precautions carefully.

Geriatric Use

It's important to note that this medication is not intended for children under 12 years of age. While there is no specific information available regarding its use in older adults, including any necessary dosage adjustments or safety concerns, you should always consult with a healthcare provider before starting any new medication. This is especially crucial for older adults, as they may have unique health considerations that need to be taken into account. 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 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 for patients with 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 to manage your treatment effectively.

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 you receive the safest and most effective care.

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 share your complete list of medications and any health conditions you have to receive the best care possible.

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 guidelines will help you use the product safely and effectively.

Additional Information

You should apply the burn spray topically, which means you will spray it directly onto the cleaned affected area. It is recommended to do this no more than 3 to 4 times a day for best results. 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 pain relief associated with minor burns.

How should I apply the burn spray?

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

Is this drug safe for children?

This drug 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.

Are there any warnings I should be aware of?

Yes, this product is for external use only and should not be used in large quantities, particularly over raw or blistered areas.

What should I do if I accidentally get the spray in my eyes?

If the spray gets in your eyes, rinse thoroughly with water.

How should I store this drug?

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

What should I do if I swallow this product?

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

Are there any specific precautions for pregnant or nursing mothers?

There are no specific warnings or considerations mentioned regarding use during pregnancy or lactation.

Packaging Info

Below are the non-prescription pack sizes of Unishield First Aid Burn (lidocaine hcl). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Unishield First Aid Burn.
Details

Drug Information (PDF)

This file contains official product information for Unishield First Aid Burn, 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 specified drug.

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

The affected area should be cleaned prior to application. An over layer of burn spray is to be applied to the cleaned area, not exceeding 3 to 4 times daily. This product is contraindicated for use in children under 12 years of age.

Contraindications

Use is contraindicated in the following situations:

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

Warnings and Precautions

For external use only. It is imperative that this product is kept out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

General precautions must be observed to ensure safe application. The product should not be used in large quantities, especially on raw or blistered areas, as this may exacerbate the condition. Care should also be taken to avoid contact with the eyes; should contact occur, the affected area must be rinsed thoroughly with water.

Healthcare professionals should advise patients to discontinue use and consult a doctor if the condition worsens, persists for more than 7 days, or if symptoms resolve and then return. Monitoring for these signs is essential to ensure appropriate medical intervention if necessary.

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 currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Unishield First Aid Burn (lidocaine hcl). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Unishield First Aid Burn.
Details

Pediatric Use

Pediatric patients under 12 years of age should not use this medication. It is essential to keep the product out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact a Poison Control Center without delay.

Geriatric Use

Elderly patients, defined as those aged 65 years and older, have not been specifically studied in relation to the use of this medication. Consequently, there is no available information regarding dosage adjustments, safety concerns, or special precautions for this population.

Healthcare providers should exercise caution when prescribing this medication to geriatric patients, given the lack of targeted clinical data. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, as individual responses may vary.

Additionally, this medication is contraindicated in children under 12 years of age, which underscores the importance of careful patient selection and consideration of age-related factors in treatment decisions.

Pregnancy

There is no specific information regarding the use of Unishield First Aid Burn Spray (Lidocaine HCL 2.0%) in pregnant patients. The prescribing information does not provide safety concerns, dosage modifications, or special precautions for use during pregnancy. Therefore, healthcare professionals should exercise caution when considering the use of this product in pregnant women, as the potential risks and effects on fetal outcomes are not established. It is advisable to weigh the benefits against any unknown risks when treating pregnant patients with this medication.

Lactation

There are no specific warnings or considerations regarding nursing mothers or lactation mentioned in the provided text. Therefore, healthcare professionals may consider the use of this medication in lactating mothers without specific concerns related to breastfeeding. However, as with any medication, it is advisable to monitor breastfed infants for any potential adverse effects.

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 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 regarding the potential risks associated with excessive administration of the medication.

Healthcare providers are advised to monitor patients closely for any signs of adverse effects that may arise from overdosage. Symptoms may vary depending on the medication's pharmacological profile and the individual patient's response.

In the event of suspected overdosage, immediate medical intervention is recommended. Healthcare professionals should initiate supportive care and consider symptomatic treatment as necessary. It is also advisable to consult local poison control centers or relevant toxicology resources for guidance on management protocols specific to the medication in question.

Documentation of the incident, including the amount ingested and the time of exposure, is crucial for effective management and follow-up care. Continuous assessment of the patient's clinical status is necessary to ensure appropriate interventions are implemented.

In summary, while specific overdosage information is not available, healthcare professionals should exercise caution, monitor for symptoms, and be prepared to provide supportive care in the event of an overdose.

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 to keep the medication out of reach of children to prevent accidental ingestion. In the event of swallowing the medication, patients should seek medical help or contact a Poison Control Center immediately.

Patients should be instructed not to use the medication in large quantities, especially on raw or blistered areas, to avoid potential adverse effects. Additionally, it is important to inform patients to avoid contact with the eyes. If the medication does come into contact with the eyes, they should rinse thoroughly with water.

Healthcare providers should also counsel 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 essential for ensuring patient safety and effective use of the medication.

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

The product is administered topically, with the recommended direction to spray an over layer of burn spray over the cleaned affected area no more than 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 Unishield First Aid Burn, 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 Unishield First Aid Burn, 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.