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First Aid Burn

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This product has been discontinued

Active ingredient
Lidocaine Hydrochloride 20 g/1000 mL
Other brand names
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 2019
Label revision date
October 7, 2019
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Lidocaine Hydrochloride 20 g/1000 mL
Other brand names
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 2019
Label revision date
October 7, 2019
Manufacturer
Unishield
Registration number
part348
NDC root
49314-5100
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

UniShield is a first aid burn spray designed to provide temporary pain relief for minor burns. This product can help soothe discomfort and support your healing process after experiencing a burn. With its easy-to-use spray format, UniShield is a convenient option for managing minor burn injuries at home or on the go.

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, this medication does not have any known teratogenic effects, meaning it does not cause birth defects. Additionally, there are no reported nonteratogenic effects, so you can feel confident in its safety for use as directed.

Dosage and Administration

When using burn spray for treating burns, you should first clean the affected area thoroughly. For adults and children aged 2 years and older, spray an even layer of the burn spray over the area that has been burned. You can do this up to 3 to 4 times a day, ensuring that you apply it evenly each time.

If you have a child under 2 years of age, it’s important to consult a physician (doctor) before using the spray. They can provide guidance on the best treatment options for younger children. Always follow these instructions carefully to help promote healing and comfort.

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. Avoid using it in large amounts, especially on raw or blistered skin, and keep it away from your eyes. If the product accidentally gets into your eyes, rinse them thoroughly with water.

You should stop using the product and consult a doctor if your condition worsens, persists for more than 7 days, or if it clears up and then returns. Additionally, keep this product out of reach of children. If swallowed, seek medical help or contact the Poison Control Center immediately.

Warnings and Precautions

This product is intended for external use only, so please avoid applying it to large areas of your skin, especially if you have any raw or blistered spots. Be careful not to get it near your eyes; if it does come into contact with them, rinse thoroughly with water.

If your condition worsens, does not improve after 7 days, or clears up and then returns, stop using the product and consult your doctor. Always keep this product out of reach of children. If it is swallowed, seek medical help or contact the Poison Control Center immediately.

Overdose

If you or someone else has swallowed too much of this medication, it’s important to seek medical help immediately. You can do this by contacting your local Poison Control Center or going to the nearest emergency room.

Signs of an overdose can vary, but they may include unusual symptoms that you should not ignore. Always err on the side of caution and get help right away if you suspect an overdose has occurred. Your health and safety are the top priority.

Pregnancy Use

There is currently no specific information available about the use of lidocaine hydrochloride spray during pregnancy. The drug insert does not indicate whether this product is safe or unsafe for pregnant individuals, nor does it mention any potential risks to the developing fetus. Additionally, there are no recommendations for dosage adjustments or special precautions for pregnant users.

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 spray, to ensure it is appropriate for your situation.

Lactation Use

There is no specific information available about the use of FIRST AID BURN - lidocaine hydrochloride spray for nursing mothers or during lactation (the period when a mother breastfeeds her baby). This means that it’s unclear how this medication may affect you or your breast milk.

If you are breastfeeding and considering using this spray, it’s a good idea to consult with your healthcare provider to discuss any potential risks or concerns. They can help you make an informed decision that prioritizes both your health and your baby's well-being.

Pediatric Use

When using burn spray for children aged 2 years and older, you can apply an even layer over the cleaned affected area up to 3-4 times a day. However, if your child is under 2 years old, it's important to consult a physician (doctor) before using the spray to ensure it's safe for them. Always prioritize your child's safety and follow these guidelines for 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

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 condition. They can help you understand any necessary precautions or adjustments based on your kidney health.

Hepatic Impairment

If you have liver 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 standard recommendations apply, but you should always consult your healthcare provider for personalized advice. They can help determine the best approach for your treatment and monitor your liver function as needed.

Make sure to keep your doctor informed about your liver health, as they may want to conduct regular tests to ensure your safety while using any medication. Your well-being is a priority, and your healthcare team is there to support you.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking. In this case, there are no specific drug interactions or laboratory test interactions noted, which means that the medication may not have known conflicts with other drugs or tests. However, every individual is different, and your healthcare provider can help ensure that your treatment plan is safe and effective for you.

Always discuss any new medications or tests with your healthcare provider to avoid potential issues and to get the best care tailored to your needs.

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. Always keep the container upright to maintain its integrity and safety. Following these simple 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 affected area of clean skin. For adults and children aged 2 years and older, use it no more than 3 to 4 times a day. If the patient is under 2 years old, it's important to consult a physician before use.

FAQ

What is UniShield?

UniShield is a first aid burn spray designed for temporary pain relief for minor burns.

How should I use UniShield?

For adults and children 2 years and older, spray an even layer over the cleaned affected area up to 3-4 times daily. For children under 2, consult a physician.

Are there any contraindications for using UniShield?

No contraindications are listed for UniShield.

What should I do if I accidentally get UniShield in my eyes?

If UniShield gets in your eyes, rinse thoroughly with water.

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

Stop use and ask a doctor if your condition worsens or persists for more than 7 days.

Is UniShield safe to use during pregnancy?

There are no specific statements regarding the use of UniShield during pregnancy, and no teratogenic effects are mentioned.

How should I store UniShield?

Store UniShield at room temperature, protect it from light, do not freeze, and keep the container upright.

What should I do if UniShield is swallowed?

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

Is UniShield a controlled substance?

No, UniShield is not classified as a controlled substance.

Can I use UniShield on raw or blistered areas?

Do not use UniShield in large quantities, particularly over raw or blistered areas.

Packaging Info

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

Packaging configurations for First Aid Burn.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

UniShield is a first aid burn spray formulated for the temporary relief of pain associated with minor burns. The product is packaged in a net volume of 2 fluid ounces (59.1 mL). It is distributed by UniShield, located in San Fernando, California, and is manufactured in the United States.

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, an even layer of burn spray should be applied to the cleaned affected area. This application may be performed up to 3 to 4 times daily, ensuring that the area is adequately covered without excessive application.

In the case of children under 2 years of age, it is imperative to consult a physician prior to use to determine the appropriate course of action.

Contraindications

The product should not be applied in large quantities, especially over raw or blistered areas, 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 the product is not applied in large quantities, especially on raw or blistered areas, to prevent potential adverse effects. Care should be taken to avoid contact with the eyes; in the event of accidental exposure, the affected area should be rinsed thoroughly with water.

Healthcare professionals should advise patients to discontinue use and seek medical advice if the condition worsens or persists beyond 7 days, or if the symptoms resolve and then return.

Additionally, it is crucial to keep this product out of reach of children. In the case of ingestion, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

Side Effects

For external use only. Patients are advised not to use this product in large quantities, particularly over raw or blistered areas, and to avoid contact with the eyes. In the event of accidental contact with the eyes, it is recommended to rinse thoroughly with water.

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.

This product should be kept out of reach of children. In case of ingestion, immediate medical assistance should be sought, or the Poison Control Center should be contacted right away.

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions between the drug and laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the current information.

Packaging & NDC

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

Packaging configurations for First Aid Burn.
Details

Pediatric Use

Pediatric patients aged 2 years and older may use the burn spray by applying an even layer over the cleaned affected area up to 3-4 times daily. For children under 2 years of age, it is recommended to consult a physician prior to use.

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 regarding the use of lidocaine hydrochloride spray in pregnant patients. The prescribing information does not indicate whether the product is contraindicated during pregnancy or outline any associated risks to the fetus. Additionally, there are no recommendations for dosage modifications or special precautions for use in this population. Healthcare professionals should consider the lack of data when prescribing this medication to women of childbearing potential and weigh the potential benefits against any unknown risks.

Lactation

There is no specific information available regarding the use of FIRST AID BURN - lidocaine hydrochloride spray in lactating mothers or its effects on breastfed infants. Healthcare professionals should consider the lack of data when advising lactating mothers on the use of this product.

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 intervention is crucial. If the substance is ingested, it is imperative to seek medical assistance or contact the Poison Control Center without delay.

Healthcare professionals should be aware that prompt action can significantly influence the outcome of an overdosage situation. Symptoms of overdosage may vary depending on the specific substance involved; therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures should include supportive care and symptomatic treatment as necessary. Continuous evaluation of the patient's condition is recommended to address any complications that may arise.

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 that the medication is swallowed, patients should be instructed to seek medical help immediately or contact the Poison Control Center for assistance. It is essential for patients to understand the importance of these precautions to ensure their safety and the safety of others.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which are essential for identification and inventory management. It is crucial to store the product at room temperature to maintain its efficacy. Additionally, the product must be protected from light to prevent degradation. Freezing the product is strictly prohibited, as it may compromise its integrity. To ensure optimal conditions, the container should be kept upright at all times.

Additional Clinical Information

The product is administered topically, with a recommended application of an even layer of burn spray over the cleaned affected area for adults and children aged 2 years and older, not exceeding 3-4 times daily. For children under 2 years of age, it is advised to consult a physician prior to use. No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for 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 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.