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Lidocaine hydrochloride/Benzalkonium chloride

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Active ingredients
  • Lidocaine Hydrochloride 50 mg/10000 mg
  • Benzalkonium Chloride 13 mg/10000 mg
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 2018
Label revision date
January 22, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Lidocaine Hydrochloride 50 mg/10000 mg
  • Benzalkonium Chloride 13 mg/10000 mg
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 2018
Label revision date
January 22, 2024
Manufacturer
Dynarex Corporation
Registration number
M017
NDC root
67777-007
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (3 NDCs)
Packaging & NDC Codes (3)

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

1165 First Aid Burn Cream is a topical medication designed to provide temporary relief from pain and itching caused by sunburn, minor burns, insect bites, and minor skin irritations, as well as cuts and scrapes. This cream can help soothe your skin and promote comfort during the healing process.

If you experience any of these skin issues, using this cream may assist in alleviating discomfort and supporting your skin's recovery. Always remember to follow any specific instructions provided for use.

Uses

You can use this medication for the temporary relief of pain and itching caused by various skin issues. This includes discomfort from sunburn, minor burns, insect bites, and minor skin irritations, as well as cuts and scrapes. It’s designed to help soothe these conditions and make you feel more comfortable.

Rest assured, there are no known teratogenic effects (which means it doesn’t cause birth defects) associated with this medication, making it a safer option for those concerned about such risks.

Dosage and Administration

To use this product effectively, start by cleaning the affected area thoroughly. Once it's clean, apply a small amount of the product directly to the area. You should do this 3 to 4 times each day for the best results. If you prefer, you can cover the area with a sterile bandage to help protect it.

If you are using this product for a child under 2 years old, it's important to consult a doctor before applying it. This ensures that you are taking the right steps for their safety and health.

What to Avoid

It's important to use this medication safely to avoid potential issues. You should never apply it to your eyes or use it over large areas of your body. Additionally, avoid using it on deep puncture wounds, animal bites, or serious burns. Be cautious not to use large quantities, especially on raw surfaces or blistered areas, as this can lead to complications.

By following these guidelines, you can help ensure that you use the medication effectively and safely. If you have any questions or concerns about its use, please consult your healthcare provider.

Side Effects

You should only use this product on the skin and avoid applying it near your eyes or on large areas of your body, deep wounds, animal bites, or serious burns. It's important not to use it in large amounts, especially on raw or blistered skin.

If your condition worsens, clears up and then comes back within a few days, or does not improve after 7 days, you should stop using the product and consult a doctor. Additionally, if you accidentally swallow it, seek medical help or contact a Poison Control Center immediately.

Warnings and Precautions

This product is for external use only, so please avoid applying it to your eyes or using it over large areas of your body. It should not be used on deep puncture wounds, animal bites, or serious burns, and you should refrain from using large amounts, especially on raw or blistered skin.

If your condition worsens, clears up and then comes back within a few days, or does not improve after 7 days, stop using the product and consult your doctor. In case of accidental swallowing, seek medical help or contact a Poison Control Center immediately.

Overdose

If you or someone else has swallowed too much of a medication, it’s important to seek medical help immediately. You can do this by contacting a Poison Control Center or going to the nearest emergency room. Acting quickly can make a significant difference in the outcome.

Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms, don’t hesitate to get help right away. Remember, it’s always better to be safe and seek assistance if you suspect an overdose.

Pregnancy Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using this medication. They can provide guidance on whether it’s safe for you and your baby. Always prioritize your health and the health of your child by seeking professional advice.

Lactation Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using any medication. This ensures that you understand any potential risks and can make informed decisions about your health and the health of your baby. Always prioritize open communication with your healthcare provider regarding your breastfeeding journey.

Pediatric Use

When using this product for children aged 2 years and older, you should first clean the affected area. Then, apply a small amount of the product to the area 3 to 4 times a day. If desired, you can cover it with a sterile bandage to protect the area.

For children under 2 years old, it’s important to consult a doctor before using this product. This ensures that you receive the best guidance for your child's specific needs.

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 before starting the medication. 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 drug insert does not provide specific information about dosage adjustments, special monitoring, or safety considerations for your condition. This means that there are no tailored guidelines for how this medication may affect you if you have renal impairment (kidney issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your health situation. They can help monitor your kidney function and make any necessary adjustments to 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 may affect you differently due to your liver health.

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver condition and the use of this medication. They can help ensure that you receive the safest and most effective treatment 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. In this case, there are no specific drug interactions or laboratory test interactions noted, which means that this medication is generally considered safe to use alongside other treatments and tests. However, every individual is different, and your healthcare provider can help ensure that your overall treatment plan is safe and effective for you. Always feel free to ask questions or express any concerns you may have regarding your medications or tests.

Storage and Handling

To ensure the safety and effectiveness of your product, store it in a cool, dry area with a temperature between 15°-25° C (59°-79° F). This helps maintain its quality. Always use the tamper-evident sealed packets provided, as these indicate that the product has not been compromised. If you find any packets that are opened or torn, do not use them, as they may not be safe.

By following these simple storage and handling guidelines, you can help ensure that the product remains safe and effective for your use.

Additional Information

You should apply a small amount of this product to the affected area on your skin 3 to 4 times daily. This topical application is suitable for both adults and children aged 2 years and older. If you have any questions about how to use this product, be sure to consult with a healthcare professional for guidance.

FAQ

What is 1165 First Aid Burn Cream used for?

It is used for the temporary relief of pain and itching associated with sunburn, minor burns, insect bites, minor skin irritation, cuts, and scrapes.

How should I use 1165 First Aid Burn Cream?

For adults and children 2 years and over, clean the affected area and apply a small amount of the cream 3 to 4 times daily. It may be covered with a sterile bandage.

What should I do if I have a child under 2 years?

Consult a doctor before using 1165 First Aid Burn Cream on children under 2 years.

Are there any contraindications for using this cream?

There are no specific contraindications listed for 1165 First Aid Burn Cream.

What precautions should I take when using this cream?

Do not use it in the eyes, over large areas of the body, on deep puncture wounds, animal bites, or serious burns. Avoid using large quantities, especially on raw surfaces or blistered areas.

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

Stop using the cream and ask a doctor if the condition gets worse, clears up and recurs within a few days, or persists for more than 7 days.

What should I do if I accidentally swallow the cream?

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

Is it safe to use 1165 First Aid Burn Cream during pregnancy or breastfeeding?

If you are pregnant or breastfeeding, consult a healthcare professional before using this cream.

How should I store 1165 First Aid Burn Cream?

Store it in a cool, dry area at temperatures between 15°-25° C (59°-79° F) and use tamper-evident sealed packets.

Packaging Info

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

Packaging configurations for Burn First Aid.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

1165 First Aid Burn Cream is a topical formulation designed for the management of minor burns. The product is identified by the SPL Code 34089-3. Specific details regarding its chemical composition, molecular weight, and inactive ingredients are not provided in the available data. The cream is intended for external use and is formulated to aid in the healing process of burn injuries.

Uses and Indications

This drug is indicated for the temporary relief of pain and itching associated with sunburn, minor burns, insect bites, minor skin irritation, cuts, and scrapes.

There are no teratogenic or nonteratogenic effects associated with this drug.

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 product should be applied to the area 3 to 4 times daily. If desired, the treated area may be covered with a sterile bandage to protect it.

For children under 2 years of age, it is recommended to consult a doctor before use.

Contraindications

Use of this product is contraindicated in the following situations:

The product should not be applied to the eyes. Additionally, it is contraindicated for use over large areas of the body, on deep puncture wounds, animal bites, or serious burns. Caution is advised against using large quantities, especially on raw surfaces or blistered areas, due to the potential for adverse effects.

Warnings and Precautions

For external use only. This product is contraindicated for application in the eyes and should not be used over large areas of the body, on deep puncture wounds, animal bites, or serious burns. Caution is advised against the use of large quantities, particularly on raw surfaces or blistered areas.

Healthcare professionals should instruct patients to discontinue use and seek medical advice if the condition worsens, if the condition resolves and then recurs within a few days, or if the condition persists for more than 7 days.

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

Side Effects

Patients should be aware that the product is intended for external use only. It is contraindicated for use in the eyes, over large areas of the body, on deep puncture wounds, animal bites, or serious burns. Additionally, the product should not be applied in large quantities, particularly over raw surfaces or blistered areas.

Participants are advised to discontinue use and consult a healthcare professional if the condition worsens, if the condition clears up and recurs within a few days, or if the condition persists for more than 7 days.

In the event of accidental ingestion, it is crucial to seek medical assistance or contact a Poison Control Center immediately.

Drug Interactions

No specific drug interactions have been identified for the product. Additionally, there are no reported interactions with laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

Packaging & NDC

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

Packaging configurations for Burn First Aid.
Details

Pediatric Use

Pediatric patients aged 2 years and older may use this product by cleaning the affected area and applying a small amount 3 to 4 times daily. The area may be covered with a sterile bandage if desired. For children under 2 years of age, it is advised to consult a doctor 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.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a healthcare professional prior to using this medication. There is currently no available data regarding the excretion of this medication in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to 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 prescribing information.

Overdosage

In the event of an overdosage, immediate medical assistance is crucial. If the substance 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. Symptoms may vary depending on the specific substance involved; therefore, a thorough assessment by a medical professional is recommended to determine the appropriate course of action and management strategies.

Healthcare providers should ensure that patients are monitored closely for any signs of toxicity and that supportive care is initiated as necessary.

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 that in the event of accidental ingestion, it is crucial to seek medical assistance immediately or contact a Poison Control Center. This prompt action is essential to ensure the safety and well-being of the patient.

Storage and Handling

The product is supplied in tamper-evident sealed packets to ensure integrity and safety. It is essential to store the packets in a cool, dry area, maintaining a temperature range of 15° to 25° C (59° to 79° F). Healthcare professionals are advised to avoid using any packets that are opened or torn, as this may compromise the product's quality and efficacy.

Additional Clinical Information

The product is administered topically, with a recommended application of a small amount to the affected area 3 to 4 times daily for adults and children aged 2 years and older. There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

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