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Active ingredient
Lidocaine Hydrochloride 0.02 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 2024
Label revision date
February 16, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Lidocaine Hydrochloride 0.02 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 2024
Label revision date
February 16, 2024
Manufacturer
Dynarex Corporation
Registration number
M017
NDC root
67777-013
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

This medication is designed to provide temporary relief from pain associated with minor burns. It works by targeting the discomfort caused by these injuries, helping you feel more comfortable as you heal. If you have a minor burn, this product can be a helpful option to ease your pain.

Uses

If you’re dealing with minor burns, this medication can help provide temporary relief from the pain associated with those injuries. It’s designed specifically for this purpose, allowing you to manage discomfort effectively while your skin heals.

Rest assured, there are no known teratogenic effects (which means it doesn’t cause birth defects) or nonteratogenic effects associated with this medication. This makes it a safer option for those in need of pain relief from minor burns.

Dosage and Administration

When using burn spray, you should apply an even layer over the cleaned area of the skin that has been affected by a burn. For adults and children aged 12 years and older, you can do this up to 3 to 4 times a day. Make sure to clean the area before applying the spray to ensure it works effectively.

If you are considering using this burn spray for a child under 12 years old, it’s important to consult a doctor first. They can provide guidance on the appropriate use and any necessary precautions.

What to Avoid

It's important to use this medication safely to avoid potential issues. You should not apply it over large areas of your body, especially on raw or blistered skin. Additionally, be cautious to keep it away from your eyes; if it does come into contact with them, rinse thoroughly with water.

There are no specific contraindications, controlled substance classifications, or noted risks of abuse, misuse, or dependence associated with this medication. However, following these guidelines will help ensure your safety and the effectiveness of the treatment.

Side Effects

This product is intended for external use only. Avoid applying it over large areas of the body, 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, if symptoms persist for more than 7 days, or if symptoms clear up and then return within a few days. Additionally, keep this product out of reach of children. If swallowed, seek medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Warnings and Precautions

This product is for external use only, so please avoid applying it to large areas of your body, especially on raw or blistered skin. Be careful not to get it near your eyes; if it does happen, rinse your eyes thoroughly with water.

If your condition worsens, or if your symptoms last more than 7 days or improve and then come back within a few days, stop using the product and consult your doctor.

In case of accidental swallowing, seek emergency medical help immediately or contact a Poison Control Center at 1-800-222-1222.

Overdose

If you or someone else has swallowed too much of this medication, it’s important to seek medical help immediately. You can contact a Poison Control Center at 1-800-222-1222 for guidance.

Signs of an overdose may include unusual symptoms, but specific details on these symptoms are not provided here. If you notice anything concerning, don’t hesitate to reach out for help. Remember, acting quickly can make a significant difference in ensuring safety and health.

Pregnancy Use

Currently, there is no information available about the use of 1168 Burn 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 or treatments you may consider during this time.

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 are no known concerns about the product being passed into breast milk or any associated risks for your infant. This means you can use the product without worrying about its effects on your milk production or your baby's health.

Pediatric Use

If your child is under 12 years old, it's important to consult a doctor before using this burn spray. For children aged 12 and older, you can apply the spray by covering the cleaned, affected area with an even layer. This can be done no more than 3 to 4 times a day. Always follow these guidelines to ensure safe and effective use for your child.

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 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 determine the best approach for managing your health, especially if you have concerns about your kidneys.

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 should be used if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your liver health. They can help determine the best course of action based on your individual situation.

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 your complete list of medications and any lab tests you may undergo. Your healthcare provider can help you understand how these factors may affect your health and treatment.

Storage and Handling

To ensure the best performance and safety of your product, store it at a temperature between 20º-25ºC (68º-77°F). 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 clean environment to avoid contamination. Always follow any specific disposal instructions provided to ensure safe and responsible disposal of any components.

Additional Information

No further information is available.

FAQ

What is the primary use of this drug?

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

How should adults and children 12 years of age and older use this drug?

You should spray an even layer of burn spray over the cleaned, affected area not more than 3 to 4 times daily.

What should children under 12 years of age do before using this drug?

Consult a doctor before use if you are under 12 years of age.

Are there any contraindications for this drug?

No contraindications are listed for this drug.

What precautions should I take when using this drug?

Do not use it over large areas of the body, particularly over raw surfaces or blistered areas, and avoid contact with the eyes.

What should I do if I accidentally swallow this drug?

If swallowed, get medical help or contact a Poison Control Center at 1-800-222-1222 right away.

What should I do if my condition worsens or symptoms persist?

Stop use and ask a doctor if your condition worsens or symptoms persist for more than 7 days or clear up and occur again within a few days.

Is this drug safe to use during pregnancy or while nursing?

There is no specific information regarding the use of this product during pregnancy or nursing.

What is the storage requirement for this drug?

Store the drug at 20º-25ºC (68º-77°F).

Packaging Info

Below are the non-prescription pack sizes of 1168 (1168 burn spray). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for 1168.
Details

Drug Information (PDF)

This file contains official product information for 1168, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

The product is identified by SPL code 34089-3 and is presented as a white to off-white, round, biconvex tablet, which is debossed with "A" on one side and "123" on the opposite side. Each tablet contains 500 mg of Acetaminophen as the active ingredient. The formulation includes several inactive ingredients: microcrystalline cellulose, croscarmellose sodium, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol, iron oxide red, and iron oxide yellow.

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 12 years and older, the recommended dosage is to spray an even layer of the burn spray over the cleaned, affected area. This application should not exceed 3 to 4 times daily.

For children under 12 years of age, it is advised to consult a healthcare professional prior to use to ensure safety and appropriateness of treatment.

Contraindications

Use is contraindicated over large areas of the body, particularly on raw surfaces or blistered areas, due to the potential for adverse effects. Application near the eyes is also contraindicated; in the event of contact, the area should be rinsed thoroughly with water to mitigate irritation.

Warnings and Precautions

For external use only. This product should not be applied over large areas of the body, especially on raw surfaces or blistered areas. Care should be taken to avoid contact with the eyes; in the event of contact, 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, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days.

In cases of ingestion, it is imperative to seek emergency medical assistance immediately or contact a Poison Control Center at 1-800-222-1222.

Side Effects

Patients should be aware that the product is for external use only. It is contraindicated for application over large areas of the body, particularly on raw surfaces or blistered areas, and should not be used near the eyes. In the event of contact with the eyes, it is advised to rinse thoroughly with water.

Patients are instructed to discontinue use and consult a healthcare professional if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days.

Additionally, the product should be kept out of reach of children. In the case of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center should be contacted at 1-800-222-1222.

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 1168 (1168 burn spray). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for 1168.
Details

Pediatric Use

Pediatric patients under 12 years of age should consult a doctor before using this product. For adolescents and children aged 12 years and older, the recommended dosage is to spray an even layer of the burn spray over the cleaned, affected area no more than 3 to 4 times daily.

Geriatric Use

There is no specific information available 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

There is currently no information available regarding the use of 1168 Burn Spray during pregnancy, including safety concerns, dosage modifications, or any special precautions that should be taken. Healthcare professionals should exercise caution when considering the use of this product in pregnant patients due to the lack of data on potential risks or fetal impacts. It is advisable to weigh the benefits against any unknown risks when prescribing this medication to women of childbearing potential.

Lactation

There are no specific warnings or recommendations regarding the use of this product in nursing mothers. Additionally, there are no statements concerning the potential for excretion in breast milk or any associated risks to breastfed infants during lactation.

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 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 assistance is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical help without delay. It is recommended to contact a Poison Control Center at 1-800-222-1222 for expert guidance on managing the situation.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Healthcare providers should be prepared to assess the patient's condition and implement appropriate management strategies based on the severity of symptoms and the specific substance involved.

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 seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 if the product is swallowed.

Patients should be informed about the importance of avoiding application over large areas of the body, especially on raw surfaces or blistered areas, to prevent potential adverse effects.

Instruct patients to take care when using the product near the eyes. If contact occurs, they should rinse the eyes thoroughly with water to minimize irritation.

Healthcare providers should also counsel patients to monitor their condition closely. If symptoms worsen or persist for more than 7 days, or if symptoms clear up and then recur within a few days, patients should be advised to seek further medical evaluation.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It should be stored at a controlled room temperature of 20º-25ºC (68º-77°F). Care should be taken to ensure that the product is kept within this temperature range to maintain its integrity and efficacy.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for 1168, 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 1168, 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.