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Hurricaine One

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Active ingredients
  • Lidocaine Hydrochloride 40 mg/1 g
  • Benzalkonium Chloride 1.3 mg/1 g
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 2025
Label revision date
December 10, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Lidocaine Hydrochloride 40 mg/1 g
  • Benzalkonium Chloride 1.3 mg/1 g
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 2025
Label revision date
December 10, 2025
Manufacturer
Beutlich Pharmaceuticals LLC
Registration number
M017
NDC root
0283-1024
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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

Lidocaine is a medication commonly used for the temporary relief of pain. It works by numbing the area where it is applied, making it effective for minor cuts, scrapes, and burns. Additionally, Lidocaine provides first aid by helping to protect against infection in these minor injuries.

If you are dealing with small wounds or discomfort, Lidocaine can be a helpful option to alleviate pain and support healing.

Uses

You can use this medication for the temporary relief of pain, making it a helpful option when you're experiencing discomfort. Additionally, it serves as first aid to protect against infection in minor cuts, scrapes, and burns, ensuring that your skin stays safe while it heals.

Rest assured, there are no concerns regarding teratogenic effects (which are harmful effects on a developing fetus) or nonteratogenic effects associated with this medication. This means it is considered safe in these aspects.

Dosage and Administration

To use this product effectively, start by cleaning the affected area thoroughly. Once it's clean, spray a small amount of the product directly onto the area. You can do this 1 to 3 times each day, depending on your needs. If you choose to cover the area with a sterile bandage, make sure to let the spray dry completely before applying the bandage.

If you are considering using this product for a child under 2 years old, it's important to consult a physician (doctor) first, as it is not recommended for that age group. Always follow these guidelines to ensure safe and effective use.

What to Avoid

It's important to be cautious when using this product. You should not use it if the foil pouch has been previously opened, as this could compromise the product's safety and effectiveness. Additionally, this product is not suitable for children under 2 years of age, so please ensure it is kept out of their reach.

While there are no specific contraindications or concerns regarding abuse, misuse, or dependence associated with this product, always follow the usage instructions carefully to ensure your safety and well-being. If you have any questions or concerns, consult with a healthcare professional.

Side Effects

You should be aware that this product is for external use only and should not be applied to your eyes or large areas of your body, especially on raw or blistered skin. If you have deep or puncture wounds, animal bites, or serious burns, it's important to consult a doctor. If your condition worsens, or if symptoms last more than 7 days or return shortly after improvement, stop using the product and seek medical advice. Additionally, do not use it for more than one week unless directed by a healthcare professional. Please remember that this product is flammable, so keep it away from fire or flames.

You should also avoid using this product if the foil pouch has been opened previously or if you are treating a child under 2 years of age.

Warnings and Precautions

This product is for external use only, so avoid applying it to your eyes or large areas of your body, especially on raw or blistered skin. If you have deep or puncture wounds, animal bites, or serious burns, please consult a doctor. It's important to stop using the product and call your doctor if your condition worsens, if symptoms last more than 7 days, or if they improve and then return within a few days. Do not use it for longer than one week unless your doctor advises otherwise.

Keep in mind that this product is flammable, so stay away from fire or flames. Additionally, do not use it if the foil pouch has been opened previously, and avoid using it on children under 2 years old. If you accidentally swallow more than the recommended amount, seek emergency medical help or contact a Poison Control Center right away.

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’s crucial to seek immediate medical help.

In case of an emergency, 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

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. You should avoid using it without first consulting your physician. There may be potential risks to your fetus that are not well understood, so caution is advised.

If you do need to use this product while pregnant, make sure to discuss any necessary dosage modifications with your doctor. It should only be used during pregnancy if it is clearly needed and if the potential benefits outweigh any risks to your fetus. Always prioritize open communication with your healthcare provider regarding your health and any medications you may consider.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to consult your physician before using this product. There is a possibility that it may be excreted in breast milk, which means it could potentially affect your nursing infant. Additionally, the safety of this product during lactation has not been established, so discussing your options with a healthcare professional is crucial to ensure the well-being of both you and your baby.

Pediatric Use

It’s important to be cautious when using this product for children. You should not use it on children under 2 years of age. For children aged 2 years and older, start by cleaning the affected area. You can then spray a small amount of the product on the area 1 to 3 times a day. If you choose to cover the area with a sterile bandage, make sure to let it dry first.

If your child is under 2 years old, please consult a physician (a medical doctor) before using this product. Always prioritize your child's safety and follow these guidelines closely.

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 there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations for the medication do not include special monitoring or safety considerations tailored for patients with 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 provide guidance based on your individual needs and kidney function.

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 share your complete list of medications and any recent lab tests to avoid any potential issues. Your health and safety should always come first.

Storage and Handling

To ensure the best performance of your product, store it at a temperature between 15-30 °C (59-86 °F). This temperature range helps maintain the product's effectiveness and safety.

When handling the product, make sure to do so in a clean environment to avoid contamination. Always follow any specific instructions provided for use and disposal to ensure safety and compliance.

Additional Information

You should apply this product topically by spraying a small amount on the affected area 1 to 3 times daily if you are an adult or a child aged 2 years and older. It's important to keep this product out of reach of children. If someone accidentally swallows more than the recommended amount for pain relief, seek medical help or contact a Poison Control Center right away.

FAQ

What is Lidocaine used for?

Lidocaine is used for the temporary relief of pain and as first aid to help protect against infection in minor cuts, scrapes, and burns.

How should I use Lidocaine?

For adults and children 2 years of age and older, clean the affected area and spray a small amount on it 1 to 3 times daily. It may be covered with a sterile bandage after drying.

Can I use Lidocaine on children under 2 years of age?

No, do not use Lidocaine in children under 2 years of age without consulting a physician.

What should I do if I accidentally swallow Lidocaine?

If more than the recommended amount is swallowed, get medical help or contact a Poison Control Center immediately.

Are there any warnings associated with Lidocaine?

Yes, Lidocaine is for external use only. Do not use it in the eyes or on large areas of the body, especially over raw surfaces or blistered areas. Consult a doctor for deep wounds or serious burns.

Is it safe to use Lidocaine during pregnancy?

The safety of Lidocaine during pregnancy has not been established. Consult a physician before use if you are pregnant or planning to become pregnant.

Can nursing mothers use Lidocaine?

Nursing mothers should consult a physician before using Lidocaine, as there is a potential for excretion in breast milk.

What should I do if my condition worsens while using Lidocaine?

If your condition worsens or symptoms persist for more than 7 days, discontinue use and consult a doctor.

How should I store Lidocaine?

Store Lidocaine at 15-30 °C (59-86 °F).

Packaging Info

Below are the non-prescription pack sizes of Hurricaine One (topical anesthetic and antiseptic). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Hurricaine One.
Details

Drug Information (PDF)

This file contains official product information for Hurricaine One, 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. It is also indicated as first aid to help protect against infection in minor cuts, scrapes, and burns.

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 sprayed onto the area 1 to 3 times daily. If desired, the area may be covered with a sterile bandage; however, it is important to allow the product to dry completely before applying the bandage.

The product is not recommended for use in children under 2 years of age. In such cases, consultation with a physician is advised.

Contraindications

Use is contraindicated in patients with a previously opened foil pouch, as this may compromise the integrity of the product. Additionally, the product should not be used in children under 2 years of age due to safety concerns associated with this age group.

Warnings and Precautions

For external use only, this product should not be applied to the eyes or over extensive areas of the body, particularly on raw surfaces or blistered areas. In cases of deep or puncture wounds, animal bites, or serious burns, it is imperative to consult a healthcare professional.

If the condition worsens, or if symptoms persist beyond 7 days or resolve only to recur within a few days, the use of this product should be discontinued, and a doctor should be consulted. Prolonged use beyond one week is not recommended unless directed by a healthcare provider.

This product is flammable; therefore, it must be kept away from fire or flame.

General precautions include not using the product if the foil pouch has been previously opened. Additionally, it is contraindicated for use in children under 2 years of age.

In the event of accidental ingestion of more than the recommended dosage for pain, immediate medical assistance should be sought, or contact with a Poison Control Center is advised.

Should the condition worsen or symptoms persist beyond 7 days, or if there is a recurrence of symptoms after a temporary resolution, the product should be discontinued, and a healthcare professional should be consulted.

Side Effects

Patients should be aware of the following warnings and precautions associated with the use of this product. It is intended for external use only and should not be applied in or around the eyes, nor should it be used over large areas of the body, particularly on raw surfaces or blistered areas. In cases of deep or puncture wounds, animal bites, or serious burns, it is advised to consult a doctor prior to use.

If a patient's condition worsens, or if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days, the use of this product should be discontinued, and a doctor should be consulted. The product should not be used for longer than 1 week unless directed by a healthcare professional. Additionally, the product is flammable and should be kept away from fire or flame.

Patients should not use this product if the foil pouch has been previously opened or if they are under 2 years of age.

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 Hurricaine One (topical anesthetic and antiseptic). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Hurricaine One.
Details

Pediatric Use

Pediatric patients under 2 years of age should not use this product. For children aged 2 years and older, the affected area should be cleaned prior to application. A small amount of the product may be sprayed on the area 1 to 3 times daily. If the area is covered with a sterile bandage, it should be allowed to dry first before bandaging. For any concerns regarding use in children under 2 years, consultation with a physician is advised.

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. Pregnant patients or those planning to become pregnant should not use this product without consulting a physician. Potential risks to the fetus are not well characterized; therefore, caution is advised. It is recommended that healthcare professionals consult with a physician regarding dosage modifications if the patient is pregnant. Use during pregnancy should only occur if clearly needed, and the potential benefits must justify the potential risks to the fetus.

Lactation

Lactating mothers should consult a physician before using this product. There is a potential for excretion in breast milk, and the safety of this product during lactation has not been established. Therefore, healthcare professionals should exercise caution when recommending this product to nursing mothers.

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 absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant regarding the potential for overdose with this medication. In cases where an overdose is suspected, immediate medical attention should be sought.

Healthcare providers are advised to monitor patients closely for any signs or symptoms that may indicate an overdose. These may include, but are not limited to, increased severity of known side effects, unusual behavioral changes, or any other atypical clinical manifestations.

Management of an overdose should be guided by the clinical presentation of the patient. Supportive care is paramount, and symptomatic treatment should be initiated as necessary. It is recommended that healthcare professionals consult local poison control centers or relevant toxicology resources for specific guidance on the management of overdose cases.

In summary, while specific overdosage information is not available, healthcare professionals should exercise caution, remain observant for potential overdose symptoms, and implement appropriate management strategies as needed.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available in the insert.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center if more than the recommended dosage for pain is accidentally ingested.

Patients should be informed that the product should not be used if the foil pouch has been previously opened, as this may compromise the safety and efficacy of the medication.

It is essential to communicate that this product is not suitable for children under 2 years of age, and caregivers should be made aware of this restriction to prevent accidental use.

Additionally, healthcare providers should instruct patients to avoid contact with the eyes while using this product, as this could lead to irritation or other adverse effects.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a temperature range of 15-30 °C (59-86 °F) to ensure its stability and efficacy. Proper storage conditions must be maintained, and the product should be kept in its original container to protect it from environmental factors. Special handling requirements should be observed to prevent any compromise to the product's integrity.

Additional Clinical Information

The product is administered topically, with a recommended application of a small amount to the affected area 1 to 3 times daily for adults and children aged 2 years and older. Clinicians should advise patients to keep the product out of reach of children. In the event of accidental ingestion beyond the recommended dosage for pain relief, patients should seek medical assistance or contact a Poison Control Center immediately.

Drug Information (PDF)

This file contains official product information for Hurricaine One, 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 Hurricaine One, 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

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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.