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Alocane Max

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Active ingredients
  • Lidocaine Hydrochloride 4 g/100 mL
  • Benzalkonium Chloride 0.13 g/100 mL
Other brand names
Drug classes
Amide Local Anesthetic, Antiarrhythmic
Dosage form
Liquid
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
November 5, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Lidocaine Hydrochloride 4 g/100 mL
  • Benzalkonium Chloride 0.13 g/100 mL
Other brand names
Drug classes
Amide Local Anesthetic, Antiarrhythmic
Dosage form
Liquid
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
November 5, 2024
Manufacturer
Quest Products LLC
Registration number
M017
NDC root
68229-407
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

This medication is designed for first aid use to help prevent bacterial contamination or skin infections. It also provides temporary relief from pain and itching associated with minor conditions. You can use it for various skin issues, including burns, cuts, sunburn, scrapes, and minor skin irritations.

Uses

You can use this product for first aid to help prevent bacterial contamination or skin infections. It provides temporary relief from pain and itching caused by minor burns, cuts, sunburn, scrapes, and other minor skin irritations. This makes it a handy option for treating everyday skin issues and keeping your skin protected.

Rest assured, there are no teratogenic effects (which means it doesn't cause birth defects) associated with this product, making it a safe choice for most users.

Dosage and Administration

To use the Burn Pad effectively, start by cleaning the affected area and allowing it to dry completely. Once dry, gently place the Burn Pad over the burn or wound. To keep it in place, cover the pad with adhesive tape or stretch gauze. You can apply this treatment to the affected area no more than 3 or 4 times a day.

If you are caring for a child under 2 years of age, it’s important to consult a doctor before using the Burn Pad. This ensures that you receive the appropriate guidance for their specific needs.

What to Avoid

You should avoid using this product in or near your eyes, as it can cause irritation or harm. Additionally, do not apply it in large quantities or over large areas of your body, and refrain from using it on raw surfaces or blistered areas to prevent adverse effects. Always follow these guidelines to ensure your safety and well-being.

Side Effects

You should be aware that this product is for external use only. Before using it, consult your doctor if you have deep or puncture wounds, animal bites, or serious burns. Avoid applying it in or near your eyes, using it in large amounts or over extensive areas of your body, and putting it on raw or blistered skin.

If your condition worsens, or if symptoms last more than 7 days or return after clearing up, stop using the product and consult your doctor. If you are pregnant or breastfeeding, it's important to speak with a healthcare professional before use. Keep this product out of reach of children, and if swallowed, 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, using it in large amounts, or putting it on raw or blistered skin. If you have deep or puncture wounds, animal bites, or serious burns, consult your doctor before using this product.

If your condition worsens, or if symptoms last more than 7 days or return shortly after improvement, stop using the product and contact your doctor. Additionally, keep this product out of reach of children. If it is swallowed, seek medical help or call a Poison Control Center immediately.

Overdose

It's important to keep this medication out of reach of children. If a child accidentally swallows it, you should seek medical help immediately or call a Poison Control Center.

In case of an overdose, you may notice symptoms such as unusual drowsiness, confusion, or difficulty breathing. If you or someone else experiences these signs, it's crucial to get medical assistance right away. Always prioritize safety and act quickly in these situations.

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

If your child is under 2 years old, it's important to consult a doctor before using this product. For children aged 2 and older, you should first clean the affected area and allow it to dry. Then, gently apply the Burn Pad over the burn or wound and secure it with adhesive tape or stretch gauze. You can use this treatment on the affected area no more than 3 to 4 times a day. Always follow these guidelines to ensure your child's safety and comfort.

Geriatric Use

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. Since older adults may have different health needs and may be taking multiple medications, it’s always a good idea to consult with a healthcare provider before starting any new medication. They can help ensure that the treatment is safe and appropriate for your individual health situation.

If you or a loved one is an older adult, be sure to discuss any concerns about potential side effects or interactions with other medications you may be taking. Your healthcare provider can provide guidance tailored to your specific needs.

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 should be used 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 determine the best course of action based on your kidney function and overall health.

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 you may have regarding your liver health and medication use. They can help ensure that you receive the safest and most effective treatment.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking, even if there are no specific drug interactions or laboratory test interactions noted for your treatment. This ensures that your healthcare team can monitor your health effectively and make informed decisions about your care.

Always feel free to ask questions and share any concerns you may have regarding your medications or tests. Your safety and well-being are the top priorities, and your healthcare provider is there to help you navigate your treatment plan.

Storage and Handling

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

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

You should apply the medication topically, meaning you will put it directly on the affected area of your skin. It is recommended to use it no more than 3 to 4 times a day for the best results. If you have any questions about how to use the medication or its effects, be sure to consult your healthcare provider for guidance.

FAQ

What is this drug used for?

This drug is used as first aid to help prevent bacterial contamination or skin infection and provides temporary relief of pain and itching associated with minor burns, cuts, sunburn, scrapes, and minor skin irritations.

How should I use this drug?

For adults and children 2 years and older, clean the affected area, let it dry, gently apply the Burn Pad, and cover it with adhesive tape or stretch gauze. Use it no more than 3 or 4 times daily.

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

If your child is under 2 years of age, you should ask a doctor before use.

Are there any warnings I should be aware of?

Yes, this drug is for external use only. Do not use it in or near the eyes, in large quantities, or on raw surfaces or blistered areas.

What should I do if my condition worsens?

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

Is it safe to use this drug if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, you should ask a healthcare professional before use.

What should I do if this drug is swallowed?

Keep this drug out of reach of children. If swallowed, get medical help or call a Poison Control Center right away.

Packaging Info

Below are the non-prescription pack sizes of Alocane Max (lidocaine hydrochloride and benzalkonium chloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Alocane Max.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The product is packaged in a 10 Pad Carton, containing a total of 10 pads. The effective date for the product is November 15, 2023. The principal display panel features a reference image labeled 10pcPDP, which is provided in JPEG format.

Uses and Indications

This drug is indicated for first aid to help prevent bacterial contamination or skin infection. It provides temporary relief of pain and itching associated with minor burns, cuts, sunburn, scrapes, and minor skin irritations.

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 and allowed to dry prior to application. The Burn Pad should be gently applied over the burn or wound. It is recommended to cover the Burn Pad with adhesive tape or stretch gauze to secure it in place. The application may be repeated on the affected area no more than 3 to 4 times daily.

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

Contraindications

The product is contraindicated for use in or near the eyes, as this may lead to irritation or injury. Additionally, it should not be applied in large quantities or over extensive areas of the body due to the potential for systemic absorption and adverse effects. Use is also contraindicated on raw surfaces or blistered areas, as this may exacerbate irritation or delay healing.

Warnings and Precautions

For external use only. Healthcare professionals should advise patients to consult a physician prior to use if they have deep or puncture wounds, animal bites, or serious burns, as these conditions may require specialized treatment.

The product should not be applied in or near the eyes, in large quantities, or over extensive areas of the body. Additionally, it is contraindicated for use on raw surfaces or blistered areas, as these applications may lead to adverse effects.

Patients are instructed to discontinue use and seek medical advice if their condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days.

It is imperative to keep this product out of reach of children. 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 for external use only. It is important to consult a healthcare professional before use if there are deep or puncture wounds, animal bites, or serious burns present. The product should not be applied in or near the eyes, in large quantities, or over extensive areas of the body. Additionally, it should not be used on raw surfaces or blistered areas.

Patients are advised to discontinue use and seek medical advice if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. Pregnant or breastfeeding individuals should consult a healthcare professional prior to use.

This product should be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or a Poison Control Center should be contacted.

Drug Interactions

There are no specific drug interactions or laboratory test interactions identified in the available data. Therefore, no dosage adjustments or monitoring recommendations are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Alocane Max (lidocaine hydrochloride and benzalkonium chloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Alocane Max.
Details

Pediatric Use

Pediatric patients under 2 years of age should consult a healthcare professional before use. For children aged 2 years and older, the affected area should be cleaned and allowed to dry before gently applying the Burn Pad over the burn or wound. The application should be secured with adhesive tape or stretch gauze. The Burn Pad may be used on the 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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

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 drug 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, it is imperative to keep the product out of reach of children. Should ingestion occur, immediate medical assistance is required. Healthcare professionals should advise caregivers to contact a Poison Control Center without delay for further guidance.

Prompt intervention is crucial in managing potential overdosage scenarios to mitigate risks and ensure patient safety.

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 question.

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. Instruct patients that if the medication is swallowed, they should seek medical help or contact a Poison Control Center immediately.

Patients should be informed not to use the medication in or near the eyes, in large quantities, or over large areas of the body. Additionally, it should not be applied to raw surfaces or blistered areas.

Healthcare providers should counsel patients to stop using the medication and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days.

It is also important for healthcare providers to encourage patients to ask a doctor before using the medication if they have deep or puncture wounds, animal bites, or serious burns.

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 room temperature, maintaining a range of 15° to 30°C (59° to 86°F). Proper storage conditions are crucial to ensure the integrity and efficacy of the product.

Additional Clinical Information

The medication is administered topically, with a recommended application frequency of no more than 3 to 4 times daily on the affected area. 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 Alocane Max, 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 Alocane Max, 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.