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Bactine Max Lidocaine Roll-on 2.5oz

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Active ingredient
Lidocaine Hydrochloride 4 g/100 g
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 2024
Label revision date
April 25, 2023
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Lidocaine Hydrochloride 4 g/100 g
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 2024
Label revision date
April 25, 2023
Manufacturer
WellSpring Pharmaceutical Corporation
Registration number
M017
NDC root
65197-840
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

Bactine Max is a liquid bandage that contains lidocaine, a medication that numbs pain and itch. It is designed to provide fast-acting relief for minor pain associated with conditions like minor burns, bug bites, and sunburn. With its maximum strength formula, Bactine Max not only helps alleviate discomfort but also kills 99.9% of germs, promoting a cleaner healing environment.

This non-greasy, quick-drying bandage dries clear and is breathable, which helps maximize the healing process. Bactine Max is also eligible for Health Savings Accounts (HSA) and Flexible Spending Accounts (FSA), making it a convenient option for managing minor injuries.

Uses

You can use this medication to temporarily relieve minor pain. It is effective for various types of discomfort, including pain from minor burns, bug bites, and sunburn. This means that if you experience any of these issues, this product can help ease your discomfort.

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

Dosage and Administration

If you are an adult or a child aged 2 years and older, you should apply a thin layer of the medication to the affected area every 6 to 8 hours. However, make sure not to exceed three applications within a 24-hour period.

For children who are 12 years old or younger, it’s important to consult a doctor before use. Additionally, if your child is under 2 years of age, you should not use this medication at all. Always follow these guidelines to ensure safe and effective use.

What to Avoid

It's important to use this medication safely to avoid potential issues. You should not apply it to large areas of your body or on skin that is cut, irritated, or swollen. Additionally, avoid using it on puncture wounds. If you find that you need to use this medication for more than one week, please consult your doctor for guidance. Following these instructions will help ensure your safety and the effectiveness of the treatment.

Side Effects

When using this product, it's important to be aware of potential side effects and safety precautions. You should only apply it to the skin as directed and avoid using it on large areas, cut or irritated skin, or puncture wounds. If your condition worsens, symptoms last more than seven days, or if they improve and then return shortly after, stop using the product and consult a doctor.

Additionally, this product is flammable, so keep it away from fire or flames. If you are pregnant or breastfeeding, it's best to consult a healthcare professional before use. Always keep the product out of reach of children and pets, and seek immediate medical help if it is swallowed.

Warnings and Precautions

This product is for external use only, so please avoid applying it to large areas of your body or on any cut, irritated, or swollen skin. It should not be used on puncture wounds, and you should not use it for more than one week without consulting your doctor. Always follow the directions on the packaging carefully.

While using this product, be cautious to prevent contact with your eyes, and do not apply any bandages or use local heat, like heating pads, on the area where you applied it. If your condition worsens or if symptoms last longer than seven days, or if they improve and then return within a few days, stop using the product and contact your doctor. If you accidentally swallow it, seek medical help or call 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 get checked by a medical professional.

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 expert 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 doctor regarding your breastfeeding journey.

Pediatric Use

If you are considering using this medication for your child, it's important to know the guidelines for different age groups. For children 12 years old or younger, you should consult a doctor before using it. Specifically, for children under 2 years of age, this medication should not be used at all.

For children aged 2 years and older, you can apply a thin layer of the medication to the affected area every 6 to 8 hours, but be careful not to exceed three applications in a 24-hour period. Always follow these recommendations to ensure your child's safety and well-being.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about how it may affect you or if any dosage adjustments are necessary. This means that the usual guidelines for safety and precautions for elderly patients have not been established.

If you or a caregiver are considering this medication, it’s important to consult with a healthcare professional who can provide personalized advice based on your health needs and any other medications you may be taking. Always prioritize open communication with your doctor 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 your kidneys are not functioning properly.

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your kidney health. They can help monitor your condition 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 should be used if you have hepatic impairment (liver issues).

Before starting any new medication, including this one, you should discuss your liver health with your healthcare provider. They can help determine the best approach for your treatment and ensure your safety.

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 any concerns you may have regarding your medications or tests. Your healthcare provider is there to help you understand how to manage your health safely.

Storage and Handling

To ensure the best performance of your product, store it at room temperature. This helps maintain its effectiveness and safety. When handling the product, be sure to follow any specific instructions provided to avoid contamination or damage. Always keep the product in a clean environment to ensure it remains safe for use. If you have any questions about disposal or specific handling procedures, please refer to the guidelines provided with your product.

Additional Information

You should apply a thin layer of the medication to the affected area every 6 to 8 hours if you are an adult or a child aged 2 years and older. However, do not exceed three applications in a 24-hour period. If the patient is a child under 12 years old, consult a doctor before use. For children under 2 years of age, the medication should not be used.

FAQ

What is Bactine Max?

Bactine Max is a liquid bandage that contains lidocaine, which numbs away pain and itch. It is fast-acting, non-greasy, and has a quick-dry formula.

What are the uses of Bactine Max?

Bactine Max temporarily relieves minor pain associated with minor burns, bug bites, and sunburn.

How should I apply Bactine Max?

For adults and children 2 years and older, apply a thin layer to the affected area every 6 to 8 hours, not exceeding 3 applications in 24 hours.

Are there any age restrictions for using Bactine Max?

Do not use Bactine Max on children under 2 years of age. For children 12 years or younger, consult a doctor before use.

What precautions should I take when using Bactine Max?

Use only as directed, avoid contact with eyes, and do not bandage or apply heat to the area of use. Do not use on large areas of the body or on puncture wounds.

What should I do if my condition worsens while using Bactine Max?

Stop use and consult a doctor if your condition worsens or if symptoms persist for more than 7 days.

Is Bactine Max safe to use during pregnancy or breastfeeding?

If you are pregnant or breastfeeding, ask a health professional before using Bactine Max.

What should I do if I accidentally swallow Bactine Max?

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

Does Bactine Max have any side effects?

Bactine Max is for external use only, and you should stop use and consult a doctor if you experience any adverse effects.

Packaging Info

Below are the non-prescription pack sizes of Bactine Max Lidocaine Roll-on 2.5oz (lidocaine). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Bactine Max Lidocaine Roll-on 2.5oz.
Details

Drug Information (PDF)

This file contains official product information for Bactine Max Lidocaine Roll-on 2.5oz, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

NO MESS MAX PAIN RELIEF WITH LIDOCAINE is a topical analgesic formulation designed to provide effective relief from pain and itching associated with minor burns, bug bites, and sunburn. The product features a maximum strength concentration of lidocaine hydrochloride, adhering to the FDA External Analgesic OTC monograph guidelines.

This formulation is characterized by its fast-acting properties and includes aloe vera, contributing to its soothing effects. The non-greasy, quick-dry formula ensures ease of application without mess, facilitated by a specialized applicator. The product is eligible for Health Savings Account (HSA) and Flexible Spending Account (FSA) reimbursement.

The National Drug Code (NDC) for this product is 65197-840-25. A money-back guarantee is also offered.

Uses and Indications

This drug is indicated for the temporary relief of minor pain associated with conditions such as minor burns, bug bites, and sunburn.

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

Dosage and Administration

For adults and children aged 2 years and older, a thin layer of the medication should be applied to the affected area every 6 to 8 hours. The total number of applications must not exceed 3 times within a 24-hour period.

For children aged 12 years or younger, it is advised to consult a physician prior to use. The medication is contraindicated for use in children under 2 years of age.

Contraindications

Use is contraindicated on large areas of the body or on cut, irritated, or swollen skin due to the potential for adverse effects. Application on puncture wounds is also contraindicated to prevent complications. Prolonged use beyond one week without consulting a healthcare professional is not recommended, as it may lead to unforeseen risks.

Warnings and Precautions

For external use only, this product should not be applied to large areas of the body or on cut, irritated, or swollen skin. It is contraindicated for use on puncture wounds. Healthcare professionals are advised to instruct patients to use this product strictly as directed, ensuring that all directions and warnings on the carton are read and followed.

Patients should be cautioned against allowing the product to come into contact with the eyes. Additionally, it is important to avoid bandaging or applying local heat, such as heating pads, to the area of application.

If the condition worsens or if symptoms persist for more than seven days, or if symptoms clear up and then recur within a few days, patients should discontinue use and consult a healthcare provider. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center should be made without delay.

Furthermore, it is recommended that patients do not use the product for more than one week without prior consultation with a healthcare professional.

Side Effects

Patients should be aware that this product is for external use only. It is contraindicated for application on large areas of the body, on cut, irritated, or swollen skin, and on puncture wounds. The product should not be used for more than one week without consulting a healthcare professional.

When using this product, it is essential to adhere strictly to the directions provided. Patients should avoid contact with the eyes and should not bandage or apply local heat, such as heating pads, to the area of use.

Patients are advised to discontinue use and consult a doctor if their condition worsens, if symptoms persist for more than seven days, or if symptoms clear up and then recur within a few days.

Additionally, the product is flammable; therefore, it should be kept away from fire or flame. Pregnant or breastfeeding individuals should seek advice from a healthcare professional before using this product.

It is crucial to keep this product out of reach of children and pets. In the event of ingestion, medical assistance should be sought immediately, or contact with a Poison Control Center should be made.

Drug Interactions

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

Packaging & NDC

Below are the non-prescription pack sizes of Bactine Max Lidocaine Roll-on 2.5oz (lidocaine). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Bactine Max Lidocaine Roll-on 2.5oz.
Details

Pediatric Use

Pediatric patients 12 years of age or younger should consult a healthcare professional before use. The product is contraindicated in children under 2 years of age. For patients aged 2 years and older, a thin layer should be applied to the affected area every 6 to 8 hours, with a maximum of 3 applications within a 24-hour period.

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 adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to evaluate the potential risks and benefits associated with the use of this drug during pregnancy and lactation. Healthcare providers should consider the available data and individual patient circumstances when advising on the use of this medication in these populations.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is no specific data available regarding the excretion of this medication in 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 not been specifically addressed in the drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of detailed guidance 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 intervention is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical assistance or contact a Poison Control Center without delay.

Prompt action 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 aware of the importance of timely reporting of any suspected overdosage to facilitate effective treatment and minimize risks.

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 understanding of potential risks associated with the compound in nonclinical settings.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of the product. Reports of allergic reactions have been documented, including manifestations such as rash, itching, and swelling. Additionally, other adverse reactions reported include dizziness, headache, and nausea.

Serious skin reactions have also been noted, with instances of blistering and peeling occurring in some cases. Furthermore, there have been reports of systemic toxicity, particularly in situations involving excessive use or application to broken skin.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center if the product is swallowed. It is essential for patients to use the product only as directed and to carefully read and follow all directions and warnings provided on the carton.

Patients should be informed to avoid any contact with the eyes, as this may lead to irritation or injury. Additionally, healthcare providers should counsel patients against bandaging or applying local heat, such as heating pads, to the area of use, as this may exacerbate any potential 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 room temperature to maintain its integrity and efficacy. No special handling requirements are necessary beyond standard storage practices.

Additional Clinical Information

The medication is administered topically. For adults and children aged 2 years and older, a thin layer should be applied to the affected area every 6 to 8 hours, with a maximum of 3 applications within a 24-hour period. For children aged 12 years or younger, it is advised to consult a doctor before use, and the product should not be used in children under 2 years of age.

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 Bactine Max Lidocaine Roll-on 2.5oz, 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 Bactine Max Lidocaine Roll-on 2.5oz, 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.

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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.