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Panama Jack

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This product has been discontinued

Active ingredient
Lidocaine Hydrochloride 7.128 mg/1 mL
Other brand names
Dosage form
Gel
Route
Topical
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2018
Label revision date
January 17, 2020
Active ingredient
Lidocaine Hydrochloride 7.128 mg/1 mL
Other brand names
Dosage form
Gel
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2018
Label revision date
January 17, 2020
Manufacturer
Prime Enterprises Inc.
Registration number
part348
NDC root
58443-0261

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Drug Overview

Panama Jack Burn Relief Topical Analgesic Gel is designed to provide temporary relief from pain caused by sunburn, insect bites, and minor skin irritations. This gel can help soothe discomfort and promote a sense of relief when you experience these common skin issues.

While the specific mechanism of action isn't detailed, its formulation is intended to target the pain associated with these conditions, making it a helpful option for managing discomfort from everyday skin irritations.

Uses

You can use this medication for the temporary relief of pain caused by sunburn, insect bites, and minor skin irritations. It helps soothe discomfort and provides a sense of relief from these common skin issues.

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

If you are an adult or a child aged 2 years and older, you can apply the medication to the affected area up to 3 to 4 times a day. Make sure to follow this guideline to ensure the best results.

For children under 2 years of age, it’s important to consult a doctor before using this medication. They can provide the best advice tailored to your child's needs. Always remember to use the medication as directed for safety and effectiveness.

What to Avoid

It's important to be cautious when using this product. You should not apply it to damaged or broken skin, as this could lead to complications or hinder the healing process.

Currently, there are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with this product. Always follow the usage instructions carefully to ensure your safety and well-being.

Side Effects

This product is intended for external use only, so it's important to avoid applying it to damaged or broken skin. While using it, be careful to keep it away from your eyes; if it does get in your eyes, rinse them with water immediately.

You should stop using the product and consult a doctor if you develop a rash. Additionally, keep the product out of reach of children. If the product is swallowed, seek medical help or contact a Poison Control Center right away.

Warnings and Precautions

This product is intended for external use only, so please avoid applying it to damaged or broken skin. While using it, be careful to keep it away from your eyes; if it does get into your eyes, rinse them thoroughly with water.

If you notice a rash while using this product, stop using it immediately and consult your doctor. Additionally, keep this product out of reach of children. If a child accidentally swallows it, seek medical help or contact a Poison Control Center right away.

Overdose

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

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 planning to become pregnant, it's important to know that the safety of this product during pregnancy has not been established. It is not recommended for use in pregnant women due to a lack of safety data, and the potential risks to your fetus are unknown. Therefore, you should consult your healthcare provider before using this product.

Additionally, there are no specific dosage modifications for pregnant women, but it is crucial to seek medical advice to ensure the safety of both you and your baby. Always prioritize open communication with your healthcare provider regarding any medications or treatments during pregnancy.

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 is no information available about whether this product is excreted in breast milk or any potential risks it may pose to your infant. Always consult with your healthcare provider if you have any concerns or questions about medications while breastfeeding.

Pediatric Use

If your child is under 2 years old, it's important to consult a doctor before using this medication. For children aged 2 years and older, you can apply the medication to the affected area, but be sure not to exceed 3 to 4 applications per day. Always follow these guidelines to ensure your child's safety and well-being.

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. As you age, your body may process medications differently, and factors like kidney function (renal impairment) and changes in cognition can affect how well a drug works or how it may impact you.

If you are an older adult or a caregiver, it’s wise to discuss any concerns with your healthcare provider. They can help determine the best approach for your individual health needs and ensure that any medication is safe and effective for you. Always keep an open line of communication with your doctor about any changes you notice while taking a new medication.

Renal Impairment

If you have kidney problems, it's important to know that there are no specific guidelines, dosage adjustments, or monitoring requirements mentioned for your condition in the provided information. This means that the standard recommendations for medication use may apply to you without any special considerations. However, always consult your healthcare provider for personalized advice and to ensure your treatment is safe and effective based on your kidney health.

Hepatic Impairment

If you have liver 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 apply, and there are no special monitoring or precautions outlined for patients like you.

However, it's always a good idea to discuss your liver health with your healthcare provider before starting any new medication. They can provide personalized advice and ensure that your treatment is safe and effective for your specific situation.

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, it's important to store it properly. Keep it in a cool place, away from heat sources, and maintain a controlled room temperature. This helps preserve its quality and functionality.

When handling the product, always do so with care to avoid any damage. Following these simple storage and handling guidelines will help you use the product safely and effectively.

Additional Information

For adults and children aged 2 years and older, you should apply the medication to the affected area no more than 3 to 4 times a day. If the patient is under 2 years old, it's important to consult a doctor before use. There are no additional details available regarding laboratory tests, abuse potential, or patient counseling information.

FAQ

What is Panama Jack Burn Relief Topical Analgesic Gel used for?

It is used for the temporary relief of pain associated with sunburn, insect bites, and minor skin irritations.

How should I apply this gel?

Adults and children 2 years of age and older should apply it to the affected area not more than 3 to 4 times daily. For children under 2 years of age, consult a doctor.

Are there any contraindications for using this gel?

Do not use it on damaged or broken skin. There are no other specific contraindications mentioned.

Is it safe to use during pregnancy?

Safety during pregnancy has not been established, and potential risks to the fetus are unknown. Consult a healthcare provider before use.

What should I do if I experience a rash after using this product?

Stop use and ask a doctor if a rash occurs.

What precautions should I take when using this gel?

Keep it out of your eyes and rinse with water if contact occurs. Also, keep it out of reach of children.

What should I do if the product is swallowed?

Get medical help or contact a Poison Control Center right away.

Are there any known drug interactions with this gel?

No specific drug interactions are mentioned.

How should I store this product?

Protect it from heat and store at controlled room temperature.

Packaging Info

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

Packaging configurations for Panama Jack.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Panama Jack Burn Relief Topical Analgesic Gel is formulated to provide relief from the discomfort associated with burns. The product is designed for topical application and is intended for use on affected skin areas. The effective date of this formulation is January 25, 2018.

Uses and Indications

This drug is indicated for the temporary relief of pain associated with sunburn, insect bites, 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 recommended application is to the affected area not more than 3 to 4 times daily. It is important to ensure that the application is limited to the specified frequency to avoid potential adverse effects.

For children under 2 years of age, it is advised to consult a physician prior to use. This precaution ensures that appropriate guidance is provided based on the individual needs of the child.

Contraindications

Use is contraindicated in patients with damaged or broken skin due to the potential for adverse effects and compromised healing. No other contraindications have been specified in the provided data.

Warnings and Precautions

This product is intended for external use only. It is imperative that it not be applied to damaged or broken skin, as this may lead to adverse effects. Care should be taken to avoid contact with the eyes; in the event of contact, the affected area should be rinsed thoroughly with water to remove the product.

Healthcare professionals should advise patients to discontinue use and seek medical attention if a rash develops during the application of this product. Additionally, it is crucial to keep this product out of the reach of children. In the case of accidental ingestion, immediate medical assistance should be sought, or the local Poison Control Center should be contacted without delay.

Side Effects

For external use only, this product should not be applied to damaged or broken skin. When using this product, it is important to keep it out of the eyes; in case of contact, rinse with water to remove.

Patients are advised to stop use and consult a doctor if a rash occurs. Additionally, this product should be kept out of reach of children. If the product is swallowed, medical help should be sought immediately, or contact a Poison Control Center right away.

Drug Interactions

There are no specific drug interactions identified for this medication. Additionally, no laboratory test interactions have been reported. 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 Panama Jack (lidocaine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Panama Jack.
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 recommended application is to 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, given the lack of targeted data for this population.

Pregnancy

Safety during pregnancy has not been established for this product. It is contraindicated for use in pregnant women due to the lack of safety data. The potential risks to the fetus are unknown; therefore, it is essential for pregnant patients to consult a healthcare provider before use. There are no specific dosage modifications provided for pregnant women. Special precautions should be taken, and pregnant women are advised to seek medical advice prior to using this product.

Lactation

There are no specific warnings or recommendations regarding the use of this product in lactating mothers. Additionally, there is no information available about the potential for excretion in breast milk or any associated risks to breastfed infants.

Renal Impairment

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

Hepatic Impairment

There is no information available regarding the use of this medication in patients with hepatic impairment. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions specified for individuals with compromised liver function. Healthcare professionals should exercise clinical judgment when considering the use of this medication in patients with liver problems, as the absence of data does not preclude the need for careful evaluation and monitoring based on individual patient circumstances.

Overdosage

In the event of an overdosage, it is imperative to keep the product out of reach of children to prevent accidental ingestion. Should the product be swallowed, immediate medical assistance is required. Healthcare professionals should advise caregivers to contact a Poison Control Center without delay for further guidance.

Prompt action is crucial in managing potential overdosage situations to ensure the safety and well-being of the patient.

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 text.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. In the event that the product is swallowed, patients should seek medical help or contact a Poison Control Center immediately.

Patients should be informed not to use the product on damaged or broken skin, as this may lead to adverse effects. Additionally, while using the product, it is important to avoid contact with the eyes. If the product does come into contact with the eyes, patients should rinse thoroughly with water to remove it.

Healthcare providers should also instruct patients to discontinue use and consult a doctor if a rash occurs, as this may indicate an allergic reaction or other sensitivity to the product.

Storage and Handling

The product is supplied in configurations that ensure optimal handling and storage. It must be protected from heat and stored at a controlled room temperature. Proper storage conditions are essential to maintain the integrity and efficacy of the product.

Additional Clinical Information

Patients aged 2 years and older are advised to apply the medication to the affected area no more than 3 to 4 times daily. For children under 2 years of age, it is recommended to consult a doctor before use. No further information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Panama Jack, 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 Panama Jack, 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.