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Predator

Last content change checked dailysee data sync status

This product has been discontinued

Active ingredient
Lidocaine Hydrochloride 400 mg/1 mg
Other brand names
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2013
Label revision date
February 25, 2013
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Lidocaine Hydrochloride 400 mg/1 mg
Other brand names
Dosage form
Cream
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 2013
Label revision date
February 25, 2013
Manufacturer
Sambria Pharmaceuticals, LLC
Registration number
part348
NDC root
54723-150
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

It seems that the specific name and details about the drug are not provided in the information you shared. However, based on the instruction to rub 1ml in a circular motion for 60 seconds on the affected area, it appears that this drug is likely a topical treatment designed to be applied directly to a specific area of the skin.

Topical medications like this are often used to treat various skin conditions, providing localized relief or treatment. If you have any specific questions about its use or effects, please consult a healthcare professional for more detailed information.

Uses

You can use this product by rubbing 1ml onto the affected area in a circular motion for 60 seconds. This method is designed to help with your specific condition.

It's important to note that there are no teratogenic effects (which means it doesn't cause birth defects) or nonteratogenic effects associated with this product. This makes it a safe option for use without concerns about these specific risks.

Dosage and Administration

To use this medication effectively, you should apply 1 milliliter (ml) of the product to the area that is affected. Make sure to rub it in using a circular motion for a full 60 seconds. This helps ensure that the medication is absorbed properly into your skin for the best results.

What to Avoid

It's important to ensure that this product is kept out of the reach of children under twelve (12) years of age. This precaution helps prevent any potential misuse or accidental ingestion, which can be harmful.

Currently, there are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with this product. Always follow the recommended guidelines to ensure safe use.

Side Effects

Using this product incorrectly can lead to serious issues. It should never be taken by mouth or applied near the eyes. If you accidentally use it orally, it may numb your throat, making it harder to swallow and increasing the risk of aspiration (inhaling food or liquid into the lungs). To avoid this, ensure that any tools or your hands used to apply the product are thoroughly cleaned before touching your eyes, nose, or mouth.

Warnings and Precautions

It’s important to use this product correctly to ensure your safety. Do not take it by mouth or apply it to your eyes. If you accidentally use it orally, be aware that it can numb your throat, making it harder to swallow and increasing the risk of choking (aspiration). Always clean any device, including your hands, thoroughly before using it on your skin to avoid any accidental contact with your eyes or mouth.

If you experience any unusual symptoms or have concerns about how to use this product, stop using it and call your doctor for guidance. Your health and safety are the top priority, so please follow these instructions carefully.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While there is no specific information available about the signs of overdose for this medication, general symptoms can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these signs, or if you are unsure, seek medical help right away.

In case of an overdose, contact your local emergency services or go to the nearest hospital. It's always better to be safe and get checked by a healthcare professional if you have any concerns about your health. Remember, timely intervention can make a significant difference.

Pregnancy Use

It’s important to note that this product should not be taken by mouth or applied to the eyes. While the information provided does not include specific guidelines about using this product during pregnancy, it’s always best to consult with your healthcare provider if you are pregnant or planning to become pregnant. They can offer personalized advice and ensure your safety and that of your baby.

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 to your infant. Always consult with your healthcare provider if you have any concerns or questions about medications while breastfeeding.

Pediatric Use

It's important to keep this product out of the reach of children under twelve years old. This precaution helps ensure their safety, as the product may not be suitable for younger children. Always store medications and similar items in a secure place to prevent accidental access. If you have any concerns about its use in children, consult your healthcare provider for guidance.

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. If you or a loved one is an older adult, it’s wise to discuss any potential risks or benefits with a healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken.

Always keep in mind that older adults may have different responses to medications, so regular check-ins with your healthcare team are essential to ensure safety and effectiveness.

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 usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment plan.

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 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 provide the best care tailored to your needs.

Always feel free to ask questions and share all the medications and supplements you are using. This helps your provider monitor your health effectively and make informed decisions about your treatment.

Storage and Handling

It’s important to keep this product safely stored away from children under twelve years of age to prevent any accidental misuse. Make sure to place it in a secure location that is out of their reach. Proper handling is essential for safety, so always follow any specific instructions provided with the product to ensure it is used correctly. If you have any questions about storage or handling, don’t hesitate to reach out for more information.

Additional Information

You should apply this product topically by rubbing 1ml in a circular motion on the affected area for 60 seconds. It's important to remember that this product is not meant to be taken orally or applied near the eyes. If it is used incorrectly by mouth, it can cause numbness that may make swallowing difficult, increasing the risk of choking. Therefore, ensure that any tools or hands used for application are thoroughly cleaned before they come into contact with your eyes, nose, or mouth.

Additionally, keep this product out of reach of children under twelve years old to prevent accidental ingestion or misuse.

FAQ

How should I apply this product?

You should rub 1ml of the product in a circular motion on the affected area for 60 seconds.

Are there any contraindications for this product?

No specific contraindications are mentioned for this product.

Is this product safe for use during pregnancy?

There are no specific statements regarding the safety of this product during pregnancy.

Can this product be administered orally?

No, this product is not to be administered orally or in the ocular (eye) area.

What should I do if I accidentally ingest this product?

If used improperly by oral administration, be aware that it may impair swallowing and enhance the danger of aspiration.

Is this product safe for children?

This product should be kept out of the reach of children under twelve (12) years of age.

Are there any known drug interactions?

No specific drug interactions are mentioned for this product.

What precautions should I take when using this product?

Ensure that any device used to apply the product is cleaned well before possible contact with the eyes, mouth, or nasal area.

Is there any information regarding nursing mothers?

There are no specific warnings or recommendations regarding the use of this product in nursing mothers.

What if I have kidney or liver problems?

No specific information regarding dosage adjustments or safety considerations for patients with kidney or liver problems is provided.

Packaging Info

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

Packaging configurations for Predator.
Details

Drug Information (PDF)

This file contains official product information for Predator, 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 the SPL Code 34089-3 and is designated as a Predator Pouch. The effective date of the insert is February 11, 2013. An image of the product is available, referenced as Predator Pouch.jpg.

Uses and Indications

This drug is indicated for topical application to the affected area. The recommended administration involves rubbing 1 ml of the product in a circular motion for 60 seconds.

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

Dosage and Administration

Healthcare professionals are advised to administer 1 ml of the product by rubbing it in a circular motion on the affected area for a duration of 60 seconds. This technique ensures optimal absorption and effectiveness of the treatment.

Contraindications

This product should be kept out of the reach of children under twelve (12) years of age. Use in this population is contraindicated due to safety concerns. No other contraindications have been specified in the provided data.

Warnings and Precautions

The product is contraindicated for oral administration and should not be applied in the ocular area. Administration via the mouth may lead to the development of topical anesthesia, which can impair swallowing and increase the risk of aspiration.

To mitigate this risk, it is imperative that any device used for topical application, including hands and fingers, is thoroughly cleaned prior to any potential contact with the eyes, nasal passages, or oral cavity. Healthcare professionals should ensure that patients are adequately informed about these precautions to prevent adverse effects associated with improper use.

Side Effects

Patients should be informed that this product is contraindicated for oral administration and should not be applied in the ocular area. Improper use, particularly through oral administration, may lead to the production of topical anesthesia, which can impair swallowing and increase the risk of aspiration. Therefore, it is crucial that any device, including hands and fingers, used for the topical application of this product is thoroughly cleaned prior to any potential contact with the eyes, nasal passages, or mouth.

These warnings highlight the importance of adhering to the recommended administration routes to prevent serious adverse reactions associated with misuse.

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 Predator (lidocaine hcl). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Predator.
Details

Pediatric Use

This product should be kept out of the reach of children under twelve (12) years of age. There are no specific dosage recommendations or study outcomes provided for pediatric patients in this age group. Caution is advised when considering the use of this product in children, and healthcare professionals should ensure that it is stored safely to prevent accidental ingestion.

Geriatric Use

There is no specific information 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

The safety of this product during pregnancy has not been established, as there are no specific statements regarding its use, safety concerns, dosage modifications, or special precautions for pregnant patients. Given the lack of data, healthcare professionals should exercise caution when considering the administration of this product to women of childbearing potential. It is important to weigh the potential benefits against any unknown risks to fetal outcomes. Additionally, this product is contraindicated for oral or ocular administration, which should be taken into account when evaluating its use in pregnant patients.

Lactation

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

Renal Impairment

There is no specific information regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients 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 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 information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should initiate supportive care, which may include monitoring vital signs, providing symptomatic treatment, and ensuring the patient's safety.

If available, consultation with a poison control center or a medical toxicologist is recommended to guide further management and treatment options.

Documentation of the incident, including the substance involved, the amount taken, and the time of ingestion, is crucial for effective management and follow-up care.

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 keep this product out of the reach of children under twelve (12) years of age. It is important to emphasize the potential risks associated with accidental ingestion or misuse by young children. Providers should encourage patients to store the product in a secure location to prevent access by children.

Storage and Handling

This product is supplied in configurations that ensure safe handling and storage. It is essential to keep this product out of the reach of children under twelve (12) years of age to prevent accidental ingestion or misuse.

For optimal storage, the product should be maintained at a controlled room temperature, away from direct sunlight and moisture. Special handling precautions should be observed to ensure the integrity of the product is preserved throughout its shelf life.

Additional Clinical Information

The product is intended for topical administration only, with a recommended method of application involving the rubbing of 1 ml onto the affected area in a circular motion for 60 seconds. Clinicians should counsel patients that the product must not be administered orally or applied to the ocular area. Improper oral use may lead to the production of topical anesthesia, which can impair swallowing and increase the risk of aspiration. Therefore, any device used for application should be thoroughly cleaned before any potential contact with the eyes, nasal passages, or mouth. Additionally, it is crucial to keep this product out of the reach of children under twelve years of age.

Drug Information (PDF)

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