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Predator

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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
March 13, 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
March 13, 2013
Manufacturer
Sambria Pharmaceuticals, LLC
Registration number
part348
NDC root
54723-101
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

This medication is designed to provide temporary relief from pain and itching associated with minor skin irritations, such as those caused by minor cuts, scrapes, sunburn, and minor burns. It can also help alleviate itching related to rashes from insect bites, poison ivy, poison oak, poison sumac, as well as reactions to soaps, detergents, cosmetics, and jewelry.

By targeting the discomfort caused by these irritations, this medication aims to soothe your skin and improve your comfort during recovery.

Uses

You can use this medication for temporary relief from pain and itching caused by minor skin irritations. This includes discomfort from minor cuts, scrapes, sunburn, and minor burns. Additionally, it helps alleviate itching associated with rashes from insect bites, poison ivy, poison oak, and poison sumac, as well as reactions to soaps, detergents, cosmetics, and jewelry.

Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) or nonteratogenic effects associated with this medication.

Dosage and Administration

When using this medication, you should apply it directly to the affected area of your skin. This is suitable for both adults and children who are two years old or older. It's important to remember that you should not apply the medication more than three to four times a day to avoid any potential side effects.

Make sure to follow these guidelines closely to ensure the best results and keep your skin healthy. If you have any questions or concerns about how to use the medication, don’t hesitate to reach out to your healthcare provider for more information.

What to Avoid

It's important to keep this medication out of reach of children to ensure their safety. There are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with this medication. Always follow the guidance provided to use it safely and effectively.

Side Effects

It's important to be aware of some potential side effects when using this product. It is meant for external use only, so be sure to avoid contact with your eyes. If you notice any redness, irritation, swelling, or pain that worsens, stop using the product and consult your doctor. Additionally, if your symptoms last longer than seven days or improve and then return within a few days, you should also discontinue use and seek medical advice.

If the product is accidentally swallowed, please contact your physician immediately. Keeping these precautions in mind can help ensure your safety while using the product.

Warnings and Precautions

This product is intended for external use only, so please avoid getting it in your eyes. If you experience any redness, irritation, swelling, pain, or if your symptoms worsen, stop using the product and consult your doctor.

If your symptoms last longer than seven days or improve and then return within a few days, it's important to discontinue use and seek medical advice. Additionally, if the product is accidentally swallowed, please contact your physician immediately for guidance.

Overdose

If you or someone else has swallowed too much of this medication, it’s important to consult a physician right away. Signs of an overdose can vary, but they may include unusual symptoms that are not typical when taking the medication as prescribed.

In case of an overdose, do not wait for symptoms to appear; seek medical help immediately. Your health and safety are the top priority, so reaching out to a healthcare professional is crucial.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the safety of lidocaine hydrochloride cream during pregnancy has not been established. In fact, using this cream is generally not recommended due to potential risks to your developing baby. If you are considering using this product, please consult your healthcare provider for personalized advice and to discuss any possible risks.

Additionally, if your healthcare provider does recommend its use, be aware that dosage adjustments may be necessary. Always follow their guidance and avoid using lidocaine cream unless specifically directed by a medical professional. Your health and the health of your baby are the top priority, so open communication with your healthcare team is essential.

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 the ingredients may be passed into your breast milk, which could pose risks to your infant. Therefore, exercising caution is advised when considering this product while nursing. Always prioritize your health and your baby's safety by discussing any concerns with your healthcare provider.

Pediatric Use

When using this medication for children aged two years and older, you should apply it externally to the affected area. It's important not to exceed three to four applications per day. Always ensure that the medication is kept out of reach of children to prevent accidental ingestion or misuse.

If you have any concerns about its use or dosage, consult your healthcare provider for guidance tailored to your child's needs.

Geriatric Use

When it comes to using Predator (lidocaine hydrochloride cream) for older adults, there are no specific guidelines or dosage adjustments needed. This means that the same dosage can be used for elderly patients as for younger adults, and there are no unique safety concerns or precautions to be aware of.

As always, it's important to consult with a healthcare provider before starting any new medication, especially if you or your loved one has other health conditions or is taking multiple medications. This ensures that the treatment is safe and appropriate for individual needs.

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 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 regarding your liver health and how it may relate to your treatment. They can help ensure that you receive the safest and most effective care.

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 about how different medications might affect each other or any tests you may undergo. Your health and safety are the top priority, and discussing these details can help prevent any unforeseen issues.

Storage and Handling

To ensure the best quality and safety of your product, store it in a cool, dry place at a temperature between 20°C to 25°C (68°F to 77°F). It’s acceptable for the temperature to occasionally range from 15°C to 30°C (59°F to 86°F), but try to keep it within the recommended limits. Make sure to protect the product from light, as exposure can affect its effectiveness.

Always keep the product out of reach of children to prevent accidental ingestion or misuse. Once you open the product, remember to discard it after use to maintain safety and effectiveness.

Additional Information

For adults and children aged two years and older, you should apply the medication externally to the affected area, but limit use to no more than three to four times a day. It's important to avoid contact with your eyes. If your symptoms last longer than seven days, or if they improve and then return within a few days, stop using the product and talk to your doctor. Additionally, if you experience increased redness, irritation, swelling, or pain, discontinue use and consult your physician. If the medication is swallowed, seek medical advice immediately.

FAQ

What is the primary use of this drug?

This drug is used for temporary relief of pain and itching from minor skin irritations, including cuts, scrapes, sunburn, and minor burns.

Can I use this drug for insect bites?

Yes, it is also used for temporary relief of itching associated with minor skin irritations and rashes from insect bites, poison ivy, poison oak, and poison sumac.

Who can use this drug?

This drug can be applied externally by adults and children two years or older.

How often can I apply this drug?

You should not use this drug more than three to four times per day.

Are there any warnings I should be aware of?

Yes, it is for external use only, avoid contact with eyes, and consult a physician if symptoms persist for more than seven days or worsen.

Is this drug safe to use during pregnancy?

The safety of this drug during pregnancy has not been established, and it is contraindicated due to potential risks to the fetus.

What should nursing mothers do before using this drug?

Nursing mothers should consult a physician before using this product due to the potential for excretion in breast milk.

How should I store this drug?

Store the drug at 20°C to 25°C (68°F to 77°F) and protect it from light. Keep it out of reach of children.

Packaging Info

Below are the non-prescription pack sizes of Predator (lidocaine hydrochloride). 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. No specific description details are provided in the text.

Uses and Indications

This drug is indicated for the temporary relief of pain and itching associated with minor skin irritations due to minor cuts and scrapes, sunburn, and minor burns. It is also indicated for the temporary relief of itching related to minor skin irritations and rashes caused by insect bites, poison ivy, poison oak, poison sumac, as well as reactions to soaps, detergents, cosmetics, and jewelry.

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

Dosage and Administration

For adults and children aged two years and older, the medication should be applied externally to the affected area. The application frequency should not exceed three to four times per day. Care should be taken to ensure that the product is used as directed to avoid potential adverse effects associated with overuse.

Contraindications

Use is contraindicated in individuals who are unable to keep the product out of reach of children. This precaution is necessary to prevent accidental ingestion or misuse by pediatric patients. No other contraindications have been identified.

Warnings and Precautions

For external use only. It is imperative to avoid contact with the eyes to prevent irritation or injury. In the event that symptoms persist for more than seven days, or if symptoms resolve and then recur within a few days, the product should be discontinued, and a physician should be consulted for further evaluation.

Should any signs of redness, irritation, swelling, pain, or other adverse symptoms increase, the use of the product must be stopped immediately, and medical advice should be sought. In cases of accidental ingestion, it is essential to consult a physician without delay.

Side Effects

Patients should be aware that the product is intended for external use only and must avoid contact with the eyes. In clinical practice, if symptoms persist for more than seven days, or if symptoms clear up and then recur within a few days, it is advised to discontinue use and consult a physician.

Additionally, if patients experience increased redness, irritation, swelling, pain, or any other worsening symptoms, they should also discontinue use and seek medical advice. In the event of accidental ingestion, it is important to consult a physician immediately.

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 hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Predator.
Details

Pediatric Use

Pediatric patients aged two years and older may use the product externally on the affected area. The recommended application frequency is three to four times per day. It is important to keep the product out of reach of children to ensure safety.

Geriatric Use

Elderly patients do not have specific geriatric use considerations, dosage adjustments, safety concerns, or special precautions associated with the use of Predator (lidocaine hydrochloride cream) as indicated in the prescribing information. Therefore, standard dosing and administration guidelines apply to this population without the need for modification. Healthcare providers should continue to monitor the overall health status of geriatric patients as part of routine clinical practice.

Pregnancy

The safety of lidocaine hydrochloride cream during pregnancy has not been established. The use of this product is contraindicated in pregnant patients due to potential risks to the fetus. There may be associated risks with the use of lidocaine during pregnancy; therefore, it is essential for women of childbearing potential to consult a healthcare provider for personalized advice.

Dosage adjustments may be necessary for pregnant individuals, and specific recommendations should be obtained from a healthcare professional. Pregnant women should avoid using lidocaine hydrochloride cream unless directed by a healthcare provider, ensuring that any potential risks are carefully considered.

Lactation

Lactating mothers should consult a physician before using this product. There is a potential for excretion in breast milk, and caution is advised when using this product while breastfeeding due to the potential risk to the infant.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the text. Therefore, healthcare professionals should exercise caution and consider individual patient factors when prescribing to this population. Regular assessment of renal function may be warranted to ensure safe and effective use of the medication in patients with reduced kidney function.

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 event of an overdosage, it is imperative that healthcare professionals take immediate action. If the substance is ingested, the individual should consult a physician without delay.

Potential symptoms of overdosage may vary depending on the specific substance involved; therefore, a thorough assessment of the patient's condition is essential. Healthcare providers should monitor the patient for any adverse effects and provide supportive care as necessary.

Management procedures may include symptomatic treatment and monitoring of vital signs. It is crucial to follow established protocols for overdose management, which may involve contacting poison control or utilizing specific antidotes if applicable.

Prompt medical intervention is vital to mitigate the risks associated with overdosage and to ensure the best possible outcome for 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 limits the assessment of potential risks associated with the use of the compound in question. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

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 to prevent accidental ingestion or misuse. It is important to emphasize the necessity of proper storage to ensure the safety of young children.

Storage and Handling

The product is supplied in packaging that includes specific NDC numbers. It should be stored at a temperature range of 20°C to 25°C (68°F to 77°F), with permissible excursions between 15°C to 30°C (59°F to 86°F). It is essential to protect the product from light to maintain its integrity. Additionally, the product must be kept out of reach of children, and any unused portion should be discarded after opening to ensure safety and efficacy.

Additional Clinical Information

For patients aged two years and older, the medication should be applied externally to the affected area, with a maximum frequency of three to four times per day. Clinicians should advise patients to avoid contact with the eyes. If symptoms persist beyond seven days, or if they resolve and then recur within a few days, patients are instructed to discontinue use and consult a physician. Additionally, if any redness, irritation, swelling, pain, or other symptoms worsen, patients should also discontinue use and seek medical advice. In the event of accidental ingestion, patients should consult a physician.

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

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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.