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Bite Relief

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This product has been discontinued

Active ingredient
Benzocaine 5 g/100 mL
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 2012
Label revision date
March 29, 2018
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Benzocaine 5 g/100 mL
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 2012
Label revision date
March 29, 2018
Manufacturer
Product Quest Mfg.
Registration number
part348
NDC root
64048-7336
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

You can use this medication for the temporary relief of pain and itching caused by insect bites. It is designed to help soothe discomfort, allowing you to feel more comfortable while your skin heals. If you experience irritation from insect bites, this product may provide the relief you need.

Uses

If you're dealing with discomfort from insect bites, this medication can help. It provides temporary relief from both pain and itching, allowing you to feel more comfortable. Whether you're enjoying the outdoors or just dealing with pesky bugs, this treatment can make a difference in easing your symptoms.

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. This will help ensure safety and proper care for younger children. Always follow your healthcare provider's advice regarding dosage and application.

What to Avoid

It's important to be aware of certain precautions when using this product. If you accidentally swallow it, you should seek medical help or contact a Poison Control Center immediately. This is crucial to ensure your safety and well-being.

Additionally, if you or someone else ingests the product unintentionally, do not hesitate to reach out for professional assistance or contact a Poison Control Center right away. Taking these steps can help prevent any potential health issues.

Side Effects

When using this product, it's important to remember that it is for external use only. Be careful to avoid contact with your eyes and mucous membranes, as this can cause irritation. If your condition worsens, or if your symptoms last more than seven days or improve and then return within a few days, you should stop using the product and consult a doctor.

Warnings and Precautions

This product is intended for external use only, so please avoid getting it in your eyes or on mucous membranes. If your condition worsens, if symptoms persist for more than 7 days, or if they seem to improve and then return within a few days, stop using the product and consult your doctor.

In case of accidental swallowing, it’s important to seek emergency medical help or contact a Poison Control Center immediately. Your safety is a priority, so don’t hesitate to reach out for professional assistance if needed.

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

If you are pregnant or planning to become pregnant, it's important to know that there are no specific guidelines or safety information available regarding the use of this product during pregnancy. This means that there are no established recommendations about how to use it safely, whether you need to adjust the dosage, or if there are any special precautions you should take.

Given the lack of information, it's best to consult with your healthcare provider before using this product. They can help you weigh the potential risks and benefits based on your individual situation. Always prioritize your health and the health of your baby when considering any medication or treatment 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 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 to do this no more than 3 to 4 times a day. Always follow these guidelines 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 dosage adjustments, safety concerns, or special precautions. This means that if you or a loved one is an older adult considering this medication, it’s important to consult with a healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

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 standard recommendations for the medication do not include special monitoring or safety considerations tailored for patients with renal impairment (kidney issues).

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your specific health needs. They can provide guidance based on your kidney function and overall 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 requirements or precautions outlined for patients with liver impairment.

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 you.

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, based on the available information, this medication is not known to interfere with other drugs or lab tests. However, every individual is different, and your healthcare provider can help ensure that your treatment plan is safe and effective for you. Always discuss any concerns or questions you may have regarding your medications or tests.

Storage and Handling

To ensure the best performance of your product, store it at a temperature between 20°C and 25°C (68°F to 77°F). It’s okay 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 quality. When not in use, always keep the tube tightly closed to maintain its integrity, and remember to discard it after opening to ensure safety and effectiveness.

Additional Information

You should apply this medication topically to the affected area, using it no more than 3 to 4 times a day if you are an adult or a child aged 2 years and older. 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.

FAQ

What is the purpose of this drug?

This drug is used for the temporary relief of pain and itching associated with insect bites.

Who can use this drug?

Adults and children 2 years of age and older can use it, applying to the affected area no more than 3 to 4 times daily. Children under 2 years of age should consult a doctor.

What should I do if the product is swallowed?

If the product is swallowed, get medical help or contact a Poison Control Center right away.

Are there any warnings I should be aware of?

Yes, this product is for external use only. Avoid contact with eyes and mucous membranes, and stop use if the condition worsens or symptoms last more than 7 days.

How should I store this drug?

Store at 20°C to 25°C (68°F to 77°F), protect from light, and keep the tube tightly closed when not in use.

Is there any information about using this drug during pregnancy or while nursing?

There are no specific statements regarding the use of this product during pregnancy or nursing.

What should I do if symptoms clear up and then occur again?

If symptoms clear up and occur again within a few days, you should stop use and ask a doctor.

Packaging Info

Below are the non-prescription pack sizes of Bite Relief (benzocaine - 5.00%). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Bite Relief.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

No relevant information is available for SPL code 34089-3.

Uses and Indications

This drug is indicated for the temporary relief of pain and itching associated with insect bites.

Limitations of Use: This product is intended for symptomatic relief and does not address the underlying cause of insect bites. It is recommended for use in patients experiencing localized discomfort due to insect bites.

Dosage and Administration

For adults and children aged 2 years and older, the recommended application frequency is 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 advised to consult a doctor prior to use.

Contraindications

There are no specific contraindications listed for this product. However, in the event of accidental ingestion, it is imperative to seek medical assistance or contact a Poison Control Center immediately. If the product is swallowed, prompt medical help should be obtained.

Warnings and Precautions

This product is intended for external use only. Healthcare professionals should advise patients to avoid contact with the eyes and mucous membranes during application. In the event that the condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days, patients are instructed to discontinue use and consult a physician.

In cases of accidental ingestion, immediate medical assistance should be sought. Patients should be directed to contact a Poison Control Center or seek emergency medical help without delay if the product is swallowed.

It is imperative that patients stop using the product and contact their healthcare provider if they experience worsening symptoms, if symptoms last longer than 7 days, or if there is a recurrence of symptoms after a temporary resolution.

Side Effects

Patients should be aware that this product is for external use only. It is important to avoid contact with the eyes and mucous membranes during application.

In clinical practice, patients are advised to discontinue use and consult a healthcare professional if any of the following occur: the condition worsens, symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. These warnings are crucial for ensuring patient safety and effective use of the product.

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions between the drug and laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the current information.

Packaging & NDC

Below are the non-prescription pack sizes of Bite Relief (benzocaine - 5.00%). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Bite Relief.
Details

Pediatric Use

Pediatric patients under 2 years of age should consult a doctor prior to 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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

There are no specific statements regarding the use of this product during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the lack of data when prescribing this product to pregnant patients and weigh the potential benefits against any unknown risks to fetal outcomes. Women of childbearing potential should be counseled on the importance of effective contraception during treatment.

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 available 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 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 consider general principles of management for potential overdose situations.

It is essential to monitor patients closely for any signs or symptoms that may arise following an overdose. Common symptoms may include, but are not limited to, altered mental status, cardiovascular instability, and gastrointestinal disturbances.

In the event of suspected overdosage, immediate medical intervention is recommended. Healthcare providers should initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and ensuring adequate circulation.

Additionally, it is advisable to contact a poison control center or a medical toxicologist for guidance on specific management strategies tailored to the substance involved. Continuous monitoring of vital signs and symptomatic treatment should be implemented as necessary until the patient stabilizes.

Documentation of the incident, including the amount and timing of the substance taken, is crucial for ongoing management and treatment decisions.

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 the product out of reach of children to prevent accidental ingestion. It is important to inform patients that if the product is swallowed, they should seek medical help or contact a Poison Control Center immediately. In the event of accidental ingestion, patients must be instructed to seek professional assistance or reach out to a Poison Control Center without delay.

Storage and Handling

The product is supplied in a tube format, with specific storage and handling requirements to ensure its integrity and efficacy. 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).

To maintain product quality, it is essential to protect the tube from light exposure. Additionally, the tube must be kept tightly closed when not in use to prevent contamination and degradation. It is important to note that the product should be discarded after opening to ensure safety and effectiveness.

Additional Clinical Information

The medication is administered topically, with a recommended application frequency of no more than 3 to 4 times daily for adults and children aged 2 years and older. For children under 2 years of age, clinicians are advised to consult a doctor prior to use. There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Bite Relief, 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 Bite Relief, 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.