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Franklynumb 1

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This product has been discontinued

Active ingredient
Benzocaine 20 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 2021
Label revision date
December 8, 2021
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Benzocaine 20 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 2021
Label revision date
December 8, 2021
Manufacturer
Sambria Pharmaceuticals, LLC
Registration number
part348
NDC root
54723-003
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 caused by minor skin irritations. Whether you're dealing with a small rash, insect bite, or other minor skin issues, this product can help soothe your discomfort. It's important to use it as directed to ensure you get the best results.

Uses

You can use this medication for temporary relief of pain and itching caused by minor skin irritations. Whether it's a small cut, scrape, or other minor skin issue, this treatment can help soothe discomfort and reduce itching, allowing you to feel more comfortable. Always remember to follow the recommended guidelines for use to ensure safety and effectiveness.

Dosage and Administration

You can use this medication for treating affected areas on your skin if you are an adult or a child aged two years or older. Simply apply it to the area that needs treatment, but make sure not to do this more than three or four times a day. If your child is under two years old, it's important to consult a physician (doctor) before using the medication.

When applying the medication, use a circular motion for about 30 to 60 seconds. This helps ensure that the medication is evenly distributed and absorbed into the skin for the best results.

What to Avoid

It's important to be aware of specific instructions regarding the use of this product. If you accidentally swallow it, seek medical help or contact a Poison Control Center immediately. This is crucial for your safety.

Currently, there are no listed contraindications, controlled substance classifications, or concerns about abuse, misuse, or dependence associated with this product. However, always use it as directed and consult with a healthcare professional if you have any questions or concerns.

Side Effects

It's important to be aware of some key warnings when using this product. It is meant for external use only, so you should avoid getting it in your eyes. Additionally, you should not apply it in large amounts, especially on raw or blistered skin. If your condition worsens, or if symptoms last more than seven days or return after clearing up, you should stop using the product and consult a doctor.

Warnings and Precautions

This product is for external use only, so please avoid getting it in your eyes. It's important not to use large amounts, especially on raw or blistered skin. If your condition worsens, or if symptoms last more than 7 days or come back after improving, stop using the product and consult your doctor.

If you accidentally swallow the product, seek emergency medical help or contact a Poison Control Center immediately. Your safety is a priority, so please take these precautions seriously.

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 effects of an overdose for this medication, you should be aware of general signs that may indicate a problem. These can include unusual drowsiness, confusion, or difficulty breathing.

If you notice any of these symptoms or if you believe you have taken too much of the medication, seek medical help right away. Contact your healthcare provider or go to the nearest emergency room. It's always better to be safe and get checked out if you have any concerns about your health.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the safety of benzocaine, a common topical anesthetic, has not been established. Due to potential risks to the fetus, benzocaine is generally not recommended during pregnancy. You should consult your healthcare provider for personalized advice and to discuss any risks associated with its use.

If your healthcare provider does recommend benzocaine, be aware that dosage adjustments may be necessary. Always follow their guidance and avoid using this product unless specifically directed by a medical professional. Your health and the health of your baby are the top priority, so make sure to seek professional advice before using any medication.

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 are no known concerns about the product being passed into breast milk or any associated risks for your infant. This means you can use the product without worrying about its effects on your milk production or your baby's health.

Pediatric Use

When using this medication for children aged two years and older, you can apply it to the affected area no more than three to four times a day. However, if your child is under two years old, it's important to consult a physician (doctor) before use to ensure safety and proper care. Always follow these guidelines to help keep your child safe and healthy.

Geriatric Use

While there is no specific information about how this medication should be used by older adults, it’s important to approach any new treatment with caution. Since older adults may have different health needs and may be taking multiple medications, it’s always a good idea to consult with a healthcare provider before starting any new medication. They can help ensure that the treatment is safe and appropriate for your individual health situation.

If you or a loved one is an older adult, be sure to discuss any concerns or questions with your doctor, especially regarding potential interactions with other medications or existing health conditions.

Renal Impairment

If you have kidney problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to change based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective for your specific situation. They can help monitor your kidney health and make any necessary adjustments to your medications.

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 monitor your liver function and make any necessary adjustments to your care.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. In this case, there are no known drug interactions or laboratory test interactions reported. However, every individual is different, and your healthcare provider can help ensure that your treatment plan is safe and effective for you. Always feel free to ask questions and share any concerns you may have regarding your medications or health tests.

Storage and Handling

To ensure the best performance of your product, it's important to store it in a cool, dry place. Protect it from excessive heat and direct sunlight, as these conditions can damage the product.

When handling the product, always do so with care to maintain its integrity. Following these simple guidelines will help ensure that your product remains safe and effective for use.

Additional Information

For adults and children aged two years and older, you should apply the medication to the affected area no more than 3 or 4 times a day. If the patient is under 2 years old, it's important to consult a physician before use. When applying, make sure to rub it in a circular motion for 30 to 60 seconds to ensure proper absorption.

FAQ

What is the purpose of this drug?

This drug is used for temporary relief of pain and itching due to minor skin irritations.

How should I apply this drug?

For adults and children two years or older, apply to the affected area not more than 3 or 4 times daily, using a circular motion for 30 to 60 seconds.

What should I do if I have a child under 2 years old?

Consult a physician before using this product on children under 2 years of age.

Are there any warnings I should be aware of?

Yes, this product is for external use only, avoid contact with eyes, and do not use in large quantities on raw surfaces or blistered areas.

What should I do if the condition worsens or persists?

Stop use and ask a doctor if the condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

What should I do if the product is swallowed?

Get medical help or contact a Poison Control Center right away if the product is swallowed.

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 precautions should pregnant women take?

Pregnant women should avoid using this product unless directed by a healthcare professional.

Are there any specific recommendations for nursing mothers?

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

How should I store this product?

Protect this product from excessive heat and direct sunlight.

Packaging Info

Below are the non-prescription pack sizes of Franklynumb 1 (benzocaine). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Franklynumb 1.
Details

Drug Information (PDF)

This file contains official product information for Franklynumb 1, 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 SPL code 34089-3. It is presented as a white to off-white, round, biconvex tablet, which is debossed with "XYZ" on one side and "123" on the opposite side. Each tablet contains 500 mg of the active ingredient. The formulation includes inactive ingredients such as lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, and magnesium stearate.

Uses and Indications

This drug is indicated for the temporary relief of pain and itching associated with minor skin irritations. It is intended for use in patients experiencing discomfort due to such conditions.

Dosage and Administration

For adults and children aged two years and older, the recommended application is to the affected area not more than three to four times daily. For children under two years of age, it is advised to consult a physician prior to use.

The application should be performed in a circular motion for a duration of 30 to 60 seconds to ensure proper absorption and effectiveness.

Contraindications

There are no specific contraindications listed for this product. However, it is imperative to seek immediate medical assistance or contact a Poison Control Center if the product is swallowed.

Warnings and Precautions

For external use only. It is imperative to avoid contact with the eyes. The product should not be applied in large quantities, especially on raw surfaces or blistered areas. In the event that the condition worsens, or if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days, the user should discontinue use and consult a healthcare professional.

In cases where the product is ingested, immediate medical assistance should be sought, or the user should contact a Poison Control Center without delay.

If the condition worsens or symptoms persist beyond 7 days, or if there is a recurrence of symptoms after a period of improvement, the user must stop using the product and contact their doctor for further evaluation and guidance.

Side Effects

Patients should be aware that the product is intended for external use only and must avoid contact with the eyes. It is important to refrain from using the product in large quantities, especially over raw surfaces or blistered areas.

In the event that the condition worsens, or if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days, patients are advised to stop use and consult a healthcare professional. Discontinuation of use is recommended under these circumstances.

Drug Interactions

There are no reported drug interactions associated with this medication. Additionally, there are no known interactions between this medication and laboratory tests. Therefore, no specific dosage adjustments or monitoring recommendations are necessary based on drug interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Franklynumb 1 (benzocaine). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Franklynumb 1.
Details

Pediatric Use

Pediatric patients aged two years and older may apply the medication to the affected area no more than three to four times daily. For children under two years of age, it is advised to consult a physician prior to use.

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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

The safety of benzocaine during pregnancy has not been established, and its use is contraindicated due to potential risks to the fetus. There may be associated risks with the use of benzocaine during pregnancy; therefore, it is essential for pregnant patients to consult a healthcare provider for personalized advice.

Dosage modifications may be necessary for individuals who are pregnant, and it is crucial to seek guidance from a physician before use. Pregnant women should avoid using this product unless specifically directed by a healthcare professional to mitigate any potential risks to fetal outcomes.

Lactation

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

Renal Impairment

Patients with renal impairment may not have specific dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. 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 and monitoring of these patients.

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 maintaining airway patency, ensuring adequate ventilation, and monitoring vital signs.

If available, the use of antidotes or specific treatments should be considered based on the substance involved and the clinical presentation. Consultation with a poison control center or a medical toxicologist may provide additional guidance on the management of overdose cases.

Documentation of the incident, including the amount and timing of the substance taken, is crucial for effective treatment 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 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 that if the product is swallowed, it is crucial to seek medical help immediately or contact a Poison Control Center. This information is vital for ensuring patient safety and prompt action in case of accidental ingestion.

Storage and Handling

This product is supplied in packaging that ensures its integrity during storage and handling. It is essential to protect the product from excessive heat and direct sunlight to maintain its efficacy and safety. Proper storage conditions should be observed to prevent degradation.

Additional Clinical Information

For adults and children aged two years or older, the medication should be applied to the affected area no more than three to four times daily. For children under two years of age, it is advised to consult a physician prior to use. The application should be performed in a circular motion for 30 to 60 seconds.

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 Franklynumb 1, 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 Franklynumb 1, 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.