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Makesense

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This product has been discontinued

Active ingredient
Benzocaine 20 g/100 g
Other brand names
Dosage form
Gel
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2014
Label revision date
July 30, 2014
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Benzocaine 20 g/100 g
Other brand names
Dosage form
Gel
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 2014
Label revision date
July 30, 2014
Manufacturer
Cherry Hill Sales Co
Registration number
part356
NDC root
69020-207
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 may find that this medication provides temporary relief from pain associated with toothaches, canker sores, cold sores, fever blisters, and minor dental procedures. It is designed to help ease discomfort in these situations, allowing you to feel more comfortable while dealing with oral health issues.

Uses

If you're experiencing pain from a toothache, canker sore, cold sore, fever blister, or after a minor dental procedure, this medication can provide you with temporary relief. It’s designed to help ease discomfort associated with these common oral issues, allowing you to feel more comfortable while you recover.

Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) or nonteratogenic effects associated with this medication. This makes it a safer option for those concerned about potential risks.

Dosage and Administration

To use this medication, start by cutting open the tip of the tube. You can then apply it to the affected area up to four times a day, or as your dentist or physician directs. If you are using this product for a child under 12 years old, make sure they are supervised during application to ensure safety.

For infants who are under 2 years of age, it’s important to consult with a doctor or healthcare provider before use. This will help ensure that the treatment is appropriate and safe for your little one.

What to Avoid

It's important to use this medication responsibly. You should not take more than the directed amount, as exceeding the recommended dosage can lead to unwanted effects. Additionally, avoid using this medication for more than 7 days unless your physician or healthcare provider specifically instructs you to do so. Following these guidelines will help ensure your safety and the effectiveness of the treatment.

Side Effects

If your child has a history of allergies to local anesthetics like procaine or butacaine, it's important not to use this product. You should also stop using it and consult a doctor if your child's sore mouth symptoms do not improve within 7 days, or if they experience ongoing irritation, pain, or redness. Additionally, seek medical advice if any swelling, rash, or fever occurs.

Warnings and Precautions

You should be aware of some important warnings and precautions when using this product. If your child has a history of allergies to local anesthetics, such as procaine or butacaine (often ending in "caine"), do not use this product.

It's crucial to monitor for any signs of overdose or allergic reactions. If you suspect either, seek medical help or contact a Poison Control Center right away. Additionally, stop using the product and consult your doctor if your child's sore mouth symptoms do not improve within 7 days, if there is ongoing irritation, pain, or redness, or if any swelling, rash, or fever occurs.

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 concerned about a possible overdose, seek medical help right away.

In case of an overdose, contacting your local emergency services or going to the nearest hospital is crucial. Always keep the medication packaging with you, as it can help healthcare professionals understand what you've taken. Remember, it's better to be safe and get checked out if you have any doubts.

Pregnancy Use

When considering the use of Makesense Pain Relief (benzocaine gel) during pregnancy, it's important to note that the drug insert does not provide specific information about its safety for pregnant individuals. There are no warnings indicating that the product is contraindicated (not recommended) during pregnancy, nor are there any stated risks to the developing fetus. Additionally, there are no dosage adjustments or special precautions mentioned for pregnant users.

As always, it's best to consult with your healthcare provider before using any medication during pregnancy to ensure it is safe for you and 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 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

If your child has a history of allergies to local anesthetics, such as procaine or butacaine, it's important not to use this product. For children aged 2 years and older, you can apply it to the affected area up to four times a day, but it's best to follow the advice of a dentist or physician.

For children under 12, make sure they are supervised while using this product. If your child is an infant under 2 years old, please consult a doctor or healthcare provider before use to ensure safety.

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. If you or a loved one is an older adult, it’s always a good idea to discuss any medications with a healthcare provider. They can help ensure that the treatment is safe and appropriate, considering any unique health needs or conditions that may be present.

Remember, even if there are no specific dosage adjustments or safety concerns mentioned, your healthcare provider may still recommend monitoring for any potential side effects or interactions with other medications you may be taking. Always prioritize open communication with your healthcare team to ensure the best care.

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 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 should be used if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your liver health. They can help determine the best course of action based on your individual situation.

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 associated with the medication. However, every individual is different, and your healthcare provider can help ensure that your treatment is safe and effective for you. Always feel free to ask questions and share your complete list of medications and any tests you may be undergoing.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 59 to 77°F (15-25°C). This temperature range helps maintain the product's effectiveness and safety.

When handling the product, be cautious not to use it if the tube tip is cut before you open it, as this could compromise its integrity. Following these guidelines will help you use the product safely and effectively.

Additional Information

You can use this product topically on the affected area up to four times a day, or as directed by your dentist or physician, if you are an adult or a child aged 2 years and older. If your child is under 12, make sure they are supervised while using it. For infants under 2 years old, consult a doctor or healthcare provider before use.

FAQ

What is the drug used for?

This drug provides temporary relief of pain associated with toothache, canker sores, cold sores, fever blisters, and minor dental procedures.

Who can use this product?

Adults and children 2 years of age and older can use this product. Children under 12 should be supervised, and for infants under 2 years, consult a doctor.

How should I apply the product?

Cut open the tip of the tube and apply to the affected area up to 4 times daily or as directed by a dentist or physician.

Are there any contraindications for this product?

No specific contraindications are mentioned, but do not use if your child has a history of allergy to local anesthetics like procaine or butacaine.

What should I do if symptoms do not improve?

Stop use and ask a doctor if sore mouth symptoms do not improve in 7 days, or if irritation, pain, or redness persists.

What are the storage conditions for this product?

Store the product at 59 to 77°F (15-25°C) and do not use if the tube tip is cut prior to opening.

Is this product safe to use during pregnancy?

There are no specific warnings or contraindications regarding the use of this product during pregnancy.

Can nursing mothers use this product?

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

What should I do in case of an overdose?

In case of overdose or allergic reaction, get medical help or contact a Poison Control Center immediately.

Packaging Info

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

Packaging configurations for Makesense.
Details

Drug Information (PDF)

This file contains official product information for Makesense, 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 associated with toothache, canker sores, cold sores, fever blisters, and minor dental procedures.

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

Dosage and Administration

Adults and children aged 2 years and older are instructed to cut open the tip of the tube and apply the product to the affected area. The application may be performed up to four times daily or as directed by a dentist or physician.

It is essential that children under 12 years of age are supervised while using this product to ensure safe and appropriate application. For infants under 2 years of age, consultation with a doctor or healthcare provider is recommended prior to use.

Contraindications

Use of this product is contraindicated in patients who exceed the recommended dosage or duration of use. Specifically, it should not be used for more than 7 days unless directed by a physician or healthcare provider. Adherence to these guidelines is essential to prevent potential adverse effects associated with prolonged use.

Warnings and Precautions

The use of this product necessitates careful consideration of potential allergies and adverse reactions.

Allergy Alert This product is contraindicated in individuals with a known history of allergy to local anesthetics, including but not limited to procaine, butacaine, or other "caine" anesthetics. Healthcare professionals should ensure that patients are screened for such allergies prior to administration.

General Precautions In the event of an overdose or suspected allergic reaction, immediate medical assistance should be sought. It is advisable to contact a Poison Control Center without delay to ensure appropriate management.

Monitoring and Follow-Up Patients should be advised to discontinue use and consult a healthcare provider if any of the following occur:

  • Symptoms of a sore mouth persist beyond 7 days.

  • Any irritation, pain, or redness does not resolve.

  • Signs of swelling, rash, or fever develop.

These precautions are essential to ensure the safe use of the product and to mitigate potential risks associated with its administration.

Side Effects

Patients should be aware of the potential adverse reactions associated with this product. A significant warning includes an allergy alert; the product should not be used in individuals with a history of allergy to local anesthetics, specifically procaine, butacaine, or other "caine" anesthetics.

In clinical practice, patients are advised to discontinue use and consult a healthcare professional if sore mouth symptoms do not improve within 7 days. Additionally, if irritation, pain, or redness persists, or if any swelling, rash, or fever develops, medical advice should be sought promptly. These recommendations are crucial for ensuring patient safety and addressing any serious reactions that may arise during treatment.

Drug Interactions

There are no reported drug interactions associated with the use of this medication. Additionally, no interactions with laboratory tests have been identified. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug interactions.

Packaging & NDC

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

Packaging configurations for Makesense.
Details

Pediatric Use

Pediatric patients with a history of allergy to local anesthetics, such as procaine, butacaine, or other "caine" anesthetics, should not use this product. For children aged 2 years and older, the recommended application is up to 4 times daily, or as directed by a dentist or physician. It is advised that children under 12 years of age be supervised while using this product. For infants under 2 years of age, consultation with a doctor or healthcare provider is necessary 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 Makesense Pain Relief (benzocaine gel) during pregnancy has not been established, as no specific information regarding its use in pregnant patients is provided in the drug insert. There are no contraindications noted for use during pregnancy, nor are there any associated risks to the fetus documented. Additionally, the prescribing information does not indicate any required dosage modifications or special precautions for pregnant patients. Healthcare professionals should consider the lack of data when advising women of childbearing potential regarding the use of this product during pregnancy.

Lactation

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

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

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 consider 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 and symptomatic treatment as necessary. This may include monitoring vital signs, providing respiratory support, and administering intravenous fluids if indicated.

Additionally, healthcare professionals should consult local poison control centers or relevant toxicology resources for guidance on specific management protocols tailored to the substance involved.

Documentation of the incident, including the amount and timing of the substance taken, 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 seek immediate medical assistance or contact a Poison Control Center in the event of an overdose or allergic reaction. It is important to instruct patients not to exceed the recommended dosage and to refrain from using the product for more than 7 days unless specifically directed by a physician or healthcare provider.

Patients should be informed to discontinue use and consult a doctor if symptoms of a sore mouth do not improve within 7 days. Additionally, they should be advised to stop using the product and seek medical advice if they experience any irritation, pain, or redness that does not resolve. Patients should also be cautioned to stop use and contact a healthcare professional if they develop swelling, rash, or fever.

Furthermore, when using this product, healthcare providers should emphasize that fever and nasal congestion are not typical symptoms of teething and may suggest an underlying infection. If these symptoms persist, patients should be encouraged to consult their physician for further evaluation.

Storage and Handling

The product is supplied in a configuration that includes specific packaging details, which are essential for proper handling and storage. It should be stored at a temperature range of 59 to 77°F (15 to 25°C) to maintain its integrity and effectiveness.

Healthcare professionals are advised to ensure that the tube remains intact prior to opening; the product should not be used if the tube tip is cut before use. Proper adherence to these storage conditions and handling instructions is crucial for optimal product performance.

Additional Clinical Information

The product is administered topically, with the recommended application for adults and children aged 2 years and older being up to four times daily, or as directed by a dentist or physician. It is advised that children under 12 years of age be supervised while using this product. For infants under 2 years, consultation with a doctor or healthcare provider is recommended prior to use.

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 Makesense, 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 Makesense, 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.