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Makesense

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This product has been discontinued

Active ingredient
Benzocaine 7.5 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 7.5 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
69020-206
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 for sore gums caused by teething in children aged 2 years and older. Teething can be uncomfortable for little ones, and this product aims to help ease that discomfort, allowing them to feel more at ease during this developmental stage.

If your child is under 2 years of age, it's important to consult a physician or healthcare provider before using this medication to ensure it's appropriate for their needs.

Uses

If your child is experiencing sore gums from teething and is 2 years old or older, this medication can provide temporary relief. It's important to note that if your child is under 2 years of age, you should consult a physician or healthcare provider before using this product.

Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) associated with this medication, making it a safer option for your little one during this uncomfortable time.

Dosage and Administration

Before using MakeSense Junior Teething Gel, it's important to start by washing your hands thoroughly to ensure cleanliness. Next, cut open the tip of the tube at the score mark. Using your fingertip or a cotton applicator, apply a small amount—about the size of a pea—of the gel directly onto your child's gums.

You can apply the gel to the affected area up to four times a day, or as directed by your dentist or physician. If your child is under 2 years old, be sure to consult with a doctor or healthcare provider before using the gel. This will help ensure that it’s safe and appropriate for your little one.

What to Avoid

It's important to use this medication responsibly. You should not take more than the directed amount, and you should not use it for more than 7 days unless your doctor or healthcare provider has instructed you to do so. Following these guidelines helps ensure your safety and the effectiveness of the treatment. If you have any questions or concerns about your use of this medication, please consult with your healthcare provider.

Side Effects

If your baby has a history of allergies to local anesthetics, such as procaine or butacaine (often ending in "caine"), it's important not to use this product.

You should stop using it and consult a dentist or doctor if your baby’s sore mouth symptoms do not improve within 7 days, or if you notice any irritation, pain, or redness that persists. Additionally, seek medical advice if your baby develops swelling, a rash, or a fever.

Warnings and Precautions

If your baby has a history of allergies to local anesthetics, such as procaine or butacaine, it’s important not to use this product. Be aware of the signs of an overdose or an allergic reaction; if you notice any concerning symptoms, seek emergency medical help or contact a Poison Control Center right away.

You should also stop using the product and call your doctor if your baby’s sore mouth symptoms do not improve within 7 days, if there is ongoing irritation, pain, or redness, or if your baby develops swelling, a rash, or a fever. Keeping an eye on these symptoms can help ensure your baby's safety and well-being.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While the specific signs of an overdose are not detailed, common symptoms can include extreme drowsiness, confusion, or difficulty breathing. If you notice any of these signs, seek medical help right away.

In case of an overdose, contact your local emergency services or go to the nearest hospital. It's crucial to provide them with as much information as possible about the substance taken and the amount, if known. Remember, acting quickly can make a significant difference in your health and safety.

Pregnancy Use

When considering the use of Makesense Junior Pain Relief (benzocaine gel) during pregnancy, it's important to note that there is no specific information available regarding its safety, dosage adjustments, or any special precautions for pregnant individuals. This means that the potential risks and benefits of using this product while pregnant have not been clearly established.

If you are pregnant or planning to become pregnant, it is always best to consult with your healthcare provider before using any medication, including over-the-counter products like this one. They can help you make informed decisions based on your individual health needs and circumstances.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding nursing mothers or lactation in the information provided. This means that, based on the available data, there are no known risks associated with breastfeeding while using this medication. However, it's always a good idea to consult with your healthcare provider if you have any concerns or questions about your specific situation.

Pediatric Use

If your child is 2 years old or older and experiencing sore gums from teething, this medication can provide temporary relief. However, if your child is under 2 years of age, it’s important to consult a physician or healthcare provider before using this product. Always seek professional advice for infants to ensure their 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 healthcare providers may not have tailored guidelines for elderly patients.

If you or a loved one is an older adult considering this medication, it’s important to discuss any potential risks or concerns with your healthcare provider. They can help determine the best approach based on individual health needs and circumstances.

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 is safe and effective, especially if you have any concerns about your kidney health.

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 (issues with liver function).

Always consult your healthcare provider for personalized advice and to discuss any concerns regarding your liver health and medication use. They can help ensure that you receive the safest and most effective treatment based on your individual needs.

Drug Interactions

It's important to be aware of potential interactions when using medications. If your baby has a history of allergies to local anesthetics, such as procaine or butacaine (often ending in "caine"), you should avoid using this product. Allergic reactions can be serious, so discussing any past allergies with your healthcare provider is crucial.

Additionally, while there are no specific interactions with other drugs or laboratory tests noted, it's always a good practice to talk to your healthcare provider about all medications and tests your baby may be undergoing. This ensures safe and effective care tailored to your baby's needs.

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 helps maintain its 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. Always check the packaging before use to ensure everything is intact. Following these guidelines will help you use the product safely and effectively.

Additional Information

You will apply this medication topically, meaning you will put it directly on the affected area of your skin. You can use it up to four times a day, or follow the specific instructions given by your dentist or physician. If you have any questions about how to use it, be sure to ask your healthcare provider for guidance.

FAQ

What is the purpose of this drug?

This drug is for the temporary relief of sore gums due to teething in children 2 years of age and older.

Can I use this drug for children under 2 years old?

For children under the age of 2, you should consult a physician or healthcare provider before use.

How should I apply the drug?

Wash your hands, cut open the tip of the tube on the score mark, and apply a small pea-size amount to the affected gums using your fingertip or a cotton applicator.

How often can I apply this drug?

You can apply it to the affected area up to 4 times daily or as directed by a dentist or physician.

What should I do if symptoms do not improve?

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

Are there any allergy alerts for this drug?

Do not use this product if your baby has a history of allergy to local anesthetics such as procaine, butacaine, or other 'caine' anesthetics.

What should I do in case of an overdose or allergic reaction?

Get emergency medical help or contact a Poison Control Center immediately.

What are the storage conditions for this drug?

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

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

No relevant information is available for SPL code 34089-3, and therefore, a detailed description cannot be provided.

Uses and Indications

This drug is indicated for the temporary relief of sore gums due to teething in children aged 2 years and older. For children under the age of 2, consultation with a physician or healthcare provider is recommended prior to use.

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

Dosage and Administration

Healthcare professionals are advised to follow the steps outlined below for the administration of MakeSense Junior Teething Gel.

Prior to application, it is essential to wash hands thoroughly to maintain hygiene. The tip of the tube should be cut open at the designated score mark to facilitate the dispensing of the gel. A small pea-sized amount of the gel should then be applied to the affected area of the gums using either a fingertip or a cotton applicator.

The gel may be applied up to four times daily, or as directed by a dentist or physician. For infants under the age of 2 years, it is recommended to consult a doctor or healthcare provider before use to ensure safety and appropriateness of treatment.

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

Patients should be advised of the following critical warnings and precautions associated with the use of this product.

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.

Emergency Medical Assistance In the event of an overdose or an allergic reaction, it is imperative to seek emergency medical assistance immediately. Healthcare providers should instruct patients or caregivers to contact a Poison Control Center without delay if such situations arise.

Monitoring and Follow-Up Patients should be closely monitored for the following symptoms, and if any of these occur, they should discontinue use and contact their healthcare provider:

  • If sore mouth symptoms do not improve within 7 days.

  • If irritation, pain, or redness persists.

  • If any swelling, rash, or fever develops.

These precautions are essential to ensure the safe and effective use of the product, and healthcare professionals should provide thorough guidance to patients regarding these warnings.

Side Effects

Patients should be aware of the potential for adverse reactions associated with the use of this product. Individuals with a history of allergy to local anesthetics, such as procaine, butacaine, or other "caine" anesthetics, should not use this product due to the risk of allergic reactions.

In clinical practice, it is advised that patients discontinue use and consult a dentist or doctor if any of the following occur: sore mouth symptoms that do not improve within 7 days, persistent irritation, pain, or redness, or the development of swelling, rash, or fever. These symptoms may indicate a need for further evaluation and management.

Drug Interactions

The use of this product is contraindicated in individuals with a known allergy to local anesthetics, specifically those with a history of hypersensitivity to procaine, butacaine, or other "caine" anesthetics.

No specific drug or laboratory test interactions have been identified in the available data. Therefore, routine monitoring or dosage adjustments related to drug interactions are not necessary.

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 aged 2 years and older may use this product for the temporary relief of sore gums due to teething. For children under the age of 2, it is advised to consult a physician or healthcare provider prior to use. Infants under 2 years of age should specifically seek guidance from a doctor or healthcare provider before administration.

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

There is no specific information regarding the use of Makesense Junior Pain Relief (benzocaine gel) during pregnancy. The prescribing information does not provide safety concerns, dosage modifications, or special precautions for pregnant patients. Therefore, healthcare professionals should exercise caution when considering the use of this product in pregnant women, as the potential risks and effects on fetal outcomes are not well characterized. It is advisable to weigh the benefits against any unknown risks when prescribing this medication to women of childbearing potential.

Lactation

There are no specific warnings or recommendations regarding the use of this medication in nursing mothers. Additionally, there are no specific warnings or recommendations related to lactation. Healthcare professionals should consider the absence of data when advising lactating mothers on the use of this medication.

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 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 specific antidotes or 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 substance, amount ingested, and time of ingestion, is crucial for effective management and treatment planning.

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 dentist or 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 consult a healthcare professional if they develop swelling, rash, or fever.

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

Storage and Handling

The product is supplied in a tube format. It should be stored at a temperature range of 59 to 77°F (15 to 25°C) to maintain its efficacy. It is imperative that the tube is not used if the tip is cut prior to opening, as this may compromise the integrity of the product. Proper handling and storage conditions are essential to ensure the product remains safe and effective for use.

Additional Clinical Information

The medication is administered topically, with application to the affected area permitted up to four times daily or as directed by a dentist or physician. There are no additional details available regarding laboratory tests, abuse information, 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.