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Family Wellness

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This product has been discontinued

Active ingredient
Benzocaine 100 mg/1 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 2020
Label revision date
July 2, 2020
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Benzocaine 100 mg/1 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 2020
Label revision date
July 2, 2020
Manufacturer
Velocity Pharma LLC
Registration number
part356
NDC root
76168-607
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 used for the temporary relief of pain caused by toothaches. It works by targeting the discomfort associated with dental issues, helping to ease your pain until you can see a dentist. If you're experiencing tooth pain, this product may provide you with some much-needed relief.

Uses

If you're experiencing a toothache, this medication can provide you with temporary relief from the pain. It's designed specifically to help ease the discomfort associated with dental issues, allowing you to feel more comfortable until you can see a dentist.

There are no known risks of teratogenic effects (which means it doesn't cause birth defects) or other nonteratogenic effects associated with this medication. Always consult with a healthcare professional if you have any concerns or questions about using this product.

Dosage and Administration

To use this product, start by cutting open the tip of the tube at the score mark. If you are an adult or a child aged 2 years and older, apply a small amount of the product directly into the cavity and around the gums near the teeth. You can use it up to four times a day, or as your doctor or healthcare provider advises.

If you are using this product for a child between the ages of 2 and 12, make sure they are supervised during application. For children under 2 years old, it’s important to consult with a physician or healthcare provider before use to ensure safety.

What to Avoid

It's important to use this medication safely. You should not use it for teething or in children under 2 years of age. Additionally, make sure to follow the dosage instructions carefully—do not use more than directed and do not use it for more than 7 days unless your doctor or healthcare provider tells you to do so. Always prioritize your health and consult with a healthcare professional if you have any questions or concerns.

Side Effects

You should be aware that this medication carries a risk of methemoglobinemia, a condition where the blood cannot carry oxygen effectively. If you notice any swelling, rash, or fever while using this medication, it's important to stop taking it and consult your doctor. Additionally, if you experience ongoing irritation, pain, or redness that worsens, or if your symptoms do not improve within seven days, seek medical advice promptly.

Warnings and Precautions

It's important to be aware of some serious risks associated with this medication, including a condition called methemoglobinemia, which affects how your blood carries oxygen. If you experience any signs of an overdose or an allergic reaction, such as difficulty breathing or swelling, seek medical help immediately or contact a Poison Control Center.

You should also stop using the medication and call your doctor if you develop swelling, a rash, or a fever. Additionally, if you notice any irritation, pain, or redness that doesn't improve, or if your symptoms do not get better within 7 days, it's essential to reach out to your healthcare provider for further guidance.

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

It’s important to note that there is currently no information available about the use of Family Wellness Regular benzocaine 10% gel during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions for pregnant individuals have not been established.

If you are pregnant or planning to become pregnant, it’s best to consult with your healthcare provider before using this product to ensure it is safe for you and your baby. Always prioritize open communication with your doctor regarding any medications or treatments you may consider during this time.

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 and experiencing teething, it's important to consult a physician or healthcare provider before using this product. For children aged 2 to 12 years, you should supervise their use of the product to ensure safety and proper application. Always prioritize your child's health by seeking professional advice when needed.

Geriatric Use

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. Since older adults may have different health needs and responses to medications, you should always consult with a healthcare provider before starting any new medication. They can help determine the right dosage and monitor for any potential side effects, ensuring that the treatment is safe and effective for you or your loved one.

Renal Impairment

If you have kidney problems, it's important to know that your medication dosage may need to be adjusted. This is particularly true if your kidneys are not functioning as well as they should be. Regular monitoring of your renal function tests is essential to ensure your kidneys are managing medications effectively.

If your creatinine clearance (a measure of kidney function) is less than 30 mL/min, you should consider a reduced dose of your medication. Always consult with your healthcare provider to determine the best approach for your specific situation.

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 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 monitor your health effectively and make informed decisions about your care.

Always feel free to ask questions and share all the medications and supplements you are using. This helps to avoid any potential issues and ensures that you receive the best possible treatment tailored to your needs.

Storage and Handling

To ensure the safety and effectiveness of your product, always check that the tape seal on the flaps of the outer packaging is intact. If the seal is damaged or missing, do not use the product. It's also important to keep the outer packaging, as it contains essential information about the product's uses, directions, and warnings. This will help you use the product correctly and safely.

Additional Information

No further information is available.

FAQ

What is the primary use of this drug?

This drug is used for the temporary relief of pain due to toothaches.

How should I apply the product?

Cut open the tip of the tube on the score mark and apply a small amount to the cavity and around the gum. You can use it up to 4 times daily or as directed by a healthcare provider.

Are there any age restrictions for using this product?

Do not use this product in children under 2 years of age. Children between 2 and 12 years should be supervised during use.

What should I do if I experience side effects?

Stop use and ask a physician if you develop swelling, rash, or fever, or if irritation, pain, or redness persists or worsens.

How long can I use this product?

Do not use for more than 7 days unless directed by a physician or healthcare provider.

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.

Is there any warning associated with this product?

Yes, there is a warning for methemoglobinemia; please refer to the package warning for more details.

Can I use this product if I have kidney problems?

Dosage adjustments may be necessary for patients with reduced renal function, and renal function tests should be monitored regularly.

Is this product safe to use during pregnancy or while nursing?

There is no specific information regarding the use of this product during pregnancy or nursing, so consult a healthcare provider before use.

What should I check before using the product?

Do not use if the tape seal on the outer packaging is damaged or missing, and retain the outer packaging for full product uses, directions, and warnings.

Packaging Info

Below are the non-prescription pack sizes of Family Wellness (benzocaine 10%). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Family Wellness.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The product is available in two gel formulations: gel1 and gel2. Each formulation is designed to provide specific therapeutic benefits. The gels are characterized by their unique compositions, which may include various active and inactive ingredients tailored for optimal efficacy and stability. The appearance of the gels is consistent with standard pharmaceutical preparations, ensuring ease of application and patient compliance.

Uses and Indications

This drug is indicated for the temporary relief of pain associated with toothaches. There are no known teratogenic or nonteratogenic effects associated with its use.

Dosage and Administration

Cut open the tip of the tube at the score mark to prepare for application. For adults and children aged 2 years and older, a small amount of the product should be applied to the cavity and around the gums surrounding the teeth. This application may be performed up to four times daily or as directed by a physician or healthcare provider.

Children between the ages of 2 and 12 years should be supervised during the use of this product to ensure safe and effective application. For children under 2 years of age, it is recommended to consult a physician or healthcare provider prior to use.

Contraindications

Use is contraindicated in the following situations:

The product should not be used for teething. Additionally, it is contraindicated in children under 2 years of age due to safety concerns.

Patients should not exceed the directed dosage or use the product for more than 7 days unless specifically instructed by a physician or healthcare provider.

Warnings and Precautions

Methemoglobinemia is a serious condition that may occur with the use of this medication; healthcare professionals should refer to the package warning for detailed information regarding this risk.

In the event of an overdose or an allergic reaction, it is imperative to seek immediate medical assistance or contact a Poison Control Center. Prompt action is essential to mitigate potential complications.

Healthcare providers should advise patients to discontinue use and consult a physician if any of the following occur: swelling, rash, or fever develops; irritation, pain, or redness persists or worsens; or if symptoms do not show improvement within 7 days. These precautions are critical to ensure patient safety and effective management of any adverse reactions.

Side Effects

Patients may experience serious adverse reactions, including methemoglobinemia, which is highlighted in the package warning. It is crucial for patients to be aware of this potential risk.

In addition to serious reactions, patients should discontinue use and consult a physician if they experience any of the following: swelling, rash, or fever; persistent or worsening irritation, pain, or redness; or if symptoms do not improve within 7 days. These reactions warrant medical attention to ensure patient safety and appropriate management.

Drug Interactions

There are no specific drug interactions or laboratory test interactions identified in the available data. Therefore, no recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Family Wellness (benzocaine 10%). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Family Wellness.
Details

Pediatric Use

For teething in pediatric patients under 2 years of age, consultation with a physician or healthcare provider is advised prior to use. Children aged 2 to 12 years should be supervised while using this product to ensure safe administration. It is essential for caregivers to seek professional guidance for infants and toddlers to mitigate potential risks associated with unsupervised use.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

There is currently no information available regarding the use of Family Wellness Regular benzocaine 10% gel during pregnancy. This includes any safety concerns, dosage modifications, or special precautions that may be necessary for pregnant patients. Healthcare professionals should exercise caution and 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 in nursing mothers. Additionally, there is no information available about the potential for excretion in breast milk or any associated risks to breastfed infants.

Renal Impairment

Dosage adjustments may be necessary for patients with reduced renal function. It is important to monitor renal function tests regularly in patients with known kidney problems. Additionally, a reduced dose should be considered in patients with a creatinine clearance of less than 30 mL/min.

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, the following management procedures should be considered:

  1. Assessment: Conduct a thorough assessment of the patient's clinical status, including vital signs and level of consciousness.

  2. Supportive Care: Provide supportive care as necessary, which may include airway management, oxygen supplementation, and intravenous fluids.

  3. Consultation: Engage with a poison control center or toxicology expert for guidance on specific interventions and antidotes, if applicable.

  4. Documentation: Document all findings, interventions, and the patient's response to treatment meticulously.

Healthcare professionals should remain vigilant and prepared to implement these general management strategies in the event of an overdose, even in the absence of specific overdosage information.

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 keep the medication out of reach of children. In the event of an overdose or allergic reaction, patients should seek medical help or contact a Poison Control Center immediately.

Patients should be instructed not to exceed the recommended dosage and to refrain from using the medication for more than 7 days unless directed by a physician or healthcare provider. It is important to inform patients that this medication is not intended for use in teething and should not be administered to children under 2 years of age.

Healthcare providers should counsel patients to discontinue use and consult a physician if any of the following occur: swelling, rash, or fever develops; irritation, pain, or redness persists or worsens; or if symptoms do not improve within 7 days.

Storage and Handling

The product is supplied in packaging that must be inspected prior to use. It is essential to refrain from using the product if the tape seal on the flaps of the outer packaging is damaged or missing. Healthcare professionals are advised to retain the outer packaging to access complete product uses, directions, and warnings.

For optimal storage and handling, it is recommended to keep the product in its original packaging until ready for use. This ensures that all necessary information remains accessible and that the product is protected from potential contamination or damage.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Family Wellness, 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 Family Wellness, 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.