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Family Wellness Pain Relief with Lidocaine

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Active ingredient
Lidocaine Hydrochloride 40 mg/1 g
Other brand names
Drug classes
Amide Local Anesthetic, Antiarrhythmic
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2023
Label revision date
August 29, 2023
Active ingredient
Lidocaine Hydrochloride 40 mg/1 g
Other brand names
Drug classes
Amide Local Anesthetic, Antiarrhythmic
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2023
Label revision date
August 29, 2023
Manufacturer
FAMILY DOLLAR (Family Wellness)
Registration number
M017
NDC root
55319-822

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Drug Overview

Family Wellness Pain Relief Cream is a topical anesthetic that contains 4% lidocaine HCL (a medication that numbs the skin). This cream is designed to temporarily relieve minor pain, making it useful for various everyday discomforts. With a convenient size of 1.75 ounces, it can be easily applied to the affected area for quick relief.

Uses

You can use this medication to temporarily relieve minor pain. It’s designed to help you feel more comfortable when dealing with everyday aches and discomforts. Rest assured, there are no known teratogenic effects (which means it doesn’t cause birth defects) associated with this medication.

Dosage and Administration

When using this medication, if you are an adult or a child over 12 years old, you should apply a thin layer to the affected area every 6 to 8 hours. However, make sure not to apply it more than three times in a 24-hour period. This helps ensure that you are using the medication safely and effectively.

If you are caring for a child under 12 years old, it’s important to consult a doctor before using this medication. They can provide guidance on the appropriate treatment for younger children. Always follow these instructions carefully to achieve the best results.

What to Avoid

It's important to use this product safely to avoid potential complications. You should not apply it to large areas of your body, on cut, irritated, or swollen skin, or on puncture wounds. Additionally, avoid using it for more than one week without consulting your doctor.

While using this product, make sure to keep it away from your eyes and mucous membranes. Do not cover the area with a bandage or apply local heat, such as heating pads, and refrain from using it alongside other topical pain relievers. Following these guidelines will help ensure your safety and the effectiveness of the treatment.

Side Effects

It's important to use this product only on the skin and not for any other purpose. If your condition worsens, if symptoms last longer than 7 days, or if they improve and then return within a few days, you should stop using the product and consult a doctor.

If you are pregnant or breastfeeding, please speak with a healthcare professional before using this product to ensure it is safe for you.

Warnings and Precautions

This product is for external use only. If you accidentally swallow it, seek medical help or contact the Poison Control Center immediately. Avoid using it on large areas of your body, on cut, irritated, or swollen skin, and do not apply it to puncture wounds. It's important not to use this product for more than one week without consulting your doctor.

You should stop using the product and call your doctor if your condition worsens, if symptoms last longer than 7 days, or if they improve and then return within a few days. If you are pregnant or breastfeeding, consult a healthcare professional before using this product.

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 or symptoms of an overdose for this medication, general signs may include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms or feel something is wrong, 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 action can make a significant difference.

Pregnancy Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using this medication. They can provide guidance on whether it’s safe for you and your baby. Always prioritize your health and the health of your child by seeking expert advice.

Lactation Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using any medication. This ensures that you understand any potential risks and can make informed decisions about your health and the health of your baby. Always prioritize open communication with your doctor regarding your breastfeeding journey.

Pediatric Use

If you have a child under 12 years old, it's important to consult with a doctor before using this medication. For children aged 12 and older, you can apply a thin layer of the medication to the affected area every 6 to 8 hours. However, be sure not to exceed three applications in a 24-hour period to ensure safety and effectiveness. Always follow these guidelines to help protect your child's health.

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 ensure that your healthcare provider is aware of your age and any existing health conditions, as they can provide personalized advice and monitor for any potential issues. Your safety and well-being are the top priority.

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. They can provide the necessary guidance based on your individual 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 may affect you if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to discuss any concerns regarding your liver health and how it may relate to your treatment. They can help ensure that you receive the safest and most effective care.

Drug Interactions

It's important to be cautious when using certain medications together. Specifically, you should avoid using this medication at the same time as other topical analgesics (pain-relieving creams or gels applied to the skin). Mixing these products can increase the risk of side effects or reduce their effectiveness.

Always discuss any medications you are taking, including over-the-counter products, with your healthcare provider. They can help ensure that your treatment is safe and effective, and they can provide guidance on how to use your medications properly.

Storage and Handling

To ensure the best performance of your product, store it at a controlled room temperature between 20° and 25°C (68° and 77°F). This temperature range helps maintain the integrity and effectiveness of the device.

When handling the product, be sure to do so with clean hands and in a safe environment to avoid contamination. Always follow any specific disposal instructions provided to ensure safety and compliance.

Additional Information

No further information is available.

FAQ

What is Family Wellness Pain Relief Cream used for?

Family Wellness Pain Relief Cream is a topical anesthetic that temporarily relieves minor pain.

What is the active ingredient in this cream?

The active ingredient is Lidocaine HCL 4%.

How should I apply the cream?

Adults and children over 12 years should apply a thin layer to the affected area every 6 to 8 hours, not exceeding 3 applications in a 24-hour period.

Can children under 12 use this cream?

Children under 12 years should ask a doctor before use.

Are there any warnings I should be aware of?

This cream is for external use only. Avoid contact with eyes and mucous membranes, and do not use on large areas of the body or on cut, irritated, or swollen skin.

What should I do if my condition worsens?

Stop use and ask a doctor if your condition worsens or if symptoms persist for more than 7 days.

Is it safe to use if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, you should ask a health professional before use.

What should I do if I accidentally swallow the cream?

If swallowed, get medical help or contact Poison Control Center right away.

How should I store the cream?

Store the cream at controlled room temperature between 20°-25°C (68°-77°F).

Packaging Info

Below are the non-prescription pack sizes of Family Wellness Pain Relief with Lidocaine (pain relief with lidocaine). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Family Wellness Pain Relief with Lidocaine.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Family Wellness Pain Relief Cream is a topical anesthetic formulation containing 4% Lidocaine HCl. It is designed for localized pain relief. The product is packaged in a net weight of 1.75 ounces (49.6 grams). The National Drug Code (NDC) for this formulation is 55319-822-50.

Uses and Indications

This drug is indicated for the temporary relief of minor pain.

There are no teratogenic effects associated with this drug. Additionally, no nonteratogenic effects have been reported.

Dosage and Administration

For adults and children over 12 years of age, a thin layer of the medication should be applied to the affected area every 6 to 8 hours. The total number of applications must not exceed 3 times within a 24-hour period.

For children under 12 years of age, it is recommended to consult a physician prior to use.

Contraindications

Use of this product is contraindicated in the following situations:

Application on large areas of the body or on cut, irritated, or swollen skin is prohibited due to the potential for increased systemic absorption and adverse effects. The product should not be applied to puncture wounds, as this may lead to complications or delayed healing.

Prolonged use beyond one week without consulting a healthcare professional is contraindicated to prevent potential misuse or exacerbation of underlying conditions.

During use, contact with the eyes or mucous membranes must be avoided to prevent irritation or injury. Additionally, the area of application should not be bandaged or subjected to local heat, such as heating pads, as this may enhance absorption and increase the risk of adverse reactions. Concurrent use with other topical analgesics is also contraindicated to avoid potential additive effects and toxicity.

Warnings and Precautions

For external use only. This product is not intended for internal use, and ingestion may lead to serious health consequences. In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

General precautions must be observed when using this product. It is contraindicated for application on large areas of the body, as well as on cut, irritated, or swollen skin. Additionally, the product should not be applied to puncture wounds. Prolonged use beyond one week is not recommended without prior consultation with a healthcare professional.

Healthcare providers should advise patients to discontinue use and seek medical advice if any of the following occur: the condition worsens, symptoms persist for more than seven days, or if symptoms resolve and then recur within a few days. Pregnant or breastfeeding individuals should consult a healthcare professional before using this product to ensure safety for both mother and child.

In case of accidental ingestion, it is imperative to obtain emergency medical help or contact the Poison Control Center immediately.

Side Effects

For external use only. Patients are advised to stop use and consult a doctor if the condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then occur again within a few days. Additionally, it is recommended that individuals who are pregnant or breastfeeding seek guidance from a health professional before using this product.

Drug Interactions

Concurrent use of this medication with other topical analgesics is contraindicated. The combination may increase the risk of adverse effects without providing additional therapeutic benefit. It is advised to avoid using multiple topical analgesics simultaneously to ensure patient safety and efficacy of treatment. Monitoring for any signs of irritation or adverse reactions is recommended if there is a need to switch to or from another topical analgesic.

Packaging & NDC

Below are the non-prescription pack sizes of Family Wellness Pain Relief with Lidocaine (pain relief with lidocaine). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Family Wellness Pain Relief with Lidocaine.
Details

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. For adolescents aged 12 years and older, the recommended dosage is to apply a thin layer to the affected area every 6 to 8 hours, with a maximum of 3 applications within a 24-hour period.

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 potential adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully considered in these populations to ensure the safety of both the mother and the fetus or infant.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data regarding the excretion of this medication in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

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 excessive dosing. Symptoms of overdosage 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 implement supportive care measures, which may include monitoring vital signs, providing symptomatic treatment, and ensuring the patient's safety.

If available, consultation with a poison control center or a medical toxicologist is recommended to guide further management and intervention strategies.

Nonclinical Toxicology

If pregnant or breast-feeding, it is advised to consult a health professional prior to use. No non-teratogenic effects have been specified in the available data. Additionally, there are no details provided regarding nonclinical toxicology or animal pharmacology and toxicology.

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 the Poison Control Center if the product is swallowed. It is important to instruct patients not to apply the product to large areas of the body or on cut, irritated, or swollen skin, and to avoid using it on puncture wounds.

Patients should be informed that the product should not be used for more than one week without consulting a healthcare professional. They should be advised to discontinue use and consult a doctor if their condition worsens or if symptoms persist for more than seven days, or if symptoms clear up and then recur within a few days.

For patients who are pregnant or breastfeeding, it is essential to recommend that they consult a healthcare professional before using the product. Patients should be reminded to use the product only as directed and to read and follow all directions and warnings provided on the carton.

Additionally, healthcare providers should caution patients against allowing the product to come into contact with the eyes or mucous membranes. They should also advise against bandaging or applying local heat, such as heating pads, to the area of use, and inform them not to use the product concurrently with other topical analgesics.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a controlled room temperature, maintaining a range of 20° to 25°C (68° to 77°F). Proper storage conditions are crucial to ensure the integrity and efficacy of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Family Wellness Pain Relief with Lidocaine, 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 Pain Relief with Lidocaine, 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.

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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.