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Family Wellness Pain Relieving

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This product has been discontinued

Active ingredients
  • Menthol, Unspecified Form 100 mg/1 g
  • Methyl Salicylate 150 mg/1 g
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 2020
Label revision date
July 2, 2020
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Menthol, Unspecified Form 100 mg/1 g
  • Methyl Salicylate 150 mg/1 g
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 2020
Label revision date
July 2, 2020
Manufacturer
Velocity Pharma LLC
Registration number
part348
NDC root
76168-606
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 temporarily relieve minor aches and pains in your muscles and joints. It can be helpful for various conditions, including simple backache, arthritis, strains, bruises, and sprains. By targeting these discomforts, it aims to improve your overall comfort and mobility.

Uses

You can use this medication to temporarily relieve minor aches and pains in your muscles and joints. It is effective for conditions such as simple backache, arthritis, strains, bruises, and sprains. Whether you're dealing with discomfort from a recent injury or chronic pain, this medication can help ease your symptoms and improve your comfort.

Rest assured, there are no known teratogenic effects (which means it does not cause birth defects) associated with this medication, making it a safer option for those concerned about such risks.

Dosage and Administration

It's important to use this medication only as directed by your healthcare provider. If you are an adult or a child aged 12 years and older, you can apply it to the affected area up to 3 to 4 times a day. Make sure to follow the recommended frequency to ensure safety and effectiveness.

If the patient is a child under 12 years old, it's essential to consult a doctor before use. They can provide guidance on the appropriate dosage and application for younger patients. Always prioritize safety and follow the advice of a healthcare professional.

What to Avoid

You should avoid using this product on wounds or damaged skin, as well as with a heating pad. It is also important not to use it on children under 12 years of age who have arthritis-like conditions. Additionally, make sure to keep it away from your eyes and mucous membranes, and do not apply a tight bandage over the area.

By following these guidelines, you can help ensure your safety and the effectiveness of the product. If you have any questions or concerns, please consult a healthcare professional.

Side Effects

When using this product, it's important to be aware of some potential side effects and precautions. You should avoid using it on wounds or damaged skin, and it should not be applied with a heating pad. If you are under 12 years old and have arthritis-like conditions, do not use this product. If you notice redness in the area where you apply it, consult your doctor before continuing use.

While using the product, make sure to keep it away from your eyes and mucous membranes, and do not wrap the area tightly. If your condition worsens, symptoms last more than 7 days, or if you experience excessive skin irritation, stop using the product and seek medical advice. Additionally, keep this product out of reach of children, as accidental ingestion can be serious; if swallowed, contact a medical professional or Poison Control Center immediately.

Warnings and Precautions

This product is for external use only, so please avoid applying it to wounds or damaged skin. It should not be used with a heating pad or on children under 12 years old who have arthritis-like conditions. If you notice redness in the area where you plan to use the product, consult your doctor before proceeding.

While using this product, be careful to keep it away from your eyes and mucous membranes, and do not wrap the area tightly with a bandage. If your condition worsens, symptoms last longer than 7 days, or if you experience excessive skin irritation, stop using the product and contact your doctor. Additionally, if symptoms improve and then return within a few days, reach out to your healthcare provider. Always keep this product out of reach of children, and if it is swallowed, seek medical help or contact a Poison Control Center immediately.

Overdose

It's important to keep this medication out of reach of children to prevent accidental ingestion. If you or someone else accidentally swallows it, seek medical help right away or contact a Poison Control Center.

Signs of an overdose can vary, but if you notice unusual symptoms or feel unwell after taking the medication, don't hesitate to get help. Acting quickly can make a significant difference in ensuring safety and health.

Pregnancy Use

When considering the use of Family Wellness Pain Relieving cream (which contains menthol and methyl salicylate) during pregnancy, it's important to note that there is no specific information available about its safety, dosage adjustments, or any special precautions for pregnant individuals. This means that the effects of this cream on you or your developing baby are not well understood.

If you are pregnant or planning to become pregnant, it’s best to consult with your healthcare provider before using this product. They can help you weigh the potential risks and benefits based on your individual situation. Always prioritize your health and the health of your baby when making decisions about medication use during pregnancy.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to talk to your healthcare professional before using this product. There is a possibility that it may be excreted in breast milk, which means it could pass to your baby. Since the effects on nursing infants have not been thoroughly studied, it's best to exercise caution. Your healthcare provider can help you weigh the benefits and risks to ensure the safety of both you and your baby.

Pediatric Use

If your child is under 12 years old and has arthritis-like conditions, it's important not to use this medication. For children in this age group, you should consult a doctor before use.

For those aged 12 and older, you can apply the medication to the affected area up to 3 to 4 times a day. Always follow the guidance of a healthcare professional to ensure safe and effective use.

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, it’s important to consult with a healthcare provider for personalized advice. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

Renal Impairment

If you have kidney problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or safety considerations for your condition. This means that there are no tailored guidelines for how this medication may affect you if you have renal impairment (kidney issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your health situation. They can help monitor your kidney function and make any necessary adjustments to your treatment plan.

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).

Before starting any new medication, including this one, you should discuss your liver health with your healthcare provider. They can help determine the best approach for your treatment and ensure your safety.

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 way, you can work together to ensure your treatment is safe and effective.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 20° to 25°C (68° to 77°F). This temperature range helps maintain the product's effectiveness and safety.

When handling the product, be sure to follow any specific instructions provided to avoid contamination or damage. Always keep it in a clean environment to ensure it remains safe for use. If you have any questions about disposal or further handling, consult the guidelines provided with your product.

Additional Information

You should apply this medication topically to the affected area, using it no more than 3 to 4 times a day if you are an adult or a child aged 12 years and older. If the patient is under 12 years old, it's important to consult a doctor before use. Always follow the recommended application guidelines for safe and effective treatment.

FAQ

What conditions does this drug temporarily relieve?

This drug temporarily relieves minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains.

How should I use this drug?

Apply to the affected area not more than 3 to 4 times daily for adults and children 12 years of age and older. For children under 12 years, consult a doctor.

Are there any contraindications for using this drug?

Do not use on wounds or damaged skin, with a heating pad, or on a child under 12 years of age with arthritis-like conditions.

What should I do if I experience excessive skin irritation?

Stop use and ask a doctor if excessive skin irritation occurs or if the condition worsens or persists for more than 7 days.

Is this drug safe to use during pregnancy?

There is no specific information regarding the safety of this drug during pregnancy; consult a healthcare professional for advice.

Can nursing mothers use this drug?

Nursing mothers should consult a healthcare professional before using this product, as there is a potential for excretion in breast milk.

What should I do if I accidentally swallow this drug?

Keep out of reach of children to avoid accidental ingestion. If swallowed, get medical help or contact a Poison Control Center immediately.

What precautions should I take while using this drug?

Avoid contact with eyes or mucous membranes, do not bandage tightly, and consult a doctor if you have redness over the affected area.

Packaging Info

Below are the non-prescription pack sizes of Family Wellness Pain Relieving (menthol and methyl salicylate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Family Wellness Pain Relieving.
Details

Drug Information (PDF)

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

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with muscles and joints. Specifically, it is effective for conditions such as simple backache, arthritis, strains, bruises, and sprains.

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

Dosage and Administration

The medication should be used only as directed. For adults and children aged 12 years and older, it is recommended to apply the product to the affected area no more than 3 to 4 times daily. For children under 12 years of age, it is advised to consult a physician before use.

Contraindications

Use is contraindicated in the following situations:

  • Application on wounds or damaged skin is prohibited due to the risk of exacerbating the injury or causing irritation.

  • Concurrent use with a heating pad is contraindicated, as this may lead to increased risk of burns or skin irritation.

  • The product should not be used in children under 12 years of age with arthritis-like conditions, as safety and efficacy have not been established in this population.

  • Contact with eyes or mucous membranes must be avoided to prevent irritation or injury.

  • Tight bandaging is contraindicated to ensure proper circulation and prevent tissue damage.

Warnings and Precautions

For external use only. This product is contraindicated for application on wounds or damaged skin and should not be used in conjunction with a heating pad. It is also not recommended for children under 12 years of age who present with arthritis-like conditions.

Healthcare professionals should advise patients to consult a physician prior to use if there is any redness present over the affected area. During application, it is crucial to avoid contact with the eyes or mucous membranes, and to refrain from tightly bandaging the treated area.

Patients should be instructed to discontinue use and seek medical advice if any of the following occur: the condition worsens or symptoms persist beyond 7 days; symptoms resolve only to recur within a few days; or if excessive skin irritation develops.

Additionally, this product must be kept out of reach of children to prevent accidental ingestion. In the event of swallowing, immediate medical assistance should be sought or contact with a Poison Control Center is recommended.

Side Effects

Patients using this product should be aware of several important safety considerations. The product is intended for external use only and should not be applied to wounds or damaged skin. It is contraindicated for use with a heating pad and should not be used on children under 12 years of age with arthritis-like conditions.

Before using this product, patients are advised to consult a healthcare professional if there is redness over the affected area. During use, it is crucial to avoid contact with the eyes or mucous membranes and to refrain from tightly bandaging the area.

Patients should discontinue use and seek medical advice if the condition worsens, if symptoms persist for more than 7 days, if symptoms resolve and then recur within a few days, or if excessive skin irritation occurs.

Additionally, it is important to keep the product out of reach of children to prevent accidental ingestion. In the event of swallowing the product, patients should seek medical assistance or contact a Poison Control Center immediately.

Drug Interactions

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

Packaging & NDC

Below are the non-prescription pack sizes of Family Wellness Pain Relieving (menthol and methyl salicylate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Family Wellness Pain Relieving.
Details

Pediatric Use

Pediatric patients under 12 years of age with arthritis-like conditions should not use this medication. For children in this age group, it is advised to consult a healthcare professional before use.

For adolescents aged 12 years and older, the recommended application is to the affected area no more than 3 to 4 times daily.

Geriatric Use

There is no specific information available 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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

There is no specific information available regarding the use of Family Wellness Pain Relieving cream (menthol and methyl salicylate) during pregnancy. As such, the safety of this product in pregnant patients has not been established, and there are no known dosage modifications or special precautions recommended for use during pregnancy. Healthcare professionals should consider the lack of data when advising women of childbearing potential and weigh the potential risks and benefits before recommending this product to pregnant patients.

Lactation

Lactating mothers should consult a healthcare professional before using this product. There is a potential for excretion in breast milk, and the effects on nursing infants are not well studied; therefore, caution is advised.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this medication. Consequently, there are no 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 prescribing information.

Overdosage

Accidental ingestion of the medication can pose serious health risks, particularly in children. Therefore, it is imperative to keep the product out of reach of children to prevent any potential overdosage incidents.

In the event of accidental swallowing, immediate medical assistance should be sought. Healthcare professionals are advised to contact a Poison Control Center without delay to ensure appropriate management and intervention. Prompt action is crucial in mitigating the effects of overdosage and ensuring patient safety.

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 compound in these areas.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. In the event of swallowing, patients should seek medical assistance or contact a Poison Control Center immediately.

Patients should be instructed not to use the product on wounds or damaged skin, and to avoid using it in conjunction with a heating pad. It is important to inform patients that this product should not be used on children under 12 years of age who have arthritis-like conditions.

Healthcare providers should counsel patients to discontinue use and consult a doctor if their condition worsens or if symptoms persist for more than 7 days. Additionally, patients should be advised to stop using the product and seek medical advice if symptoms resolve and then recur within a few days, or if excessive skin irritation occurs.

While using this product, patients should be cautioned to avoid contact with eyes or mucous membranes. They should also be informed not to bandage the area tightly. Lastly, healthcare providers should recommend that patients consult a doctor before use if there is redness over the affected area.

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 temperature range of 20° to 25°C (68° to 77°F) to maintain its integrity and efficacy. Proper storage conditions should be ensured to prevent any degradation of the product.

Additional Clinical Information

The medication is administered topically, with the recommended frequency for adults and children aged 12 years and older being 3 to 4 applications to the affected area daily. For children under 12 years of age, it is advised to consult a doctor regarding the appropriate use.

There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

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