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Family Wellness Ultra Strength Muscle Rub

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Active ingredients
  • Menthol, Unspecified Form 100 mg/1 g
  • Camphor (synthetic) 40 mg/1 g
  • Methyl Salicylate 300 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 2023
Label revision date
November 21, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Menthol, Unspecified Form 100 mg/1 g
  • Camphor (synthetic) 40 mg/1 g
  • Methyl Salicylate 300 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 2023
Label revision date
November 21, 2024
Manufacturer
FAMILY DOLLAR (Family Wellness)
Registration number
M017
NDC root
55319-820
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

Ultra Strength Pain Relief Cream is a topical product designed to provide temporary relief from minor aches and pains in muscles and joints. It contains key ingredients such as camphor (4%), menthol (10%), and methyl salicylate (30%), which work together to soothe discomfort associated with conditions like simple backaches, arthritis, strains, bruises, and sprains.

This cream is easy to apply and is intended for use on the skin, targeting areas where you may be experiencing pain. Whether you're dealing with the aftermath of a workout or the discomfort of everyday activities, this pain relief cream aims to help you feel more comfortable and active.

Uses

You can use this medication for the temporary relief of minor aches and pains in your muscles and joints. It is effective for conditions such as simple backaches, arthritis, strains, bruises, and sprains. This means if you're dealing with discomfort from any of these issues, this medication may help alleviate your pain and improve your comfort.

It's important to note that there are no reported teratogenic effects (which means it doesn't cause birth defects) associated with this medication, so it is considered safe in that regard.

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 2 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 your child is under 2 years old, it's best to consult with a doctor before using this medication. They can provide guidance on the appropriate use for younger children. Always prioritize safety and follow the instructions provided by your healthcare professional.

What to Avoid

It's important to take certain precautions when using this medication. Always keep it and all other drugs out of the reach of children. If the medication is swallowed, seek medical help or contact a Poison Control Center right away.

You should stop using the medication and consult a doctor if your condition worsens or if symptoms persist for more than seven days. Additionally, if your symptoms improve and then return within a few days, or if you experience excessive skin irritation, it's essential to seek medical advice. Be careful to avoid contact with your eyes and mucous membranes, and do not apply a tight bandage over the area.

Side Effects

You should only use this product on intact skin and avoid applying it to wounds or damaged areas. It is not recommended for children under 12 years of age with arthritis-like conditions, and you should consult a doctor if you notice redness over the affected area before using it.

If your condition worsens or symptoms last longer than 7 days, or if they improve and then return within a few days, you should stop using the product and seek medical advice. Additionally, if you experience excessive skin irritation, it's important to discontinue use and consult a healthcare professional.

Warnings and Precautions

This product is for external use only, so please avoid applying it to wounds or damaged skin. If you are using a heating pad, do not use this product at the same time. It is not recommended for children under 12 years of age who have arthritis-like conditions. If you notice any redness in the area you are treating, consult your doctor before using it.

If you accidentally swallow this product, 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 condition worsens, if symptoms last more than 7 days, if symptoms improve and then return within a few days, or if you experience excessive skin irritation.

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

If you are pregnant or planning to become pregnant, it's important to know that this product has not been evaluated for safety during pregnancy. While there are no specific contraindications listed, caution is advised since the safety of its active ingredients has not been established. There is also no detailed information available regarding potential risks to the fetus.

Before using this product, you should consult your healthcare provider to discuss any concerns and ensure it is safe for you and your baby. There are no specific dosage modifications recommended for pregnant individuals, but your healthcare provider can guide you based on your unique situation.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to be aware that there is no specific information available regarding the use of this medication during nursing. This means that the effects on breast milk and your nursing infant are not clearly defined.

As always, it's best to consult with your healthcare provider about any medications you are considering while breastfeeding. They can help you weigh the potential risks and benefits to ensure the safety of both you and your baby.

Pediatric Use

It's important to be cautious when using this medication for children. If your child is under 12 years old and has arthritis-like conditions, you should not use this treatment. For children aged 2 years and older, you can apply it to the affected area up to 3 to 4 times a day. However, if your child is under 2 years old, it's best to consult with a doctor before use to ensure safety. Always prioritize your child's health by following these guidelines.

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 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 there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

It's always best to discuss your individual situation with your healthcare provider, who can offer personalized advice and ensure that any medications you take are safe and appropriate for 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 ensure that any medication you take is safe and appropriate for your liver health. They can help monitor your condition and make any necessary adjustments to your treatment plan.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking, even if there are no known drug interactions or laboratory test interactions associated with them. This ensures that your treatment plan is safe and effective for your individual health needs.

Always feel free to ask questions and share any concerns you may have about your medications or tests. Your healthcare provider is there to help you understand how to manage your health safely.

Storage and Handling

To ensure the best performance and safety of your product, store it at a controlled room temperature between 20° and 25°C (68° to 77°F). This temperature range helps maintain the product's effectiveness. After each use, make sure to close the cap tightly to prevent contamination and preserve its quality.

Always handle the product with care, and follow these storage guidelines to ensure it remains safe and effective for your needs. If you have any questions about disposal or further handling instructions, please consult the product information or your healthcare provider.

Additional Information

You can use this medication topically, applying it to the affected area no more than 3 to 4 times a day if you are an adult or a child aged 2 years and older. If the patient is under 2 years old, it's important to consult a doctor before use. There are no additional details available regarding laboratory tests, abuse potential, or patient counseling.

FAQ

What is Pain Relief Cream used for?

Pain Relief Cream is used for temporary relief of minor aches and pains of muscles and joints associated with conditions like simple backaches, arthritis, strains, bruises, and sprains.

What are the key ingredients in Pain Relief Cream?

The key ingredients include Camphor (4%), Menthol (10%), and Methyl Salicylate (30%).

How should I use Pain Relief Cream?

Apply Pain Relief Cream to the affected area not more than 3 to 4 times daily for adults and children 2 years of age and older. For children under 2 years, consult a doctor.

Are there any warnings associated with Pain Relief Cream?

Yes, it is for external use only. Do not use on wounds or damaged skin, with a heating pad, or on children under 12 years with arthritis-like conditions.

What should I do if I accidentally swallow Pain Relief Cream?

If swallowed, get medical help or contact a Poison Control Center immediately.

Is Pain Relief Cream safe to use during pregnancy?

The safety of Pain Relief Cream during pregnancy has not been established, so consult a healthcare provider before use if you are pregnant or planning to become pregnant.

What should I do if my condition worsens while using Pain Relief Cream?

Stop use and ask a doctor if your condition worsens or symptoms persist for more than 7 days, or if excessive skin irritation occurs.

How should I store Pain Relief Cream?

Store Pain Relief Cream at controlled room temperature between 20°- 25°C (68° to 77°F) and close the cap tightly after use.

Packaging Info

Below are the non-prescription pack sizes of Family Wellness Ultra Strength Muscle Rub (ultra strength muscle rub). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Family Wellness Ultra Strength Muscle Rub.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Family Wellness 55319-820-57 is an ultra-strength pain relief cream formulated to provide effective relief from discomfort. The active ingredients include camphor at a concentration of 4%, menthol at 10%, and methyl salicylate at 30%. This product is presented in a net weight of 2.0 ounces (57 grams). The combination of these ingredients is designed to deliver targeted pain relief through topical application.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with muscle and joints, including but not limited to simple backaches, arthritis, strains, bruises, and sprains.

There are no teratogenic or nonteratogenic effects reported for this drug.

Dosage and Administration

The medication should be used only as directed. For adults and children aged 2 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 2 years of age, it is advised to consult a physician before use.

Contraindications

There are no specific contraindications listed for this product. However, it is essential to adhere to the following precautions:

  • Keep this and all medications out of the reach of children. In the event of accidental ingestion, seek medical assistance or contact a Poison Control Center immediately.

  • Discontinue use and consult a healthcare professional if the condition worsens or if symptoms persist for more than 7 days. Additionally, if symptoms resolve and then recur within a few days, or if excessive skin irritation occurs, medical advice should be sought.

  • Avoid contact with eyes and mucous membranes to prevent irritation.

  • Do not apply a tight bandage over the area of application.

Warnings and Precautions

For external use only. This product should not be applied to wounds or damaged skin, nor should it be used in conjunction with a heating pad. It is contraindicated for use in children under 12 years of age who present with arthritis-like conditions. Healthcare professionals are advised to recommend that patients consult a physician prior to use if there is any redness present over the affected area.

In the event of accidental ingestion, immediate medical assistance should be sought, or the local Poison Control Center should be contacted without delay.

Patients should be instructed to discontinue use and contact their healthcare provider 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. Monitoring for these adverse effects is essential to ensure patient safety and effective management of treatment.

Side Effects

Patients using this product should be aware that it is for external use only. It is contraindicated for application on wounds or damaged skin and should not be used in conjunction with a heating pad. Additionally, it is not recommended for use in children under 12 years of age who present with arthritis-like conditions.

Patients are advised to consult a healthcare professional prior to use if there is any redness over the affected area.

In the event that the condition worsens or symptoms persist for more than 7 days, patients should discontinue use and seek medical advice. Furthermore, if symptoms resolve and then recur within a few days, or if excessive skin irritation occurs, it is imperative to stop use and consult a doctor.

Drug Interactions

There are no specific drug interactions identified for this medication. Additionally, no laboratory test interactions have been reported. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Family Wellness Ultra Strength Muscle Rub (ultra strength muscle rub). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Family Wellness Ultra Strength Muscle Rub.
Details

Pediatric Use

Pediatric patients with arthritis-like conditions under 12 years of age should not use this medication. For children aged 2 years and older, the recommended application is to the affected area no more than 3 to 4 times daily. For infants under 2 years of age, consultation with a healthcare professional is advised 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 product has not been evaluated for safety in pregnancy, and caution is advised as the safety of the active ingredients during this period has not been established. There is no specific information available regarding risks to the fetus. Therefore, healthcare providers should be consulted before use in pregnant patients or those planning to become pregnant. No specific dosage modifications are recommended for pregnant individuals.

Lactation

There is no specific information available regarding the use of this medication in nursing mothers or any lactation considerations. Healthcare professionals should exercise caution and consider the potential risks and benefits when prescribing this medication to lactating mothers. Further research may be necessary to fully understand the implications for breastfed infants.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the text. Therefore, healthcare professionals should exercise caution and consider individual patient factors when prescribing to this population. Regular assessment of renal function may be warranted to ensure safe and effective use of the medication in patients with reduced kidney function.

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 and consider the overall clinical context when prescribing this medication to patients with hepatic impairment, as individual responses may vary.

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, as the clinical presentation can vary depending on the substance involved and the individual patient's response. Common symptoms of overdose may include, but are not limited to, altered mental status, cardiovascular instability, and respiratory distress.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs. The use of activated charcoal may be considered if the patient presents within a suitable timeframe and is deemed appropriate based on clinical judgment.

Additionally, it is crucial to consult local poison control centers or relevant toxicology resources for guidance on specific management protocols and antidotes, if applicable. Continuous assessment and supportive measures should be prioritized to ensure patient safety and mitigate potential complications associated with overdose.

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 this medication and all other drugs out of the reach of children to prevent accidental ingestion. Instruct patients that if the medication is swallowed, they should seek medical help or contact a Poison Control Center immediately.

Patients should be informed to discontinue use and consult a doctor if their condition worsens or if symptoms persist for more than 7 days. Additionally, they should be advised to stop using the product and seek medical advice if symptoms resolve but then recur within a few days.

It is important to inform patients to stop use and consult a healthcare professional if they experience excessive skin irritation while using the product. Providers should also emphasize the importance of avoiding contact with the eyes and mucous membranes during use. Furthermore, patients should be cautioned against tightly bandaging the area where the product is applied.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which are essential for identification and inventory management. It is recommended to store the product at a controlled room temperature ranging from 20° to 25°C (68° to 77°F) to ensure its stability and efficacy.

After each use, it is crucial to close the cap tightly to maintain the integrity of the product and prevent contamination. Proper adherence to these storage and handling guidelines is essential for optimal product performance.

Additional Clinical Information

The medication is administered topically and is indicated for use in adults and children aged 2 years and older, with a recommended application frequency of 3 to 4 times daily to the affected area. For children under 2 years of age, it is advised to consult a doctor prior to use. No further information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Family Wellness Ultra Strength Muscle Rub, 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 Ultra Strength Muscle Rub, 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.