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Family Wellness Hot and Cold Pain Relief

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Active ingredients
  • Menthol, Unspecified Form 100 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
  • 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
55319-824
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

Cold & Hot Pain Relief Cream is a topical product designed to provide temporary relief from minor aches and pains in muscles and joints. It contains menthol (a compound that creates a cooling sensation) at 10% and methyl salicylate (a compound that produces a warming effect) at 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 can be a helpful option for managing everyday pain, allowing you to continue with your daily activities more comfortably.

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 experiencing 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 remember to follow the instructions carefully for the best results.

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 crucial 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 where the medication is used.

Side Effects

You should be aware that this product is for external use only and should not be applied to wounds or damaged skin. It is also not recommended for use with a heating pad or on children under 12 years of age who have arthritis-like conditions. If you notice any redness over the affected area, it's best to consult a doctor before using the product.

If your condition worsens or symptoms last longer than 7 days, you should stop using the product and seek medical advice. Additionally, if your symptoms improve and then return within a few days, or if you experience excessive skin irritation, please contact your healthcare provider.

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 any redness in the area you plan to treat, consult your doctor before using it.

Keep this medication out of reach of children. If a child accidentally swallows it, seek medical help or contact a Poison Control Center right away. You should stop using the product and call your doctor if your condition worsens, if symptoms last longer than 7 days, if symptoms improve and then return within a few days, or if you experience excessive skin irritation.

In case of accidental ingestion, seek emergency medical help or contact a Poison Control Center immediately.

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 effects of an overdose for this medication, you should be aware of general signs that may indicate a problem. These can include unusual drowsiness, confusion, or difficulty breathing.

If you notice any of these symptoms or have concerns about an overdose, seek medical help right away. It's always better to err on the side of caution when it comes to your health. Remember, if you are ever in doubt, contacting a healthcare professional is the best course of action.

Pregnancy Use

If you are pregnant or planning to become pregnant, you can feel reassured that there are no specific warnings, precautions, or contraindications related to the use of Family Wellness Hot and Cold Pain Relief cream during pregnancy. This means that, based on the information available, the cream is considered safe for use without any known risks to you or your developing baby. However, it's always a good idea to consult with your healthcare provider before using any new products during pregnancy to ensure they are appropriate for your individual situation.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding nursing mothers in the information provided. Additionally, there are no particular considerations or precautions mentioned for lactation (the process of producing milk). This suggests that the use of the medication may not pose significant risks to you or your nursing infant. However, it's always a good idea to consult with your healthcare provider about any concerns you may have while breastfeeding.

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 medication. 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 and follow these guidelines closely.

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 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.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect 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 differently due to your liver health.

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your liver condition. They can help monitor your liver function 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 or tests you may be taking. In this case, there are no known drug interactions or laboratory test interactions associated with this medication. However, every individual is different, and your healthcare provider can help ensure that your treatment is safe and effective for you. Always feel free to ask questions and share your complete list of medications and any tests you may be undergoing.

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 integrity of the device.

When handling the product, make sure to do so in a clean environment to avoid contamination. Always follow any specific instructions provided for use and disposal to ensure safety and effectiveness.

Additional Information

No further information is available.

FAQ

What is Cold & Hot Pain Relief Cream used for?

Cold & Hot 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 active ingredients in Cold & Hot Pain Relief Cream?

The cream contains 10% menthol and 30% methyl salicylate.

How should I use Cold & Hot Pain Relief Cream?

Apply the 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 Cold & Hot Pain Relief Cream?

Yes, it is for external use only and should not be used 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 Cold & Hot Pain Relief Cream?

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

What should I do if my condition worsens or symptoms persist?

Stop using the cream and consult a doctor if your condition worsens or symptoms persist for more than 7 days.

Is Cold & Hot Pain Relief Cream safe to use during pregnancy or while nursing?

There are no specific warnings or recommendations regarding the use of this cream during pregnancy or lactation.

How should I store Cold & Hot Pain Relief Cream?

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

Packaging Info

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

Packaging configurations for Family Wellness Hot and Cold Pain Relief.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Family Wellness Cold & Hot Pain Relief Cream is formulated with 10% menthol and 30% methyl salicylate. The product is packaged in a net weight of 1.25 ounces (35.4 grams). It is identified by the National Drug Code (NDC) 55319-824-35.

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 associated with 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.

General precautions must be observed, including the necessity to keep this and all medications out of the reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

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

In cases of ingestion, it is imperative to seek emergency medical help or contact a Poison Control Center without delay.

Side Effects

Patients using this product should be aware that it is intended 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 healthcare provider.

Drug Interactions

There are no documented drug interactions associated with this medication. Additionally, there are no known interactions with laboratory tests. 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 Hot and Cold Pain Relief (hot and cold pain relief). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Family Wellness Hot and Cold Pain Relief.
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 doctor 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. 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 are no specific warnings, precautions, or contraindications regarding pregnancy associated with the use of Family Wellness Hot and Cold Pain Relief cream. Available data do not indicate any known risks to pregnant patients or potential adverse fetal outcomes. However, as with any medication, healthcare professionals should consider the benefits and risks when recommending this product to women of childbearing potential. It is advisable for pregnant patients to consult their healthcare provider before using this cream to ensure it aligns with their individual health needs and circumstances.

Lactation

There are no specific warnings or recommendations regarding nursing mothers. Additionally, there are no specific considerations or precautions mentioned related to lactation.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

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 event of an overdosage, there is currently no specific information available regarding the effects or management of such an occurrence. Healthcare professionals are advised to monitor the patient closely for any unusual symptoms and to provide supportive care as necessary.

In the absence of detailed guidance, it is recommended that healthcare providers consult local poison control centers or relevant medical authorities for further assistance in managing potential overdosage situations. Continuous assessment of the patient's condition is essential to ensure appropriate interventions are implemented promptly.

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. 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 stop using the product and consult a doctor if their condition worsens or if symptoms persist for more than 7 days. They should also be advised to seek medical attention if symptoms clear up and then recur within a few days, or if they experience excessive skin irritation.

While using this product, patients must be cautioned to avoid contact with their eyes and mucous membranes. Additionally, they should be instructed not to bandage the area tightly.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It should be stored at a controlled room temperature of 20° to 25°C (68° to 77°F) to maintain its efficacy and stability. Proper container requirements must be adhered to, ensuring that the product is kept in an appropriate environment. Special handling needs should be observed to prevent any compromise to the product's integrity.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Family Wellness Hot and Cold Pain Relief, 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 Hot and Cold Pain Relief, 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.