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Meijer Cold and Hot Therapy

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This product has been discontinued

Active ingredients
  • Menthol 10 g/100 g
  • Methyl Salicylate 30 g/100 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
December 15, 2022
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Menthol 10 g/100 g
  • Methyl Salicylate 30 g/100 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
December 15, 2022
Manufacturer
Meijer, Inc.
Registration number
part348
NDC root
41250-858
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

You can use this medication to help relieve pain in specific areas of your body. It is designed for adults and children aged 12 years and older, and you should apply it generously to the affected area, massaging it into the skin until it is fully absorbed. You can repeat this process as needed, but not more than four times a day. If you have a child under 12, it's best to consult a doctor before use.

Uses

You can use this product as directed for relief from pain. It is suitable for adults and children aged 12 years and older. To use it, apply a generous amount to the affected area and massage it into the skin until it is fully absorbed. You can repeat this process as needed, but do not apply it more than four times a day.

If you have a child under 12 years old, it's important to consult a doctor before using this product. Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) or nonteratogenic effects associated with this medication.

Dosage and Administration

It's important to know how to properly store your medication to ensure it remains effective. You should keep it at room temperature, ideally between 20-25ºC (68-77ºF). This helps maintain the quality of the medication until you need to use it.

Currently, there are no specific instructions regarding how to take or apply the medication, so be sure to follow any guidance provided by your healthcare provider or pharmacist when you receive it. If you have any questions about how to use your medication, don’t hesitate to ask for clarification.

What to Avoid

It's important to use this product safely to avoid potential issues. You should never apply it to wounds or damaged skin, and avoid using it with a heating pad, as this can lead to complications. Additionally, keep it away from your eyes and mucous membranes, and do not bandage the area tightly after application.

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 with a healthcare professional.

Side Effects

If you are considering using this product, please note that it is for external use only. If you have a history of allergic reactions to aspirin or salicylates, it’s important to consult your doctor before using it.

You should stop using the product and seek medical advice if your condition worsens, if symptoms last longer than 7 days, if symptoms improve and then return within a few days, if you experience excessive skin irritation, or if you notice any redness on your skin.

Warnings and Precautions

This product is for external use only, so please avoid applying it to wounds or damaged skin. If you have a history of allergic reactions to aspirin or salicylates, consult your doctor before using it. While using this product, be careful not to let it come into contact with your eyes or mucous membranes, and do not use it with a heating pad or bandage it tightly.

If you accidentally swallow this product, seek emergency medical help immediately or contact a Poison Control Center at 1-800-222-1222. You should also stop using the product and call your doctor if your condition worsens, if symptoms persist for more than 7 days, if symptoms improve and then return within a few days, if you experience excessive skin irritation, or if you notice any redness on your skin.

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 unusual drowsiness, confusion, or difficulty breathing. If you notice any of these signs, or if you are unsure, seek medical help right away.

In case of an overdose, contact your local emergency services or go to the nearest hospital. It's 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 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. This ensures that the treatment is safe and appropriate for your child's specific needs. Always prioritize your child's health by seeking professional guidance when it comes to their medication.

Geriatric Use

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. If you or a loved one is an older adult, be sure to discuss any potential risks or concerns with your healthcare provider. They can help determine the best approach, considering any unique health needs or conditions that may be present.

Always keep in mind that older adults may respond differently to medications, so regular check-ins with your doctor are essential to ensure safety and effectiveness.

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 (issues with liver function).

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver health and medication use. They can help ensure that you receive the safest and most effective treatment based on your individual needs.

Drug Interactions

It's important to talk to your healthcare provider before using this medication, especially if you have a history of allergic reactions to aspirin or salicylates (a group of drugs that includes aspirin). Your doctor can help determine if this medication is safe for you.

While there are no specific interactions with other drugs or laboratory tests noted, discussing all medications and tests you are undergoing with your healthcare provider is always a good practice. This ensures your safety and helps avoid any potential issues.

Storage and Handling

To ensure the best performance of your product, store it at room temperature, ideally between 20-25ºC (68-77ºF). This temperature range helps maintain the product's effectiveness and safety.

When handling the product, make sure to do so in a clean environment to avoid contamination. Always follow any specific instructions provided for use to ensure safety and effectiveness. If you have any questions about disposal or other safety measures, please refer to the guidelines provided with your product.

Additional Information

You should apply this medication topically to the affected area. For adults and children aged 12 and older, apply a generous amount and massage it into the skin until fully absorbed. You can repeat this process as needed, but do not exceed four applications in one day. If the patient is under 12 years old, it's important to consult a doctor before use.

FAQ

How should I use this product?

Use only as directed. For adults and children 12 years and older, apply generously to the affected area and massage until absorbed. You can repeat this up to 4 times daily.

What should I do if I am under 12 years old?

If you are under 12 years of age, you should ask a doctor before using this product.

Are there any warnings I should be aware of?

This product is for external use only. Avoid contact with eyes or mucous membranes, and do not use on wounds or damaged skin.

What should I do if I experience 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.

How should I store this product?

Store at room temperature between 20-25ºC (68-77ºF).

What should I do if I swallow this product?

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

Can I use this product while pregnant or breastfeeding?

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

Is there an allergy alert for this product?

Yes, if you are prone to allergic reactions from aspirin or salicylates, consult a doctor before use.

Packaging Info

Below are the non-prescription pack sizes of Meijer Cold and Hot Therapy (menthol, methyl salicylate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Meijer Cold and Hot Therapy.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The product is identified by the SPL code 34089-3. No specific description details are provided in the text.

Uses and Indications

This drug is indicated for the topical treatment of localized pain in adults and children aged 12 years and older. It should be applied generously to the affected area and massaged into the skin until thoroughly absorbed. The application may be repeated as necessary, not to exceed four times daily.

For children under 12 years of age, it is advised to consult a healthcare professional before use.

This drug should be used only as directed. There are no teratogenic or nonteratogenic effects associated with its use.

Dosage and Administration

Healthcare professionals are advised to store the product at room temperature, specifically between 20-25ºC (68-77ºF). No specific dosage or administration information is provided in the available data. It is essential to consult relevant clinical guidelines or product literature for detailed dosing recommendations and administration techniques.

Contraindications

Use is contraindicated in the following situations:

Application on wounds or damaged skin is prohibited due to the risk of exacerbating the condition and delaying healing. The use of a heating pad concurrently is contraindicated as it may increase the risk of burns or skin irritation. Additionally, contact with eyes or mucous membranes should be avoided to prevent irritation or injury. Tight bandaging is also contraindicated to ensure proper circulation and prevent tissue damage.

Warnings and Precautions

For external use only. Individuals with a known allergy to aspirin or salicylates should consult a healthcare professional prior to use to mitigate the risk of an allergic reaction.

It is imperative to adhere to the following precautions to ensure safe application of this product. The product should not be applied to wounds or damaged skin, as this may exacerbate irritation or lead to adverse effects. Additionally, the use of a heating pad in conjunction with this product is contraindicated. Care should be taken to avoid contact with the eyes or mucous membranes during application, and the area should not be tightly bandaged to prevent potential complications.

In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center (1-800-222-1222) should be contacted without delay.

Users are advised 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 recur within a few days; excessive skin irritation develops; or if there is noticeable redness of the skin.

Side Effects

Patients should be aware that the product is for external use only. An allergy alert is warranted; individuals who are prone to allergic reactions from aspirin or salicylates should consult a doctor prior to use.

In clinical practice, patients are advised to discontinue use and seek medical advice if any of the following occur: the condition worsens or symptoms persist for more than 7 days, symptoms resolve and then recur within a few days, excessive skin irritation develops, or if there is noticeable redness of the skin. These considerations are important to ensure patient safety and effective management of adverse reactions.

Drug Interactions

Patients with a known allergy to aspirin or salicylates should consult a healthcare professional prior to use, as there is a potential risk of allergic reactions.

No specific drug or laboratory test interactions have been identified in the available data. Therefore, routine monitoring or dosage adjustments related to drug interactions are not necessary based on the current information.

Packaging & NDC

Below are the non-prescription pack sizes of Meijer Cold and Hot Therapy (menthol, methyl salicylate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Meijer Cold and Hot Therapy.
Details

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. It is important to assess the appropriateness of treatment and dosage for this age group, as specific recommendations may vary based on individual health needs and conditions.

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. It is important to assess the potential risks and benefits in these populations, as the effects on fetal outcomes and lactation are not fully established. Healthcare providers should evaluate the necessity of treatment against any potential risks to the mother and child.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data on the excretion of this drug 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 may not have specific dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. 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. Regular monitoring of renal function is advisable to ensure patient safety and therapeutic efficacy.

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 the management of the overdose effectively. Additionally, healthcare professionals should refer to local protocols and guidelines for the management of overdose situations, as these may provide specific recommendations based on the substance involved.

Documentation of the incident, including the amount and timing of the overdose, is crucial for ongoing patient management and for informing any necessary follow-up care.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

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 the product, patients should seek medical assistance or contact a Poison Control Center immediately at 1-800-222-1222.

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 to avoid contact with the eyes or mucous membranes while using this product.

Healthcare providers should counsel patients against bandaging the area tightly after application. Patients should be advised to stop using the product and consult a doctor if their condition worsens or if symptoms persist for more than 7 days. Additionally, they should be informed to discontinue use and seek medical advice if symptoms resolve and then recur within a few days, if excessive skin irritation occurs, or if there is any redness of the skin.

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 room temperature, maintaining a range of 20-25ºC (68-77ºF). Proper storage conditions are crucial to ensure the integrity and efficacy of the product. No special handling requirements are noted; however, adherence to the specified temperature range is recommended to maintain optimal quality.

Additional Clinical Information

The medication is administered topically. For adults and children aged 12 years and older, it should be applied generously to the affected area and massaged into the skin until fully absorbed. This process may be repeated as necessary, but should not exceed four applications per day. For children under 12 years of age, it is advised to consult a doctor before use.

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

Drug Information (PDF)

This file contains official product information for Meijer Cold and Hot Therapy, 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 Meijer Cold and Hot Therapy, 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.