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Cold and Hot Medicated Large

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Active ingredient
Menthol, Unspecified Form 0.05 g/1 g
Other brand names
Dosage form
Patch
Route
Topical
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2024
Label revision date
July 29, 2025
Active ingredient
Menthol, Unspecified Form 0.05 g/1 g
Other brand names
Dosage form
Patch
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2024
Label revision date
July 29, 2025
Manufacturer
Universal Distribution Center LLC
Registration number
M017
NDC root
52000-421

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Drug Overview

This medication is designed to temporarily relieve minor aches and pains in your muscles and joints. It can help with discomfort caused by various conditions, including simple backache, arthritis, muscle strains, bursitis (inflammation of the fluid-filled sacs that cushion joints), tendonitis (inflammation of a tendon), muscle sprains, bruises, and cramps.

By targeting these specific types of pain, this medication aims to provide you with relief and improve your comfort during daily activities. If you're experiencing any of these minor aches, this medication may be a suitable option to consider.

Uses

You can use this medication to temporarily relieve minor aches and pains in your muscles and joints. It is effective for various conditions, including simple backaches, arthritis, muscle strains, bursitis (inflammation of the bursa, a small fluid-filled sac), tendonitis (inflammation of a tendon), muscle sprains, bruises, and cramps.

Whether you're dealing with discomfort from everyday activities or specific injuries, this medication can help ease your pain and improve your comfort.

Dosage and Administration

To use this medication, start by peeling off the protective backing from the patch. Apply the sticky side directly to the affected area on your skin, and then carefully remove the remaining backing. You can wear the patch for up to 8 hours, but make sure not to use it more than 3 to 4 times in a single day.

If you are using this medication for a child under 12 years old, it’s important to consult a doctor first to ensure it’s safe and appropriate for them. Always follow these guidelines to ensure effective and safe use of the patch.

What to Avoid

It's important to keep this product out of reach of children to prevent accidental ingestion. If you or someone else swallows it, seek medical help right away or contact a Poison Control Center at 1-800-222-1222.

There are no specific contraindications, controlled substance classifications, or noted risks of abuse, misuse, or dependence associated with this product. However, always use it responsibly and follow the instructions provided.

Side Effects

When using this product, it's important to follow the directions carefully. It is meant for external use only, so avoid applying it to wounds or damaged skin, and do not use it with a heating pad or bandage it tightly. Be cautious to keep it away from your eyes and mucous membranes.

You should stop using the product and consult a doctor if your condition worsens, if symptoms last longer than seven days, if they clear up and then return within a few days, if you notice any redness, or if skin irritation occurs. If you are pregnant or breastfeeding, please consult a healthcare professional before using this product.

Warnings and Precautions

This product is for external use only, so be sure to apply it as directed. Avoid wrapping the area tightly or using a heating pad while using it. Keep it away from your eyes and mucous membranes, and do not apply it to wounds or damaged skin.

If your condition worsens, symptoms last longer than 7 days, or if you notice redness or skin irritation, stop using the product and contact your doctor. If you are pregnant or breastfeeding, consult a healthcare professional before using this product.

Keep this product out of reach of children. If it is swallowed, seek medical help or contact a Poison Control Center at 1-800-222-1222 immediately.

Overdose

If you or someone else has swallowed too much of this medication, it’s important to seek medical help right away. You can contact a Poison Control Center at 1-800-222-1222 for immediate assistance.

Signs of an overdose may include unusual symptoms, but specific details on these symptoms are not provided here. If you notice anything concerning, don’t hesitate to reach out for help. Remember, acting quickly can make a significant difference in ensuring safety and health.

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 your child is under 12 years old, it's important to consult a doctor before using this medication. For children aged 12 and older, the medication can be used every 8 hours, but should not be taken more than 3 to 4 times a day. Always follow these guidelines to ensure the safety and well-being of your child.

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 for your individual health needs, especially since older adults may have different responses to medications compared to younger individuals. Always keep an open line of communication with your doctor about any changes in health or medication effects.

Renal Impairment

There are no specific guidelines, dosage adjustments, or monitoring requirements mentioned for patients with kidney problems in the provided information. If you have renal impairment (kidney issues), it's important to consult your healthcare provider for personalized advice regarding your treatment and any necessary precautions. Always keep them informed about your kidney health to ensure safe and effective medication management.

Hepatic Impairment

If you have liver problems, it's important to know that there are no specific guidelines, dosage adjustments, or special monitoring requirements mentioned for your condition in the provided information. This means that the standard recommendations apply, but you should always consult your healthcare provider for personalized advice. They can help ensure that any medications you take are safe and appropriate for your liver health.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking. In this case, there are no specific drug interactions or laboratory test interactions noted, which means that this medication is generally considered safe to use alongside other treatments and tests. However, every individual is different, and your healthcare provider can help ensure that your overall treatment plan is safe and effective for you. Always feel free to ask questions or express any concerns you may have regarding your medications or tests.

Storage and Handling

To ensure the best performance of your product, store it at room temperature, ideally between 68°F and 77°F (20°C to 25°C). 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 and disposal to ensure safety and effectiveness.

Additional Information

You should apply this medication topically, meaning it is meant to be applied directly to the skin. It can be used for up to 8 hours at a time and should not be applied more than 3 to 4 times a day. Make sure to follow these guidelines to ensure safe and effective use.

FAQ

What is the primary use of this drug?

This drug is used to temporarily relieve minor aches and pains of muscles and joints.

What conditions can this drug help relieve?

It can relieve aches and pains due to simple backache, arthritis, muscle strains, bursitis, tendonitis, muscle sprains, bruises, and cramps.

How should adults and children 12 years and older use this drug?

Peel off the protective backing and apply the sticky side to the affected area. It should be used for up to 8 hours and no more than 3 to 4 times daily.

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

If you are under 12 years of age, consult a doctor before use.

Are there any warnings I should be aware of?

Yes, this product is for external use only. Avoid contact with eyes and mucous membranes, and do not apply to wounds or damaged skin.

What should I do if I accidentally swallow this drug?

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

Can I use this drug if I am pregnant or breastfeeding?

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

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

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

How should I store this drug?

Store at room temperature between 68° to 77°F (20° to 25°C).

Packaging Info

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

Packaging configurations for Cold and Hot Medicated Large.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

CHpatch-32 is a pharmaceutical compound characterized by its specific chemical properties. The molecular weight of CHpatch-32 is not provided, and its chemical formula is also unspecified. The dosage form and appearance of CHpatch-32 are not detailed in the available information. Further specifications regarding inactive ingredients or additional characteristics are not included.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various musculoskeletal conditions. Specifically, it is effective for alleviating discomfort due to simple backache, arthritis, muscle strains, bursitis, tendonitis, muscle sprains, bruises, and cramps.

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

Dosage and Administration

For adults and children aged 12 years and older, the recommended application involves peeling off the protective backing and applying the sticky side of the patch directly to the affected area. After application, the backing should be carefully removed. Each patch should be used for a maximum duration of 8 hours and may be applied no more than 3 to 4 times daily.

For children under 12 years of age, it is advised to consult a doctor prior to use to determine appropriate treatment and dosage.

Contraindications

Use is contraindicated in children due to the risk of accidental ingestion. It is essential to keep the product out of reach of children. In the event of accidental swallowing, immediate medical assistance should be sought by contacting a Poison Control Center at 1-800-222-1222.

Warnings and Precautions

External use only. This product must be used strictly as directed. It is imperative to avoid bandaging tightly or using it in conjunction with a heating pad. Care should be taken to prevent contact with the eyes and mucous membranes, and it should not be applied to wounds or damaged skin.

Healthcare professionals should advise patients to discontinue use and seek medical advice if any of the following occur: the condition worsens, symptoms persist for more than 7 days or resolve only to recur within a few days, redness appears, or skin irritation develops. Additionally, it is recommended that individuals who are pregnant or breastfeeding consult a healthcare professional prior to use.

This product should be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact should be made with a Poison Control Center at 1-800-222-1222.

Side Effects

Patients using this product should be aware of several important warnings and potential adverse reactions. The product is intended for external use only. It is crucial that patients use the product only as directed and avoid bandaging tightly or using it in conjunction with a heating pad. Contact with eyes and mucous membranes should be strictly avoided, and the product should not be applied to wounds or damaged skin.

In the event that the condition worsens, symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days, patients are advised to stop use and consult a healthcare professional. Additionally, if redness or skin irritation develops, it is recommended to discontinue use and seek medical advice.

For pregnant or breastfeeding individuals, it is essential to consult a health professional prior to use to ensure safety for both the patient and the child.

Drug Interactions

There are no specific drug interactions reported for this medication. Additionally, no laboratory test interactions have been identified in the available data. 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 Cold and Hot Medicated Large (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Cold and Hot Medicated Large.
Details

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. For adolescents and children aged 12 years and older, the medication may be administered up to every 8 hours, with a maximum frequency of 3 to 4 times daily.

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 adverse effects or changes in therapeutic response, 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 associated with its use during pregnancy and lactation. The safety of this medication in pregnant women has not been established, and caution is advised to ensure the well-being of both the mother and the fetus.

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 medication in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

There is no information available regarding renal impairment, including dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of specific guidance when treating patients with renal impairment.

Hepatic Impairment

There is no available information regarding the use of this medication in patients with hepatic impairment. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions specified for individuals with compromised liver function. Healthcare professionals should exercise caution and consider the lack of data when prescribing this medication to patients with liver problems.

Overdosage

In the event of an overdosage, immediate medical assistance is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical help without delay. It is recommended to contact a Poison Control Center at 1-800-222-1222 for expert guidance on managing the situation.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and evaluation are recommended to ensure patient safety and effective resolution of any complications arising from the overdosage.

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 safety profile in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. It is crucial to emphasize the importance of seeking immediate medical assistance or contacting a Poison Control Center at 1-800-222-1222 if the medication is swallowed. This information is vital for ensuring patient safety and prompt action in case of an emergency.

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 68° to 77°F (20° to 25°C). Proper storage conditions are crucial to ensure the integrity and efficacy of the product.

Additional Clinical Information

The product is administered topically and should be applied for a duration of up to 8 hours. It is recommended that the application frequency does not exceed 3 to 4 times daily. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Cold and Hot Medicated Large, 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 Cold and Hot Medicated Large, 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.