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Cold Hot Patch

Last content change checked dailysee data sync status

This product has been discontinued

Active ingredient
Menthol 5 g/100 g
Other brand names
Dosage form
Patch
Route
Topical
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2014
Label revision date
March 18, 2014
Active ingredient
Menthol 5 g/100 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 2014
Label revision date
March 18, 2014
Manufacturer
Zhejiang Bangli Medical Products CO. , LTD
Registration number
part348
NDC root
57900-002

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Drug Overview

This medication is designed to temporarily relieve minor aches and pains in your muscles and joints. It can be used for various conditions, including arthritis, simple backache, strains, sprains, bursitis, tendonitis, bruises, and cramps. By targeting these discomforts, it helps you feel more comfortable and active in your daily life.

Uses

You can use this medication to temporarily relieve minor aches and pains in your muscles and joints. It is effective for discomfort caused by conditions such as arthritis, simple backache, strains, sprains, bursitis, tendonitis, bruises, and cramps. If you're experiencing any of these issues, this medication may help ease your pain and improve your comfort.

Dosage and Administration

When using this medication, you can apply the patch to the area where you feel pain. If you are an adult or a child aged 12 years and older, you can use the patch as needed, but make sure not to apply it more than four times a day. If the person using the patch is under 12 years old, it’s important to consult a doctor first.

To apply the patch easily, hold both ends of the pad firmly and pull them apart until the backing separates. Once you have done that, remove the protective film and place the pad directly on the painful area. This method ensures that you get the most benefit from the medication while keeping the application straightforward.

What to Avoid

It's important to keep this medication out of reach of children. If a child accidentally swallows it, seek medical help or contact a poison control center immediately. There are no specific contraindications, controlled substance classifications, or noted risks of abuse, misuse, or dependence associated with this medication. Always use it responsibly and as directed.

Side Effects

When using this product, it's important to be aware of some potential side effects and warnings. You should only use it externally and avoid contact with your eyes and mucous membranes. Do not apply it to wounds or damaged skin, and refrain from tightly bandaging the area or using a heating pad. If you notice excessive redness or irritation, if your condition worsens, or if pain lasts more than 7 days, stop using the product and consult your doctor. Additionally, if symptoms improve and then return within a few days, seek medical advice.

If you are pregnant or breastfeeding, please consult a healthcare professional before using this product. Keep it out of reach of children, and if swallowed, seek medical help or contact a poison control center immediately.

Warnings and Precautions

This product is for external use only, so be sure to follow the instructions carefully. Avoid getting it in your eyes or on mucous membranes, and do not apply it to wounds or damaged skin. It's important not to bandage the area tightly or use a heating pad while using this product.

You should stop using the product and consult your doctor if you notice excessive redness or irritation, if your condition worsens, if pain lasts more than 7 days, or if symptoms improve and then return within a few days. If you are pregnant or breastfeeding, please consult a healthcare professional before using this product. Keep it out of reach of children, and if it is swallowed, seek medical help or contact a poison control center immediately.

Overdose

If you or someone else has swallowed too much of this medication, it’s important to seek medical help immediately or contact a poison control center. Acting quickly can make a significant difference in ensuring safety.

To prevent accidental ingestion, always keep this medication out of reach of children. Being cautious can help avoid potential overdoses and keep everyone safe.

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 and any medications you may consider.

Pediatric Use

If you have a child under 12 years old, it's important to consult with a doctor before using this medication. For children aged 12 and older, you can apply the patch to the affected area as needed, but be sure not to exceed four applications in a single day. Always follow these guidelines to ensure the safe use of the medication for your child.

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 there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations for the medication do not change based on liver impairment. However, it’s always a good idea to discuss your liver health with your healthcare provider before starting any new medication. They can help ensure that your treatment is safe and effective for you.

Drug Interactions

It's great to know that there are no reported interactions between this medication and other drugs or laboratory tests. However, it's still very important to discuss all medications you are taking, including over-the-counter drugs and supplements, with your healthcare provider. This ensures that your treatment is safe and effective.

Always keep your healthcare provider informed about any changes in your health or new medications you may start. Open communication helps prevent any potential issues and supports your overall well-being.

Storage and Handling

To ensure the safety and effectiveness of your product, store it at room temperature. It's important to keep it out of reach of children to prevent any accidental ingestion or misuse. Once you open the product, be sure to discard it after use to maintain safety and hygiene. Following these simple guidelines will help you use the product safely and effectively.

Additional Information

You can use this medication topically by applying the patch to the affected area as needed, but do not exceed four applications in a day if you are an adult or a child aged 12 years and older. If the patient is under 12 years old, consult a doctor for guidance.

If you are pregnant or breastfeeding, it's important to talk to a healthcare professional before using this product. Always keep it out of reach of children, and if the patch is swallowed, seek medical help or contact a poison control center immediately.

FAQ

What is the primary use of this drug?

This drug temporarily relieves minor aches and pains of muscles and joints.

What conditions can this drug help with?

It is indicated for conditions such as arthritis, simple backache, strains, sprains, bursitis, tendonitis, bruises, and cramps.

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

Apply the patch to the affected area as needed, but not more than 4 times daily.

What should children under 12 do before using this drug?

Children under 12 years should ask a doctor before use.

Are there any warnings associated with this drug?

Yes, it is for external use only, and you should avoid contact with eyes and mucous membranes. Do not apply to wounds or damaged skin.

What should I do if I experience excessive redness or irritation?

Stop use and ask a doctor if excessive redness or irritation is present, or if the condition worsens.

What precautions should I take if I am pregnant or breastfeeding?

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

What should I do if the patch is swallowed?

Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

How should I store this drug?

Store at room temperature and keep out of reach of children. Discard after opening.

Packaging Info

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

Packaging configurations for Cold Hot Patch.
Details

Drug Information (PDF)

This file contains official product information for Cold Hot Patch, 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 additional specific description details are provided in the available text.

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 arthritis, simple backache, strains, sprains, bursitis, tendonitis, bruises, and cramps.

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

Dosage and Administration

Adults and children aged 12 years and older may apply the patch to the affected area as needed, with a maximum frequency of four applications per day. For children under 12 years of age, it is advised to consult a physician prior to use.

For optimal application, healthcare professionals should instruct patients to grasp both ends of the pad firmly and pull at both ends to stretch the pad until the backing separates. The protective film should be removed while applying the pad directly to the site of pain.

Contraindications

Use of this product is contraindicated in children due to the risk of accidental ingestion. In the event of swallowing, immediate medical assistance or contact with a poison control center is advised.

Warnings and Precautions

This product is intended for external use only. It is imperative that healthcare professionals advise patients to use the product strictly as directed. Care should be taken to avoid contact with the eyes and mucous membranes. The product should not be applied to wounds or damaged skin, and it is important to refrain from tightly bandaging the area or using a heating pad in conjunction with the product.

Patients should be instructed to discontinue use and consult a healthcare provider if any of the following occur: excessive redness or irritation, worsening of the condition, persistent pain lasting more than 7 days, or if symptoms resolve and then recur within a few days.

For individuals who are pregnant or breastfeeding, it is essential to seek guidance from a healthcare professional prior to using this product.

Additionally, this product should be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a poison control center should be made without delay.

Side Effects

Patients using this product should be aware of several important safety warnings and potential adverse reactions. This product is intended for external use only and should not come into contact with the eyes or mucous membranes. It is contraindicated for application on wounds or damaged skin, and patients are advised against tightly bandaging the area or using a heating pad in conjunction with the product.

In the event of excessive redness or irritation, patients should discontinue use and consult a healthcare professional. Additionally, if the condition worsens, if pain persists for more than 7 days, or if symptoms resolve only to recur within a few days, medical advice should be sought.

For pregnant or breastfeeding individuals, it is recommended to consult a healthcare professional prior to use. This product should be kept out of reach of children, and in the case of accidental ingestion, immediate medical assistance or contact with a poison control center is necessary.

Drug Interactions

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

Packaging & NDC

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

Packaging configurations for Cold Hot Patch.
Details

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. For adolescents and adults aged 12 years and older, the patch may be applied to the affected area as needed, with a maximum frequency of four 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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in 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, as well as any available data regarding fetal outcomes and lactation. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing infant.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data regarding 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

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 monitoring of renal function may be warranted in patients with reduced kidney function to ensure safety and 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 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 considered as part of standard clinical practice.

Overdosage

In the event of an overdosage, immediate medical assistance is crucial. If the substance is swallowed, it is imperative to seek medical help or contact a poison control center without delay.

To prevent accidental ingestion, it is essential to keep the product out of reach of children. This precautionary measure is vital in minimizing the risk of overdosage and ensuring the safety of pediatric populations.

Healthcare professionals should be prepared to provide appropriate management and intervention based on the specific circumstances of the overdosage incident.

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 the medication out of reach of children to prevent accidental ingestion. In the event that the medication is swallowed, patients should be instructed to seek medical help or contact a poison control center immediately. This information is crucial for ensuring the safety of children and minimizing potential risks associated with accidental exposure.

Storage and Handling

The product is supplied in a configuration that ensures optimal usability. It should be stored at room temperature, away from direct sunlight and moisture. To maintain safety, it is essential to keep the product out of reach of children. Once opened, the product must be discarded to ensure proper handling and safety.

Additional Clinical Information

The product is administered topically, with the recommended application for adults and children aged 12 years and older being up to four times daily on the affected area as needed. For children under 12 years, it is advised to consult a doctor prior to use.

Clinicians should counsel patients to seek advice from a health professional if they are pregnant or breastfeeding. Additionally, it is important to keep the product out of reach of children, and in the event of ingestion, immediate medical assistance or contact with a poison control center is necessary.

Drug Information (PDF)

This file contains official product information for Cold Hot Patch, 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 Hot Patch, 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.