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Cold and Heat Pain Relieving Cream

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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 2018
Label revision date
August 9, 2018
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 2018
Label revision date
August 9, 2018
Manufacturer
Velocity Pharma LLC
Registration number
part348
NDC root
76168-402
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'nHot is a medication designed to temporarily relieve minor pain associated with various conditions. You may find it helpful for managing discomfort related to arthritis, simple backaches, muscle strains, sprains, bruises, and cramps. This product works by targeting the pain directly, providing you with relief when you need it most.

Uses

If you're dealing with minor pain, this medication can help provide temporary relief. It's effective for various types of discomfort, including pain from arthritis, simple backaches, muscle strains, sprains, bruises, and cramps.

You can rely on this treatment to ease your pain and help you get back to your daily activities. Remember, it's designed for short-term use to manage these specific types of pain.

Dosage and Administration

When using this medication, if you are an adult or a child over 12 years old, you should apply a generous amount to the area that is causing you pain. Make sure to massage it into your skin until it is fully absorbed. You can repeat this process as needed, but do not apply it more than four times in a single day.

If you are caring for a child who is 12 years old or younger, it’s important to consult a doctor before using this medication. They can provide guidance on the appropriate use for younger patients.

What to Avoid

It's important to use this medication safely to avoid any potential issues. You should not bandage the area tightly or use a heating pad while using this product. Additionally, make sure to avoid contact with your eyes or any mucous membranes, as this can cause irritation. Do not apply the medication to wounds or any skin that is damaged, broken, or irritated, as this could lead to further complications. Following these guidelines will help ensure your safety and the effectiveness of the treatment.

Side Effects

If you have a history of allergic reactions to aspirin or salicylates, it's important to talk to your doctor before using this medication.

You should stop using the product and consult your doctor if your condition worsens, if you notice any redness or irritation, or if your symptoms last longer than 7 days or return after clearing up.

Warnings and Precautions

This product is for external use only, so please avoid ingesting it. If you have a history of allergic reactions to aspirin or salicylates, it's important to consult your doctor before using this product.

You should stop using the product and contact your doctor if your condition worsens, if you notice any redness or irritation, or if your symptoms last longer than 7 days or return after clearing up. In case of accidental swallowing, seek medical help immediately or contact a Poison Control Center. For complete drug facts, please refer to the label inside the packaging.

Overdose

If you or someone else has swallowed too much of a medication, it’s important to seek medical help immediately. You can do this by contacting a Poison Control Center or going to the nearest emergency room. Acting quickly can make a significant difference in the outcome.

Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms, don’t hesitate to get help right away. Remember, it’s always better to be safe and seek assistance if you suspect an overdose.

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 professional 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 healthcare provider regarding your breastfeeding journey.

Pediatric Use

If you are considering using this medication for a child who is 12 years old or younger, it’s important to consult with a doctor first. This ensures that the treatment is safe and appropriate for your child's specific needs. Always prioritize your child's health by seeking professional advice before administering any 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. Since elderly patients may have different health needs and responses to medications, it’s always a good idea to consult with a healthcare provider before starting any new medication. They can help determine the best approach for you or your loved one, considering any existing health conditions or medications that may interact.

Always prioritize safety and open communication with your healthcare team to ensure the best outcomes.

Renal Impairment

If you have kidney problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or safety considerations for your condition. This means that there are no tailored guidelines for how this medication may affect you if your kidneys are not functioning properly.

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your kidney health. They can help monitor your condition and make any necessary adjustments to 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 should be used if you have hepatic impairment (issues with liver function).

Before starting any new medication, including this one, you should discuss your liver health with your healthcare provider. They can help determine the best approach for your treatment and ensure your safety.

Drug Interactions

It's important to be aware of potential interactions with any medications you may be taking. If you have a history of allergic reactions to aspirin or salicylates, it's crucial to talk to your healthcare provider before using this medication. They can help ensure that it's safe for you and discuss any alternatives if necessary.

While there are no specific interactions with laboratory tests mentioned, it's always a good practice to inform your doctor about all the medications you are taking. This way, they can provide the best care tailored to your needs. Always prioritize open communication with your healthcare team regarding your medications and any tests you may undergo.

Storage and Handling

To ensure the best performance of your product, store it at room temperature and protect it from excessive heat. It's important not to freeze the product, as this can affect its effectiveness. When you're not using the tube, make sure to keep it tightly closed to maintain its integrity. Remember to discard the product after opening to ensure safety and effectiveness. Following these guidelines will help you use the product safely and effectively.

Additional Information

You should apply this medication topically to the affected area, gently massaging it into the skin until fully absorbed. For adults and children over 12 years, you can repeat this process as needed, but do not exceed four applications in one day. If the user is a child under 12 years old, consult a doctor before use.

It's important to be aware of a few safety precautions. If you have a history of allergic reactions to aspirin or salicylates, talk to your doctor before using this product. Additionally, if you are pregnant or breastfeeding, consult a healthcare professional first. Always keep this medication out of reach of children, and if it is swallowed, seek medical help or contact a Poison Control Center immediately.

FAQ

What is Cold'nHot used for?

Cold'nHot is used to temporarily relieve minor pain associated with conditions like arthritis, simple backache, muscle strains, sprains, bruises, and cramps.

How should I use Cold'nHot?

Apply generously to the affected area and massage until thoroughly absorbed. You can repeat this up to 4 times daily.

Is Cold'nHot safe for children?

For children 12 years or younger, you should ask a doctor before use.

Are there any contraindications for Cold'nHot?

There are no contraindications listed for Cold'nHot.

What should I avoid while using Cold'nHot?

Do not bandage tightly, use with a heating pad, or apply to wounds or irritated skin. Avoid contact with eyes and mucous membranes.

What should I do if I experience irritation or redness?

Stop using Cold'nHot and consult a doctor if irritation develops, redness is present, or if symptoms persist for more than 7 days.

Can I use Cold'nHot if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, consult a healthcare professional before using Cold'nHot.

What should I do if Cold'nHot is swallowed?

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

How should I store Cold'nHot?

Store Cold'nHot at room temperature, protect it from excessive heat, and keep the tube tightly closed when not in use.

Packaging Info

Below are the non-prescription pack sizes of Cold and Heat Pain Relieving Cream (menthol and methyl salicylate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Cold and Heat Pain Relieving Cream.
Details

Drug Information (PDF)

This file contains official product information for Cold and Heat Pain Relieving Cream, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

Cold'nHot is a cream formulation designed for topical application. It is packaged in a 1.25 oz container, ensuring convenient use and storage.

Uses and Indications

This drug is indicated for the temporary relief of minor pain associated with various conditions, including arthritis, simple backache, muscle strains, sprains, bruises, and cramps.

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

Dosage and Administration

For adults and children over 12 years of age, the recommended dosage is to apply the product generously to the affected area. The application should be followed by a gentle massage into the painful area until the product is thoroughly absorbed into the skin. This process may be repeated as necessary, but should not exceed four applications within a 24-hour period.

For children 12 years of age or younger, it is advised to consult a physician before use.

Contraindications

Use of this product is contraindicated in the following situations:

  • Tight bandaging or use with a heating pad is not recommended, as it may lead to adverse effects.

  • Contact with eyes or mucous membranes should be avoided to prevent irritation or injury.

  • Application to wounds or damaged, broken, or irritated skin is contraindicated due to the risk of exacerbating the condition or causing further harm.

Warnings and Precautions

For external use only. Healthcare professionals should advise patients to refer to the inside label for complete drug facts to ensure proper understanding and usage.

Allergy Alert Patients with a known allergy to aspirin or salicylates are advised to consult a healthcare provider prior to use. This precaution is essential to prevent potential allergic reactions.

Monitoring and Discontinuation Patients should be instructed to discontinue use and seek medical advice if any of the following occur: worsening of the condition, presence of redness, development of irritation, or if symptoms persist for more than 7 days or resolve only to recur within a few days. These signs may indicate a need for reevaluation of the treatment approach.

Emergency Response In the event of accidental ingestion, it is critical to seek immediate medical assistance or contact a Poison Control Center. Prompt action is necessary to address any potential health risks associated with swallowing the product.

Side Effects

Patients should be aware of the potential for adverse reactions associated with the use of this medication.

In terms of serious adverse reactions, individuals who are prone to allergic reactions from aspirin or salicylates are advised to consult a healthcare professional prior to use.

Common adverse reactions may include worsening of the condition, the presence of redness, the development of irritation, or persistence of symptoms beyond 7 days. Patients are encouraged to discontinue use and seek medical advice if any of these symptoms occur or if symptoms resolve and then recur within a few days.

Monitoring for these reactions is essential to ensure patient safety and effective management of their condition.

Drug Interactions

Patients with a known allergy to aspirin or salicylates should consult a healthcare professional prior to use, as there is a potential for 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 indicated at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Cold and Heat Pain Relieving Cream (menthol and methyl salicylate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Cold and Heat Pain Relieving Cream.
Details

Pediatric Use

Pediatric patients 12 years of age or younger should consult a healthcare professional prior to use. This precaution is essential to ensure safety and appropriateness of treatment in this age group.

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

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a healthcare professional prior to using this medication. There is currently no available data regarding 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 have not been specifically addressed in the drug insert regarding dosage adjustments, special monitoring, or safety considerations. 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 may be advisable in these patients, although specific recommendations are not provided.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this medication. Consequently, there are no 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 prescribing information.

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 or contact a Poison Control Center without delay.

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 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 provided text.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. Instruct patients that if the product 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 any of the following occur: the condition worsens, redness appears, irritation develops, or if symptoms persist for more than 7 days or resolve and then recur within a few days.

When using this product, patients must be reminded to use it only as directed. They should not bandage the area tightly or use it in conjunction with a heating pad. Additionally, patients should be cautioned to avoid contact with the eyes or mucous membranes and not to apply the product to wounds or damaged, broken, or irritated skin.

Storage and Handling

The product is supplied in a tube format, with specific handling and storage requirements to ensure its integrity and efficacy. It should be stored at room temperature, away from excessive heat sources. Freezing the product is not permitted, as it may compromise its quality.

To maintain optimal conditions, the tube must be kept tightly closed when not in use. Additionally, it is important to discard the product after opening to prevent any potential degradation or contamination.

Additional Clinical Information

The product is administered topically, with adults and children over 12 years advised to apply it generously to the affected area and massage until fully absorbed, with a maximum frequency of four times daily. For children aged 12 years or younger, consultation with a doctor is recommended prior to use.

Clinicians should counsel patients on specific precautions, including an allergy alert for those with a history of reactions to aspirin or salicylates. Pregnant or breastfeeding individuals should seek advice from a healthcare professional before use. Additionally, the product should be kept out of reach of children, and in the event of ingestion, medical assistance or contact with a Poison Control Center is necessary.

Drug Information (PDF)

This file contains official product information for Cold and Heat Pain Relieving Cream, 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 Heat Pain Relieving Cream, 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.