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Care One Cool Heat Pain Relieving

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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 2012
Label revision date
March 1, 2012
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 2012
Label revision date
March 1, 2012
Manufacturer
AMERICAN SALES COMPANY
Registration number
part348
NDC root
41520-863
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 may be looking for a topical medication designed to relieve pain when applied to the skin. This type of treatment is typically used for various types of discomfort, helping to soothe the affected area. It is important to apply the medication generously and massage it into the skin until it is fully absorbed.

For adults and children over 12 years old, you can use this medication up to four times a day as needed. If you have any questions about its use for children under 12, it's best to consult a doctor for guidance.

Uses

You can use this product to help relieve pain in specific areas of your body. To apply, make sure to use a generous amount and massage it into the affected area until it is fully absorbed by your skin. You can repeat this process as needed, but do not apply it more than four times a day.

If you are considering using this product for a child who is 12 years old or younger, it’s important to consult with a doctor first to ensure it’s safe for them.

Dosage and Administration

It seems that there is no specific dosage or administration information available for the medication you are inquiring about. This means that details such as how much to take, how to take it, or how often to use it are not provided.

If you have any questions about how to use this medication or need guidance on its administration, it's best to consult with your healthcare provider or pharmacist. They can give you the most accurate and personalized information based on your health needs.

What to Avoid

It's important to use this medication safely to avoid 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, damaged, broken, or irritated skin to 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. Be aware of certain signs that may indicate you should stop using it and consult a healthcare professional. These include if your condition worsens, if symptoms last longer than 7 days, if they improve and then return within a few days, if you notice any redness, or if irritation develops. Your health and safety are paramount, so don't hesitate to seek advice if you experience any of these issues.

Warnings and Precautions

This product is for external use only. If you have a history of allergies to aspirin or salicylates, please consult your doctor before using it. It's important to keep this product out of reach of children. If a child accidentally ingests it, seek medical help or contact a Poison Control Center immediately.

You should stop using this product and call your doctor if your condition worsens, if symptoms last longer than 7 days, if they improve and then return within a few days, if you notice any redness, or if irritation develops. In case of accidental ingestion, seek emergency medical help right away.

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 signs of overdose for this medication, general 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 always better to be safe and get checked by a healthcare professional if you have any concerns about your health. Remember, timely intervention can make a significant difference.

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 are considering 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 professional guidance when it comes to the health of your little ones.

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 considering this medication, it’s important to consult with a healthcare provider. 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 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 plan is safe and effective for your specific situation. They can help monitor your kidney health and make any necessary adjustments to your medications.

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 (liver issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your liver health. They can help determine the best course of action based on your individual situation.

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 crucial. This ensures that you receive the best care and avoid any potential issues.

Storage and Handling

To ensure the best performance of your product, store it at room temperature. After each use, make sure to keep the cap tightly closed to maintain its integrity. It's also important to keep the original carton, as it contains essential information that you may need later. Following these simple steps will help you handle 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 old, you can repeat this process as needed, but do not exceed four applications in a day.

Before using this product, consult your doctor if you have a history of allergic reactions to aspirin or salicylates. If you are pregnant or breastfeeding, it's important to seek advice from a healthcare professional. Always keep this medication out of reach of children, and if it is accidentally ingested, seek medical help or contact a Poison Control Center immediately.

FAQ

How should I apply this medication?

Apply generously to the affected area and massage it into the skin until thoroughly absorbed. You can repeat this process as necessary, but do not exceed 4 times daily.

What should I do if I am using this medication for a child under 12?

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

Are there any specific warnings I should be aware of?

This medication is for external use only. If you are prone to allergic reactions from aspirin or salicylates, consult a doctor before use.

What should I do if my condition worsens or does not improve?

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

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

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

What precautions should I take when using this medication?

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

What should I do in case of accidental ingestion?

Keep this medication out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Center right away.

How should I store this medication?

Store at room temperature and keep the cap tightly closed after use. Retain the carton as it contains important information.

Packaging Info

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

Packaging configurations for Care One Cool Heat Pain Relieving.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The provided text does not contain specific details regarding the drug's description. Therefore, a concise "Description" section cannot be formulated without additional information. Please provide the relevant details for a comprehensive rewrite.

Uses and Indications

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

For pediatric patients aged 12 years or younger, it is advised to consult a healthcare professional prior to use.

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

Dosage and Administration

No dosage and administration information is available for this product. Healthcare professionals are advised to consult the prescribing information or relevant clinical guidelines for specific dosing recommendations and administration techniques.

Contraindications

Use of this product is contraindicated in the following situations:

Tight bandaging or the application of a heating pad in conjunction with this product is not recommended, as it may lead to adverse effects.

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

Application to wounds, damaged, broken, or irritated skin is contraindicated due to the potential for exacerbating the condition or causing further harm.

Warnings and Precautions

For external use only. Healthcare professionals should advise patients to consult a doctor prior to use if they have a known allergy to aspirin or salicylates, as this may increase the risk of an allergic reaction.

It is imperative to keep this product out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

Patients should be instructed to discontinue use and consult a healthcare provider if any of the following occur: the condition worsens, symptoms persist for more than 7 days, symptoms resolve and then recur within a few days, redness appears, or irritation develops.

In cases of accidental ingestion, it is crucial to obtain emergency medical help or contact a Poison Control Center immediately to ensure patient safety.

Side Effects

Patients should be aware of the potential for allergic reactions, particularly if they have a history of sensitivity to aspirin or salicylates. It is advised that individuals consult a healthcare professional prior to use if they are prone to such reactions.

In clinical practice, patients are instructed to discontinue use and seek medical advice if any of the following occur: the condition worsens, symptoms persist for more than 7 days, symptoms resolve and then recur within a few days, redness appears, or if irritation develops. These guidelines are essential for ensuring 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 Care One Cool Heat Pain Relieving (menthol, methyl salicylate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Care One Cool Heat Pain Relieving.
Details

Pediatric Use

Pediatric patients 12 years of age or younger 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 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 the use of this drug during pregnancy and lactation. Healthcare providers can offer guidance based on individual circumstances and the latest clinical data.

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 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 available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

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 an overdose. Symptoms 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 maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

If available, specific antidotes or treatments should be administered as per established protocols. Continuous assessment and supportive care are critical in managing the patient's condition effectively.

Healthcare professionals are encouraged to report any cases of overdose to the appropriate regulatory authorities to enhance the understanding of the substance's safety profile.

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 data.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children. In the event of accidental ingestion, patients should seek medical help or contact a Poison Control Center immediately.

Patients should be instructed to stop using the product and consult a doctor if any of the following occur: the condition worsens, symptoms persist for more than 7 days or clear up and then recur within a few days, redness is present, or irritation develops.

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. It is important to avoid contact with the eyes or mucous membranes and to refrain from applying the product to wounds, damaged, broken, or irritated skin.

Storage and Handling

The product is supplied in a configuration that includes a tightly sealed cap to ensure integrity after use. It is essential to store the product at room temperature to maintain its efficacy. Additionally, the carton should be retained, as it contains important information pertinent to the product's use and handling.

Additional Clinical Information

The product is administered topically, with instructions for adults and children over 12 years to apply generously to the affected area and massage until fully absorbed. This application may be repeated as necessary, but should not exceed four times daily.

Clinicians should counsel patients regarding potential allergies, advising those with a history of allergic reactions to aspirin or salicylates to consult a healthcare professional prior to use. Additionally, pregnant or breastfeeding individuals should seek advice from a health professional before using the product. It is important to keep the product out of reach of children, and in the event of accidental ingestion, medical assistance or contact with a Poison Control Center is recommended.

Drug Information (PDF)

This file contains official product information for Care One Cool Heat Pain Relieving, 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 Care One Cool Heat Pain Relieving, 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.