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Cool Breeze

Last content change checked dailysee data sync status

This product has been discontinued

Active ingredients
  • Menthol, Unspecified Form 5 g/100 g
  • Methyl Salicylate 4 g/100 g
Other brand names
Dosage form
Gel
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2021
Label revision date
December 3, 2021
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Menthol, Unspecified Form 5 g/100 g
  • Methyl Salicylate 4 g/100 g
Other brand names
Dosage form
Gel
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 2021
Label revision date
December 3, 2021
Manufacturer
Cool Breeze US LLC
Registration number
part348
NDC root
72744-778
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

This medication is designed to temporarily relieve minor pain associated with various conditions, including arthritis, backaches, muscle pain, strains, sprains, bruises, and cramps. It can be a helpful option for managing discomfort in everyday situations, allowing you to feel more comfortable and active.

Uses

You can use this medication to temporarily relieve minor pain from various conditions. If you’re dealing with discomfort from arthritis, backaches, muscle pain, strains, sprains, bruises, or cramps, this medication may help ease your symptoms.

It's important to note that there are no reported teratogenic effects (which means it doesn't cause birth defects) associated with this medication, making it a safer option for those concerned about such risks.

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 considering this medication for a child who is 12 years old or younger, it’s important to consult with a doctor first to ensure it’s safe and appropriate for them.

What to Avoid

It's important to keep this medication out of reach of children to prevent any accidental ingestion. If you or someone else accidentally takes this medication, seek medical help immediately or contact a Poison Control Center for assistance.

There are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with this medication. However, always use it responsibly and follow the guidance provided by your healthcare professional.

Side Effects

You may experience a burning sensation when applying this medication, but it usually goes away quickly. It's important to monitor your condition while using it. If your symptoms worsen, persist for more than seven days, or if you continue to feel pain, you should stop using the product and consult your doctor.

Warnings and Precautions

It's important to use this product safely. Remember that it is flammable, so keep it away from fire or flames. This product is for external use only, and you should store it in a cool, dry place. Always follow the directions for use, and avoid applying it to wounds or any broken or irritated skin. Be cautious not to bandage tightly or use it with a heating pad, and keep it away from your eyes and mucous membranes. A mild burning sensation may occur upon application, but this usually goes away quickly. If the gel does get into your eyes, rinse them with warm water.

You should stop using the product and consult your doctor if your condition worsens, if symptoms last longer than 7 days, or if pain continues. If you are pregnant or breastfeeding, it's best to talk to a healthcare professional before using this product. In case of accidental ingestion, seek emergency medical help or contact a Poison Control Center immediately.

Overdose

If you or someone else accidentally takes too much of a medication, it's important to act quickly. You should seek medical help immediately or contact a Poison Control Center. They can provide guidance on what to do next.

Signs of an overdose can vary, but they may include unusual symptoms that are not typical for the medication. If you notice any concerning changes in behavior or health, don’t hesitate to get help. Remember, it’s always better to be safe and get professional advice in these situations.

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 who is 12 years old or younger, 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 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 there are no specific guidelines, dosage adjustments, or monitoring requirements mentioned for your condition in the provided information. This means that the standard recommendations for medication use may apply to you without any special considerations. However, always consult your healthcare provider for personalized advice and to ensure your treatment is safe and effective based on your kidney health.

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 apply, but you should always consult your healthcare provider for personalized advice. They can help determine the best approach for your treatment and monitor your liver function as needed.

Make sure to keep your doctor informed about your liver health, as they may need to conduct regular tests to ensure your safety while using any medication. Your well-being is a priority, so don't hesitate to ask questions or express any concerns you may have.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. In this case, there are no known drug interactions or laboratory test interactions associated with the medication. However, always ensure that your healthcare provider is aware of all the medications you are using, as this helps them provide the best care tailored to your needs.

By discussing your full medical history and any other treatments, you can help prevent potential issues and ensure your safety.

Storage and Handling

To ensure the safety and effectiveness of your product, store it in a cool, dry place. This helps maintain its quality and prevents any degradation. It's important to remember that the product is flammable, so keep it away from fire or any open flames to avoid potential hazards.

When handling the product, always do so with care to maintain a safe environment. Make sure to follow these storage and handling guidelines closely to ensure your safety and the product's integrity.

Additional Information

You should apply this medication topically to the affected area, using a generous amount and massaging it into the skin until fully absorbed. For adults and children over 12 years, you can repeat this process up to four times a day. If the user is a child under 12, it's important to consult a doctor before use.

If you are pregnant or breastfeeding, please consult a healthcare professional before using this product. Always keep it out of reach of children, and in case of accidental ingestion, seek medical help or contact a Poison Control Center immediately.

FAQ

What conditions does this drug temporarily relieve?

This drug temporarily relieves minor pain associated with arthritis, backache, muscles, strains, sprains, bruises, and cramps.

How should adults and children over 12 use this drug?

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

What should children 12 years or younger do before using this drug?

Please speak with a doctor before use.

What precautions should I take when using this drug?

Keep it away from fire or flame, avoid contact with eyes and mucous membranes, and do not apply to wounds or damaged skin.

What should I do if I accidentally ingest this drug?

Get medical help or contact a Poison Control Center right away.

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

Stop use and ask a doctor if your condition worsens or if symptoms persist for more than 7 days.

Is this drug safe to use during pregnancy or breastfeeding?

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

Where should I store this drug?

Store it in a cool, dry place.

Packaging Info

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

Packaging configurations for Cool Breeze.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The SPL code for the drug is 34089-3. No additional relevant information is available for the Description section.

Uses and Indications

This drug is indicated for the temporary relief of minor pain associated with various conditions, including arthritis, backache, muscle pain, 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 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 aged 12 years or younger, it is advised to consult a healthcare professional for appropriate dosing and administration guidance.

Contraindications

Use is contraindicated in children due to the risk of accidental ingestion. In the event of accidental ingestion, it is imperative to seek medical assistance or contact a Poison Control Center immediately.

Warnings and Precautions

The product is flammable; therefore, it must be kept away from fire or flame. It is intended for external use only and should be stored in a cool, dry place. Users are advised to apply the product strictly as directed. It is important to avoid bandaging tightly or using the product in conjunction with a heating pad. Care should be taken to prevent contact with the eyes and mucous membranes. The product should not be applied to wounds or to damaged, broken, or irritated skin. A burning sensation may occur upon application, but this typically subsides shortly thereafter. In the event that the gel comes into contact with the eyes, it is recommended to wash the area with warm water.

Patients should discontinue use and consult a healthcare professional if the condition worsens or if symptoms persist for more than 7 days, or if pain continues to occur.

For individuals who are pregnant or breastfeeding, it is essential to seek advice from a healthcare professional prior to use.

In cases of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is advised.

Side Effects

Patients may experience a burning sensation upon application of the product; however, this sensation typically resolves on its own.

In clinical practice, it is advised that patients discontinue use and consult a healthcare professional if their condition worsens, if symptoms persist for more than 7 days, or if pain continues to occur. These recommendations are based on clinical observations and are intended to ensure patient safety and effective management of their condition.

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 Cool Breeze (menthol, methyl salicylate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Cool Breeze.
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. The potential risks and benefits must be carefully considered in these populations to ensure the safety of both the mother and the fetus or 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

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

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 accidental ingestion, it is imperative to seek immediate medical assistance or contact a Poison Control Center. Prompt action is crucial to mitigate potential risks associated with overdosage.

Healthcare professionals should be aware that symptoms of overdosage may vary depending on the substance involved. Therefore, a thorough assessment of the patient's condition is essential.

Management of overdosage should be guided by the specific clinical scenario and may include supportive care and symptomatic treatment. Continuous monitoring of the patient's vital signs and clinical status is recommended to ensure appropriate interventions are implemented as needed.

In all cases of suspected overdosage, timely communication with poison control and adherence to established treatment protocols are vital for optimal patient outcomes.

Nonclinical Toxicology

There is currently no available information regarding teratogenic effects, non-teratogenic effects, or any specific findings in the nonclinical toxicology section. Additionally, no data has been provided concerning animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. In the event of accidental ingestion, patients should be instructed to seek medical help immediately or contact a Poison Control Center for assistance. It is important for patients to understand the potential risks associated with improper use and to take necessary precautions to ensure safety.

Storage and Handling

The product is supplied in a configuration that ensures optimal handling and storage. It is essential to store the product in a cool, dry place to maintain its integrity and effectiveness.

Due to its flammable nature, it is critical to keep the product away from fire or flame to prevent any hazardous situations. Proper storage conditions are vital for ensuring safety and efficacy.

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. This application may be repeated as necessary, but should not exceed four times daily. For children aged 12 years or younger, consultation with a doctor is recommended prior to use.

Clinicians should counsel patients to consult a health professional if they are pregnant or breastfeeding before using the product. Additionally, 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 should be sought immediately.

Drug Information (PDF)

This file contains official product information for Cool Breeze, 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 Cool Breeze, 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.