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Toast Freezin Cold

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Active ingredients
  • Menthol 11 g/100 g
  • Methyl Salicylate 31 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 2025
Label revision date
June 16, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Menthol 11 g/100 g
  • Methyl Salicylate 31 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 2025
Label revision date
June 16, 2025
Manufacturer
IDEAZ, LLC
Registration number
M017
NDC root
78983-104
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 find this medication helpful for the temporary relief of minor aches and pains. It is commonly used to alleviate discomfort associated with conditions such as arthritis, strains, bruises, and sprains.

By targeting the source of your pain, this medication can provide you with the comfort you need to go about your daily activities. If you're experiencing any of these types of discomfort, this drug may be a suitable option for you.

Uses

If you're dealing with minor aches and pains in your muscles and joints, this medication can help provide temporary relief. It's effective for discomfort associated with conditions like arthritis, as well as injuries such as strains, bruises, and sprains.

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

Dosage and Administration

It's important to use this medication only as directed by your healthcare provider. If you are an adult or a child aged 12 years or older, you can apply it to the affected area up to 3 to 4 times a day. Make sure to follow the recommended frequency to ensure safety and effectiveness.

If the patient is a child under 12 years old, it's essential to consult a physician (doctor) before use. This will help ensure that the medication is appropriate and safe for younger patients. Always follow your healthcare provider's instructions for the best results.

What to Avoid

It's important to use this product safely to avoid potential issues. You should never apply it on wounds or damaged skin, and avoid using it immediately before or after bathing or using a hot tub. Additionally, do not use it with a heating pad, under a bandage, or in areas where you are likely to sweat.

While using this product, be careful to keep it away from your eyes and mucous membranes, and avoid wrapping or bandaging the area too tightly. Following these guidelines will help ensure your safety and the effectiveness of the product.

Side Effects

When using this product, it's important to be aware of certain precautions. You should only apply it externally and avoid using it on wounds, damaged skin, or areas where you might sweat. Additionally, do not use it immediately before or after bathing, in a hot tub, or with a heating pad. Be careful to keep it away from your eyes and mucous membranes, and avoid wrapping or bandaging the area tightly.

If your condition worsens, symptoms last more than 7 days, or if you experience excessive skin irritation, stop using the product and consult a doctor. If you notice that symptoms clear up and then return within a few days, seek medical advice as well. Always keep this product out of reach of children, and if ingested accidentally, contact a medical professional or Poison Control Center. If you are pregnant or breastfeeding, consult a healthcare professional before use.

Warnings and Precautions

This product is for external use only, so please avoid applying it to wounds, damaged skin, or areas where you might sweat. Do not use it immediately before or after bathing, in a hot tub, or with a heating pad. It's important to keep the product away from your eyes and mucous membranes, and avoid wrapping or bandaging the area tightly.

If your condition worsens or symptoms last longer than 7 days, or if symptoms improve and then return within a few days, stop using the product and consult your doctor. Additionally, if you experience excessive skin irritation, seek medical advice. In case of accidental ingestion, please get emergency medical help or contact a Poison Control Center right away.

Overdose

If you accidentally take too much of a medication, it's important to seek medical help right away. You can contact a Poison Control Center for guidance on what to do next.

Signs of an overdose can vary, but they may include unusual symptoms that are not typical for you. If you notice any concerning changes in your health after taking a medication, don’t hesitate to reach out for help. Remember, acting quickly can make a difference in your safety.

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 your child is under 12 years old, it's important to consult a physician (doctor) before using this medication. For children aged 12 and older, you can apply the medication to the affected area, but be sure not to exceed 3 to 4 applications in a day. Always follow these guidelines to ensure your child's safety and well-being.

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, it’s always a good idea to discuss any medications with a healthcare provider. They can help ensure that the treatment is safe and appropriate, considering any unique health needs or conditions.

Since there are no dosage adjustments or special precautions mentioned for elderly patients, your healthcare provider will be the best resource for personalized advice. Always keep them informed about any other medications or health issues to help manage your overall care effectively.

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 you have renal impairment (kidney issues).

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

Hepatic Impairment

If you have liver problems, it's important to know that the provided drug insert does not include specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no established guidelines for how this medication may affect you if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to discuss any concerns regarding your liver health and medication use. They can help ensure that your treatment is safe and effective based on your individual health needs.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking, even if there are no specific drug interactions or laboratory test interactions noted for your treatment. This ensures that your healthcare team can monitor your health effectively and make informed decisions about your care.

Always feel free to ask questions and share all the medications and supplements you are using. This helps to avoid any potential issues and ensures that you receive the best possible treatment tailored to your needs.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 20-25°C (68-77°F). It's important to keep it away from freezing temperatures, as this can damage the product.

When handling the product, make sure to do so with clean hands and in a clean environment to maintain its integrity. Following these guidelines will help you use the product safely and effectively.

Additional Information

No further information is available.

FAQ

What is the primary use of this drug?

This drug is used for the temporary relief of minor aches and pains associated with muscles and joints, including conditions like arthritis, strains, bruises, and sprains.

How should I apply this drug?

Adults and children 12 years of age or older should apply it to the affected area no more than 3 to 4 times daily. Children under 12 years should consult a physician before use.

Are there any warnings I should be aware of?

Yes, this product is for external use only. Avoid using it on wounds, damaged skin, or areas where perspiration is likely to occur.

What should I do if I experience excessive skin irritation?

If excessive skin irritation occurs, stop using the product and consult a doctor.

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

If you are pregnant or breastfeeding, you should ask a healthcare professional before using this drug.

What should I do in case of accidental ingestion?

In case of accidental ingestion, seek medical help or contact a Poison Control Center immediately.

What should I avoid while using this product?

Avoid contact with eyes and mucous membranes, and do not bandage tightly. Do not use it immediately before or after bathing or using a hot tub.

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

If your condition worsens or symptoms persist for more than 7 days, you should stop using the product and consult a doctor.

Packaging Info

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

Packaging configurations for Toast Freezin Cold.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The product is a suspension identified by SPL code 34089-3. It contains acetaminophen as the active ingredient, with each 5 mL of the suspension delivering 160 mg of acetaminophen. The formulation includes several inactive ingredients: sorbitol, glycerin, sodium benzoate, artificial cherry flavor, water, and xanthan gum. The suspension is characterized by its red color and cherry flavor.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains of muscles and joints associated with conditions such as arthritis, strains, bruises, and sprains.

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

Dosage and Administration

The medication should be used only as directed. For adults and children aged 12 years and older, it is recommended to apply the product to the affected area no more than 3 to 4 times daily. For children under 12 years of age, it is advised to consult a physician prior to use to determine appropriate dosing and administration.

Contraindications

The product is contraindicated for use on wounds or damaged skin due to the potential for irritation and delayed healing. Application immediately before or after bathing or using a hot tub is not recommended, as this may alter the product's effectiveness. Additionally, the use of a heating pad in conjunction with this product is contraindicated due to the risk of increased skin irritation.

Application under wrapping or bandages is also not advised, as this may lead to excessive moisture retention and skin maceration. Furthermore, use is contraindicated in areas where perspiration is likely to occur, as this can compromise the product's efficacy.

Contact with eyes and mucous membranes should be avoided to prevent irritation. It is also advised not to bandage tightly over the application site to ensure proper circulation and prevent skin damage.

Warnings and Precautions

For external use only. This product is contraindicated for application on wounds or damaged skin. It should not be used immediately before or after bathing or using a hot tub, nor in conjunction with a heating pad. Additionally, it is advised against using this product under wrapping or bandages, and in areas where perspiration is likely to occur.

When utilizing this product, it is imperative to avoid contact with the eyes and mucous membranes. Bandaging should not be applied tightly to the area of application.

Healthcare professionals should instruct patients to discontinue use and seek medical advice if any of the following occur: the condition worsens or symptoms persist beyond 7 days; symptoms resolve and then recur within a few days; or if excessive skin irritation develops.

In the event of accidental ingestion, immediate medical assistance should be sought, or contact should be made with a Poison Control Center.

Side Effects

Patients should be aware that this product is for external use only. It is contraindicated for application on wounds, damaged skin, or immediately before or after bathing or using a hot tub. Additionally, it should not be used in conjunction with a heating pad, under wrapping or bandages, or in areas where perspiration is likely to occur.

While using this product, patients are advised to avoid contact with the eyes and mucous membranes and to refrain from tightly bandaging the treated area.

Patients should discontinue use and consult a healthcare professional if their condition worsens, if symptoms persist for more than 7 days, if symptoms clear up and then recur within a few days, or if excessive skin irritation occurs.

This product should be kept out of reach of children. In the event of accidental ingestion, medical assistance should be sought immediately or contact should be made with a Poison Control Center.

For pregnant or breastfeeding individuals, it is recommended to consult a healthcare professional prior to use.

Drug Interactions

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

Packaging & NDC

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

Packaging configurations for Toast Freezin Cold.
Details

Pediatric Use

Pediatric patients under 12 years of age should consult a physician before use. For adolescents and adults aged 12 years and older, the recommended application is to the affected area not more than 3 to 4 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. 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 healthcare professional prior to using this medication. There is currently no available data on 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 no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. 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.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in clinical trials for this medication. Consequently, there is no information available regarding 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.

Overdosage

In the event of accidental ingestion, it is imperative to seek immediate medical assistance or contact a Poison Control Center. Prompt intervention is crucial to mitigate potential adverse effects associated with overdosage.

Healthcare professionals should be aware that symptoms of overdosage may vary depending on the substance involved. Monitoring for any signs of toxicity is essential, and appropriate management should be initiated based on the clinical presentation.

Management procedures may include supportive care and symptomatic treatment, tailored to the specific symptoms exhibited by the patient. Continuous assessment and monitoring are recommended to ensure patient safety and effective management of the overdosage situation.

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 potential effects in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center in the event of accidental ingestion of the product. It is important to instruct patients not to apply the product on wounds or damaged skin, as this may lead to adverse effects.

Patients should be informed to avoid using the product immediately before or after bathing or using a hot tub, as well as not to use it in conjunction with a heating pad. Additionally, they should refrain from using the product under any wrapping or bandage, and in areas where perspiration is likely to occur.

Healthcare providers should counsel patients to discontinue use and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. Patients should also be advised to stop using the product and seek medical advice if they experience excessive skin irritation.

Furthermore, it is essential to remind patients to avoid contact with eyes and mucous membranes while using the product. They should also be cautioned against applying a tight bandage over the area of application.

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 a temperature range of 20-25°C (68-77°F) to maintain its efficacy. Additionally, the product must be protected from freezing to ensure its integrity and effectiveness. Proper handling and storage conditions are crucial for preserving the quality of the product throughout its shelf life.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Toast Freezin Cold, 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 Toast Freezin Cold, 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.