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Freezin Cold Toast

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This product has been discontinued

Active ingredients
  • Menthol, Unspecified Form 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 2012
Label revision date
January 17, 2022
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Menthol, Unspecified Form 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 2012
Label revision date
January 17, 2022
Manufacturer
Q. A. Laboratories
Registration number
part348
NDC root
52099-8000
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 medication that is applied to affected areas of the skin. This treatment is suitable for adults and children aged 12 years and older, and it is typically used up to three to four times a day. If you have a child under 12, it's important to consult a doctor before use.

While specific details about the drug's identity and mechanism of action are not provided, it is designed to help alleviate certain skin conditions. Always remember to use it only as directed for the best results.

Uses

You can use this medication to treat specific skin conditions by applying it to the affected area. For adults and children aged 12 years and older, it is recommended to apply the medication no more than 3 to 4 times a day. If you have a child under 12 years of age, it's important to consult a doctor before use.

This medication has been evaluated and does not have any known teratogenic effects, which means it does not cause birth defects. Additionally, there are no reported nonteratogenic effects, indicating that it is generally safe for use in the specified age groups. Always follow the guidance of a healthcare professional for the best results.

Dosage and Administration

You should apply the medication to the affected area no more than 3 to 4 times each day. Make sure to follow this guideline to ensure the best results and avoid any potential side effects. If you have any questions about how to use the medication or if you notice any unusual reactions, be sure to consult your healthcare provider for advice.

What to Avoid

You should avoid using this product on wounds or damaged skin, as it may cause irritation or complications. Additionally, do not use it in conjunction with a heating pad, as this could lead to unwanted effects. If you are considering using this product for a child under 12 years of age who has arthritis-like conditions, please refrain from doing so, as it is not recommended for that age group. Always prioritize safety and consult a healthcare professional if you have any questions or concerns.

Side Effects

You should be aware that this product is intended for external use only. If you notice that your condition worsens or symptoms last longer than 7 days, it's important to stop using the product and consult your doctor. Additionally, if your symptoms improve but then return within a few days, or if you experience excessive skin irritation, you should also stop use and seek medical advice.

Before using this product, consider asking your doctor if you have any redness in the area you plan to treat. This can help ensure that the product is safe and appropriate for your situation.

Warnings and Precautions

This product is for external use only, so please avoid using it on any internal areas. Keep it out of reach of children. If a child accidentally swallows it, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

You should stop using this product and consult your doctor if your condition worsens, if symptoms last longer than 7 days, if symptoms clear up and then return within a few days, or if you experience excessive skin irritation. Your health and safety are important, so don’t hesitate to reach out for help if you need it.

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 effects of an overdose for this medication, you should be aware of general signs that may indicate a problem. These can include unusual drowsiness, confusion, or difficulty breathing.

If you notice any of these symptoms or if you believe you have taken too much of the medication, seek medical help right away. Contact your healthcare provider or go to the nearest emergency room. It's always better to be safe and get checked out if you have any concerns about your health.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the safety of this product during pregnancy has not been established. You should consult your doctor before using it, as there may be potential risks to your fetus that are not clearly defined.

While there are no specific dosage modifications provided for pregnant individuals, it's always best to seek guidance from a healthcare professional regarding any medications you may consider. Taking these precautions can help ensure the health and safety of both you and your baby.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of this product while nursing. Additionally, there are no known concerns about the product being passed into breast milk or any associated risks for your infant. This means you can use the product without worrying about its effects on your milk production or your baby's health.

Pediatric Use

If you are considering this medication for your child, it's important to know that it should not be used in children under 12 years of age who have arthritis-like conditions. For any child under 12, you should consult with a doctor before using this medication to ensure it is safe and appropriate for their specific situation. Always prioritize your child's health by seeking professional guidance when it comes to their medication needs.

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 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 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 how it may relate to your treatment. They can help ensure that you receive the safest and most effective care.

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, every individual is different, and your healthcare provider can help ensure that your treatment is safe and effective for you. Always feel free to ask questions and share your complete list of medications and tests during your appointments.

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 maintain a clean environment to avoid contamination. Always follow any specific instructions provided for safe use and disposal to ensure your safety and the effectiveness of the product.

Additional Information

No further information is available.

FAQ

How should I use this product?

Use only as directed. For adults and children 12 years of age or older, apply to the affected area not more than 3 to 4 times daily.

What should I do if I am under 12 years of age?

If you are under 12 years of age, ask a doctor before use.

Are there any contraindications for using this product?

Do not use on wounds, damaged skin, or with a heating pad. Also, do not use on a child under 12 years of age with arthritis-like conditions.

What should I do if my condition worsens?

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

Is this product safe to use during pregnancy?

The safety of this product during pregnancy has not been established. Consult a doctor if you are pregnant or planning to become pregnant.

What should I do in case of accidental ingestion?

In case of accidental ingestion, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

How should I store this product?

Store between 20-25° C (68-77°F) and protect from freezing.

Packaging Info

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

Packaging configurations for Freezin Cold Toast.
Details

Drug Information (PDF)

This file contains official product information for Freezin Cold Toast, 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 specific description details are provided in the text.

Uses and Indications

This drug is indicated for the topical treatment of affected areas in adults and children aged 12 years and older, with application not exceeding 3 to 4 times daily. For children under 12 years of age, consultation with a healthcare professional is advised prior to use.

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

Dosage and Administration

The medication should be applied to the affected area no more than 3 to 4 times daily. Healthcare professionals are advised to instruct patients on the appropriate technique for application to ensure optimal therapeutic effect. Care should be taken to avoid excessive use, and patients should be monitored for any adverse reactions or signs of irritation at the application site.

Contraindications

Use of this product is contraindicated in the following situations:

The product should not be applied to wounds or damaged skin due to the risk of exacerbating the condition or causing further injury. Additionally, it should not be used in conjunction with a heating pad, as this may lead to increased irritation or adverse effects. Furthermore, the product is contraindicated for use in children under 12 years of age who present with arthritis-like conditions, as safety and efficacy have not been established in this population.

Warnings and Precautions

External use only is strictly advised for this product. It is imperative that the product is kept out of reach of children to prevent accidental ingestion. In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center should be contacted at 1-800-222-1222.

Healthcare professionals should instruct patients to discontinue use and consult a physician if the condition worsens or if symptoms persist for more than 7 days. Additionally, patients should be advised to stop using the product if symptoms clear up and then reoccur within a few days, or if excessive skin irritation develops.

In cases of accidental ingestion, it is crucial to obtain emergency medical help or contact the Poison Control Center without delay.

Side Effects

Patients should be aware that the product is for external use only.

In the event of adverse reactions, patients are advised to stop use and consult a doctor if any of the following occur: the condition worsens or symptoms persist for more than 7 days; symptoms clear up and then reoccur within a few days; or if excessive skin irritation occurs.

Additionally, patients should seek medical advice before using the product if there is redness over the affected area.

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 Freezin Cold Toast (methyl salicylate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Freezin Cold Toast.
Details

Pediatric Use

Pediatric patients under 12 years of age with arthritis-like conditions should not use this medication. For children in this age group, it is advised to consult a healthcare professional prior to use.

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 potential adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

The safety of this product during pregnancy has not been established. Pregnant patients or those planning to become pregnant should consult a healthcare professional before use. While potential risks to the fetus are not clearly defined, caution is advised when considering the use of this product in this population. There are no specific dosage modifications for pregnant individuals; therefore, healthcare professionals should provide guidance based on individual circumstances.

Lactation

There are no specific warnings or recommendations regarding the use of this product by lactating mothers. Additionally, there are no statements concerning the potential for excretion in breast milk or any associated risks to breastfed infants during the use of this product.

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, the following management procedures are recommended:

  1. Assessment: Conduct a thorough assessment of the patient's clinical status, including vital signs and level of consciousness.

  2. Supportive Care: Provide supportive care as necessary, which may include airway management, oxygen supplementation, and intravenous fluids.

  3. Consultation: Engage with a poison control center or a medical toxicologist for guidance on specific interventions and antidotes, if applicable.

  4. Documentation: Document all findings, interventions, and the patient's response to treatment meticulously.

Healthcare professionals should remain vigilant and prepared to implement these general management strategies in the event of an overdose, even in the absence of specific overdosage information.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. In the event of accidental ingestion, patients should seek medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Patients should be instructed not to use this product on wounds or damaged skin, and to avoid using it in conjunction with a heating pad. It is important to inform patients that this product should not be used on children under 12 years of age who have arthritis-like conditions.

Healthcare providers should counsel patients to discontinue use and consult a doctor if their condition worsens or if symptoms persist for more than 7 days. Additionally, patients should be advised to stop using the product and seek medical advice if symptoms clear up and then reoccur within a few days, or if excessive skin irritation develops.

While using this product, patients should be cautioned to avoid contact with eyes and mucous membranes. They should also be informed not to bandage the area tightly. Finally, patients should be encouraged to consult a doctor before use if there is redness over the affected area.

Storage and Handling

The product is supplied in packaging that ensures its integrity during storage and handling. It should be stored at a temperature range of 20-25°C (68-77°F) to maintain its efficacy. Care must be taken to protect the product from freezing, as exposure to low temperatures may compromise its quality.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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