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Ak47 Menthol Warming

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This product has been discontinued

Active ingredient
Menthol 5.6 g/112 g
Other brand names
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2020
Label revision date
August 3, 2020
Active ingredient
Menthol 5.6 g/112 g
Other brand names
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2020
Label revision date
August 3, 2020
Manufacturer
RENU LABORATORIES, INC.
Registration number
part348
NDC root
76348-521

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Drug Overview

Cooling Cream is a topical product designed to provide temporary relief from minor aches and pains. It can be particularly helpful for conditions such as arthritis, simple backaches, muscle strains, sprains, and bruises. By applying the cream to the affected area, you may experience soothing relief that can help you manage discomfort in your daily activities.

Uses

You can use this medication for the temporary relief of minor aches and pains that may arise from various conditions. This includes discomfort associated with arthritis, simple backaches, muscle strains, sprains, and bruises.

It's important to note that there are no reported teratogenic effects (which means it does not cause birth defects) or nonteratogenic effects (which refers to effects that do not cause birth defects) related to this medication. Always consult with your healthcare provider if you have any questions or concerns about using this treatment.

Dosage and Administration

When using this medication, you should apply a generous amount directly to the area that is causing you pain. It's important to massage the medication into your skin until it is fully absorbed. You can repeat this process as needed to help relieve your discomfort. This method is suitable for both adults and children aged 12 years and older.

What to Avoid

It's important to use this medication safely. You should avoid bandaging tightly, as this can cause complications. Make sure to keep the product away from your eyes and do not apply it to any wounds or damaged skin. Additionally, refrain from using heating pads or other heating devices while using this medication.

If your condition worsens, or if your symptoms last longer than 7 days or return after clearing up, please stop using the product and consult your doctor for further guidance. Your health and safety are paramount, so always follow these instructions carefully.

Side Effects

This product is intended for external use only. If your condition worsens, or if your symptoms last more than 7 days or improve and then return within a few days, you should stop using the product and consult a doctor. It's important to monitor your symptoms closely to ensure your safety and well-being.

Warnings and Precautions

This product is intended for external use only, so please avoid applying it to any areas that are not meant for topical treatment. It's important to keep this product out of reach of children. If a child accidentally swallows it, seek medical help or contact a poison control center immediately.

If your condition worsens, or if your symptoms last longer than 7 days, or if they improve and then return within a few days, stop using the product and consult your doctor for further advice. 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 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 action can make a significant difference.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the safety of this medication during pregnancy has not been established. It is not recommended for use while you are pregnant because there may be potential risks to your developing baby. Always consult with your healthcare provider to discuss any medications you are considering and to ensure the best care for you and your baby.

Lactation Use

When it comes to breastfeeding, it's important to be aware that there are no specific guidelines or statements regarding nursing mothers or lactation (the process of producing milk). This means that if you are breastfeeding, you may not find detailed information about how certain medications or treatments could affect you or your baby.

If you have concerns about breastfeeding while taking any medication, it's always best to consult with your healthcare provider for personalized advice and to ensure the safety of both you and your infant.

Pediatric Use

This product is suitable for children aged 12 years and older. When using it, you should apply a generous amount to the affected area and gently massage it into the skin until it is fully absorbed. You can repeat this process as needed to help relieve discomfort. Always ensure that your child follows these directions for the best results.

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 older adults may have different health needs and may be taking multiple medications, it’s always a good idea to consult with a healthcare provider before starting any new medication. They can help ensure that the treatment is safe and appropriate for your individual health situation.

If you or a loved one is an older adult, be sure to discuss any concerns about potential side effects or interactions with other medications you may be taking. Your healthcare provider can provide guidance tailored to your specific needs.

Renal Impairment

If you have kidney 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 usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect 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 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, 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 the product, store it at room temperature and keep it out of reach of children. When using the product, avoid bandaging it tightly, as this can cause discomfort. It's important to prevent contact with your eyes and to refrain from applying the product to any wounds or damaged skin. Additionally, do not use heating pads or other heating devices with this product, as they may interfere with its intended use. Remember to discard the product after opening to maintain safety and hygiene.

Additional Information

This medication is applied to the skin (topical use) and is intended for external use only. While using this product, be sure to avoid bandaging tightly, contact with your eyes, and applying it to wounds or damaged skin. Additionally, do not use heating pads or other heating devices while using this medication.

If your condition worsens, symptoms persist for more than 7 days, or if symptoms clear up and then return within a few days, stop using the product and consult your doctor. Keep this medication out of reach of children; if swallowed, seek medical help or contact a poison control center immediately.

FAQ

What is Cooling Cream used for?

Cooling Cream provides temporary relief of minor aches and pains associated with conditions like arthritis, simple backache, muscle strains, sprains, and bruises.

How should I use Cooling Cream?

Apply generously to the affected area and massage it into the skin until thoroughly absorbed. You can repeat this as necessary.

Are there any warnings for using Cooling Cream?

Yes, it is for external use only. Avoid contact with eyes, do not apply to wounds or damaged skin, and do not use heating pads or other heating devices.

What should I do if my condition worsens?

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

Is Cooling Cream safe to use during pregnancy?

Safety during pregnancy has not been established, and it is not recommended for use due to potential risks to the fetus.

What should I do if Cooling Cream is swallowed?

Keep Cooling Cream out of reach of children. If swallowed, get medical help or contact a poison control center right away.

Are there any contraindications for Cooling Cream?

No specific contraindications are mentioned, but it is not recommended for use during pregnancy.

Packaging Info

Below are the non-prescription pack sizes of Ak47 Menthol Warming (menthol warming). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Ak47 Menthol Warming.
Details

Drug Information (PDF)

This file contains official product information for Ak47 Menthol Warming, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

The product is presented in a cooling cream formulation, designed for topical application. It is packaged in a labeled container that ensures proper identification and usage instructions. The cooling cream is contained within a box that provides additional information regarding the product's properties and intended use.

Uses and Indications

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

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

Dosage and Administration

Adults and children 12 years of age and older should apply the medication generously to the affected area. It is important to massage the formulation into the painful area until it is thoroughly absorbed into the skin. This application may be repeated as necessary, depending on the severity of symptoms and individual response to treatment.

Contraindications

The product should not be used in the following situations:

  • Bandaging should not be performed tightly, as this may lead to complications.

  • Contact with the eyes must be avoided to prevent irritation or injury.

  • Application to wounds or damaged skin is contraindicated due to the risk of adverse effects.

  • The use of heating pads or other heating devices in conjunction with this product is not recommended, as it may exacerbate side effects.

Patients should discontinue use and consult a healthcare professional if their condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days.

Warnings and Precautions

For external use only. 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 contact a poison control center without delay.

Healthcare professionals should advise patients to discontinue use and consult a physician if the condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. Monitoring for these signs is essential to ensure patient safety and effective management of the condition being treated.

Side Effects

For external use only. Patients should stop use and consult a doctor if the condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then occur again within a few days.

Drug Interactions

There are no reported drug interactions associated with the use of this medication. Additionally, no interactions with laboratory tests have been identified. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Ak47 Menthol Warming (menthol warming). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Ak47 Menthol Warming.
Details

Pediatric Use

Pediatric patients aged 12 years and older are indicated for use of the product. It is recommended that the product be applied generously to the affected area and massaged into the skin until thoroughly absorbed. This application may be repeated as necessary to achieve the desired effect.

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

Safety during pregnancy has not been established for this medication. It is not recommended for use during pregnancy due to potential risks to the fetus. Healthcare professionals should consider the potential risks and benefits when prescribing this medication to women of childbearing potential. Pregnant patients should be informed of the potential risks associated with the use of this medication during pregnancy.

Lactation

There are no specific statements regarding the use of this medication in lactating mothers or its effects on breastfed infants. Healthcare professionals should consider the absence of data when advising lactating mothers about the use of this medication.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

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.

Additionally, it is recommended to consult local poison control centers or relevant toxicology resources for guidance on specific management protocols and antidotes, if applicable.

Documentation of the incident, including the substance involved, estimated dose, and time of exposure, is crucial for effective management and follow-up care.

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 insert text.

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 assistance or contact a poison control center immediately.

Patients should be instructed 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.

When using this product, it is important to inform patients of the following precautions: they should not bandage the area tightly, avoid contact with the eyes, and refrain from applying the product to wounds or damaged skin. Additionally, patients should be cautioned against using heating pads or other heating devices in conjunction with this product.

Storage and Handling

The product is supplied in a configuration that ensures optimal usability. It should be stored at room temperature, away from direct sunlight and moisture. To maintain safety, it is essential to keep the product out of reach of children.

Special handling precautions must be observed. The product should not be bandaged tightly, and care should be taken to avoid contact with eyes. It is contraindicated to apply the product to wounds or damaged skin. Additionally, the use of heating pads or other heating devices is not recommended.

Once opened, the product should be discarded to ensure safety and efficacy.

Additional Clinical Information

The product is administered topically and is intended for external use only. Clinicians should advise patients to stop use and consult a doctor if the condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. Patients should be instructed to keep the product out of reach of children; if swallowed, they should seek medical help or contact a poison control center immediately.

While using the product, patients should avoid bandaging tightly, contact with eyes, application to wounds or damaged skin, and the use of heating pads or other heating devices. No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Ak47 Menthol Warming, 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 Ak47 Menthol Warming, 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.

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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.