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Ak47 Menthol Cooling

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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
July 23, 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
July 23, 2020
Manufacturer
RENU LABORATORIES, INC.
Registration number
part348
NDC root
76348-522

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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 used for various conditions, including arthritis, simple backaches, muscle strains, sprains, and bruises. By applying the cream to the affected area, you may experience soothing relief that helps ease discomfort.

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) associated with 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 who are 12 years of age and older.

What to Avoid

It's important to use this medication safely. You should not bandage the area tightly or apply it to wounds or damaged skin. Avoid getting it in your eyes, and do not use heating pads or other heating devices while using this product.

If your condition worsens, or if your symptoms last more than 7 days or improve and then return within a few days, please stop using the medication and consult your doctor. Your health and safety are the top priority, so always follow these guidelines closely.

Side Effects

This product is intended for external use only. If you notice that your condition worsens, or if your symptoms last longer than 7 days, or if they improve and then return within a few days, it’s important to stop using the product and consult a doctor.

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 come back 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 intervention 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 generally not recommended for use while pregnant due to potential risks to your developing baby (fetus). Before considering this medication, you should consult your healthcare provider to discuss any possible risks and to determine if it is necessary for your situation.

If your healthcare provider does recommend it, be aware that dosage adjustments may be needed, so it's essential to follow their guidance closely. Always prioritize open communication with your healthcare professional 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. If your child falls within this age range, you should apply it generously to the affected area and massage it into the skin until it is fully absorbed.

It's important to keep this product out of reach of younger children. If a child accidentally swallows it, seek medical assistance or contact a poison control center immediately. Always prioritize safety when using any medication.

Geriatric Use

While there is no specific information about how this medication should be used by 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 discuss any new prescriptions with your healthcare provider. They can help ensure that the medication is safe and appropriate for you or your loved one, considering any existing health conditions or medications.

If you have concerns about how this medication might affect you or an older adult in your care, please consult with a healthcare professional for personalized advice.

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 information provided does not include specific guidelines for dosage adjustments, special monitoring, or precautions related to your condition. This means that there are no tailored recommendations for how the medication may affect you differently due to your liver health.

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your specific situation. They can help determine the best approach based on your liver function and overall health.

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 interactions between this medication and other drugs or laboratory tests. 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 any tests you may be undergoing.

Storage and Handling

To ensure the best quality and safety of your product, store it at room temperature and keep it away from direct light. It's important to keep the container tightly closed when not in use to prevent contamination. Once you open the container, be sure to discard any remaining product after use to maintain safety and effectiveness. Following these guidelines will help you use the product safely and effectively.

Additional Information

This medication is intended for external use only and should be applied topically. 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 contraindications for using Cooling Cream?

There are no specific contraindications mentioned, but it is not recommended for use during pregnancy due to potential risks.

What precautions should I take when using Cooling Cream?

Do not bandage tightly, avoid contact with eyes, and do not apply to wounds or damaged skin. Also, do not use heating pads or other heating devices.

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

Stop using Cooling Cream and consult a doctor if your condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days.

Is Cooling Cream safe to use during pregnancy?

Safety during pregnancy has not been established, and there may be risks to the fetus. Consult a healthcare provider before use.

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.

How should I store Cooling Cream?

Store Cooling Cream at room temperature, protect it from light, and keep the container tightly closed. Discard after opening.

Packaging Info

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

Packaging configurations for Ak47 Menthol Cooling.
Details

Drug Information (PDF)

This file contains official product information for Ak47 Menthol Cooling, 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 also enclosed in 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 individual's needs and response to treatment.

Contraindications

Use is contraindicated in the following situations:

Tight bandaging should be avoided to prevent compromised circulation. 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 exacerbating the condition. The use of heating pads or other heating devices is not recommended, as it may lead to increased irritation or adverse effects.

Patients should discontinue use and consult a healthcare professional if the 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 the local poison control center should be contacted without delay.

Healthcare professionals are advised to instruct 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

No drug interactions or drug and laboratory test interactions have been identified for this product. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

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

Packaging configurations for Ak47 Menthol Cooling.
Details

Pediatric Use

Pediatric patients aged 12 years and older are indicated for use of the product. For this age group, the recommended application involves generously applying the product to the affected area and massaging it into the skin until fully absorbed.

Caution is advised to keep the product out of reach of younger children. In the event of accidental ingestion, immediate medical assistance should be sought or a poison control center contacted.

Geriatric Use

There is no specific information 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

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 providers should be consulted prior to use, as there may be risks to fetal outcomes.

Dosage adjustments may be necessary for pregnant patients, and it is essential to seek medical advice regarding any modifications. This medication should only be used if clearly needed and after thorough discussion with a healthcare professional.

Lactation

There are no specific statements regarding the use of this medication in lactating mothers. Additionally, there are no known data on excretion in breast milk or effects on breastfed infants. Healthcare professionals should consider the absence of information when advising lactating mothers about the use of this medication.

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 initiate supportive care, which may include maintaining airway patency, ensuring adequate ventilation, and monitoring vital signs.

If available, the use of specific antidotes or treatments should be considered based on the substance involved and the clinical presentation. Consultation with a poison control center or a medical toxicologist may provide additional guidance on the management of overdose cases.

Documentation of the incident, including the substance, amount ingested, and time of ingestion, is crucial for effective management and treatment planning.

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. 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 includes specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at room temperature to maintain its integrity. The container must be kept tightly closed to prevent contamination and degradation. Additionally, the product should be protected from light exposure to ensure optimal stability. Once opened, the product must 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 discontinue 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 and to seek medical assistance or contact a poison control center immediately if swallowed. While using the product, it is important to avoid tight bandaging, contact with the eyes, application to wounds or damaged skin, and the use of heating pads or other heating devices.

Drug Information (PDF)

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