Ak47 Menthol Cooling Cream Packet

Description

The product is a Cooling Pack, designed for therapeutic use. It is packaged in a box containing 10 individual cooling packets, each intended for single use. The cooling packets are formulated to provide localized cooling relief.

Uses and Indications

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

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

Dosage and Administration

For adults and children aged 12 years and older, the recommended application is to the affected area, not exceeding 10 times per day as needed for pain relief.

In children under 12 years of age, the product should not be used without consulting a healthcare professional.

Contraindications

Use of this product 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 or causing further harm.

• Concurrent use with heating pads or other heating devices is not recommended, as it may lead to increased absorption and potential adverse effects.

Warnings and Precautions

For external use only. It is imperative that this product is kept out of reach of children to prevent accidental ingestion. In the event of swallowing, 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. These actions are crucial to ensure patient safety and effective management of their condition.

In cases of accidental ingestion, it is essential to seek emergency medical help or contact a Poison Control Center immediately. Prompt action is necessary to mitigate potential risks associated with ingestion.

Side Effects

For external use only. Patients should 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.

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 Cream Packet (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should not use this medication without consulting a doctor. For adolescents and adults aged 12 years and older, the recommended application is to the affected area no more than 10 times a day as needed for pain.

Geriatric Use

There is no specific information regarding the use of AK47 Menthol Cooling Cream in geriatric patients. Healthcare providers should exercise caution when administering this product to elderly patients, as they may have different physiological responses compared to younger populations.

Due to the lack of clinical data in this demographic, it is advisable to monitor elderly patients closely for any adverse effects or unusual reactions following the use of this cream. Additionally, healthcare providers should consider individual patient factors, such as comorbidities and concurrent medications, when recommending this product to geriatric patients.

Pregnancy

There is no information available regarding the use of AK47 Menthol Cooling Cream during pregnancy. As such, the safety of this product in pregnant patients has not been established, and there are no known dosage modifications or special precautions recommended for use in this population. Healthcare professionals should exercise caution and consider the lack of data when advising women of childbearing potential regarding the use of this product during pregnancy.

Lactation

There are no specific statements or considerations regarding nursing mothers or lactation in the provided text. Therefore, the effects of the drug on breastfed infants and the excretion of the drug in human milk remain undetermined. Healthcare professionals should exercise caution and consider the potential risks and benefits when prescribing this medication to lactating mothers.

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 implement supportive care measures, which may include monitoring vital signs, providing symptomatic treatment, and ensuring the patient's safety.

If available, consultation with a poison control center or a medical toxicologist is recommended to guide the management of the overdose effectively.

Documentation of the incident, including the substance involved, the amount taken, and the time of ingestion, is crucial for appropriate treatment 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 for SPL code 90375-7.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. In the event of swallowing the product, patients should seek medical help 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 that they should not bandage the area tightly. They should also be cautioned to avoid contact with the eyes and to refrain from applying the product to wounds or damaged skin. Additionally, patients should be advised against using this product in conjunction with heating pads or other heating devices to prevent adverse effects.

Storage and Handling

The product is supplied in packaging that includes specific NDC numbers. It should be stored at room temperature, ensuring that it is protected from light exposure. Freezing the product is not permitted, as it may compromise its integrity. Additionally, once opened, the product must be discarded to ensure safety and efficacy.

Additional Clinical Information

The medication is administered topically, with a recommended application frequency of no more than 10 times a day for adults and children aged 12 years and older, as needed for pain. For children under 12 years of age, consultation with a doctor is advised prior to use.

Clinicians should counsel patients on several important safety measures: avoid tight bandaging of the application site, prevent contact with eyes, and refrain from applying the product to wounds or damaged skin. Additionally, patients should not use the medication in conjunction with heating pads or other heating devices. They are advised 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. It is crucial to keep the product out of reach of children, and in the event of ingestion, medical assistance or contact with a Poison Control Center should be sought immediately.

Drug Information (PDF)

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

View product document (PDF)