Ak47 Menthol Warming

Description

SPL code 34089-3 is packaged in a box containing 10 individual packettes. Each packette is designed for convenient dispensing and storage.

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 product liberally to the affected area. The application should be followed by gentle massage into the skin until the product is thoroughly absorbed. This process may be repeated as necessary, depending on the individual's needs and the severity of the condition.

The product is intended for topical application exclusively to the affected area. It is important to ensure that the application is massaged into the skin effectively to facilitate absorption. The frequency of administration is as needed, allowing for flexibility based on the patient's response and comfort.

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.

• The use of heating pads or other heating devices in conjunction with this product is not recommended, as it may lead to increased irritation or adverse effects.

Warnings and Precautions

For external use only. It is imperative to avoid contact with the eyes and sensitive areas to prevent irritation or adverse reactions.

General precautions should be observed to ensure safe application. Bandaging should not be done tightly, as this may impede circulation. Additionally, the product should not be applied to wounds or damaged skin, and the use of heating pads or other heating devices in conjunction with the product is contraindicated.

In the event of accidental ingestion, immediate medical assistance should be sought, or a poison control center should be contacted 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 their condition.

Side Effects

Patients should be aware that the product is intended for external use only and must avoid contact with the eyes and sensitive areas to prevent irritation or adverse effects.

In clinical practice, it is advised that patients 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. These precautions are essential to ensure patient safety and to mitigate the risk of potential complications associated with prolonged use or inappropriate application.

Drug Interactions

There are no specific drug interactions identified for this medication. Additionally, no laboratory test interactions have been reported. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

Packaging & NDC

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

Pediatric Use

Pediatric patients should be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance or contact with a poison control center is advised.

For dosing, the product is indicated for use in adults and children aged 12 years and older, who should apply it liberally to the affected area. Safety and efficacy in children under 12 years of age have not been established.

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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

Pregnancy

The safety of this product during pregnancy has not been established. Use is not recommended during pregnancy due to potential risks to the fetus. Pregnant patients or those planning to become pregnant should consult a healthcare provider before use to discuss potential risks and benefits.

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 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 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 compound in these areas.

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 that the product is swallowed, patients should seek medical help or contact a poison control center immediately.

Patients should be informed to discontinue use and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days.

When using this product, it is important to instruct patients not to bandage tightly, to avoid contact with the eyes, and to 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 protect the contents from light exposure, which can compromise the product's efficacy. Additionally, it is important to discard the product after opening to ensure safety and effectiveness.

Additional Clinical Information

The product is administered topically, with instructions for adults and children aged 12 years and older to apply liberally to the affected area and massage until fully absorbed. This application may be repeated as necessary.

Clinicians should counsel patients on proper usage, advising against tight bandaging, contact with eyes, application to wounds or damaged skin, and the use of heating pads or other heating devices. Patients are instructed to discontinue use and consult a doctor if the condition worsens, symptoms persist beyond 7 days, or if symptoms resolve and then recur within a few days. Additionally, the product should be kept out of reach of children, and immediate medical assistance should be sought if ingested.

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)