Ak47 Cooling Roll-on

Description

AK47 is presented in a packaging format that includes a product box and a label. The effective date of this labeling is June 1, 2020. The product box is visually represented in an image file labeled "AK47 BOX.jpg," while the label is depicted in another image file titled "AK47 label.jpg." Both images are in JPEG format and serve to provide a visual reference for the product's packaging and labeling.

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 no more than 10 times per day, as needed for pain relief. It is essential to ensure that the application does not exceed this frequency to avoid potential adverse effects.

For children under 12 years of age, the product is not recommended for use. Healthcare professionals should advise caregivers to consult a doctor for appropriate alternatives or guidance regarding pain management in this age group.

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 adverse effects.

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

Warnings and Precautions

For external use only. This product is not intended for ingestion. In the event of accidental swallowing, it is imperative to seek emergency medical assistance or contact a Poison Control Center immediately.

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 of the patient's condition is essential to ensure appropriate management and to prevent potential complications.

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

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 Cooling Roll-on (menthol roll-on). 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 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

Elderly patients may not have specific information regarding the use of this medication, as the prescribing information does not provide any recommendations or considerations related to age. Furthermore, there are no dosage adjustments, safety concerns, or special precautions indicated for geriatric patients.

Healthcare providers should remain vigilant when prescribing this medication to elderly patients, as individual responses may vary. Monitoring for efficacy and potential adverse effects is advisable, given the general variability in pharmacokinetics and pharmacodynamics in 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. Potential risks to the fetus are not well-documented; therefore, caution is advised when considering the use of this product in pregnant individuals. There are no specific dosage modifications for pregnant patients; healthcare professionals should be consulted for guidance regarding use in this population.

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 may not have specific dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. Therefore, healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the lack of detailed guidance necessitates careful clinical judgment and individualized patient assessment. Regular monitoring of renal function is advisable to ensure patient safety and therapeutic efficacy.

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 prescribing information.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution when administering the medication. It is essential to monitor patients closely for any signs of adverse effects or symptoms that may arise from excessive dosing.

In the event of suspected overdosage, immediate medical attention should be sought. Healthcare providers should implement supportive measures as necessary, which may include symptomatic treatment and monitoring of vital signs.

Due to the lack of detailed overdosage information, it is recommended that healthcare professionals refer to established clinical guidelines and protocols for managing overdose situations relevant to the specific medication in question. Additionally, contacting a poison control center may provide further guidance on appropriate management strategies.

Continued vigilance and patient assessment are crucial in mitigating potential risks associated with overdosage.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available in the insert.

Patient Counseling

Healthcare providers should advise patients to keep the product out of reach of children to prevent accidental ingestion. Instruct patients that if the product is swallowed, they 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.

While using the product, healthcare providers should emphasize the importance of not bandaging tightly and avoiding contact with the eyes. Patients should also be cautioned against applying the product to wounds or damaged skin. Additionally, it is important to inform patients not to use the product in conjunction with heating pads or other heating devices to prevent adverse effects.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which are essential for identification and inventory management. It is recommended to store the product at room temperature to maintain its efficacy.

To ensure optimal preservation, the product must be protected from light exposure. Additionally, it is crucial to keep the container tightly closed when not in use to prevent contamination and degradation. Once opened, the product should be discarded after use to ensure safety and effectiveness.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)