Kens Pain and Arthritis Formula

Description

The product is identified by the SPL code 34089-3. No additional specific description details are provided in the available data.

Uses and Indications

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

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

Dosage and Administration

For adults and children over 12 years of age, the product should be shaken well before each use. A generous amount should be applied to the affected area, followed by a thorough massage into the skin until fully absorbed. This application may be repeated as necessary, but should not exceed 3 to 4 times daily.

For children 12 years of age or younger, it is advised to consult a physician before use.

Contraindications

Use of this product is contraindicated in the following situations:

• The product should be kept out of reach of children to prevent accidental ingestion.

• In the event of accidental swallowing, immediate medical assistance or contact with a Poison Control Center is required.

Warnings and Precautions

For external use only, this product must be utilized strictly as directed. Healthcare professionals should advise patients against bandaging the area tightly or using it in conjunction with a heating pad. It is imperative to avoid contact with the eyes and mucous membranes, and the product should not be applied to wounds or any damaged, broken, or irritated skin. Patients may experience a transient burning sensation or redness upon application; however, these effects typically resolve within several days. Should a severe burning sensation occur, patients are instructed to discontinue use immediately. Additionally, the treated area should not be exposed to heat or direct sunlight.

This product is flammable; therefore, it should be kept away from fire or flame. Pregnant or breastfeeding individuals are advised to consult a healthcare professional prior to use.

Patients should be instructed to stop using the product and seek medical advice if their condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. In the event of ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

General precautions include keeping the product out of reach of children to prevent accidental ingestion or misuse.

Side Effects

Patients using this product should be aware that it is for external use only and must be applied strictly as directed. It is important to avoid bandaging the area tightly or using it in conjunction with a heating pad. Contact with eyes and mucous membranes should be avoided, and the product should not be applied to wounds or damaged, broken, or irritated skin.

Upon application, patients may experience a transient burning sensation or redness, which typically resolves within several days. However, if a severe burning sensation occurs, patients are advised to discontinue use immediately. Additionally, the treated area should not be exposed to heat or direct sunlight.

Patients should stop using the product and consult a healthcare professional if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. It is also important to note that the product is flammable; therefore, it should be kept away from fire or flame. Pregnant or breastfeeding patients should seek advice from a healthcare professional before using this product.

Drug Interactions

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

Packaging & NDC

Below are the non-prescription pack sizes of Kens Pain and Arthritis Formula (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients 12 years of age or younger should consult a healthcare professional prior to use. This precaution is essential to ensure safety and appropriateness of treatment in this age group.

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 potential adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing infant.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data regarding the excretion of this medication in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

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 event of an overdosage, immediate medical assistance is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical help or contact a Poison Control Center without delay.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved; therefore, a thorough assessment by a medical professional is recommended to determine the appropriate course of action.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and evaluation are advised to ensure patient safety and effective resolution of any complications arising from the 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 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 the medication out of reach of children to prevent accidental ingestion. It is important to emphasize that if the medication is swallowed, patients should seek medical help or contact a Poison Control Center immediately. This guidance is crucial for ensuring the safety and well-being of patients and their families.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It should be stored at room temperature, ensuring that it is kept away from fire or flame to maintain safety and efficacy. Prior to each use, it is essential to shake the container well to ensure proper mixing of the contents.

Additional Clinical Information

The product is administered topically, with specific instructions for different age groups. Adults and children over 12 years should apply the product generously to the affected area, massaging it into the skin until fully absorbed, with a maximum frequency of 3 to 4 times daily. For children aged 12 years or younger, consultation with a doctor is advised prior to use.

Clinicians should counsel patients on the following precautions: the product is for external use only and should be used strictly as directed. Patients should avoid tight bandaging or the use of heating pads in conjunction with the product, and contact with eyes and mucous membranes should be avoided. It should not be applied to wounds or damaged skin. A transient burning sensation or redness may occur but typically resolves within several days; however, if a severe burning sensation occurs, use should be discontinued immediately. Patients should also avoid exposing the treated area to heat or direct sunlight. Pregnant or breastfeeding individuals should consult a healthcare professional before use, and the product should be kept out of reach of children. In case of ingestion, medical assistance or contact with a Poison Control Center is necessary.

Drug Information (PDF)

This file contains official product information for Kens Pain and Arthritis Formula, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)