Pain Relief Stick

Description

Sagely Naturals Pain Relief Stick is formulated to provide instant cooling relief from discomfort. This topical preparation contains 10% menthol, which contributes to its cooling effect. The product is composed of 95% natural ingredients, ensuring a more natural approach to pain management. It is packaged in a convenient stick form, with a net weight of 1.7 ounces (50 grams).

Uses and Indications

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

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

Dosage and Administration

For adults and children over 12 years of age, a thin layer of the medication should be applied to the affected area. The application should be followed by gentle massage into the painful area to enhance absorption. This process may be repeated as necessary, but should not exceed 3 to 4 applications within a 24-hour period.

For children 12 years of age or younger, it is advised to consult a physician before use to determine appropriate dosing and administration.

Contraindications

Use is contraindicated on wounds or damaged, broken, or irritated skin due to the potential for exacerbating the condition and delaying healing. Additionally, application with a heating pad is contraindicated, as this may lead to increased irritation or adverse effects.

Warnings and Precautions

This product is intended for external use only. It is imperative that it not be applied to wounds, or to damaged, broken, or irritated skin. Additionally, the use of this product in conjunction with a heating pad is contraindicated.

While using this product, it is essential to avoid contact with the eyes and mucous membranes. Furthermore, users should refrain from applying tight bandages over the treated area to prevent complications.

In the event that the condition worsens, or if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days, it is crucial to discontinue use and consult a healthcare professional.

This product should be kept out of reach of children. In the case of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center should be made without delay.

Side Effects

Patients should be aware that this product is intended for external use only. It is contraindicated for application on wounds, or on damaged, broken, or irritated skin. Additionally, the use of this product in conjunction with a heating pad is not recommended.

While using this product, patients should take care to avoid contact with the eyes or mucous membranes. It is also advised not to bandage the area tightly after application.

Patients are instructed to discontinue use and consult a healthcare professional if the condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days.

For those who are pregnant or breastfeeding, it is essential to seek advice from a health professional prior to use.

This product should be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center should be made without delay.

Drug Interactions

There are no reported drug interactions associated with the use of this medication. Additionally, no interactions with laboratory tests have been identified. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Pain Relief Stick (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 before use. It is important to assess the appropriateness of treatment and dosage for this age group, as specific recommendations may vary based on individual health needs and conditions.

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

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully considered in these populations to ensure the safety of both the mother and the fetus or 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 drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of data necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients, although specific recommendations are not provided.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to 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 event of an overdosage, immediate medical intervention is crucial. If the substance is ingested, it is imperative to seek medical assistance or contact a Poison Control Center without delay.

Healthcare professionals should be aware that prompt action can significantly influence the outcome of an overdosage situation. Symptoms of overdosage may vary depending on the specific substance involved; therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous evaluation and appropriate interventions should be implemented based on the clinical presentation and severity of symptoms.

In all cases of suspected overdosage, the involvement of poison control and emergency medical services is recommended to ensure optimal patient care and safety.

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 the product out of reach of children. Instruct patients that if the product is swallowed, they should seek medical help or contact a Poison Control Center immediately.

Patients should be informed not to use the product on wounds or on damaged, broken, or irritated skin. It is also important to caution patients against using the product in conjunction with a heating pad.

Healthcare providers should recommend that patients stop using the product 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.

Additionally, patients should be advised to avoid contact with eyes or mucous membranes while using the product. It is essential to inform patients not to bandage the area tightly when using this product.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product in a cool, dry place to maintain its integrity and efficacy. Proper storage conditions are crucial to ensure the product remains effective throughout its shelf life.

Additional Clinical Information

The product is administered topically. For adults and children over 12 years, a thin layer should be applied to the affected area and massaged in, with the application being repeated as necessary, but not exceeding 3 to 4 times daily. For children 12 years or younger, it is advised to consult a doctor before use.

There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)