Pain Relief Roll-on

Description

Sagely Naturals Pain Relief Roll-On is formulated to provide instant cooling relief from discomfort. This topical solution 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 2 fluid ounce (60 mL) container, designed for convenient application.

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

The medication should be used only as directed. For adults and children over 12 years of age, a thin layer of the product should be applied to the affected area. The area should be gently massaged to ensure proper absorption. 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 doctor before use.

Contraindications

The product is contraindicated for use on wounds or damaged, broken, or irritated skin due to the potential for exacerbating the condition and hindering healing. Additionally, the use of this product in conjunction with a heating pad is contraindicated, as it may lead to increased irritation or adverse effects.

Warnings and Precautions

For external use only. This product is contraindicated for application on wounds, or on damaged, broken, or irritated skin. Additionally, it should not be used in conjunction with a heating pad.

When utilizing this product, it is imperative to avoid contact with the eyes or mucous membranes. Users should refrain from applying tight bandages over the treated area to prevent complications.

If 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 essential to discontinue use and consult a healthcare professional.

In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is advised.

Pregnant or breastfeeding individuals should consult a healthcare professional prior to use to ensure safety.

This product must be kept out of reach of children to prevent accidental ingestion or misuse.

Side Effects

Patients should be aware that this product is for external use only. It is contraindicated for use on wounds, or on damaged, broken, or irritated skin, and should not be used in conjunction with a heating pad.

During the use of this product, patients are advised to avoid contact with the eyes or mucous membranes and to refrain from tightly bandaging the area of application.

Patients should discontinue use 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.

For individuals who are pregnant or breastfeeding, it is recommended to seek advice from a healthcare professional prior to use.

This product should be kept out of reach of children. In the event of accidental ingestion, it is crucial to seek medical assistance or contact a Poison Control Center immediately.

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 Roll-on (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

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 breastfeeding safety. Healthcare providers should consider individual circumstances and the specific needs of the patient when making recommendations.

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 text regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

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 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 and management strategies.

Healthcare providers should ensure that patients are monitored closely for any signs of toxicity and that supportive care is initiated as necessary.

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 question.

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 and to seek immediate medical assistance or contact a Poison Control Center if the product is swallowed. Patients should be instructed not to use the product on wounds or on damaged, broken, or irritated skin, as this may exacerbate their condition.

It is important to inform patients that the product should not be used in conjunction with a heating pad, as this may lead to adverse effects. Patients should be counseled 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.

Additionally, healthcare providers should emphasize the importance of avoiding contact with the eyes or mucous membranes while using the product. Patients should also be advised not to bandage the area tightly when using the product, as this could lead to complications.

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. Additionally, the product must be protected from light exposure to prevent degradation. The container should be kept tightly closed when not in use to ensure optimal preservation of the contents. It is important to discard the product after opening to ensure safety and efficacy.

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 option to repeat this process as necessary, but not exceeding 3 to 4 applications daily. For children aged 12 years or younger, it is advised to consult a doctor before use.

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

Drug Information (PDF)

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

View product document (PDF)