Pain Relief

Description

Sagely Naturals Extra Strength Pain Relief Spray is formulated with 95% natural ingredients, providing an effective solution for pain relief. This spray features an instant cooling effect, enhanced by the inclusion of 10% menthol. The product is available in a 2 fluid ounce (60 mL) dosage form, designed for convenient application.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains of muscles and joints associated with strains, bruises, simple backache, arthritis, and sprains.

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 not more than 3 to 4 times daily. It is important to ensure that the application is performed with clean hands and that the affected area is clean and dry prior to application.

For children under 12 years of age, it is advised to consult a physician for appropriate dosing and administration guidance.

Contraindications

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

Warnings and Precautions

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

While using this product, it is imperative 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 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.

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 is advised.

Side Effects

Patients should be aware that this product is for external use only. It is contraindicated for use on wounds or 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, immediate medical assistance should be sought or contact with a Poison Control Center should be made without delay.

Drug Interactions

There are no specific drug interactions identified for this medication. Additionally, no laboratory test interactions have been noted in the available data. 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 Pain Relief (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. For adolescents and adults aged 12 years and older, the recommended application is to the affected area no more than 3 to 4 times daily.

It is important to keep the product out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is advised.

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. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. 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 drug 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 no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data 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, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and evaluation are recommended 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 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 this 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 not to use the product on wounds or on damaged, broken, or irritated skin. Additionally, it is important to caution patients against using the product in conjunction with a heating pad, as this may lead to adverse effects.

Healthcare providers should encourage patients to stop using the product and consult a doctor if their condition worsens, or if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days.

While using the product, patients should be advised to avoid contact with their eyes or mucous membranes. Furthermore, they should be instructed not to bandage the area tightly when applying the product to ensure proper usage and minimize the risk of complications.

Storage and Handling

The product is supplied in a container that must be kept tightly closed to maintain its integrity. It should be stored at room temperature, away from direct light exposure to protect its quality. Once opened, the product should be discarded to ensure safety and efficacy.

Additional Clinical Information

The medication is administered topically, with the recommended application frequency for adults and children aged 12 years and older being 3 to 4 times daily to the affected area. For children under 12 years of age, it is advised to consult a doctor regarding the appropriate use. No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

Drug Information (PDF)

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

View product document (PDF)