Natures Oil 16% Menthol

Description

Nature's Oil is a topical spray formulation containing 16% menthol. The product is packaged in a net weight of 4 oz (113 g). It is manufactured for Nature's Oil, located at 1800 Miller Parkway, Streetsboro, Ohio 44241. For additional information, visit www.NaturesOil.com.

Uses and Indications

This drug is indicated for the relief of minor pain associated with muscles and joints, specifically in patients experiencing conditions such as arthritis, simple backache, strains, bruises, and sprains.

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

Dosage and Administration

The product should be shaken well before use. For adults and children aged 12 years and older, the recommended administration is to spray the product on the affected area no more than 1 to 3 times daily. For children under 12 years of age, it is advised to consult a physician prior to use.

Contraindications

Application is contraindicated on wounds or damaged, broken, or irritated skin. Contact with eyes or mucous membranes must be avoided due to potential irritation. Additionally, do not bandage tightly, use in conjunction with a heating pad, or puncture or incinerate the product, as it is under pressure. Storage temperatures should not exceed 120°F to prevent risk of rupture or explosion.

Warnings and Precautions

For external use only, this product is flammable and should not be used while smoking or near heat or flame. It is imperative that the product is not applied to wounds or any damaged, broken, or irritated skin. Care must be taken to avoid contact with the eyes or mucous membranes.

General precautions include keeping the product out of the eyes and avoiding tight bandaging of the area where it is applied. The use of heating pads in conjunction with this product is contraindicated. It should be used only as directed, and users must not puncture or incinerate the container, as it is under pressure. Storage should be at temperatures not exceeding 120°F.

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

Patients should discontinue use and consult a healthcare provider if their condition worsens, if symptoms persist for more than seven days, or if symptoms resolve and then recur within a few days. Additionally, if the product is needed for longer than one week, medical advice should be sought.

Side Effects

Patients should be aware of several important warnings and precautions associated with the use of this product. It is intended for external use only and is flammable; therefore, it should not be used while smoking or near heat or flame. The product should not be applied to wounds or damaged, broken, or irritated skin, and contact with eyes or mucous membranes must be avoided.

When using this product, patients are advised to keep it out of the eyes, avoid tight bandaging, and refrain from using it with a heating pad. It is crucial to use the product only as directed and to avoid puncturing or incinerating the container, as it is under pressure. Additionally, the product should not be stored at temperatures exceeding 120°F.

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. If the product is needed for longer than a week, medical advice should be sought.

For pregnant or breastfeeding individuals, it is recommended to consult a health professional prior to use. Furthermore, the product should be kept out of reach of children and pets. In the event of accidental ingestion, immediate medical assistance should be sought or contact with a Poison Control Center should be made.

Drug Interactions

There are currently no known drug interactions associated with the use of this medication. Additionally, no interactions with laboratory tests have been identified. Therefore, no specific dosage adjustments or monitoring recommendations are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Natures Oil 16% Menthol (menthol, unspecified form). 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 dosage is to apply the spray product to the affected area no more than 1 to 3 times daily.

Geriatric Use

There is no specific information available 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, given the lack of targeted data.

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 weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is no specific data available regarding the excretion of this medication in 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 absence of guidance necessitates careful clinical judgment.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this medication. Consequently, there are no 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.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. It is imperative that healthcare providers remain vigilant and prepared to address any complications that may arise from an overdosage scenario.

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 these contexts.

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 and pets to prevent accidental ingestion or exposure. 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 apply the product to wounds or any damaged, broken, or irritated skin. It is important to emphasize that contact with the eyes or mucous membranes should be avoided. Healthcare providers should counsel patients to 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 discontinue use and seek medical advice if they find they need to use the product for longer than a week. While using the product, patients should be reminded to keep it away from their eyes and to avoid bandaging tightly. They should also be cautioned against using the product with a heating pad.

Healthcare providers should instruct patients to use the product only as directed and to avoid puncturing or incinerating the container, as it is under pressure. Furthermore, patients should be informed not to store the product at temperatures exceeding 120°F to ensure safety and efficacy.

Storage and Handling

The product is supplied in configurations that may vary, and it is important to handle it with care due to its potential to cause staining. Users are advised to exercise caution when spraying the product near fabrics and unprotected surfaces to prevent any unwanted discoloration.

For optimal storage, it is recommended to keep the product in a cool, dry place, away from direct sunlight and extreme temperatures. Specific temperature ranges for storage have not been provided; however, maintaining a stable environment is essential to preserve the product's integrity. Additionally, ensure that the container is securely closed when not in use to prevent leakage or contamination.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Natures Oil 16% Menthol, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)