Natureance Miracle

Description

MIRACLE OIL is a product identified by the title NATUREANCE. The effective date for this formulation is October 23, 2024. The product is represented in a media type of image/jpeg, with the reference image labeled as FD-00987 EROS GLOBAL MIRACLE OIL 80465-008-01.jpg.

Uses and Indications

This drug is indicated for the temporary local relief of minor pain in muscles or joints.

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

Dosage and Administration

For adults and children over 12 years of age, a small amount of the product should be applied directly to the affected area. The application should be followed by a gentle massage in a circular motion, allowing the product to set for a few seconds. This process may be repeated as necessary, but should not exceed 3 to 4 applications per day.

For children under 12 years of age, the product is not recommended for use. Consultation with a healthcare professional is advised prior to administration in this age group.

Contraindications

The product should not be used in the following situations:

Tight bandaging or the use of heating pads in conjunction with the product is contraindicated, as this may exacerbate adverse effects. Contact with eyes and mucous membranes must be avoided to prevent irritation or injury. Application to wounds or damaged, broken, or irritated skin is contraindicated due to the risk of further skin damage or infection. Additionally, exposure of the treated area to heat or direct sunlight should be avoided to prevent potential complications.

Warnings and Precautions

For external use only. Healthcare professionals should advise patients to consult a physician prior to use if there is any redness present over the affected area.

In the event of accidental ingestion, immediate medical assistance should be sought, or the patient should contact a Poison Control Center without delay.

Patients are instructed to discontinue use and seek medical advice if any of the following occur: the condition worsens, redness develops, irritation arises, symptoms persist for more than 7 days, or if symptoms resolve only to recur within a few days. Additionally, if patients experience signs of injury, such as pain, swelling, or blistering at the site of application, they should promptly contact their healthcare provider.

Side Effects

Patients using this product may experience a range of adverse reactions. It is important to note that the product is intended for external use only. Patients should consult a healthcare professional prior to use if there is any redness over the affected area.

In the event of worsening conditions, the presence of redness, or the development of irritation, patients are advised to discontinue use. Additionally, if symptoms persist for more than 7 days or if they resolve only to recur within a few days, it is recommended that patients stop using the product. Signs of injury, such as pain, swelling, or blistering at the site of application, also warrant immediate cessation of use and consultation with a healthcare provider.

These precautions are essential to ensure patient safety and to mitigate the risk of serious adverse reactions.

Drug Interactions

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

Packaging & NDC

Below are the non-prescription pack sizes of Natureance Miracle (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should not use this medication without consulting a healthcare professional. It is important for healthcare providers to evaluate the appropriateness of treatment in this age group, considering potential risks and the need for alternative therapies.

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

Pregnancy

Pregnant patients should consult a healthcare professional before using this medication. The safety of this drug during pregnancy has not been established, and potential risks to fetal outcomes are not fully understood. It is essential for women of childbearing potential to discuss their individual circumstances with their healthcare provider to weigh the benefits and risks associated with the use of this medication during pregnancy.

Lactation

There are no specific warnings or recommendations regarding the use of this product in nursing mothers. Additionally, there are no statements concerning the potential for excretion in breast milk or any associated risks to breastfed infants.

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 absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

Additionally, it is recommended to consult local poison control centers or relevant toxicology resources for guidance on specific management protocols and antidotes, if applicable.

Documentation of the incident, including the substance involved, estimated dose, and time of exposure, is crucial for effective management and follow-up care.

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

Postmarketing experience has identified several events reported voluntarily or through surveillance programs. A transient burning sensation or redness may occur upon application, typically resolving within several days. Instances of irritation have been noted, with some reports indicating that redness may be present. In certain cases, symptoms may persist for more than seven days or may resolve only to recur shortly thereafter. Additionally, there have been reports of worsening conditions, and users have been advised to discontinue use and consult a healthcare professional if they experience signs of an allergic reaction. Signs of injury, such as pain, swelling, or blistering at the application site, have also been documented.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center if the product is swallowed. It is essential to instruct patients to use the product only as directed to ensure safety and efficacy.

Patients should be cautioned against bandaging the treated area tightly or using a heating pad in conjunction with the product. They must also be informed to avoid contact with the eyes and mucous membranes, as well as to refrain from applying the product to wounds or any damaged, broken, or irritated skin.

Healthcare providers should inform patients that a transient burning sensation or redness may occur upon application, but this typically resolves within several days. If patients experience any signs of an allergic reaction, they should discontinue use immediately and consult a doctor.

Additionally, patients should be advised not to expose the treated area to heat or direct sunlight. They must be instructed to monitor their condition closely and to report to their healthcare provider if the condition worsens, if redness is present, if irritation develops, or if symptoms persist for more than 7 days or recur within a few days. Patients should also be vigilant for signs of injury, such as pain, swelling, or blistering at the application site, and seek medical advice if these occur.

Storage and Handling

The product is supplied in packaging that includes specific NDC numbers. It should be stored at room temperature, ensuring that it is protected from light exposure. Freezing the product is not permitted, as it may compromise its integrity. Additionally, once opened, the product must be discarded to ensure safety and efficacy.

Additional Clinical Information

The product is intended for topical administration. Patients should apply a small amount to the affected area, massaging it in a circular motion and allowing it to set for a few seconds. This process may be repeated as necessary, but should not exceed 3 to 4 applications daily.

Clinicians should counsel patients that the product is for external use only. Patients are advised to consult a doctor prior to use if there is redness over the affected area. It is important to avoid tight bandaging or the use of heating pads, and to prevent contact with eyes and mucous membranes. The product should not be applied to wounds or damaged skin. A transient burning sensation or redness may occur upon application, typically resolving within several days. Patients should discontinue use and seek medical advice if they experience an allergic reaction, if the condition worsens, if redness or irritation develops, or if symptoms persist beyond 7 days or recur shortly after resolution. Additionally, patients should avoid exposing the treated area to heat or direct sunlight. In the event of accidental ingestion, immediate medical assistance or contact with a Poison Control Center is recommended.

Drug Information (PDF)

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

View product document (PDF)