Lumina Natures Creation Unveiled

Description

The product is presented in a 3 oz roll-on dosage form.

Uses and Indications

This drug is indicated for the temporary relief of minor pain associated with various conditions, including arthritis, simple backache, muscle strains, sprains, bruises, and cramps.

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

Dosage and Administration

For adults and children aged 2 years and older, the recommended dosage involves applying a generous amount of the product to the affected area. The application should be followed by a gentle massage into the painful area until the product is thoroughly absorbed into the skin. This process may be repeated as necessary, but should not exceed four applications within a 24-hour period.

For children under 2 years of age, it is advised to consult a physician before use.

Contraindications

Use of this product is contraindicated in the following situations:

Pregnancy and Breastfeeding: Patients who are pregnant or breastfeeding should consult a healthcare professional prior to use.

Pediatric Use: Keep out of reach of children to prevent accidental ingestion.

Accidental Ingestion: In the event of accidental ingestion, seek immediate medical assistance or contact a poison control center.

Worsening Conditions: Discontinue use and consult a physician if the condition worsens, symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days.

Presence of Redness or Irritation: If redness or irritation develops, stop use and seek medical advice.

Application Restrictions: Avoid contact with eyes and mucous membranes, do not apply to wounds or damaged skin, and do not bandage tightly. Use only as directed.

Warnings and Precautions

For external use only. Healthcare professionals should advise patients to consult a health professional prior to use if they are pregnant or breastfeeding. It is imperative to keep this product out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact a Poison Control Center without delay.

Patients should be instructed to discontinue use and seek medical advice if any of the following occur: the condition worsens or symptoms persist for more than 7 days, if there is a recurrence of symptoms after initial improvement within a few days, if redness is observed, or if irritation develops.

Side Effects

For external use only. Patients should discontinue use and consult a physician if the condition worsens or if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. Additionally, if redness is present or irritation develops, medical advice should be sought.

Drug Interactions

There are no specific drug interactions identified for this medication. Additionally, no laboratory test interactions have been reported. 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 Lumina Natures Creation Unveiled (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 2 years and older may apply the medication generously to the affected area, massaging it into the skin until thoroughly absorbed. This application may be repeated as necessary, but should not exceed four times daily.

For children under 2 years of age, it is advised to consult a doctor before use.

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 associated with its use during pregnancy and lactation. The safety of this medication in pregnant women has not been established, and therefore, caution is advised.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data on 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 mothers.

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 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 initiate supportive care, which may include maintaining airway patency, ensuring adequate ventilation, and monitoring vital signs.

If available, the use of antidotes or specific treatments should be considered based on the substance involved and the clinical presentation. Consultation with a poison control center or a medical toxicologist may provide additional guidance on the management of overdose cases.

Documentation of the incident, including the amount and timing of the substance taken, is crucial for effective treatment 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 in these areas limits the understanding of the compound's safety profile in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available for SPL code 90375-7.

Patient Counseling

Healthcare providers should advise patients to consult a health professional if they are pregnant or breastfeeding before using this medication. It is important for patients to understand the potential risks and benefits associated with its use during these periods.

Providers should also emphasize the importance of keeping the medication out of reach of children. In the event of accidental ingestion, patients must be instructed to seek medical help immediately or contact a poison control center for assistance. This information is crucial for ensuring the safety and well-being of both patients and their families.

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 ensure optimal stability. Once opened, the product should be discarded after use to prevent any potential degradation or contamination.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Lumina Natures Creation Unveiled, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)