Aromalief Calming Pain Relief Cream Lavender

Description

Aromalief Calming Pain Relief Lavender is a topical formulation designed for pain relief. The product features a calming lavender scent, which is intended to enhance the user experience. The formulation is specifically designed to provide localized relief from discomfort.

Uses and Indications

This drug is indicated for the temporary relief of pain.

There are no teratogenic effects associated with this drug. Additionally, no nonteratogenic effects have been reported.

Dosage and Administration

For adults and children aged 2 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 limited to the specified frequency to avoid potential adverse effects.

For children under 2 years of age, it is advised to consult a healthcare professional prior to use to determine the appropriate course of action.

Contraindications

Use is contraindicated in the following situations:

• The product should be kept out of reach of children to prevent accidental ingestion.

• In the event of accidental swallowing, immediate medical assistance or contact with a Poison Control Center is necessary.

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

• Discontinue use and seek medical advice if the condition worsens, if symptoms persist for more than 7 days, or if new symptoms develop.

Warnings and Precautions

For external use only; contact with the eyes should be strictly avoided to prevent irritation or injury.

Healthcare professionals should advise patients to discontinue use and seek medical advice if the condition worsens, if symptoms persist for more than 7 days, or if new symptoms develop. These actions are crucial to ensure patient safety and appropriate management of their condition.

It is imperative to keep this product out of the reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

Additionally, pregnant or breastfeeding individuals are encouraged to consult with a healthcare professional prior to use to ensure safety for both the mother and child.

Side Effects

Patients using this product should be aware that it is for external use only and must avoid contact with the eyes. In the event that the condition worsens, symptoms persist for more than 7 days, or new symptoms occur, patients are advised to stop use and consult a doctor.

It is crucial to keep this product out of reach of children. If swallowed, patients should seek medical help or contact a Poison Control Center immediately.

For those who are pregnant or breastfeeding, it is recommended to consult a health professional prior to use.

Drug Interactions

No drug interactions or drug and laboratory test interactions have been identified for this product. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Aromalief Calming Pain Relief Cream Lavender (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 2 years and older may apply the medication to the affected area no more than 3 to 4 times daily. For children under 2 years of age, it is advised to consult a doctor prior to use.

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.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional before using this medication. It is essential to evaluate the potential risks and benefits associated with the use of this drug during pregnancy and lactation. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the fetus or nursing infant.

Lactation

Lactating mothers are advised to consult a health professional if they are pregnant or breastfeeding. There is no specific data available regarding the excretion of this medication in breast milk or its effects on breastfed infants. Therefore, healthcare providers should evaluate the potential risks and benefits before prescribing 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 clinical trials for this medication. Consequently, there is no available information regarding dosage adjustments, special monitoring requirements, or precautions 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 warranted based on clinical judgment.

Overdosage

In the event of an overdosage, it is imperative to keep the product out of reach of children. Should ingestion occur, immediate medical assistance should be sought. Healthcare professionals are advised to contact a Poison Control Center without delay to ensure appropriate management and intervention.

Prompt recognition of symptoms associated with overdosage is crucial for effective treatment. While specific symptoms are not detailed in the provided information, healthcare providers should remain vigilant for any unusual or severe reactions following ingestion.

Management of overdosage should be guided by established protocols, which may include supportive care and symptomatic treatment as necessary. It is essential for healthcare professionals to follow local guidelines and recommendations when addressing cases of overdosage to ensure patient safety and optimal outcomes.

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

No postmarketing experience details are available in the insert.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children. In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center immediately.

Patients who are pregnant or breastfeeding should be encouraged to consult with a healthcare professional before using the medication to ensure safety for themselves and their child.

Additionally, healthcare providers should instruct patients to discontinue use and seek medical advice if their condition worsens, if symptoms persist for more than 7 days, or if new symptoms develop. This guidance is essential for ensuring patient safety and effective management of their health condition.

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 in a cool, dry place, maintaining a temperature range between 68ºF and 77ºF, with relative humidity not exceeding 65%.

Care should be taken to ensure that the product is not used if the seal is broken, torn, or missing, as this may compromise the integrity of the product. Proper handling and storage conditions are crucial to maintain the quality and efficacy of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)