Aromalief Pain Relief Cream Orange Ginger

Description

Energizing Pain Relief Cream is available in two formulations: a 4 oz container and a 2 oz container with a ginger orange scent. This topical cream is designed to provide localized pain relief through its energizing properties. The formulation is intended for external use and is characterized by its specific aroma and texture, which contribute to the overall user experience.

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 frequency is to 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 healthcare professional prior to use.

Contraindications

Use is contraindicated in the following situations:

• The product should be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance or contact with a Poison Control Center is required.

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

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

Warnings and Precautions

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

Patients are advised to discontinue use and consult a healthcare professional if the condition worsens, if symptoms persist for more than 7 days, or if new symptoms develop. These actions are crucial to ensure appropriate management and to rule out any underlying conditions that may require further intervention.

In the event of accidental ingestion, immediate medical assistance should be sought, or the local Poison Control Center should be contacted without delay. Prompt action is essential to mitigate potential adverse effects associated with ingestion.

General precautions should be observed, particularly in pregnant or breastfeeding individuals. It is recommended that these patients consult 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 individuals who are pregnant or breastfeeding, it is recommended to consult a health professional prior to use.

Drug Interactions

No specific drug interactions have been identified for this medication. Additionally, there are no reported interactions with laboratory tests. 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 Aromalief Pain Relief Cream Orange Ginger (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 2 years of age should consult a doctor prior to use. For children aged 2 years and older, the recommended application is to the affected area not more than 3 to 4 times daily.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. As such, 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 therapeutic response, given the lack of targeted data for this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional regarding the use of this medication. It is important for women of childbearing potential to discuss potential risks and benefits with their healthcare provider to ensure informed decision-making during pregnancy and lactation.

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 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 event of an overdosage, it is imperative to keep the product out of reach of children. Should ingestion occur, immediate medical assistance is required. Healthcare professionals should advise caregivers 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 assess the patient's condition thoroughly and implement appropriate measures based on clinical judgment and available resources.

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 potential effects in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children. Instruct patients that if the medication is swallowed, they should seek medical help or contact a Poison Control Center immediately.

Additionally, healthcare providers should counsel patients who are pregnant or breastfeeding to consult with a health professional before using the medication. This ensures that patients receive appropriate guidance regarding the safety and potential risks associated with the use of the medication during these critical periods.

Storage and Handling

The product is supplied in packaging that ensures its integrity and quality. It should be stored in a cool, dry place, maintaining a temperature range between 68ºF and 77ºF, with relative humidity not exceeding 65%.

Healthcare professionals are advised to inspect the product prior to use; it should not be utilized if the seal is broken, torn, or missing, as this may compromise the product's safety and efficacy.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)