Pain Relief Cream

Description

SanaMax Plus is a balanced formula comprising 12 essential oils. This product is designed for quick absorption without leaving a greasy residue or staining surfaces. It features a relaxing scent and provides a calming effect without causing a burning sensation upon application. SanaMax Plus is manufactured in the USA using USP grade ingredients and is free from parabens and propylene glycol. The product is not tested on animals and is available in a net weight of 1 ounce (28 grams).

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with muscles and joints. Specifically, it is effective for conditions such as simple backache, arthritis, strains, bruises, and sprains.

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

Dosage and Administration

The medication should be used only as directed. For adults and children aged 12 years and older, it is recommended to apply the product to the affected area 3 to 4 times daily. For children under 12 years of age, it is advised to consult a physician prior to use.

Contraindications

Use is contraindicated in the following situations:

Application on wounds, damaged, broken, or irritated skin is prohibited due to the potential for exacerbating the condition and causing further irritation. The use of a heating pad in conjunction with this product is also contraindicated, as it may lead to increased risk of burns or skin damage. Additionally, this product should not be used in children under 12 years of age who present with arthritis-like conditions, as safety and efficacy have not been established in this population.

Warnings and Precautions

For external use only. It is imperative to keep this product out of reach of children to prevent accidental ingestion. In the event of ingestion, immediate medical assistance should be sought, or contact a Poison Control Center without delay.

General precautions must be observed to ensure safe usage. This product should not be applied to wounds, damaged, broken, or irritated skin. Additionally, it is contraindicated for use with heating pads. Special caution is advised when considering use in children; this product should not be administered to individuals under 12 years of age who present with arthritis-like conditions.

Healthcare professionals should instruct patients to discontinue use and consult a physician if the condition worsens or if symptoms persist beyond 7 days. Furthermore, if any skin irritation occurs, it is essential to stop use and seek medical advice.

In cases of accidental ingestion, immediate medical help is required, and contacting a Poison Control Center is strongly recommended.

Side Effects

For external use only. Patients should be advised to stop use and consult a doctor if the condition worsens or if symptoms persist for more than 7 days. Additionally, if skin irritation occurs, it is recommended to seek medical advice.

Before using this product, patients should ask a doctor if they have redness over the affected area, as this may indicate a more serious condition that requires medical evaluation.

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 Pain Relief Cream (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age with arthritis-like conditions should not use this medication. For children in this age group, it is advised to consult a healthcare professional before use.

For adolescents and children aged 12 years and older, the recommended application is to the affected area 3 to 4 times daily.

Geriatric Use

There is no specific information regarding the use of SanaMax Plus Pain Relief Cream in geriatric patients. The prescribing information does not provide guidance on dosage adjustments, safety concerns, or special precautions for elderly patients. Therefore, healthcare providers should exercise caution when considering the use of this product in individuals aged 65 and older, as the absence of data necessitates careful monitoring and clinical judgment.

Pregnancy

Pregnant patients should be aware that there are no specific safety concerns or dosage modifications associated with the use of this medication during pregnancy. Additionally, no special precautions regarding its use in pregnant individuals have been identified. As such, healthcare professionals should consider the overall clinical context when prescribing this medication to women of childbearing potential. It is advisable to monitor any potential fetal outcomes as part of standard prenatal care.

Lactation

There are no specific warnings or recommendations regarding the use of this product by lactating mothers. Additionally, there is no information available about 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 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 absence of specific information regarding overdosage in the provided sections of the Summary of Product Characteristics (SPL), healthcare professionals are advised to exercise caution and consider general principles of management for suspected overdosage.

Recommended Actions In cases of suspected overdosage, it is essential for healthcare providers to assess the patient's clinical status and initiate appropriate supportive care. Monitoring of vital signs and symptomatic treatment should be prioritized.

Potential Symptoms While specific symptoms related to overdosage are not detailed, healthcare professionals should remain vigilant for any unusual or severe reactions that may arise, given the pharmacological profile of the medication.

Management Procedures In the event of an overdosage, healthcare professionals should follow established protocols for managing overdose situations, which may include activated charcoal administration if the patient presents within a suitable timeframe. Additionally, consultation with a poison control center or toxicology expert may be warranted to guide further management.

It is crucial for healthcare professionals to document any overdosage incidents thoroughly and report them to the appropriate regulatory authorities as per local guidelines.

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 text.

Patient Counseling

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

Patients should be instructed not to use the product on wounds, damaged, broken, or irritated skin, and to avoid using it in conjunction with a heating pad. It is important to inform patients that this product should not be used on children under 12 years of age who have arthritis-like conditions.

Healthcare providers should counsel patients to discontinue use and consult a doctor if their condition worsens or if symptoms persist for more than 7 days. Additionally, patients should be advised to stop using the product and seek medical advice if they experience any skin irritation.

While using this product, patients should be cautioned to avoid contact with the eyes or mucous membranes. They should also be informed not to bandage the area tightly. Lastly, patients should be encouraged to consult a doctor before use if there is any redness over the affected area.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a temperature range of 68° to 77°F (20° to 25°C) to ensure its stability and efficacy. Proper storage conditions must be maintained, and the product should be kept in a suitable container to protect it from environmental factors. Special handling requirements should be observed to preserve the integrity of the product throughout its shelf life.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)