Sanamax Menthol Pain Relief Cream

Description

SanaMax is a menthol pain relief cream formulated with 300 mg of cannabidiol (CBD) as the active ingredient. The product is presented in a volume of 3.4 fluid ounces (100 mL). It is distributed by SanaMax Plus, LLC, located in McAllen, Texas, 78501. For inquiries or comments, additional information can be found at the website sanamaxplus.com.

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, the recommended application is 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 to ensure safety and appropriateness of treatment.

Contraindications

Use is contraindicated in the following situations:

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

Contact with eyes or mucous membranes must be avoided to prevent irritation or injury. Furthermore, tight bandaging is contraindicated, as it may restrict circulation and lead to adverse effects.

Warnings and Precautions

For external use only. It is imperative that this product is not ingested, and precautions should be taken to ensure it remains out of reach of children to prevent accidental ingestion. In the event of swallowing, immediate medical assistance should be sought, or contact a Poison Control Center without delay.

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

Side Effects

For external use only. Patients are 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. Patients should also ask a doctor before use if there is redness over the affected area.

Drug Interactions

There are no specific drug interactions identified for this medication. Additionally, no laboratory test interactions have been noted in the available data. 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 Sanamax Menthol 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 prior to 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 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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

Pregnancy

The safety of this product during pregnancy has not been established. Pregnant patients or those planning to become pregnant should consult a healthcare provider before use. Potential risks to the fetus are not clearly defined; therefore, caution is advised. There are no specific dosage modifications for pregnant individuals; however, personalized recommendations should be sought from a healthcare professional. This product should only be used if clearly needed and after thorough discussion with a healthcare provider.

Lactation

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

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, as the clinical presentation can vary depending on the substance involved and the individual patient's response. Common symptoms of overdose may include, but are not limited to, altered mental status, cardiovascular instability, and respiratory distress.

In the event of an overdose, immediate medical intervention is recommended. Healthcare providers should initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs. The use of activated charcoal may be considered if the patient presents within a suitable timeframe and if the ingestion was recent.

Furthermore, it is crucial to consult local poison control centers or toxicology experts for guidance on specific management protocols and antidotes, if applicable. Continuous assessment and supportive measures should be prioritized until the patient stabilizes or further treatment is determined.

Documentation of the incident, including the substance involved, estimated dose, and time of ingestion, is vital for ongoing management and potential reporting requirements.

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 understanding of potential risks associated with the compound in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are provided in the insert for SPL code 90375-7.

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 the product, patients should seek medical assistance or contact a Poison Control Center immediately.

Patients should be informed 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 also important to instruct patients not to use the product 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 instructed not to bandage the area tightly. Finally, 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 maintain its efficacy and integrity. Proper container requirements should be adhered to, ensuring that the product is kept in a suitable environment. Special handling needs must be observed to prevent any compromise to the product's quality during storage and transportation.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)