Sunmed Pain Freeze

Description

Sunmed Pain-Freeze Gel is a topical formulation containing menthol as an active ingredient. This gel is designed for external use and is intended to provide a cooling sensation upon application. The formulation is characterized by its clear appearance and is packaged in a convenient dosage form suitable for targeted application to areas experiencing discomfort.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with muscles and joints, including those related to arthritis, simple backache, strains, and sprains.

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 is to apply the medication topically 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 physician prior to use.

The medication should be administered via topical application directly to the affected area, ensuring that the frequency of application does not exceed the specified limits for the appropriate age group.

Contraindications

The product is contraindicated for application on wounds or damaged skin, as well as on irritated skin, due to the potential for exacerbating the condition. Additionally, it should not be bandaged or used in conjunction with heating pads or devices, as this may lead to adverse effects.

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 swallowing, immediate medical assistance should be sought, or the local Poison Control Center should be contacted without delay.

Healthcare professionals should advise patients to discontinue use and consult a physician if the condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then reoccur within a few days. Monitoring for these signs is essential to ensure patient safety and effective management of the condition.

Side Effects

For external use only. Patients should discontinue use and consult a healthcare professional if the condition worsens or if symptoms persist for more than 7 days. Additionally, if symptoms clear up and then reoccur within a few days, patients are advised to seek medical advice.

Drug Interactions

There are no reported drug interactions associated with the use of this medication. Additionally, no interactions with laboratory tests have been identified. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Sunmed Pain Freeze (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 2 years and older are indicated for use of the product. The recommended application frequency is 3 to 4 times daily to the affected area. For children under 2 years of age, consultation with a physician is advised prior to use. It is important to keep the product out of reach of children; in the event of ingestion, medical assistance should be sought or a Poison Control Center contacted immediately.

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. 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. Caution is advised as the effects on a developing fetus are unknown. Currently, there is no specific data available regarding risks to the fetus associated with the use of this product.

Healthcare providers should be consulted before use in pregnant patients or those planning to become pregnant. No specific dosage modifications for pregnant individuals are mentioned in the available information.

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 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 when administering the medication. It is essential to monitor patients closely for any signs of adverse effects or symptoms that may arise from excessive dosing.

In the event of suspected overdosage, immediate medical attention should be sought. Healthcare providers should implement supportive measures as necessary, which may include symptomatic treatment and monitoring of vital signs.

Due to the lack of detailed overdosage information, it is recommended that healthcare professionals refer to established clinical guidelines and protocols for managing overdose situations relevant to the specific medication in question. Additionally, contacting a poison control center may provide further guidance on appropriate management strategies.

Continued vigilance and patient assessment are crucial in mitigating potential risks associated with overdosage.

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 question.

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. Instruct patients that if the product is swallowed, they should seek medical help or contact a Poison Control Center immediately.

Patients should be informed to stop using the product and consult their doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then reoccur within a few days.

When using this product, it is important to avoid contact with the eyes or mucous membranes. Patients should not apply the product to wounds, damaged skin, or irritated skin. Additionally, they should be cautioned against bandaging the area after application. It is recommended that patients wash their hands with cool water after use. Furthermore, patients should be advised not to use the product in conjunction with a heating pad or any heating device.

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 protect its quality. Once opened, the product should be discarded to ensure safety and efficacy.

Additional Clinical Information

The product is administered topically, with a recommended application frequency of 3 to 4 times daily to the affected area. Clinicians should advise patients to avoid contact with the eyes and mucous membranes, and to refrain from applying the product to wounds, damaged, or irritated skin. Bandaging the area after application is not recommended. Patients should wash their hands with cool water after use and avoid using the product in conjunction with heating pads or devices. If the condition worsens, or if symptoms persist for more than 7 days or resolve and then recur within a few days, patients should discontinue use and consult a doctor.

Drug Information (PDF)

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

View product document (PDF)