Menthol 5% Hydrogel

Description

NDC 71391-127-05 identifies UNEXO'S MENTHOL 5%, a topical analgesic formulated as a hydrogel patch. Each patch contains 5% menthol, designed for targeted, long-lasting pain relief, particularly suitable for application on the back and large areas of the body. The product is presented as an adhesive fabric patch, ensuring a no-mess application. Each package contains five single-use patches, each measuring 7.87 inches by 3.93 inches (20 cm × 10 cm). This formulation can be compared to the active ingredient of Extra Strength Icy Hot® Medicated Patch.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various musculoskeletal conditions. Specifically, it is effective for arthritis, simple backache, bursitis, tendonitis, muscle strains, muscle sprains, bruises, and cramps.

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

Dosage and Administration

Adults and children aged 12 years and over should follow these instructions for patch application. The backing of the patch must be carefully removed to expose the sticky side. The patch should then be applied directly to the affected area. Each patch may be worn for a maximum of 8 hours. If necessary, the application may be repeated, but no more than three patches should be used in a single day. After each use, the patch must be discarded, and the pouch should be resealed immediately after opening to maintain product integrity.

For children under 12 years of age, it is essential to consult a physician prior to use.

Contraindications

Use is contraindicated in the following situations:

Infants should not be treated with this product due to the potential for adverse effects.

Additionally, the product should not be applied in the following circumstances:

• Do not bandage tightly or use in conjunction with a heating pad, as this may increase the risk of skin irritation or burns.

• Avoid contact with eyes or mucous membranes to prevent irritation or injury.

• Do not apply to wounds or damaged skin, as this may exacerbate the condition or lead to systemic absorption.

• Concurrent use with other topical analgesics is contraindicated to avoid potential additive effects and increased risk of adverse reactions.

Warnings and Precautions

For external use only, this product must be utilized strictly as directed to ensure safety and efficacy. Healthcare professionals should be aware that rare cases of serious burns have been reported with similar products. It is imperative to avoid bandaging the area tightly or using a heating pad in conjunction with the product, as these practices may exacerbate the risk of adverse effects.

Contact with the eyes or mucous membranes should be strictly avoided. The product is contraindicated for application on wounds or damaged skin, and it should not be used concurrently with other topical analgesics to prevent potential interactions and complications.

Healthcare providers should advise patients to discontinue use and seek medical consultation if any of the following occur: worsening of the condition, presence of redness, development of irritation, persistence of symptoms beyond 7 days, or recurrence of symptoms after initial resolution within a few days. Additionally, patients should be instructed to report any signs of skin injury, such as pain, swelling, or blistering at the application site.

In the event of accidental ingestion, immediate medical assistance should be sought, or the local Poison Control Centre should be contacted without delay to ensure appropriate management.

Side Effects

Patients using this product should be aware that it is intended for external use only. Rare cases of serious burns have been reported with similar products, highlighting the importance of adhering to the recommended usage guidelines. It is advised not to bandage the area tightly or use the product in conjunction with a heating pad, as these practices may increase the risk of adverse reactions.

Contact with the eyes or mucous membranes should be avoided, and the product should not be applied to wounds or damaged skin. Additionally, concurrent use with other topical analgesics is not recommended, as this may lead to increased risk of adverse effects.

Patients are advised to discontinue use and consult a healthcare professional if any of the following occur: worsening of the condition, presence of redness, development of irritation, persistence of symptoms beyond 7 days, or if symptoms resolve and then recur within a few days. Signs of skin injury, such as pain, swelling, or blistering at the application site, also warrant immediate medical consultation.

Drug Interactions

Concurrent use of this medication with other topical analgesics is contraindicated. The combination may increase the risk of adverse effects without providing additional therapeutic benefit. It is advised to avoid using multiple topical analgesics simultaneously to ensure patient safety and efficacy of treatment. Monitoring for signs of irritation or systemic effects is recommended if there is any uncertainty regarding the use of concomitant topical therapies.

Packaging & NDC

Below are the non-prescription pack sizes of Menthol 5% Hydrogel (menthol, unspecified form). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should consult a physician prior to use. The product is not recommended for infants. In the event of accidental ingestion, immediate medical assistance or contact with a Poison Control Centre is advised.

For patients aged 12 years and older, the application involves carefully removing the backing from the patch and applying the sticky side to the affected area. A single patch may be worn for up to 8 hours, with a maximum of 3 applications per day. After use, the patch should be discarded, and the pouch resealed to maintain integrity.

Geriatric Use

Elderly patients may use Menthol 5% Hydrogel Patch; however, the prescribing information does not provide specific guidance regarding geriatric use. There are no recommended age considerations, dosage adjustments, or safety concerns outlined for this population. Consequently, healthcare providers should exercise clinical judgment when prescribing this treatment to geriatric patients, as individual patient factors may influence the overall safety and efficacy of the product. Regular monitoring and assessment of treatment response are advisable to ensure optimal outcomes in elderly patients.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully considered, as the effects on fetal outcomes and breastfeeding infants are not fully established. It is essential for women of childbearing potential to discuss their individual circumstances with a healthcare provider to ensure safe use during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data regarding the excretion of this drug in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the prescribing information regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as there is no available data to guide dosing or monitoring in this population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to 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 prescribing information.

Overdosage

In the event of an overdosage, immediate medical intervention is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical assistance or contact a Poison Control Centre without delay.

Prompt action is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and evaluation are recommended to ensure patient safety and effective resolution of any complications arising from the 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 these contexts.

Postmarketing Experience

Rare cases of serious burns have been reported with products of this type. These events were identified through voluntary reporting and surveillance programs.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. It is important to inform patients that this product should not be used on infants. In the event of accidental swallowing, patients should seek medical help or contact a Poison Control Centre immediately.

Patients should be instructed to stop using the product and consult a doctor if any of the following occur: the condition worsens, redness is present, irritation develops, symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. Additionally, patients should seek medical attention if they experience signs of skin injury, such as pain, swelling, or blistering at the site of application.

When using this product, patients must be reminded to use it only as directed. They should be made aware that rare cases of serious burns have been reported with similar products. It is crucial to advise patients not to bandage the area tightly or use a heating pad in conjunction with the product. Patients should also be cautioned to avoid contact with eyes or mucous membranes and not to apply the product to wounds or damaged skin. Furthermore, patients should be informed that this product should not be used simultaneously with other topical analgesics.

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 room temperature, ensuring that the temperature does not exceed 86°F (30°C). Proper storage conditions are crucial to maintain the integrity and efficacy of the product.

Additional Clinical Information

The medication is administered topically. For adults and children aged 12 years and older, the patch should be applied to the affected area by carefully removing the backing. Patients are advised to wear one patch for up to 8 hours and may repeat this process as necessary, not exceeding three applications in a single day. After use, the patch must be discarded, and the pouch should be resealed. It is recommended that children under 12 years of age consult a physician before use.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Menthol 5% Hydrogel, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)