Menthol

Description

The product contains 7.5% menthol and is formulated as a medicated patch. Each patch measures 5 1/2 × 4 inches (14 × 10 cm) and is designed to provide targeted pain relief for the shoulders, arms, neck, and legs. The patch is effective for pain relief for up to 8 hours. It is distributed by Absorbine Jr. LLC, located at 811 Broad Street, Suite 600, Chattanooga, TN 37402, and is manufactured in China.

Uses and Indications

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

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

Dosage and Administration

Menthol 7.5% is indicated for use as a topical analgesic. It should be applied directly to the affected area of the skin.

For optimal results, the application should be performed as needed, ensuring that the skin is clean and dry prior to use. A thin layer of the product should be gently massaged into the skin until fully absorbed. Care should be taken to avoid contact with eyes and mucous membranes.

Healthcare professionals are advised to monitor the patient’s response to treatment and adjust the frequency of application as necessary, based on individual patient needs and tolerability.

Contraindications

Use is contraindicated in children under 12 years of age; consultation with a healthcare professional is advised prior to use in this population. Additionally, 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 necessary.

Warnings and Precautions

For external use only. This product should not be applied to wounds or damaged skin, nor should it be used in conjunction with a heating pad. Healthcare professionals are advised to instruct patients to consult a physician prior to use if there is any redness present over the affected area.

While using this product, it is imperative to avoid contact with the eyes and mucous membranes. Additionally, patients should be cautioned against tightly bandaging the area of application.

Patients must be advised to discontinue use and seek medical advice if the condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. In cases of excessive skin irritation, immediate consultation with a healthcare provider is recommended.

Emergency medical assistance should be sought if the product is ingested. It is crucial to keep this product out of reach of children. In the event of accidental ingestion, medical help or contact with a Poison Control Center should be initiated without delay.

Side Effects

Patients using this product should be aware that it is intended for external use only. It is contraindicated for application on wounds or damaged skin and should not be used in conjunction with a heating pad. Prior to use, patients are advised to consult a healthcare professional if there is redness over the affected area.

During the application of this product, it is crucial to avoid contact with the eyes and mucous membranes. Additionally, patients should refrain from tightly bandaging the treated area.

Patients are instructed to discontinue use and seek medical advice if the condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. Furthermore, if excessive skin irritation occurs, it is recommended to stop use and consult a healthcare provider.

Drug Interactions

There are no specific drug interactions identified in the available data. Additionally, no laboratory test interactions have been reported. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the current information.

Packaging & NDC

Below are the non-prescription pack sizes of Absorbine Jr Neck and Shoulder. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 12 years and older may apply the medication to the affected area no more than 3 to 4 times daily. For children under 12 years of age, it is advised to consult a doctor prior to use.

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. There may be potential risks to the fetus; however, specific studies or data regarding these risks are not provided in the prescribing information.

Healthcare providers are advised to use this product only if clearly needed, and to discuss the associated risks and benefits with the patient. No specific dosage modifications for pregnant individuals are mentioned in the available data.

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

There is no specific information regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in 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 from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include monitoring vital signs, providing symptomatic treatment, and ensuring the patient's safety.

If available, consultation with a poison control center or a medical toxicologist is recommended to guide the management of the overdose effectively. Additionally, healthcare professionals should refer to local protocols and guidelines for the management of overdose situations to ensure optimal patient care.

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 compound in these areas.

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. In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center immediately.

For adults and children aged 12 years and older, it is recommended to apply the patch to the affected area no more than 3 to 4 times daily. Patients should be instructed on the proper application technique, which includes opening the pouch, removing the patch, peeling off the protective film, and applying the sticky side directly to the affected area.

It is important for healthcare providers to emphasize that children under 12 years of age should consult a doctor before use. This ensures that appropriate guidance is provided for younger patients.

Storage and Handling

The product is supplied in a configuration that ensures optimal usability. It should be stored at room temperature, away from direct sunlight and moisture. To maintain safety, it is essential to keep the product out of reach of children. Once opened, the product must be discarded to ensure proper handling and safety.

Additional Clinical Information

Patients aged 12 years and older are advised to apply the topical medication to the affected area no more than 3 to 4 times daily. Clinicians should counsel patients to keep the medication out of reach of children and to seek medical assistance or contact a Poison Control Center immediately if the medication is swallowed. No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Absorbine Jr Neck and Shoulder, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)