Orthogel Menthol 3.5%

Description

The drug is supplied in a 4 oz tube. It is identified by the product code "ortho_4oz_tube_10_25_24".

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

For adults and children aged 12 years and older, a thin film of the product should be applied to the affected area no more than 3 to 4 times daily. It is important to ensure that the application is limited to this frequency to avoid potential adverse effects.

For children under 2 years of age, it is recommended to consult a physician prior to use to ensure safety and appropriateness of treatment.

After application, hands should be washed thoroughly with cool water to prevent unintentional contact with other areas of the body or with other individuals.

Contraindications

The product is contraindicated for application to wounds or damaged skin, as well as to irritated skin or in cases where excessive irritation develops. Additionally, it should not be used with tight bandaging or in conjunction with heating pads or devices. These precautions are necessary to prevent exacerbation of skin conditions and to ensure patient safety.

Warnings and Precautions

For external use only. This product is flammable; therefore, it should be kept away from excessive heat or open flame to prevent fire hazards.

In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

Patients are advised to discontinue use and consult a healthcare professional if they experience any of the following: pain, swelling, or blistering of the skin; worsening of their condition; or if symptoms persist for more than 7 days or resolve only to recur within a few days. Additionally, if arthritic pain continues for more than 10 days, or if there is the presence of redness, medical consultation is necessary, particularly for conditions affecting children under 12 years of age.

Emergency medical help should be obtained immediately if the product is swallowed, reinforcing the importance of prompt action in such situations.

Side Effects

Patients should be aware that the product is for external use only and is flammable; it should be kept away from excessive heat or open flame.

In clinical practice, patients are advised to discontinue use and consult a healthcare professional if they experience pain, swelling, or blistering of the skin. Additionally, if the condition worsens, or if symptoms persist for more than 7 days or resolve and then recur within a few days, medical advice should be sought.

For those experiencing arthritic pain, it is recommended to seek medical attention if the pain persists for more than 10 days, if redness is present, or if the product is being used in children under 12 years of age.

Drug Interactions

No drug interactions or drug and laboratory test interactions have been identified in the available data. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Orthogel Menthol 3.5% (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 2 years of age should consult a physician prior to use. For children aged 12 years and older, the recommended dosage is to apply a thin film over the affected area no more than 3 to 4 times daily.

In pediatric patients under 12 years of age, if the condition worsens, or if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days, use should be discontinued and a doctor should be consulted.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any potential adverse effects or changes in efficacy, given the lack of targeted data for this population.

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 weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice 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 on 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 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 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 initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

If the substance involved is known, specific antidotes or treatments may be indicated, and healthcare professionals should refer to established guidelines for the management of overdose related to that substance.

In all cases, contacting a poison control center or a medical toxicologist for guidance is recommended to ensure appropriate management and intervention.

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 seek immediate medical assistance or contact a Poison Control Center if the product is swallowed. It is important to instruct patients to discontinue use and consult a doctor if they experience any pain, swelling, or blistering of the skin.

Patients should be informed to stop using the product and seek medical advice if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. Additionally, patients should be cautioned to stop use and consult a healthcare professional if arthritic pain persists for more than 10 days, if redness is present, or if the product is being used on children under 12 years of age.

When using this product, patients must be reminded to use it only as directed. They should avoid contact with the eyes and mucous membranes, and should not apply the product to wounds or damaged skin. Patients should also be advised against applying the product to irritated skin or if excessive irritation develops. Furthermore, it is essential to inform patients not to bandage the area tightly or use the product in conjunction with a heating pad or device.

Storage and Handling

The product is supplied in packaging that ensures its integrity during storage. It should be stored at a temperature range of 20–25ºC (68–77ºF) in a cool, dry place, away from direct sunlight. Proper storage conditions are essential to maintain the product's efficacy and safety.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Orthogel Menthol 3.5%, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)