Orthogel Menthol 3.5% Roll on

Description

The product is identified as "ortho_3oz_rollon_10_25_24". It is designed for effective use until June 6, 2025. The media type for the product image is JPEG, and a reference image is available as "ortho_3oz_rollon_10_25_24.jpg".

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. For children under 2 years of age, it is recommended to consult a physician prior to use.

After application, it is important to wash hands thoroughly with cool water to prevent accidental contact with other areas of the body or with other individuals.

Contraindications

The product is contraindicated for use in the following situations:

Application to wounds or damaged skin is prohibited due to the potential for adverse effects. Additionally, the product should not be applied to irritated skin or in cases where excessive irritation develops, as this may exacerbate the condition. It is also contraindicated to bandage tightly or to use in conjunction with heating pads or devices, as this may lead to increased risk of injury or adverse reactions.

Warnings and Precautions

This product is intended for external use only. It is important to note that the formulation is flammable; therefore, it should be kept away from excessive heat or open flames to prevent any fire hazards.

In the event of accidental ingestion, 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 any of the following occur:

• Pain, swelling, or blistering of the skin.

• Worsening of the condition, or if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days.

• Persistence of arthritic pain for more than 10 days, or the presence of redness.

• Use in children under 12 years of age is not recommended without medical guidance.

Monitoring for these adverse effects is essential to ensure patient safety and effective management of treatment.

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 use, patients are advised to stop using the product and consult a doctor if they experience any of the following adverse reactions: pain, swelling, or blistering of the skin. Additionally, if the condition worsens, or if symptoms persist for more than 7 days, or clear up and then recur within a few days, medical advice should be sought. Patients experiencing arthritic pain that persists for more than 10 days, or those who notice redness, should also seek medical attention. This is particularly important for conditions affecting children under 12 years of age.

Drug Interactions

There are no specific drug interactions identified for this medication. Additionally, no laboratory test interactions have been reported. 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 Orthogel Menthol 3.5% Roll on (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

There is no specific information regarding the use of ORTHOGEL Menthol 3.5% Roll On in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when administering this product to elderly patients, as the absence of data necessitates careful monitoring for any potential adverse effects or interactions. It is advisable to consider the overall health status and individual needs of geriatric patients when recommending this treatment.

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 regarding the excretion of this medication 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 implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

Additionally, it is recommended to consult local poison control centers or relevant toxicology resources for guidance on specific management protocols and antidotes, if applicable.

Documentation of the incident, including the substance involved, estimated dose, and time of exposure, is crucial for effective management and follow-up 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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

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 to prevent accidental ingestion. 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 discontinue use and consult a doctor if they experience any pain, swelling, or blistering of the skin. Additionally, they should be advised 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.

For those experiencing arthritic pain, it is important to inform patients to stop use and consult a doctor if the 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 should be instructed to use it only as directed. They should avoid contact with the eyes and mucous membranes, and not apply the product to wounds or damaged skin. Patients should also be cautioned against applying it to irritated skin or if excessive irritation develops. Furthermore, they should not bandage the area tightly or use it in conjunction with a heating pad or device.

Storage and Handling

The product is supplied in packaging that ensures its integrity and stability. It should be stored at a temperature range of 20–25ºC (68–77ºF) to maintain its efficacy. Additionally, it is essential to keep the product in a cool, dry place, away from direct sunlight to prevent degradation. Proper storage conditions are crucial for preserving the quality of the product throughout its shelf life.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)