Healthwise Menthol 4% Roll-on

Description

The product is identified by the SPL code 34089-3. No additional specific description details are provided in the available text.

Uses and Indications

This drug is indicated for the temporary relief of minor pain associated with various conditions, including arthritis, simple backache, muscle strains, sprains, bruises, and cramps.

There are no teratogenic or nonteratogenic effects mentioned in the available data.

Dosage and Administration

For adults and children over 12 years of age, a thin layer of the medication should be applied to the affected area. The application should be followed by gentle massage into the painful area until the product is thoroughly absorbed into the skin. This process may be repeated as necessary, but should not exceed 3 to 4 applications per day. It is important to wash hands with soap and water immediately if the medication comes into contact with them.

For children 12 years of age or younger, it is advised to consult a physician before use.

Contraindications

The product is contraindicated in the following situations:

Tight bandaging or the application of local heat, such as heating pads or medicated patches, should be avoided at the site of application to prevent adverse effects. Contact with eyes and mucous membranes must be avoided to prevent irritation or injury. The product should not be applied to wounds or areas of damaged, broken, or irritated skin due to the risk of exacerbating these conditions. Additionally, exposure of the treated area to heat or direct sunlight is contraindicated to minimize the potential for adverse reactions. Application into skin folds is also discouraged to ensure safety and efficacy.

Warnings and Precautions

For external use only, this product must be utilized strictly as directed. Healthcare professionals should advise patients to read and adhere to all instructions and warnings provided on the carton. It is important to note that rare cases of serious burns have been reported with similar products, necessitating caution during use.

To ensure safe application, patients should avoid bandaging the area tightly or applying local heat, such as heating pads or medicated patches, to the site of use. Contact with eyes and mucous membranes must be avoided, and the product should not be applied to wounds or any damaged, broken, or irritated skin. A transient burning sensation may occur upon application; however, this typically resolves within several days. Should a severe burning sensation arise, patients are advised to discontinue use immediately.

Patients should also be cautioned against exposing the treated area to heat or direct sunlight and should refrain from applying the product into skin folds.

Healthcare professionals should instruct patients to stop use 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 application site.

This product is flammable; therefore, it should be kept away from fire or flame. In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center (1-800-222-1222) should be contacted without delay.

Side Effects

Patients using this product should be aware that it is for external use only. Rare cases of serious burns have been reported with similar products, highlighting the importance of careful application. Upon application, a transient burning sensation may occur; however, this sensation typically resolves within several days. If patients experience a severe burning sensation, they are advised to discontinue use immediately.

Patients should 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, if patients notice signs of skin injury, such as pain, swelling, or blistering at the site of application, they should seek medical advice promptly.

Drug Interactions

No drug interactions have been identified for the specified medication. Additionally, there are no interactions noted between the drug and laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Healthwise Menthol 4% Roll-on (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients 12 years of age or younger should consult a healthcare professional before use. It is important to assess the appropriateness of treatment and dosage for this age group, as specific recommendations may vary based on individual health needs and conditions.

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 they may have altered pharmacokinetics and pharmacodynamics. Close monitoring is recommended to ensure safety and efficacy in 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 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 no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment.

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 assistance is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical help without delay. It is recommended to contact a Poison Control Center at 1-800-222-1222 for expert guidance on managing the situation.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Healthcare providers should be prepared to assess the patient's condition and implement appropriate management strategies based on the severity of symptoms and the specific substance involved.

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

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

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 if the product is swallowed.

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

It is important to inform patients that the product is flammable and should be kept away from fire or flame. When using the product, patients should use it only as directed and read all directions and warnings on the carton carefully. They should be made aware that rare cases of serious burns have been reported with similar products.

Patients should be cautioned against bandaging the area tightly or applying local heat, such as heating pads or medicated patches, to the area of use. They should also avoid contact with eyes and mucous membranes, and refrain from applying the product to wounds or damaged, broken, or irritated skin.

A transient burning sensation may occur upon application, but this generally resolves within several days. Patients should be advised to discontinue use immediately if a severe burning sensation occurs. Furthermore, they should avoid exposing the treated area to heat or direct sunlight and should not apply the product into skin folds.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It should be stored at room temperature, ensuring that it is kept away from fire or flame. It is important to avoid exposing the area treated with the product to heat or direct sunlight to maintain its efficacy. In the event that the medicine comes into contact with hands, it is advised to wash the area thoroughly with soap and water.

Additional Clinical Information

The product is administered topically, with specific instructions for different age groups. Adults and children over 12 years should apply a thin layer to the affected area, massaging it into the skin until fully absorbed, with a maximum frequency of 3 to 4 times daily. For children aged 12 years or younger, it is advised to consult a doctor before use.

Clinicians should counsel patients to seek professional advice if they are pregnant or breastfeeding. Additionally, it is crucial to keep the product out of reach of children; if ingested, immediate medical assistance should be sought or contact with a Poison Control Center (1-800-222-1222) is recommended. No further information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Healthwise Menthol 4% Roll-on, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)