Caring Mills Menthol 4% Roll-on

Description

No description information is available for the drug.

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, and bruises.

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

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. In the event that the medication comes into contact with the hands, it is important to wash the hands with soap and water immediately.

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:

Application is not recommended on wounds or damaged, broken, or irritated skin due to the potential for exacerbating the condition. Tight bandaging, local heat application (including heating pads), or the use of medicated patches on the treated area should be avoided to prevent adverse effects. Contact with eyes and mucous membranes must be avoided to reduce the risk of irritation or injury. Exposure of the treated area to heat or direct sunlight is contraindicated as it may lead to increased sensitivity or adverse reactions. Additionally, application into skin folds is not advised to prevent complications.

If the condition worsens, redness occurs, irritation develops, symptoms persist for more than 7 days, or if symptoms clear and recur within a few days, discontinue use and consult a healthcare professional. Signs of skin injury, such as pain, swelling, or blistering at the application site, also warrant immediate medical advice.

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.

To ensure safe application, patients should be cautioned against 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. Additionally, the treated area should not be exposed to heat or direct sunlight, and care should be taken to avoid application in skin folds.

Patients should be instructed to stop 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 recurrence of symptoms after initial improvement. Signs of skin injury, such as pain, swelling, or blistering at the application site, warrant immediate medical attention.

This product is flammable; therefore, it should be kept away from fire or flame. In the event of accidental ingestion, patients should seek emergency medical assistance or contact a Poison Control Center at 1-800-222-1222 without delay.

Side Effects

Patients using this product should be aware that it is intended for external use only. While the majority of users may not experience significant adverse reactions, there have been rare reports of serious burns associated with similar products.

Upon application, some patients may experience a transient burning sensation, which typically resolves within several days. However, if a severe burning sensation occurs, it is advised to discontinue use immediately.

Patients are instructed to stop using the product 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 clear up and then recur within a few days. Additionally, individuals should seek medical advice if they notice signs of skin injury, such as pain, swelling, or blistering at the site of application.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Caring Mills 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. For adolescents and children over 12 years, the recommended application involves applying a thin layer to the affected area and massaging it into the skin until fully absorbed. This process may be repeated as necessary, but should not exceed 3 to 4 applications daily.

Geriatric Use

There is no specific information available 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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to assess the potential risks and benefits associated with its use during pregnancy and lactation. The safety of this medication in pregnant women has not been established, and caution is advised to ensure the well-being of both the mother and the fetus.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is no specific data available regarding the excretion of this medication in 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 overdose, 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 limits the assessment of potential risks associated with the use of the compound in question. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

Postmarketing Experience

Rare cases of serious burns have been reported in association with products of this type. These events were identified through voluntary reporting and surveillance programs. The nature of these reports underscores the importance of ongoing monitoring and assessment of product safety in the postmarketing setting.

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 arises, 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 occur.

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 be reminded to use it only as directed and to read and follow all directions and warnings on the carton. 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 not apply 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. If a severe burning sensation occurs, patients should discontinue use immediately. Furthermore, patients should be advised to avoid exposing the treated area to heat or direct sunlight and to refrain from applying the product into skin folds.

Storage and Handling

The product is supplied in various configurations, with specific NDC numbers available for identification. It is essential to store the product at room temperature, ensuring that it is kept away from fire or flame. Additionally, the area treated with the product should not be exposed 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 affected area thoroughly with soap and water to prevent any potential irritation or adverse effects. Proper handling and storage are crucial to ensure the product remains safe and effective for use.

Additional Clinical Information

Patients aged 12 years and older should apply a thin layer of the product to the affected area, massaging it into the skin until fully absorbed. This application may be repeated as necessary, but should not exceed 3 to 4 times daily. For children under 12 years, it is advised to consult a doctor before use.

Clinicians should counsel patients to seek advice from a health professional if they are pregnant or breastfeeding. Additionally, it is important to keep the product out of reach of children; if ingested, medical assistance should be sought immediately or contact a Poison Control Center at 1-800-222-1222.

Drug Information (PDF)

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

View product document (PDF)