Healthwise 2x Medicated Pain Relief Cream Roll-on

Description

The product is a roll-on formulation designed for daily use, packaged in a 2X MED roll-on container. The label specifies that the product is intended for daily application, with an effective time set for April 1, 2025. The media type for the label image is JPEG, and the reference for the label image is "92-59102 0425 PKG 2X MED roll-on FOR DAILY MED.jpg".

Uses and Indications

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

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

Dosage and Administration

For adults and children aged 2 years and older, the recommended application is to the affected area not more than 3 to 4 times daily. It is important to ensure that the application is limited to the specified frequency to avoid potential adverse effects.

For children under 2 years of age, the product should not be used without consulting a healthcare professional. It is essential to seek medical advice before administering this treatment to this age group.

Contraindications

Use of this product is contraindicated in the following situations:

Application is not recommended on wounds of damaged, broken, or irritated skin due to the potential for exacerbating the condition. Additionally, the product should not be bandaged tightly or subjected to local heat, such as heating pads or medicated patches, as this may increase the risk of adverse effects. Exposure of the treated area to heat or direct sunlight should also be avoided to prevent complications. Contact with eyes and mucous membranes is contraindicated to avoid irritation. Furthermore, application into skin folds is not advised.

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 imperative to avoid contact with the eyes and mucous membranes, as this may lead to adverse effects.

There have been rare reports of serious burns associated with products of this nature. Therefore, it is crucial to refrain from applying the product to wounds or any damaged, broken, or irritated skin. Additionally, patients should be cautioned against tightly bandaging the area of application or applying local heat, such as heating pads or medicated patches, to the treated area. A transient burning sensation may occur upon application; however, this typically resolves within several days. Should a severe burning sensation arise, patients must discontinue use immediately.

Patients should also be advised to avoid exposing the treated area to heat or direct sunlight and to 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, if patients experience signs of skin injury, such as pain, swelling, or blistering at the application site, they should seek medical advice.

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.

It is important to note that this product is flammable; therefore, it should be kept away from fire or flame to ensure safety during use.

Side Effects

Patients using this product should be aware that it is for external use only. There have been rare reports of serious burns associated with similar products, emphasizing the importance of adhering to the recommended usage guidelines. It is crucial to avoid contact with the eyes and mucous membranes, and the product should not be applied to wounds or damaged, broken, or irritated skin.

Participants should refrain from tightly bandaging the area of application or applying local heat, such as heating pads or medicated patches, as these practices may exacerbate adverse reactions. A transient burning sensation may occur upon application; however, this sensation typically resolves within several days. If a severe burning sensation is experienced, patients are advised to discontinue use immediately.

Patients should also avoid exposing the treated area to heat or direct sunlight and should not apply the product into skin folds. If the condition worsens, if redness or irritation develops, or if symptoms persist for more than seven days or recur shortly after resolution, patients should stop use and consult a healthcare professional. Signs of skin injury, such as pain, swelling, or blistering at the application site, warrant immediate medical attention.

Additionally, the product is flammable and should be kept away from fire or flame.

Drug Interactions

There are no reported drug interactions associated with the use of this medication. Additionally, no interactions with laboratory tests have been identified. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Healthwise 2x Medicated Pain Relief Cream Roll-on (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 2 years of age should not use this medication; consultation with a healthcare professional is advised. For children aged 2 years and older, the recommended application is to the affected area no more than 3 to 4 times daily.

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 therapeutic response, 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. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing infant.

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 drug. Consequently, there are no 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. Contacting a Poison Control Center at 1-800-222-1222 is recommended for further guidance and support.

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

There is currently no available information regarding teratogenic or non-teratogenic effects associated with the compound. Additionally, no data has been provided concerning nonclinical toxicology, including animal pharmacology and 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.

Patient Counseling

Healthcare providers should advise patients to keep the product out of reach of children and to seek medical help or contact a Poison Control Center (1-800-222-1222) immediately if the product is swallowed. Patients should be instructed to use the product only as directed and to read and follow all directions and warnings on the carton.

It is important to inform patients to avoid contact with eyes and mucous membranes, as rare cases of serious burns have been reported with products of this type. Patients should not apply the product to wounds or damaged, broken, or irritated skin. Additionally, they should be cautioned against bandaging tightly or applying local heat, such as heating pads or medicated patches, to the area of use.

Patients may experience a transient burning sensation upon application, which generally disappears within several days. However, they should be advised to discontinue use immediately if a severe burning sensation occurs. It is also essential to instruct patients not to expose the treated area to heat or direct sunlight and to avoid applying the product into skin folds.

Healthcare providers should encourage patients to stop use and consult a doctor if the condition worsens, if redness is present, if irritation develops, or if symptoms persist for more than 7 days or clear up and recur within a few days. Patients should also be advised to seek medical attention if they experience signs of skin injury, such as pain, swelling, or blistering at the application site.

Finally, patients should be made aware that the product is flammable and should be kept away from fire or flame.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers. It should be stored at room temperature, ensuring that it is kept away from fire or flame. Additionally, it is important to avoid exposing the area treated with the product to heat or direct sunlight. Once opened, the product must be discarded to ensure safety and efficacy.

Additional Clinical Information

The product is administered topically, with a recommended application frequency of 3 to 4 times daily for adults and children aged 2 years and older. For children under 2 years of age, consultation with a healthcare professional is advised prior to use.

Clinicians should counsel patients to seek advice from a health professional if they are pregnant or breastfeeding. It is important to keep the product out of reach of children, and in the event of accidental ingestion, medical assistance should be sought immediately or contact a Poison Control Center at 1-800-222-1222. No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Healthwise 2x Medicated Pain Relief Cream Roll-on, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)