Dollar General Menthol Pain Relief Gel Rollon

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains of muscles and joints associated with 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 2 years and older, a thin film of the medication 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 the specified frequency to avoid potential adverse effects.

For children under 2 years of age, it is recommended to consult a physician prior to use to determine the appropriate course of action.

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 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 use in conjunction with a heating pad or device, as this may lead to increased risk of irritation or other complications.

Warnings and Precautions

This product is intended for external use only. It is important to note that the formulation is flammable; therefore, it must be kept away from fire or flame to prevent any risk of ignition.

In the event of accidental ingestion, immediate medical assistance should be sought by contacting the Poison Control Center at 1-800-222-1222.

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.

• Persistent arthritic pain lasting more than 10 days, presence of redness, or use in children under 12 years of age.

These precautions are essential to ensure the safe and effective use of the product.

Side Effects

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

For patients experiencing arthritic pain, it is recommended to discontinue use and 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

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 Dollar General Menthol Pain Relief Gel Rollon (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 2 years of age should consult a doctor before use. For children aged 2 years and older, the recommended application is to rub a thin film over the affected area no more than 3 to 4 times daily. It is advised to discontinue use and seek medical advice if any conditions affecting children under 12 years of age arise.

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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The safety of this drug during pregnancy has not been established, and potential risks to fetal outcomes are not fully understood. Therefore, it is essential for women of childbearing potential to seek medical advice to weigh the benefits and risks associated with the use of this medication 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 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 overdosage information, it is essential for healthcare professionals to remain vigilant regarding the potential for overdose with this medication. In cases where an overdose is suspected, immediate medical attention should be sought.

Healthcare providers are advised to monitor patients closely for any signs or symptoms that may indicate an overdose. These may include, but are not limited to, increased severity of known side effects, unusual behavioral changes, or any other atypical clinical manifestations.

Management of an overdose should be guided by the clinical presentation of the patient. Supportive care is paramount, and symptomatic treatment should be initiated as necessary. Healthcare professionals should also consider contacting a poison control center for additional guidance on the management of overdose cases.

It is crucial to document any instances of suspected overdose and report them to the appropriate regulatory authorities to enhance the understanding of the medication's safety profile.

Nonclinical Toxicology

If pregnant or breastfeeding, individuals are advised to consult a health professional prior to use. No non-teratogenic effects have been specified in the available data. Additionally, there are no details provided regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are provided in the insert.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children and pets to prevent accidental ingestion. In the event of swallowing the product, patients should seek medical help immediately or contact the Poison Control Center at 1-800-222-1222.

Patients should be instructed to stop using the product and consult a doctor if they experience any pain, swelling, or blistering of the skin. Additionally, they should be informed to discontinue use 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 advise that they 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.

Patients should be reminded to use the product only as directed and to avoid contact with the eyes or mucous membranes. They should not apply the product to wounds or damaged skin, nor should they use it on irritated skin or if excessive irritation develops. Furthermore, patients should be cautioned against tightly bandaging the area or using the product in conjunction with a heating pad or device.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at room temperature to maintain its integrity and efficacy. No special handling requirements are noted; however, standard precautions should be observed to ensure optimal storage conditions.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Dollar General Menthol Pain Relief Gel Rollon, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)