Rubbing Dots Natural Cool Pain Relief

Description

The product is identified by SPL code 34089-3 and is presented as a white to off-white, round, biconvex tablet, which is debossed with "A" on one side and "123" on the opposite side. Each tablet contains 500 mg of Acetaminophen. The formulation includes the following inactive ingredients: microcrystalline cellulose, croscarmellose sodium, stearic acid, povidone, magnesium stearate, talc, hypromellose, polyethylene glycol, titanium dioxide, iron oxide red, and iron oxide yellow.

Uses and Indications

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

Limitations of Use: There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

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

For children under two years of age, it is advised to consult a physician prior to use to determine the appropriate course of action and ensure safety.

Contraindications

The product is contraindicated for application to wounds or damaged skin due to the potential for irritation and adverse effects. Additionally, it should not be used with tight bandaging, as this may compromise circulation and lead to further complications.

Warnings and Precautions

For external use only. It is imperative to avoid contact with the eyes. Should symptoms persist for more than seven days, the product should be discontinued, and a physician should be consulted.

In the event of accidental ingestion, immediate consultation with a physician is advised. The product must not be applied to wounds or damaged skin to prevent adverse effects. Additionally, it is important to avoid tight bandaging of the area where the product is applied.

Healthcare professionals should advise patients who are pregnant or breastfeeding to contact their physician prior to using this product to ensure safety for both the mother and child.

Side Effects

Patients should be aware of the following warnings and precautions associated with the use of this product. It is intended for external use only, and contact with the eyes should be avoided. If symptoms persist for more than seven days, patients are advised to discontinue use and consult a physician.

This product should be kept out of reach of children. In the event of accidental ingestion, it is important to consult a physician immediately.

Patients should not use this product on wounds or damaged skin, and it is recommended not to bandage the area tightly after application.

For those who are pregnant or breastfeeding, it is essential to contact a physician prior to use to ensure safety for both the patient and the child.

Drug Interactions

No drug interactions or drug and laboratory test interactions have been identified in the available data. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Rubbing Dots Natural Cool Pain Relief (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged two years and older may apply the medication to the affected area no more than three to four times daily. For children under two years of age, it is advised to consult a physician prior to use.

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 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 contact their physician prior to using this medication. It is essential for healthcare providers to evaluate the potential risks and benefits associated with the use of this medication during pregnancy and lactation. The safety of this medication in pregnant women has not been established, and caution is advised.

Lactation

Lactating mothers are advised to contact their physician prior to using this medication. There is no available data on the excretion of this drug in human breast milk or its effects on breastfed infants. Therefore, healthcare professionals should exercise caution when considering this medication for lactating patients.

Renal Impairment

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there is no information available regarding dosage adjustments, special monitoring requirements, or precautions 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.

Overdosage

In the event of an overdosage, it is imperative that healthcare professionals take immediate action. If the product is ingested, the individual should be advised to consult a physician without delay.

Potential symptoms of overdosage may vary depending on the specific circumstances and the amount ingested. Therefore, a thorough assessment of the patient's condition is essential to determine the appropriate course of action.

Management of overdosage should be guided by clinical judgment and may include supportive care and symptomatic treatment as necessary. Continuous monitoring of the patient’s vital signs and overall health status is recommended to ensure any adverse effects are promptly addressed.

Healthcare professionals are encouraged to report any cases of overdosage to the relevant authorities to contribute to ongoing safety evaluations and to assist in the development of future guidelines.

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.

Patient Counseling

Healthcare providers should advise patients that if the medication is swallowed, they should consult their physician immediately. It is important for patients to understand the potential implications of swallowing the medication and to seek professional guidance without delay.

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 efficacy and integrity. No special handling requirements are noted, ensuring straightforward management within standard storage conditions.

Additional Clinical Information

The medication is administered topically, with a recommended application frequency of three to four times daily for adults and children aged two years and older. For children under two years of age, it is advised to consult a physician prior to use. There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Rubbing Dots Natural Cool Pain Relief, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)