Ralli Rapid Pain Relief Roll on

Description

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

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, the product should be applied directly onto the affected area. It is important to roll the applicator without rubbing, massaging, or bandaging the area. The application may be repeated as necessary; however, it is advised not to exceed 3 to 4 applications within a 24-hour period.

In children under 2 years of age, the product is not recommended for use. Consultation with a healthcare professional is advised prior to administration in this age group.

Contraindications

Use of this product is contraindicated in the following situations:

Tight bandaging or the application of a heating pad is not recommended, as this may exacerbate adverse effects. Additionally, the product should not be applied to wounds or damaged skin to prevent irritation or further complications.

Warnings and Precautions

For external use only; contact with eyes should be avoided to prevent irritation or injury. The product is flammable; therefore, it must be kept away from fire or flame to ensure safety.

It is imperative to use this product only as directed. Users should refrain from bandaging the area tightly or applying a heating pad, as these actions may exacerbate potential adverse effects. Additionally, the product should not be applied to wounds or damaged skin to prevent further complications.

Healthcare professionals should advise patients to discontinue use and seek medical attention if the condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. The presence of redness or excessive skin irritation also warrants immediate consultation with a healthcare provider.

In the event of accidental ingestion, it is crucial to obtain emergency medical assistance or contact a Poison Control Center without delay to ensure appropriate management of the situation.

Side Effects

Patients using this product should be aware of several important warnings and potential adverse reactions. This product is intended for external use only, and contact with the eyes should be avoided. It is also flammable; therefore, it should be kept away from fire or flame.

In the event that the condition worsens, symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days, patients are advised to stop use and consult a doctor. Additionally, the presence of redness or excessive skin irritation warrants discontinuation of use and medical consultation.

In cases where the product is ingested, immediate medical assistance should be sought, or the patient should contact a Poison Control Center without delay.

Drug Interactions

There are no specific drug interactions identified for this medication. Additionally, no laboratory test interactions have been reported. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Ralli Rapid Pain Relief 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 product and must consult a healthcare professional for guidance. For children aged 2 years and older, the product can be applied directly to the affected area without the need for rubbing, massaging, or bandaging. Application may be repeated as necessary, but it is important not to exceed 3 to 4 applications per day.

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 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 medication. 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 or contact a Poison Control Center without delay.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and evaluation are recommended to ensure patient safety and effective resolution of any complications arising from the overdosage.

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 compound in these areas.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. Instruct patients that if the product is swallowed, they should seek medical help or contact a Poison Control Center immediately.

Patients should be informed to discontinue use and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. They should also be made aware that they should stop using the product if they experience redness or excessive irritation of the skin.

It is important to emphasize that patients should use the product only as directed. They should be cautioned against bandaging the area tightly or using a heating pad while using the product. Additionally, patients should be instructed not to apply the product to wounds or damaged skin to avoid potential complications.

Storage and Handling

The product is supplied in a configuration that allows for easy application. It should be stored at room temperature, ensuring that it is kept away from fire or flame to maintain safety.

For application, the product can be rolled directly onto the affected area without the need for rubbing, massaging, or bandaging. It is recommended not to apply the product more than 3 to 4 times daily.

To ensure safety, the product must be kept out of reach of children. In the event of accidental ingestion, it is crucial to seek medical assistance or contact a Poison Control Center immediately.

Additional Clinical Information

For patients aged 2 years and older, the product should be applied directly to the affected area without rubbing, massaging, or bandaging. It may be reapplied as necessary, but should not exceed 3 to 4 applications per day. For children under 2 years of age, use is not recommended without consulting a doctor.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Ralli Rapid Pain Relief Roll on, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)