Ralli Rapid Pain Relief

Description

This product is identified by the code 51945-4 and is associated with the package label principal display panel number 63936-9501. The effective date for this labeling is January 27, 2024. An accompanying multimedia component is included, which consists of an image file labeled "Label0.jpg" in JPEG format.

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 medication should be applied directly onto the affected area. It is important to avoid rubbing, massaging, or bandaging the area after application. The application may be repeated as necessary; however, it should not exceed 3 to 4 times daily.

In children under 2 years of age, the use of this medication is not recommended. Healthcare professionals should advise caregivers to consult a doctor for appropriate alternatives or guidance.

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, this product must be handled with care to ensure safety and efficacy. Healthcare professionals should advise patients to avoid contact with the eyes, as this may lead to irritation or injury. The product is flammable; therefore, it should be kept away from fire or flame to prevent any hazardous incidents. Additionally, the contents are under pressure; patients must be cautioned against puncturing or incinerating the container and should not store it at temperatures exceeding 120°F.

It is imperative that the product is used only as directed. Patients should be instructed not to bandage the area tightly or apply a heating pad, as these actions may exacerbate the condition or lead to adverse effects. Furthermore, the product should not be applied to wounds or damaged skin to avoid complications.

Patients should be advised to discontinue use and contact their healthcare provider if their 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 professional.

In the event of accidental ingestion, it is crucial to seek 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 potential adverse reactions. 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, if redness is present or excessive irritation of the skin develops, medical advice should be sought.

This product is intended for external use only, and patients should avoid contact with the eyes. It is important to note that the product is flammable; therefore, it should be kept away from fire or flame. The contents are under pressure, and patients should not puncture or incinerate the container. Furthermore, it is recommended to store the product at temperatures not exceeding 120°F to ensure safety and efficacy.

Drug Interactions

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

Packaging & NDC

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

Pediatric Use

Pediatric patients under 2 years of age should not use this product; consultation with a healthcare professional is advised. For adults and children aged 2 years and older, the product should be applied directly to the affected area without the need for rubbing, massaging, or bandaging. Applications may be repeated as necessary, but should not exceed 3 to 4 times daily.

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. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

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 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; therefore, a thorough assessment by a medical professional is recommended to determine the appropriate course of action.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and evaluation are advised 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 use of the compound in these contexts.

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 includes contents under pressure. It is essential to store the product at room temperature, ensuring that the storage environment does not exceed a temperature of 120°F. Care should be taken to avoid puncturing or incinerating the container, as this may compromise the integrity of the product and pose safety risks.

Additional Clinical Information

For patients aged 2 years and older, the medication 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, the product is not recommended, and consultation with a doctor is advised.

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

Drug Information (PDF)

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

View product document (PDF)