Real Time Pain Relief Sports Cream

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 pain associated with various conditions, including arthritis, simple backache, muscle strains, sprains, and bruises.

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

Dosage and Administration

Healthcare professionals are advised to apply the medication generously to the affected area. The product should be massaged into the painful area until it is thoroughly absorbed into the skin. This application may be repeated as necessary, but should not exceed four times daily.

For pediatric patients, specific considerations apply: for children aged 2 years or younger, consultation with a physician is recommended prior to use. Additionally, for children aged 12 years or younger, it is also advised to seek medical guidance before administration.

Contraindications

There are no specific contraindications listed for this product. However, it is imperative to seek immediate medical assistance or contact a poison control center if the product is swallowed.

Warnings and Precautions

For external use only, this product must be utilized strictly as directed. It is imperative to avoid contact with the eyes or mucous membranes, and it should not be applied to wounds or damaged skin. Additionally, care should be taken to avoid tight bandaging of the area where the product is applied.

Healthcare professionals should advise patients to discontinue use and seek medical advice if any of the following occur: the condition worsens, symptoms persist for more than 7 days, symptoms clear up and then recur within a few days, redness is observed, or irritation develops.

In the case of pregnancy or breastfeeding, it is essential for individuals to consult a healthcare professional prior to use to ensure safety for both the mother and child.

Emergency medical assistance should be sought immediately if the product is swallowed. Patients or caregivers should contact a poison control center or seek medical help without delay in such instances.

Side Effects

Patients using this product should be aware that it is for external use only. It is essential to use the product only as directed and to avoid contact with the eyes or mucous membranes. The product should not be applied to wounds or damaged skin, and tight bandaging should be avoided.

In clinical practice, patients are advised to discontinue use and consult a healthcare professional if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. The presence of redness or the development of irritation also warrants cessation of use and medical consultation.

For pregnant or breastfeeding individuals, it is recommended to seek advice from a healthcare professional prior to using this product.

Drug Interactions

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

Packaging & NDC

Below are the non-prescription pack sizes of Real Time Pain Relief Sports Cream (menthol 0.5%). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients over 2 years of age may apply the medication generously to the affected area, massaging it into the skin until fully absorbed. This application may be repeated as necessary, but should not exceed four times daily.

For children 2 years of age or younger, it is advised to consult a doctor prior to use. Additionally, for children 12 years of age or younger, consultation with a doctor is also recommended.

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 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. The potential risks and benefits must be carefully weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use 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 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 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 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 prescribing information.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

Additionally, it is recommended to consult local poison control centers or relevant toxicology resources for guidance on specific management protocols and antidotes, if applicable.

Documentation of the incident, including the substance involved, estimated dose, and time of exposure, is crucial for effective management and follow-up care.

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 that in the event of accidental ingestion, it is crucial to seek medical assistance immediately or contact a poison control center. This prompt action is essential to ensure patient safety and appropriate management of any potential risks associated with swallowing the medication.

Storage and Handling

The product is supplied in packaging that ensures its integrity and safety. It should be stored at room temperature, away from direct light exposure to maintain its efficacy. It is essential to keep the product out of reach of children to prevent accidental ingestion. Once opened, the product must be discarded to ensure safety and effectiveness.

Additional Clinical Information

The product is administered topically. For adults and children over 2 years of age, it should be applied generously to the affected area and massaged into the skin until fully absorbed. This process may be repeated as necessary, but should not exceed four applications per day. For children aged 2 years or younger, and those 12 years or younger, it is advised to consult a doctor before use.

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 Real Time Pain Relief Sports Cream, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)