Pain Relief Cream

Description

The product is identified by SPL code 34089-3 and is formulated as a topical analgesic cream. It contains active ingredients of Menthol at a concentration of 1.5% and Methyl Salicylate at 30%. The cream's inactive ingredients comprise Aloe Vera Gel, Carbomer, Cetyl Alcohol, Ethyl Alcohol, Glycerin, Isopropyl Myristate, Mineral Oil, Propylene Glycol, Purified Water, and Triethanolamine. The cream exhibits a white to off-white coloration and possesses a characteristic odor.

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, bruises, and cramps.

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

Dosage and Administration

For adults and children over 2 years of age, the recommended application is to apply a generous amount of the product to the affected area. The product should be massaged into the painful area until it is thoroughly absorbed into the skin. This process may be repeated as necessary, but should not exceed four applications per day.

For children aged 2 years or younger, it is advised to consult a physician before use.

Contraindications

Use of this product is contraindicated in the following situations:

Tight bandaging should be avoided, as it may lead to compromised circulation. Contact with eyes or mucous membranes must be strictly avoided to prevent irritation or injury. Additionally, application to wounds or damaged skin is contraindicated due to the risk of adverse effects in compromised areas.

Warnings and Precautions

For external use only. This product should be utilized strictly as directed to ensure safety and efficacy. It is imperative to avoid bandaging the area tightly, as this may lead to complications. Care should be taken to prevent contact with the eyes or mucous membranes, as exposure may result in irritation or adverse effects. Additionally, the product must not be applied to wounds or damaged skin to avoid further injury or infection.

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 resolve and then recur within a few days, redness is observed, or if any irritation develops. These signs may indicate a need for further evaluation and potential alternative treatment options.

In the event of accidental ingestion, it is crucial to obtain emergency medical assistance immediately or contact a Poison Control Center. Prompt action is necessary to mitigate any potential health risks associated with swallowing the product.

Side Effects

Patients using this product may experience adverse reactions, which can vary in seriousness. It is important to note that this product is for external use only and should be used strictly as directed. Patients are advised not to bandage the area tightly, avoid contact with eyes or mucous membranes, and refrain from applying the product to wounds or damaged skin.

In the event that the condition worsens, symptoms persist for more than 7 days, or symptoms clear up and then recur within a few days, patients should stop use and consult a healthcare professional. The presence of redness or the development of irritation also warrants discontinuation of use and seeking medical advice.

For pregnant or breastfeeding individuals, it is recommended to consult a health professional prior to use. Additionally, this product should be kept out of reach of children. If swallowed, immediate medical assistance should be sought or contact with a Poison Control Center is advised.

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 Pain Relief Cream (menthol 6%). 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 before use.

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 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 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 intervention is crucial. If the substance is ingested, it is imperative to seek medical assistance or contact a Poison Control Center without delay.

Healthcare professionals should be aware that prompt action can significantly influence the outcome of an overdosage situation. Symptoms of overdosage may vary depending on the specific substance involved; therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous evaluation and appropriate interventions should be implemented based on the clinical presentation and severity of symptoms.

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 question. Further studies may be necessary to elucidate these aspects of nonclinical 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 to prevent accidental ingestion. In the event of swallowing the product, patients should seek medical assistance or contact a Poison Control Center immediately.

Patients should be instructed 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. Additionally, patients should be informed to stop use and seek medical advice if they notice any redness or if irritation develops.

It is important for healthcare providers to emphasize that patients should use the product only as directed. They should also be cautioned against bandaging tightly while using the product and advised to avoid contact with the eyes or mucous membranes. Furthermore, patients should not apply the product to wounds or damaged skin to ensure safe and effective use.

Storage and Handling

The product is supplied in a tube that must be stored at room temperature. It is essential to protect the tube from light exposure to maintain product integrity. To ensure optimal conditions, the tube should be kept tightly closed when not in use. Additionally, any unused product should be discarded after opening if it is not utilized within the specified time frame.

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 application can be repeated as necessary, but should not exceed four times daily. For children aged 2 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 experience.

Drug Information (PDF)

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

View product document (PDF)